Study Protocol Low Cost App-Based Intervention Dialog+ for Depression and Anxiety in Outpatient Psychiatric Settings: A Study Protocol for a Pragmatic Multisite Cluster Randomized Controlled Trial

Study Protocol Low Cost App-Based Intervention Dialog+ for Depression and Anxiety in Outpatient Psychiatric Settings: A Study Protocol for a Pragmatic Multisite Cluster Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Study Protocol Low Cost App-Based Intervention Dialog+ for Depression and Anxiety in Outpatient Psychiatric Settings: A Study Protocol for a Pragmatic Multisite Cluster Randomized Controlled Trial Hepsipa Omega Juliet, Syjo Davis, Suvarna Jyothi Kantipudi, Aishwarya M, and 13 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8416024/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Background Clinically diagnosed anxiety, and depressive disorders are widely recognised as the most common mental health issues in India, affecting approximately 15% of the population. With notable gender disparities, Tamil Nadu has some of the highest rates of depression in the nation. Despite the growing burden, countries such as India that fall within the low and middle-income countries (LMICs) continue to struggle with mental health services due to challenges in funding, a lack of qualified practitioners, and obstacles to putting evidence-based treatments like Cognitive Behaviour Therapy (CBT) into practice. Innovative, low-cost, and scalable approaches are needed to address this gap. This multisite, pragmatic randomized controlled trial (RCT) seeks to assess the feasibility, acceptability, and evaluate the effectiveness of DIALOG+, a low-cost, app-based, solution-focused intervention designed to enhance quality of life and reduce mental distress. While previously validated for psychosis and other chronic psychiatric conditions, this study aims to evaluate its potential for individuals with anxiety and depression in outpatient psychiatric services in India. Methods A pragmatic, multisite randomized controlled trial will be conducted across four outpatient psychiatric settings in Chennai and Puducherry to assess the feasibility, acceptability, and effectiveness of DIALOG+, a low-cost app-based intervention. Adults (18–65 years) with anxiety and/or depressive disorders will be randomly allocated to receive either DIALOG + together with treatment as usual (TAU) or DIALOG Scale alongside treatment as usual (TAU) over a 6-month period. The key outcome of this study is improvement in quality of life, evaluated through the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcomes will include changes in depression and anxiety measured by the Depression, Anxiety and Stress Scale (DASS-21), Hamilton Depression Rating Scale (HDRS), and Hamilton Anxiety Rating Scale (HAM-A). Feasibility will be assessed through recruitment, retention, and intervention fidelity rates, while acceptability will be explored through interviews with participants and clinicians. Assessments at follow-up will be carried out at 3 and 6 months, and analyses will follow an intention-to-treat approach. Discussion If feasible, acceptable, and effective, DIALOG + for clinically diagnosed persons with anxiety and depressive disorders could represent a transformative, scalable solution to improve mental health outcomes in India and similar LMIC contexts. Trial registration The study is registered under Clinical trial registry-India (CTRI), and the registration number is CTRI/2025/08/092477.The registration was done on 6th August 2025.The URL of the trial registry record is https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=133110&EncHid=16149.91763&modid=1&compid=19 DIALOG+ Psychosocial intervention Quality of Life Solution-focused Cluster randomised trial Patient Satisfaction Common mental disorders Mental health Outpatient setting Routine treatment Administrative information Title Low Cost App-based Intervention DIALOG+ For Depression And Anxiety In Outpatient Psychiatric Settings: A Pragmatic Multisite Randomized Controlled Trial Trial registration The study is registered under Clinical trial registry-India (CTRI), and the registration number is CTRI/2025/08/092477.The registration was done in August 2025. Protocol version Protocol version 3.1, dated 29 May 2025. Funding Indian Council of Medical Research (ICMR) Author details Hepsipa Omega Juliet¹, Syjo Davis 1 , Suvarna Jyothi Kantipudi 2 * , Aishwarya M 1 , Giftlin Elizabeth 3 , Jayashree Ganesan 3 , Kasthuri Divya G 1 , Karthick Subramanian 4 , Krithika Suresh 1 , Lakshmi Venkatraman¹, Natarajan Varadharajan 3 , Ragul Ganesh³, Ramya Vasu⁴, Rudhra Asaithambi 3 , Vikas Menon 3 , Vijayashree Rajkumar 2 , Padmavati Ramachandran 1 * Corresponding author Name and contact information for the trial sponsor There is no trial sponsor for the study Role of sponsor The funder plays no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Role and responsibilities: committees SCARF India, where the principal investigator is based, will serve as the primary coordinating site, overseeing overall study conduct. The program manager will provide guidance, financial and technical support and training among with co-investigators across all sites. Site coordinators in Chennai and Pondicherry will manage recruitment, data collection, verification, and session coordination.Co-investigators at each site will supervise daily trial activities. All sites will submit annual reports to the trial steering committee. Introduction Background and rationale Globally, around 1 in 8 individuals, totalling 970 million people, experience mental disorders, with anxiety and depressive disorders being the most prevalent[1]. India faces a significant surge in mental health disorders, affecting nearly 15% of its population[2,3], covering a wide spectrum of conditions, including depressive and anxiety disorders, bipolar disorder, schizophrenia, substance use disorders, and neurodevelopmental disorders [4,5]. The National Mental Health Survey of India reports a prevalence of 5.25% for depressive disorders and 3.7% for neurotic/stress-related disorders[6]. In Tamil Nadu, the prevalence of depression is estimated at 4.5%, with a higher prevalence observed among females (5.9%) compared to males at (2.8%). Furthermore, rates of neurosis and stress-related disorders, including phobias and anxiety conditions, are slightly higher among females (1.7%) than in males (1.6%)[7]. Among the states in the region, Tamil Nadu reports the highest prevalence of depression. Projections by the World Economic Forum suggest that by 2030, mental ill-health will contribute to over half of the global economic burden linked to non-communicable diseases[8]. Living with a mental health problem extends beyond personal challenges, impacting various aspects of daily life, including mundane tasks like washing, shopping, and social interactions[9].The repercussions extend to families and communities, and the burden is particularly severe in low-and middle-income countries (LMICs), where the gap in access to mental health treatment remains wide[10]. Mental health services are encouraged to take an essential role in supporting the recovery of individuals suffering with mental illness[11–13]. Whilst psychosocial interventions are important for addressing functional deficits and supporting recovery[14], India continues to face a significant shortfall in services for common mental disorders (CMDs). In this context, there is a pressing need for low-cost, low-burden therapeutic approaches that can be feasibly implemented within routine psychiatric care to enhance access and improve outcomes[15,16]. Rationale of the study Common mental disorders (CMDs), especially depression and anxiety, being among the most common mental health conditions worldwide and major contributors to disability. Standard treatments in high-income countries typically include antidepressant medication and structured psychotherapies including approaches like cognitive behavioural therapy and problem-solving therapy, often delivered in specialist care settings. While these approaches are effective, their reach is limited in many LMICs, including India, where availability of specialist mental health services is scarce, especially outside urban centres. As a result, most people with CMDs in India remain untreated, and this highlights the need for low-cost scalable, evidence-based interventions that can be integrated into routine services[17,18]. DIALOG+ is an app-based, structured yet flexible intervention that can be integrated directly into routine clinical meetings. It facilitates dialogue between patients and clinicians across quality of life domains and helps identify solutions that draw on patients’ existing strengths and resources. Unlike traditional therapies that are diagnosis-specific, DIALOG+ is transdiagnostic and has demonstrated benefits across psychosis, severe mental illness, depression, and anxiety in diverse cultural and health system contexts[19–22].For CMDs specifically, a cluster RCT in Bosnia and Herzegovina showed improvements in both quality of life and clinical symptoms within six months among participants with anxiety and depression[23]. DIALOG+ has several features that facilitate its use in the population. Its patient-centred nature resonates with cultural values that place importance on personal, social, and family resources in recovery. Its digital, app-based format supports consistent delivery while remaining low-cost and easy to implement within existing services. Importantly, it does not require additional sessions or specialist resources, which enhances its scalability within India’s resource-constrained health system. Preliminary feasibility work at SCARF has already shown that DIALOG+ is acceptable and feasible for patients with psychosis in India[24]. This provides a strong rationale for extending its use to CMDs. Given the global evidence, DIALOG+ represents a practical, scalable, and patient-centred approach with the potential to significantly improve outcomes among individuals with common mental disorders. This study therefore aims to assess the feasibility, acceptability and effectiveness of DIALOG+ for individuals with anxiety and depressive disorders during routine clinical contacts in outpatient psychiatric services. Objectives Primary objective To test the effectiveness of a low cost, app-based intervention (DIALOG+) delivered by mental health professionals in improving quality of life among persons with anxiety and depressive disorders, compared to routine treatment plus administering the DIALOG scale. Secondary objectives To evaluate the effectiveness of DIALOG+ in improving clinical status and related secondary outcomes in persons with anxiety and depressive disorders. To assess the acceptability and feasibility of delivering DIALOG+ in routine outpatient psychiatric services. Trial design This will be pragmatic,multi-centre,outcome assessor blinded, parallel group, cluster-based randomized controlled superiority trial with concurrent mixed methods process evaluation. It will be conducted across four clinical sites in Chennai and Puducherry. DIALOG+ will be assessed in a cluster RCT, involving mental health professionals, who are not already trained in the administration of the DIALOG+ and their patients, forming a cluster, are randomly allocated either to the experimental (treatment as usual + DIALOG+ arm) or to the control group (treatment as usual + DIALOG scale arm). This approach will minimize the risk of contamination occurring between the groups. DIALOG+ and DIALOG scale will be administered by mental health professionals once a month for 6 months during their regular clinical meetings. Methods: study participants, intervention and outcomes measures Study setting The study will take place at the following sites: Schizophrenia Research Foundation (SCARF, India) Chennai Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry Mahatma Gandhi Medical College and Research Institute (MGMCRI), Puducherry This multisite study will be coordinated by SCARF India. Participant eligibility criteria For mental health professionals/clinicians Inclusion criteria: The inclusion criteria for mental health professionals stipulate that eligible mental health professionals can be any mental health or healthcare professionals at the study sites (e.g., psychologists, psychiatrists, social workers) with a minimum of 6 months of experience in a healthcare facility, who meet their patients on at least a monthly basis, having experience in helping individuals with anxiety and depression, and have no intention of vacating their position within the next 6 months. Exclusion criteria: Mental health professionals who had previous exposure to DIALOG+ will not be considered eligible for participation in the study. For patient participants Inclusion criteria: Age: 18–60 years. Diagnosis: Depressive or anxiety disorders (ICD-10 F30-F39, F40-F49), excluding bipolar disorder. Treatment: Receiving outpatient care for depression and/or anxiety at the study sites. Quality of Life: Score ≤ 5 on MANSA (Manchester Short Assessment of Quality of Life). Consent: Capacity to provide informed consent. Language: Ability to communicate in Tamil or English. Exclusion criteria: Comorbidities: Major medical or psychiatric conditions. Substance Use: Current alcohol or substance use disorder (except nicotine). Pregnancy: Pregnant or lactating mothers. Consent: Inability to provide informed consent. Who will take informed consent? Researchers with training in good clinical practice and informed consent will screen eligible participants and obtain their consent to participate in the study. Informed consent for clinicians Post initial screening for eligibility criteria, trained researchers to set up a meeting with clinicians potentially interested to participate in the study. Researchers will go through the study procedure in detail and allow time for questions. Researchers will then check for understanding from the clinician. If the clinician agrees to take part in the study, they will be asked to sign two copies of the ‘Clinician Consent Form’ (one copy will be kept by the clinician). Researchers will collect demographic details of the clinician’s post signing of consent form and inform them about upcoming steps such as intervention and technical training. Informed consent for patient participants Post screening for eligibility criteria, potential participants will be approached for consent by trained researchers. All details of the study including but not limited to its purpose, procedure, randomisation, expected time commitment, and compensation are to be communicated in a language the person is conversant with (either English or Tamil) using a flipchart. The informed consent form is to be read by the person. If they are unable to read, the researcher will read the same slowly and clearly in the language the person is conversant with. Comprehension of the same is to be probed and any questions the person has are to be clarified. This procedure is to be followed by the administration of the UBACC (UCSD Brief Assessment of Capacity to Consent) tool[25]. If the person scores ≥12 on the same, the researcher will enroll them into the study by asking them to sign two copies of the ‘Informed Consent Form’ (one copy will be kept by the participant). In case the consent form was read by the researcher, a witness is to be present when signing and the witness will be required to sign as well. Additional consent provisions for collection and use of participant data and biological specimens Participants and clinicians will be asked for additional agreement to record some sessions on audio and video in order to aid fidelity assessments. No biological samples are being collected for the investigation. Interventions Explanation for the choice of comparators The comparator for this study is the DIALOG Scale administered alongside treatment as usual (TAU). This was selected because the DIALOG Scale provides an active control condition that assesses patient satisfaction without delivering the structured therapeutic components of DIALOG+. This allows clear identification of the additional therapeutic benefit offered by DIALOG+ compared with routine assessment and TAU. Monthly administration of the DIALOG Scale is consistent with standard monitoring practices in mental health services, enhancing feasibility and reducing bias. Intervention description Intervention arm: DIALOG+ plus TAU DIALOG+ is a therapeutic intervention which uses a solution focussed approach delivered monthly over six months using a digital application. In the intervention arm, the process begins with an assessment of the patient's level of satisfaction across eight areas of life domains (including mental health, physical health, employment status, housing, recreational activities, social connections, familial/partner relationships, and personal safety) and three aspects of treatment (such as medication, practical assistance, and consultations with professionals). DIALOG Scale uses a 7-point Likert scale to assess each life domain. The patient's evaluations are compiled and analysed, allowing for comparison with prior assessments. This review encompasses favourable remarks and the identification of domains for subsequent discourse. The patient chooses up to three domains to address with the therapist. A four-step approach is used to address the patient's concerns and reach a consensus on the actions needed to resolve them. The patient is advised to complete assignments between sessions. The four-step strategy encompasses Understanding (What is the source of the patient's dissatisfaction?) What went well nonetheless?; Anticipating the Future (What is the optimal outcome?) What constitutes the minimal advancement?; Evaluating Alternatives (What actions can the patient, doctor, or others undertake?); and ultimately, Reaching Consensus on Actions (e.g., assignments and referrals). At the beginning of the subsequent DIALOG+ session, the agreed actions will be presented, and the session will then proceed as in the first meeting. DIALOG+ is compatible with software that operates on iPads and Android tablets. Control arm: DIALOG Scale plus TAU In the control arm, the mental health professional administers the DIALOG Scale monthly and rates the patient level of satisfaction across the life and treatment domains No therapeutic steps or action-planning are carried out. Participants continue receiving TAU. DIALOG+ and DIALOG scale apps were developed by the Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Service Development)which is part of Queen Mary University of London (QMUL) created DIALOG scale and DIALOG+ apps[19,26,27]. The research was led by Professor Stefan Priebe with funding from the European Commission and the National Institute for Health and Care Research (NIHR)in the United Kingdom. Both the apps are available in Tamil and English and have been used at SCARF in an international NIHR funded PIECEs project for improving quality of life of persons with psychosis[28]. Criteria for discontinuing or modifying allocated interventions {11b} Although DIALOG+, the intervention which is being tested, has not been shown to pose risks in previous research, some participants may still experience anxiety when trying a new intervention. Participants will continue to receive their routine care, including medication and available psychosocial support, alongside the study intervention. The DIALOG+ sessions can be stopped at any point if needed. Participants may discontinue or modify the intervention if their mental health worsens and requires urgent care, if they choose to withdraw, or if participation causes significant distress. The intervention, delivered monthly over six months by trained clinicians, will be adjusted or stopped based on clinical judgement, and all changes will be recorded according to the study protocol. Strategies to improve adherence to interventions Adherence to the intervention will be supported through several strategies within the context of routine care. Flexible appointment scheduling will be offered to accommodate participants’ availability; telephone reminders will be sent prior to each session if needed. Follow-up contact will be made within one week for any missed sessions to re-engage participants. Clinicians delivering DIALOG+ will receive standardized training and fidelity monitoring to ensure the intervention is delivered consistently. Relevant concomitant care permitted or prohibited during the trail During the study, participants will continue to receive their usual treatment, including pharmacological and psychosocial interventions. These treatments are permitted alongside DIALOG+. However, they will be prohibited from concurrent participation in other research studies during the trial. Provisions for post-trial care The risk of harm during the study is very low. If a participant shares information indicating immediate danger to themselves or others, their participation will be stopped, and the researcher will notify the appropriate safeguarding authority (e.g., clinic). All researchers will be trained in safeguarding procedures and supervised to ensure correct handling of risk. The study will be carried out only by trained and experienced mental health researchers. After the six-month trial, all participants will continue receiving TAU. Any needs identified during the study will be shared with the treating team, and anyone showing deterioration will be managed according to the clinical guidelines. If DIALOG+ is found helpful, the service may consider offering it more widely after the study, subject to institutional approval, and the clinicians in the control arm will then be trained to deliver DIALOG+. Outcomes Quantitative outcome measures will be captured at 3 different time points: baseline, 3 months and 6 months of the cluster RCT. The primary outcome measures will include the Quality of Life which will be assessed using Manchester Short Assessment of Quality of Life(MANSA)[29] and the secondary outcome measures will include the Depression and Anxiety Stress Scale (DASS-21)[30], Hamilton Depression Rating Scale (HDRS)[31] and the Hamilton Anxiety Rating Scale (HAM-A)[32]. The sociodemographic details will be collected at baseline. Clinical details will be collected at baseline, 3 months and 6 months post randomization. Participant timeline The total duration of the study project is for 36 months. The study will be conducted in 3 phases. 1. Preparatory phase (6 months); 2. Data collection phase (24 months); and 3. Data analysis and report writing. A summary of the participant timeline during the data collection phase for screening,enrolment,intervention and assessments is shown below. Participant Timeline – DIALOG+ Cluster RCT Screening Baseline Intervention months Completion month TIMEPOINT 1 2 3 4 5 6 7 ENROLMENT: Eligibility screen X Informed consent X MANSA Screening (patients) X Allocation X INTERVENTIONS: DIALOG+ X X X X X X DIALOG Scale X X X X X X ASSESSMENTS: Sociodemographic Questionnaire X MANSA X X X HAM-D/HDRS X X X HAM-A X X X DASS-21 X X X Qualitative Interviews X Fidelity checks X X X X X X MANSA - Manchester Short Assessment of Quality of Life DASS-21 - Depression, Anxiety and Stress Scale - 21 items HAM-D/HDRS - Hamilton Depression Rating Scale HAM-A - Hamilton Anxiety Rating Scale Sample size The required sample size to show an effect size of 0.5 with 80% power, 5% level of significance, design effect of 2, and attrition rate of 20% was calculated to be 168 in each arm[33]. According to the above calculation, the ICC is 0.037. The cluster adjusted sample size is 336 and the number of clusters is 12 per arm. Therefore, the sample size for each cluster is approximately 14.The total number =12(# of clusters)*2(arms)*14=336 (168 per arm). We have used MANSA tool, a continuous measure of quality of life as a primary outcome measure to calculate sample size. To detect a standardized effect size of 0.5 with 80% power at a two‑tailed significance level of 5%, an individually randomized trial would require approximately 134 participants. As this is a cluster randomized controlled trial, the required sample size accounting for the design effect (DE):DE=1+(m−1)×ICC ,where m is the average cluster size and ICC is the intracluster correlation coefficient. With an assumed m = 14 participants per clinician and ICC = 0.037 (derived from similar DIALOG+ psychosocial interventions),DE ≈1.5.We have used more conservative DE = 2 to safeguard power and adjusted for 20% attrition to arrive at a sample size of 336. Recruitment To support effective recruitment at all sites, posters with details of the study will be displayed to invite participants to contact the research team. Mental Health Professionals at each location will also be informed about the study criteria and requested to refer eligible patients. For individuals with limited time, the research team will adapt the screening and consenting process by dividing it across visits as needed, ensuring that time constraints do not prevent participation. Assignment of interventions: allocation Sequence generation Randomisation will be conducted by an independent statistician using sequential computer-generated random numbers in an allocation ratio of 1:1. Mental health professionals along with their eligible patient participants will be randomised as a cluster once 14 patients are recruited under each professional to the intervention or control arm. Concealment mechanism Allocation concealment will be rigorously maintained through a centralized allocation system managed solely by the independent statistician. The project coordinator will be intimated by the treatment sites after the cluster is formed i.e mental health professional with 14 eligible consented patients are recruited. Then the project coordinator will contact the independent statistician, who will then provide the next pre-determined allocation (Intervention or Control) from the secure randomization sequence. The project co-ordinator will be the only designated contact for statistician, The randomization table will be stored exclusively on password-protected, encrypted computer, with access restricted only to the independent statistician. This procedure ensures that assignment is requested and revealed only after the commitment of the entire cluster, completely preventing selection bias based on foreknowledge of the treatment arm. Implementation Eligible patient participants will be approached for consent, and those who provide written informed consent will undergo baseline assessments conducted by blinded research assistants at their respective sites. The intervention mental health professionals and the control mental health professionals will be trained in using DIALOG+ app and DIALOG scale respectively by the unblinded researchers (SCARF Co I). The training will happen in person. The training will last approximately 3 to 4 hours. During the training, the issues of accidental unblinding will be discussed and the mental health professional will be encouraged not to discuss their randomisation status with other mental health professionals. All the patients will receive routine care in both arms with the intervention arm patients additionally receiving DIALOG+ sessions once a month and the control arm professionals will complete the DIALOG scale with the patients in the monthly sessions. Sessions will happen once a month for 6 months. The mental health professionals in the DIALOG+ arm will be supported by the unblinded researchers to audio record some of the intervention sessions to evaluate for fidelity of intervention. Assignment of interventions: blinding Who will be blinded All the patients will be assessed by blinded outcome raters at baseline, 3 months and 6 months. The unblinded researchers will extract data from the tablets once a week and store the DIALOG and DIALOG+ data in password protected files that are accessible only to the unblinded researchers. Several attempts were made to minimise bias in this study. The study is a pragmatic, outcome assessor-blinded cluster RCT. An independent statistician, who is not part of the study team, will generate randomisation sequence using computer-generated random numbers. As this is a psycho-behavioural intervention, it is not possible to blind the participating clinicians or the patient participants to their group assignment. The Project Coordinator and the Co-Investigators (Co-Is) involved in clinician training, performing in-depth interviews, and conducting fidelity checks will not be blinded, as this is necessary to fulfil their roles. Participants may be able to identify whether they are receiving DIALOG Scale or DIALOG+ due to the nature of the interventions. However, they may not be unaware of the difference between the intervention and control arms. Meticulous procedures will be in place to ensure that the research assistants responsible for collecting outcome data remain blinded to group allocation. Furthermore, participants will be instructed not to disclose their group status during assessment sessions. Procedure for unblinding if needed Unblinding will be considered when necessary for participant safety. Emergency unblinding will be considered in compliance with standard operating procedures (SOPs). In the rare event, such as in the case of a Serious Adverse Event (SAE),if the knowledge of participant allocation is deemed essential for clinical management, the treating clinician or the site's Principal Investigator can formally request the unblinding of that specific participant. This request will be directed to the project co-ordinator who is unblinded. If the request is approved, the allocation for only that individual will be revealed, and the event will be thoroughly documented. Every effort will be made to maintain the blind for the outcome assessors. Data Collection and management Plans for assessment and collection of outcomes: All the tools used to assess outcomes have been translated into the local language, Tamil. Tamil translation of MANSA and DASS 21 was already available from a previous study[34,35].The study team has undergone training in good clinical practice in an online course. Senior researchers and clinicians trained the research team in administering HAM-D, HAM–A and DASS 21. Paper case report forms (CRF) will be used to collect information from participants and subsequently the data will be entered into an electronic database, REDCap. The researchers are responsible for creating and managing the REDCap database, and data cleaning will happen once the data collection concludes. If interested anyone can request access to the data collection forms from the authors. The data assessment tools used in the study include: Primary outcome measures: 1.The Manchester Short Assessment of Quality of Life (MANSA): is utilized for evaluating quality of life. The instrument assesses overall life happiness as well as satisfaction across different life domains. The assessment comprises 16 items and is evaluated using a 7-point Likert scale. This tool has been validated and used in Indian settings. Cronbach's alpha for satisfaction ratings was 0.74[29]. Secondary outcome measures: 1. Depression and Anxiety Stress Scale (DASS-21): This instrument evaluates overall psychological suffering. It assesses depression, anxiety, and stress levels. The items are evaluated using a four-point Likert scale ranging from "never" (0) to "almost always" (3). It has been validated in the Indian setting and exhibited robust psychometric qualities with a strong correlation among subscales[35,36]. 2. Hamilton Depression Rating Scale (HDRS):This is a widely employed clinician-administered instrument for evaluating depression. The assessment has 17 items, each rated on a scale from 0 to 4, evaluating depressive symptoms encountered in the preceding week. A score of 0–7 is deemed to be the normal range (or indicative of clinical remission), while higher numbers signify increased severity of depression[31,37]. 3. Hamilton Anxiety Rating Scale (HAM-A):This is a clinician-administered tool for evaluating the degree of anxiety in clinical and research contexts, comprising 14 items, each rated on a scale from 0 (not present) to 4 (severe), yielding a total score range of 0–56. A score below 17 signifies mild severity, 18–24 denotes mild to moderate severity, and 25–30 shows moderate to severe anxiety[32]. Both HAM-A and HAM-D are clinician rating scales regularly used in clinical and research settings in India. Inter-rater reliability (IRR) will be conducted to ensure consistency among outcome assessors. Participants who discontinue the intervention or drop out will also be invited to complete end-line and follow-up assessments, in accordance with the CONSORT and ICH E9 guidelines, which recommend minimizing missing data and collecting outcomes from all randomized participants to enable an intention-to-treat analysis. This approach helps reduce attrition bias and preserves the validity and generalizability of the study findings[38,39]. Plans to promote participant retention and complete follow-up The site coordinators will reach out to each of the recruited patients for fixing appointments for the monthly sessions. This can help patient retention by offering flexible scheduling. If a study participant misses a session, they will be contacted up to five times (via telephone or their preferred mode of contact) to re-engage them and facilitate rescheduling of the appointment. Additionally, to ensure intervention quality, clinicians will receive standardized training, and regular fidelity checks to ensure consistent intervention. All the patients will be invited to participate in the follow-up assessments of 3 and 6 months, irrespective of their level of participation in the intervention sessions. Data Management Case Report Forms (CRFs) in paper format will be stored securely in locked filing cabinets at each participating site. The project coordinator will review the completed CRFs for accuracy. If any errors are detected, the forms will be returned to the original assessor for correction. After CRF verification, the data will be entered into the REDCap electronic database. Co-investigators (CO-Is) will subsequently cross-verify the electronic entries with the original CRFs to ensure data accuracy. Full details of the data management procedures are available from the authors upon request. Assessing fidelity of DIALOG+ sessions After obtaining consent from the participants, some of the sessions (3-4 sessions per participant) will be audio recorded to assess fidelity of the intervention. The Co-PIs will rate the recordings and evaluate fidelity using the DIALOG+ fidelity scale. The 19-item DIALOG + Adherence Scale was created by the DIALOG+ implementation scale group to assist the wider implementation of DIALOG within routine clinical services[40]. The items will help assess the behaviour of the mental health professional and each of the 19 items is rated 0 or 1 depending on whether the action is in accordance with the DIALOG+ manual. Confidentiality To protect confidentiality, all identifiable participant information will be pseudonymized, with each participant assigned a unique identification number. The folder containing personal data (e.g., names and contact details) and the corresponding ID list will be password protected and the access will be limited to members of the study team. Physical documents, including case report forms, consent forms, patient receipts, and socio-demographic questionnaires, will be securely stored in locked file cabinets at each site. To further ensure confidentiality, evaluations will be conducted in separate rooms, isolated from both participants and researchers. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use This study does not involve the collection of any biological samples; therefore, this section is not applicable. Statistical methods Quantitative data analysis Statistical methods for primary and secondary outcomes Quantitative data will be analysed using Statistical Package for Social Sciences (SPSS) Version 21.0(SPSS version 21. 0 )and R statistical program (Version 4. 4.3 or later). A two-tailed- value of less than 0.05 will be considered statistically significant for all inferential analyses. Descriptive characterization of the trial population will be done. The distribution of continuous variables will be checked for normality and summarised accordingly. The evaluation of the intervention' s effectiveness will be conducted using the intention-to-treat (ITT) analysis. All participants randomized to the DIALOG+ and DIALOG scale groups after the baseline assessment will be included in the ITT analysis. The primary and secondary continuous outcomes will be analysed using Linear Mixed Models (LMM). This accounts for the non- independence of observations due to clustering of patients within clinicians and repeated measurements within individual participants over time. To control for initial symptom severity, the baseline score of the respective outcome will be included as a covariate. A sensitivity analysis will be done on treatment completers to assess the effect of fully adhering to the study intervention. We will also conduct sensitivity analysis on participants who have attended at least 3 sessions, to estimate the intervention's efficacy under ideal conditions. To address the potential impact of participant attrition, multiple imputation for missing data will be conducted. Interim analyses No interim analyses are planned due to the short intervention period, the small sample size, and the cluster-randomized design, which makes interim evaluation unlikely to provide meaningful or reliable information. Method for additional analyses (e.g., subgroup analyses) A subgroup analysis will be carried out, by age and duration of illness if the data indicate potential effect modifiers Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data We will employ a comprehensive analytic approach including ITT for protocol non-adherence, multiple imputation to manage missing data, and sensitivity analyses to examine the robustness of our findings. Plans to give access to the full protocol, participant level-data and statistical code Access to full protocol, data and statistical analysis will be provided on reasonable request to the corresponding author on a case-by-case basis. Qualitative data analysis The Theoretical Domains Framework (TDF) has been specifically designed based on commonly used theories on behaviour change, documenting the various domains within which change occurs across various domains such as Knowledge, skills, social/professional role, beliefs about capabilities, beliefs about consequences, motivation and goals, memory, attention and decision processes, environmental context and resources, social influences, emotion, behavioural regulation[41],[42]. The TDF will be used to develop the interview topic guide, support the process of coding, analysis and in presenting the results. The coding process will encompass both descriptive and conceptual coding. Team members will collaboratively work on the coding framework to ensure intercoder validity and reliability. The subsequent analysis will involve other study team members categorizing coding data related to each domain. Identified themes will be rigorously reviewed by researchers through multiple iterative processes, assessing internal consistency and theme appropriateness. Detailed memos maintained by both coders will facilitate the interpretative phase of the analysis. Qualitative data will be collected through in-depth interviews with 20 purposively selected participants from the intervention arm and all DIALOG+ mental health professionals (n=12). Participant selection will ensure maximum variation based on whether they completed the intervention as intended, whether there was an improvement in outcomes and participant characteristics such as gender and sociodemographic. Interviews will be facilitated using a semi-structured topic guide and audio-recorded, conducted immediately after the intervention to ensure accurate recollection without influencing primary outcome data, and participants will be encouraged to focus on their experience of participation. Oversight and monitoring Composition of the coordinating centre and trial steering committee SCARF India where the Principal Investigator is associated is the primary site coordinating the study. The program manager will support the sites in day-to-day guidance and project related financial management support, technical support and training. A coordinator in Chennai for two of the sites and another in Pondicherry for the other two sites will support the details of recruitment, data collection, verification and session coordination in the sites. All four site have Co-investigators who oversee the daily progress of the trial. The funding agency will be the trial steering committee who will oversee the trial and will provide necessary strategies. The sites will provide annual reports to the steering committee and they will clarify any doubts or provide with additional information if and when necessary. Composition of the data monitoring committee, its role and reporting structure As the trial does not involve any use of medication, the ethics committee has determined that a data monitoring committee is not necessary for this trial. Adverse event reporting and harms The research team doesn’t expect any harm or any serious adverse event for the participants because of the intervention. But if the participants experience distress during the session the mental health professional who will be delivering the intervention will pause the intervention and will give time to the participant to recover from it. If they do not feel better, they will be given an option to terminate that session. As they will be under the clinical care continuously through the trial period and they will be provided with necessary clinical care if they need. All adverse events and serious adverse event are recorded in both the CRFs and Logs. The Project Coordinators will report every serious adverse event to the PI and necessary action will be taken. The event will also be notified to each site’s Ethics committee for their perusal. Frequency and plans for auditing trial conduct The audit inspection and monitoring can be carried out by the funding agency or the ethics committees of any of the four sites if required. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) Any amendments to the protocol will be immediately reported to all four trial site ethics committees for their approvals and the approved amendments will be immediately informed to the funding agency. Dissemination plans The study protocol will be published in a peer-reviewed journal in the first 6 months before data collection begins. To maximise the impact of the finding, publication will target high impact, open access, peer reviewed journals. Authorship guidelines will be drawn up and followed for publications. Based on the contributions to the study design, data collection, data analysis and writing up of the study authorships will be decided. Both senior and junior researchers will be encouraged to present findings of the study in suitable national and international conferences. Discussion This study will evaluate the feasibility, acceptability, and effectiveness of DIALOG+, a low cost, app-based, patient-centred intervention delivered during routine clinical meetings for individuals with anxiety and depressive disorders in four centres in Tamil Nadu and Pondicherry in South India. DIALOG + is an evidence based generic intervention that requires minimal training and it can be delivered by a range of clinical staff. Even though the centres are urban based, patients from rural settings also access these services. Use of a tablet in the clinical settings is likely to be novel for the participants. This is controlled by using an active control. The active control also ensures that additional time spent in the session is also accounted for. By combining structured need-based assessment with solution focused interaction, DIALOG + aims to strengthen clinician-patient communication and support recovery. The inclusion of an active control using the DIALOG scale, translated into Tamil, allows a clear assessment of the added therapeutic value of the structured DIALOG + components beyond routine monitoring. Both the DIALOG + intervention and DIALOG scale have been translated into Tamil to ensure cultural and linguistic appropriateness. A key strength of this trial is its randomised controlled design, which helps control for confounding and allows direct comparison of outcomes between DIALOG + plus TAU and TAU plus DIALOG scale. Evaluating the intervention within real-world outpatient services will generate important evidence on its suitability for routine practice in low and middle income settings like India. However, the study has some limitations. As the study sites are urban centres, there will be patients speaking multiple languages. However, the study is restricted to Tamil and English-speaking population avoiding the recruitment of participants who do not speak either of these languages. However, if the intervention is shown to be effective for persons with depression and anxiety, it is possible to translate the intervention into other languages and make it widely accessible in other Indian languages also. Attempts are made to ensure blinding of the researchers but blinding of the mental health professionals and patient participants will not be possible introducing potential bias and possible placebo effect. Its effectiveness may vary depending on the clinician’s skill and consistency in delivering the structured components, and the format may feel mechanical if not delivered flexibly. The intervention relies on patient engagement and reflective ability, which may be challenging for individuals with more severe symptoms. As a digital tool, its use may also be influenced by comfort with technology and availability of the functioning devices. To address these concerns and ensure methodological rigour, we plan to recruit 336 participants, anticipating up to a 20% dropout rate. Overall, the study offers an opportunity to test and explore the effectiveness of a low cost resource oriented intervention for use in anxiety and depression in a LAMI country like India. If the results demonstrate effectiveness, DIALOG + can be implemented in routine care as it does not require new services. Trial status The present study is conducted in accordance with protocol version 3.1 (dated 29 May 2025).The preparatory phase of the study commenced on 25 February 2025. All preparatory activities for the RCT including finalisation of SOPs and CRFs, ethics amendments across all participating sites, development and finalisation of the REDCap database, preparation of study materials, training of the research team, selection and recruitment of clinicians for the first batch has been completed and 8 clusters have been randomized as on submission date. The trial is expected to complete by September 2027. Trial status The present study is conducted in accordance with protocol version 3.1 (dated 29 May 2025).The preparatory phase of the study commenced on 25 February 2025. All preparatory activities for the RCT including finalisation of SOPs and CRFs, ethics amendments across all participating sites, development and finalisation of the REDCap database, preparation of study materials, training of the research team, selection and recruitment of clinicians for the first batch has been completed and 8 clusters have been randomized as on submission date. The trial is expected to complete by September 2027. Abbreviations LMICs - Low and Middle Income Countries CBT - Cognitive Behaviour Therapy RCT - Randomized Control Trial TAU - Treatment As Usual MANSA - Manchester Short Assessment of Quality of Life DASS-21 - Depression, Anxiety and Stress Scale - 21 items HAM-D/HDRS - Hamilton Depression Rating Scale HAM-A - Hamilton Anxiety Rating Scale CTRI - Clinical Trial Registry - India CMDs - Common Mental Disorders SCARF - Schizophrenia Research Foundation(I) SRIHER - Sri Ramachandra Institute of Higher Education and Research JIPMER - Jawaharlal Institute of Postgraduate Medical Education and Research MGMCRI - Mahatma Gandhi Medical College and Research Institute ICD - International Classification of Diseases UBACC - UCSD Brief Assessment of Capacity to Consent WHO - World Health Organisation QMUL - Queen Mary University, London NIHR - National Institute of Health and Care Research PIECEs - PI- Principal investigator CO-I- Co-investigator SPSS - Statistical Package for Social Sciences LMM - Linear Mixed Models ITT - Intention-to-treat TDF - Theoretical Domains Framework ICC - Intraclass Correlation Coefficient DE - Design Effect SOP - Standard Operating Procedures SAE - Serious Adverse Event CRF - Case Report Form REDCap - Research Electronic Data Capture CONSORT - Consolidated Standards of Reporting Trials ICH - International Conference on Harmonization IRR - Inter Rater Reliability Declarations Ethics approval and consent to participate This RCT study has been approved by each study site's Ethics Committee. Informed consent will be obtained from all participants at each study site. SCARF - Ethics Committee, registered under the Department of Health Research (DHR) bearing registration no: EC/NEW/INST/2023/TN/0329 SRIHER - Ethics committee registered under DHR IEC/NEW/INST/2023/TN/0293 JIPMER - Ethics committee registered under DHR ECR/342/INST/PY/2013/RR-19 MGMCRI - Ethics committee registered under DHR EC/NEW/INST/2022/PY/0169 Consent for publication Not applicable- no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trail results. Competing interests There is no competing interest for principal investigators for the overall trial and each study site. Funding The research is funded by the Indian Council of Medical Research, ICMR, via its Investigator Initiated Research Proposals-Intermediate Grant (IIRP-IG) initiatives. Grant number: IIRPIG-2024-01-01457. The views expressed in this publication are those of the author(s) and not necessarily those of ICMR. The funder plays no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. Authors’ Contribution The Principal Investigator (P.R.) and the Co-Investigators (H.O.J., L.V., S.J.K., V.M., R.G., N.V., Ka.S.) conceived the study and led the study proposal and protocol development. All authors (H.O.J., S.D., S.J.K., A.M., G.E., J.G., K.D.G., Ka.S., Kr.S., L.V., N.V., R.G., R.V., R.A., V.M., V.R., and P.R.) provided substantial intellectual contributions, reviewed the manuscript, and approved the final version for publication. Author details Schizophrenia Research Foundation (I), Chennai, India. SRMC & RI, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai, India. Jawaharlal Institute Of Postgraduate Medical Education and Research (JIPMER), Pondicherry, India. Mahatma Gandhi Medical College and Research Institute (MGMCRI), Pondicherry, India. Acknowledgements Prof. Victoria Jane Bird, Institute of Public Health and Wellbeing, University of Essex for her contribution to conceptualise this project. References GBD Results [Internet]. Inst. Health Metr. Eval. [cited 2025 Sept 21]. https://vizhub.healthdata.org/gbd-results . Accessed 21 Sept 2025 Meghrajani VR, Marathe M, Sharma R, Potdukhe A, Wanjari MB, Taksande AB. A Comprehensive Analysis of Mental Health Problems in India and the Role of Mental Asylums. Cureus. 2023;15:e42559. https://doi.org/10.7759/cureus.42559 Hossain MM, Purohit N. Improving child and adolescent mental health in India: Status, services, policies, and way forward. Indian J Psychiatry. 2019;61:415–9. https://doi.org/10.4103/psychiatry.IndianJPsychiatry_217_18 Math SB, Srinivasaraju R. Indian Psychiatric epidemiological studies: Learning from the past. Indian J Psychiatry. 2010;52:S95–103. https://doi.org/10.4103/0019-5545.69220 Bloom, D.E., Cafiero, E.T., Jané-Llopis, E., Abrahams-Gessel, S., Bloom, L.R., Fathima, S., Feigl,A.B., Gaziano, T., Mowafi, M., Pandya, A., Prettner, K., Rosenberg, L., Seligman, B., Stein, A.Z., & Weinstein, C. (2011). The Global Economic Burden of Noncommunicable Diseases. Geneva: World Economic Forum. Gururaj G, Varghese M, Benegal V, Rao GN, Pathak K, Singh LK, Mehta RY, Ram D, Shibukumar TM, Kokane A, Lenin Singh RK, Chavan BS, Sharma P, Ramasubramanian C, Dalal PK, Saha PK, Deuri SP, Giri AK, Kavishvar AB, Sinha VK, Thavody J, Chatterji R, Akoijam BS, Das S, Kashyap A, Ragavan VS, Singh SK, Misra R and NMHS collaborators group. National Mental Health Survey of India, 2015-16: Prevalence, patterns and outcomes. Bengaluru, National Institute of Mental Health and Neuro Sciences, NIMHANS Publication No. 129, 2016. Dinakaran D, Krishna A, Elangovan AR, Amudhan S, Muthuswamy S, Ramasubramanian C, et al. Epidemiological analysis of mental health morbidity in Tamil Nadu. Indian J Psychiatry. 2023;65:1275–81. https://doi.org/10.4103/indianjpsychiatry.indianjpsychiatry_829_23 Knapp M, Wong G. Economics and mental health: the current scenario. World Psychiatry Off J World Psychiatr Assoc WPA. 2020;19:3–14. https://doi.org/10.1002/wps.20692 Tungpunkom P, Maayan N, Soares-Weiser K. Life skills programmes for chronic mental illnesses. Cochrane Database Syst Rev. 2012;1:CD000381. https://doi.org/10.1002/14651858.CD000381.pub3 Fekadu W, Mihiretu A, Craig TKJ, Fekadu A. Multidimensional impact of severe mental illness on family members: systematic review. BMJ Open. 2019;9:e032391. https://doi.org/10.1136/bmjopen-2019-032391 Anthony WA. Recovery from mental illness: The guiding vision of the mental health service system in the 1990s. Psychosoc Rehabil J. 1993;16:11–23. https://doi.org/10.1037/h0095655 Davidson L, O’Connell M, Tondora J, Styron T, Kangas K. The top ten concerns about recovery encountered in mental health system transformation. Psychiatr Serv Wash DC. 2006;57:640–5. https://doi.org/10.1176/ps.2006.57.5.640 Shepherd G, Boardman J, Slade M (2008) Making recovery a reality. London: Sainsbury Centre for mental health. Juliet SHO, Joseph J, Sims S, Annamalai K, Venkatraman L, Raghavan V, et al. Does Telephone Based Intervention Combined with Face to Face Contact Improve Socio-Occupational Functioning of Persons with Schizophrenia? A Retrospective Chart Review. J Psychosoc Rehabil Ment Health. 2022;9:99–105. https://doi.org/10.1007/s40737-021-00240-w Patel V, Saxena S, Lund C, Thornicroft G, Baingana F, Bolton P, et al. The Lancet Commission on global mental health and sustainable development. Lancet Lond Engl. 2018;392:1553–98. https://doi.org/10.1016/S0140-6736(18)31612-X World Health Organization. (2021, May 26). Guidance and technical packages on community mental health services. Retrieved September 21, 2025, from https://www.who.int/publications/i/item/guidance-and-technical-packages-on-community-mental-health-services . India State-Level Disease Burden Initiative Mental Disorders Collaborators. The burden of mental disorders across the states of India: the Global Burden of Disease Study 1990–2017. Lancet Psychiatry. 2020;7:148–61. https://doi.org/10.1016/S2215-0366(19)30475-4 Patel V, Araya R, Chatterjee S, Chisholm D, Cohen A, De Silva M, et al. Treatment and prevention of mental disorders in low-income and middle-income countries. Lancet Lond Engl. England; 2007;370:991–1005. https://doi.org/10.1016/S0140-6736(07)61240-9 Priebe S, Kelley L, Omer S, Golden E, Walsh S, Khanom H, et al. The Effectiveness of a Patient-Centred Assessment with a Solution-Focused Approach (DIALOG+) for Patients with Psychosis: A Pragmatic Cluster-Randomised Controlled Trial in Community Care. Psychother Psychosom. 2015;84:304–13. https://doi.org/10.1159/000430991 Jovanović N, Russo M, Pemovska T, Francis JJ, Arenliu A, Bajraktarov S, et al. Improving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: Results from a hybrid effectiveness-implementation, pragmatic, cluster-randomized clinical trial (IMPULSE). Eur Psychiatry. 2022;65:e50. https://doi.org/10.1192/j.eurpsy.2022.2302 McNamee P, Matanov A, Jerome L, Kerry S, Walker N, Feng Y, et al. Clinical- and cost-effectiveness of a technology-supported and solution-focused intervention (DIALOG+) in treatment of patients with chronic depression-study protocol for a multi-site, cluster randomised controlled trial [TACK]. Trials. 2022;23:237. https://doi.org/10.1186/s13063-022-06181-4 van Loggerenberg F, Akena D, Alinaitwe R, Birabwa-Oketcho H, Méndez CAC, Gómez-Restrepo C, et al. Feasibility and outcomes of using DIALOG + in primary care to improve quality of life and mental distress of patients with long-term physical conditions: an exploratory non-controlled study in Bosnia and Herzegovina, Colombia and Uganda. BMC Prim Care. 2023;24:241. https://doi.org/10.1186/s12875-023-02197-0 Slatina Murga S, Janković S, Muhić M, Sikira H, Burn E, Priebe S, et al. Effectiveness of a structured intervention to make routine clinical meetings therapeutically effective (DIALOG+) for patients with depressive and anxiety disorders in Bosnia and Herzegovina: A cluster randomised controlled trial. Psychiatry Res Commun. 2021;1:None. https://doi.org/10.1016/j.psycom.2021.100010 Qureshi O, Divya K, Dawood M, Davis S, Venkatraman L, Baig M, et al. Exploring the feasibility and acceptability of DIALOG+ (a structured digital communication tool) in strengthening psychiatric care in India and Pakistan: a qualitative pilot study. BMJ Open. 2025;15:e091852. https://doi.org/10.1136/bmjopen-2024-091852 Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, et al. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007;64:966–74. https://doi.org/10.1001/archpsyc.64.8.966 Application and results of the Manchester Short Assessment of Quality of Life (MANSA) - PubMed [Internet]. [cited 2025 Dec 2]. https://pubmed.ncbi.nlm.nih.gov/10443245/ . Accessed 2 Dec 2025 Priebe S, Golden E, Kingdon D, Omer S, Walsh S, Katevas K, et al. Effective patient–clinician interaction to improve treatment outcomes for patients with psychosis: a mixed-methods design [Internet]. Southampton (UK): NIHR Journals Library; 2017 [cited 2025 Dec 2]. http://www.ncbi.nlm.nih.gov/books/NBK424433/ . Accessed 2 Dec 2025 Bird VJ, Sajun SZ, Peppl R, Evans-Lacko S, Priebe S, Singh S, et al. Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan—a cluster RCT. Trials. 2023;24:59. https://doi.org/10.1186/s13063-022-07032-y Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999;45:7–12. https://doi.org/10.1177/002076409904500102 Lovibond PF, Lovibond SH. Depression Anxiety and Stress Scales [Internet]. 2015 [cited 2025 Sept 21]. https://doi.org/10.1037/t39835-000 Hamilton M. A Rating Scale for Depression. J Neurol Neurosurg Psychiatry. BMJ Publishing Group Ltd; 1960;23:56–62. https://doi.org/10.1136/jnnp.23.1.56 Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988;14:61–8. https://doi.org/10.1016/0165-0327(88)90072-9 Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020;49:979–95. https://doi.org/10.1093/ije/dyz237 Bird VJ, Sajun SZ, Peppl R, Evans-Lacko S, Priebe S, Singh S, et al. Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan-a cluster RCT. Trials. 2023;24:59. https://doi.org/10.1186/s13063-022-07032-y Alagarsamy S, Sugirthan N, Mehrolia S, Elangovan N. Translation and validation of the Tamil version of depression anxiety stress scales-21. J Affect Disord Rep. 2022;10:100398. https://doi.org/10.1016/j.jadr.2022.100398 Sharma MK, Hallford DJ, Anand N. Confirmatory factor analysis of the Depression, Anxiety, and Stress Scale among Indian adults. Indian J Psychiatry. 2020;62:379–83. https://doi.org/10.4103/psychiatry.IndianJPsychiatry_313_19 Prasad MK, Udupa K, Kishore KR, Thirthalli J, Sathyaprabha TN, Gangadhar BN. Inter-rater reliability of Hamilton depression rating scale using video- recorded interviews - Focus on rater-blinding. Indian J Psychiatry. 2009;51:191–4. https://doi.org/10.4103/0019-5545.55085 Abraham J. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. In: Tietje C, Brouder A, editors. Handb Transnatl Econ Gov Regimes [Internet]. Brill | Nijhoff; 2010 [cited 2025 Sept 21]. p. 1041–53. https://doi.org/10.1163/ej.9789004163300.i-1081.897 Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. https://doi.org/10.1136/bmj.e7586 Resources | East London NHS Foundation Trust [Internet]. [cited 2025 Sept 21]. https://www.elft.nhs.uk/dialog/resources . Accessed 21 Sept 2025 Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, et al. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005;14:26–33. https://doi.org/10.1136/qshc.2004.011155 Atkins L, Francis J, Islam R, O’Connor D, Patey A, Ivers N, et al. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017;12:77. https://doi.org/10.1186/s13012-017-0605-9 Additional Declarations No competing interests reported. Supplementary Files SPIRIT2025editablechecklistDIALOG.docx Supplementarymaterial2.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 14 May, 2026 Reviewers invited by journal 13 May, 2026 Editor assigned by journal 04 May, 2026 Submission checks completed at journal 22 Jan, 2026 First submitted to journal 20 Jan, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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09:36:39","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":33289,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementarymaterial2.docx","url":"https://assets-eu.researchsquare.com/files/rs-8416024/v1/9dd9036daefb6b6038361e94.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eStudy Protocol Low Cost App-Based Intervention Dialog+ for Depression and Anxiety in Outpatient Psychiatric Settings: A Study Protocol for a Pragmatic Multisite Cluster Randomized Controlled Trial\u003c/p\u003e","fulltext":[{"header":"Administrative information","content":"\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTitle\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eLow Cost App-based Intervention DIALOG+ For Depression And Anxiety In Outpatient Psychiatric Settings: A Pragmatic Multisite Randomized Controlled Trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTrial registration\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThe study is registered under Clinical trial registry-India (CTRI), and the registration number is CTRI/2025/08/092477.The registration was done in August 2025.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProtocol version\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eProtocol version 3.1, dated 29 May 2025.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFunding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIndian Council of Medical Research (ICMR)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAuthor details\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eHepsipa Omega Juliet\u0026sup1;, Syjo Davis\u003csup\u003e1\u003c/sup\u003e, Suvarna Jyothi Kantipudi\u003csup\u003e2\u003c/sup\u003e*\u003c/em\u003e, Aishwarya M\u003csup\u003e1\u003c/sup\u003e, Giftlin Elizabeth\u003csup\u003e3\u003c/sup\u003e, Jayashree Ganesan\u003csup\u003e3\u003c/sup\u003e, Kasthuri Divya G\u003csup\u003e1\u003c/sup\u003e, Karthick Subramanian\u003csup\u003e4\u003c/sup\u003e, Krithika Suresh\u003csup\u003e1\u003c/sup\u003e, Lakshmi Venkatraman\u0026sup1;, Natarajan Varadharajan\u003csup\u003e3\u003c/sup\u003e, Ragul Ganesh\u0026sup3;, Ramya Vasu⁴, Rudhra Asaithambi\u003csup\u003e3\u003c/sup\u003e, Vikas Menon\u003csup\u003e3\u003c/sup\u003e, Vijayashree Rajkumar\u003csup\u003e2\u003c/sup\u003e, Padmavati Ramachandran\u003csup\u003e1\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e* Corresponding author\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThere is no trial sponsor for the study\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRole of sponsor\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eThe funder plays no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRole and responsibilities: committees\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSCARF India, where the principal investigator is based, will serve as the primary coordinating site, overseeing overall study conduct. The program manager will provide guidance, financial and technical support and training among with co-investigators across all sites. Site coordinators in Chennai and Pondicherry will manage recruitment, data collection, verification, and session coordination.Co-investigators at each site will supervise daily trial activities. All sites will submit annual reports to the trial steering committee.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Introduction","content":"\u003ch3\u003eBackground and rationale\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eGlobally, around 1 in 8 individuals, totalling 970 million people, experience mental disorders, with anxiety and depressive disorders being the most prevalent[1]. India faces a significant surge in mental health disorders, affecting nearly 15% of its population[2,3], covering a wide spectrum of conditions, including depressive and anxiety disorders, bipolar disorder, schizophrenia, substance use disorders, and neurodevelopmental disorders [4,5]. The National Mental Health Survey of India \u0026nbsp;reports a prevalence of 5.25% for depressive disorders and 3.7% for neurotic/stress-related disorders[6]. In Tamil Nadu, the prevalence of depression is estimated at 4.5%, with a higher prevalence observed among females (5.9%) compared to males at (2.8%). Furthermore, rates of neurosis and stress-related disorders, \u0026nbsp; including phobias and anxiety conditions, are slightly higher among \u0026nbsp;females (1.7%) than in males (1.6%)[7]. Among the states in the region, Tamil Nadu reports the highest prevalence of depression. Projections by the World Economic Forum suggest that by 2030, mental ill-health will contribute to over half of the global economic burden linked to non-communicable diseases[8].\u003c/p\u003e\n\u003cp\u003eLiving with a mental health problem extends beyond personal challenges, impacting various aspects of daily life, including mundane tasks like washing, shopping, and social interactions[9].The repercussions extend to families and communities, and the burden is particularly severe \u0026nbsp;in low-and middle-income countries (LMICs), where the gap in access to mental health treatment remains wide[10]. Mental health services are encouraged to take an essential role in supporting \u0026nbsp; the recovery of individuals suffering with mental illness[11–13].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhilst psychosocial interventions are important for addressing functional deficits and supporting recovery[14], India continues to face a significant shortfall in services for common mental disorders (CMDs). In this context, there is a pressing need for low-cost, low-burden therapeutic approaches that can be feasibly implemented within routine psychiatric care to enhance access and improve outcomes[15,16].\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eRationale of the study\u003c/h3\u003e\n\u003cp\u003eCommon mental disorders (CMDs), especially depression and anxiety, being among the most common mental health conditions worldwide and major contributors to disability. Standard treatments in high-income countries typically include antidepressant medication and structured psychotherapies including approaches like cognitive behavioural therapy and problem-solving therapy, often delivered in specialist care settings. While these approaches are effective, their reach is limited in many LMICs, including India, where availability of specialist mental health services is scarce, especially outside urban centres. As a result, most people with CMDs in India remain untreated, and this highlights the need for low-cost \u0026nbsp;scalable, evidence-based interventions that can be integrated into routine services[17,18].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDIALOG+ is an app-based, structured yet flexible intervention that can be integrated directly into routine clinical meetings. It facilitates dialogue between patients and clinicians across quality of life domains and helps identify solutions that draw on patients’ existing strengths and resources. Unlike traditional therapies that are diagnosis-specific, DIALOG+ is transdiagnostic and has demonstrated benefits across psychosis, severe mental illness, depression, and anxiety in diverse cultural and health system contexts[19–22].For CMDs specifically, a cluster RCT in Bosnia and Herzegovina showed improvements in both quality of life and clinical symptoms within six months among participants with anxiety and depression[23].\u003c/p\u003e\n\u003cp\u003eDIALOG+ has several features that facilitate its use in the population. Its patient-centred nature resonates with cultural values that place importance on personal, social, and family resources in recovery. Its digital, app-based format supports consistent delivery while remaining low-cost and easy to implement within existing services. Importantly, it does not require additional sessions or specialist resources, which enhances its scalability within India’s resource-constrained health system. Preliminary feasibility work at SCARF has already shown that DIALOG+ is acceptable and feasible for patients with psychosis in India[24]. This provides a strong rationale for extending its use to CMDs.\u003c/p\u003e\n\u003cp\u003eGiven the global evidence, DIALOG+ represents a practical, scalable, and patient-centred approach with the potential to significantly improve outcomes among individuals with common mental disorders. This study therefore aims to assess the feasibility, acceptability and effectiveness of DIALOG+ for individuals with anxiety and depressive disorders during routine clinical contacts in outpatient psychiatric services.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eObjectives\u0026nbsp;\u003c/h3\u003e\n\u003ch2\u003ePrimary objective\u003c/h2\u003e\n\u003cul\u003e\n \u003cli\u003eTo test the effectiveness of a low cost, app-based intervention (DIALOG+) delivered by mental health professionals in improving quality of life among persons with anxiety and depressive disorders, compared to routine treatment plus administering the DIALOG scale.\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003e\u003cem\u003eSecondary objectives\u003c/em\u003e\u003c/h3\u003e\n\u003cul\u003e\n \u003cli\u003eTo evaluate the effectiveness of DIALOG+ in improving clinical status and related secondary outcomes in persons with anxiety and depressive disorders.\u003c/li\u003e\n \u003cli\u003eTo assess the acceptability and feasibility of delivering DIALOG+ in routine outpatient psychiatric services.\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003eTrial design\u003c/h3\u003e\n\u003cp\u003eThis will be \u0026nbsp;pragmatic,multi-centre,outcome assessor blinded, parallel group, cluster-based randomized controlled superiority trial with concurrent mixed methods process evaluation. It will be conducted across four clinical sites in Chennai and Puducherry.\u003c/p\u003e\n\u003cp\u003eDIALOG+ will be assessed in a cluster RCT, involving mental health professionals, who are not already trained in the administration of the DIALOG+ and their patients, forming a cluster, are randomly allocated either to the experimental (treatment as usual + DIALOG+ arm) or to the control group (treatment as usual + DIALOG scale arm). This approach will minimize the risk of contamination occurring between the groups. DIALOG+ and DIALOG scale will be administered by mental health professionals once a month for 6 months during their regular clinical meetings.\u0026nbsp;\u003c/p\u003e"},{"header":"Methods: study participants, intervention and outcomes measures","content":"\u003ch3\u003eStudy setting\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe study will take place at the following sites:\u0026nbsp;\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eSchizophrenia Research Foundation (SCARF, India) Chennai\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai\u003c/li\u003e\n \u003cli\u003eJawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry\u003c/li\u003e\n \u003cli\u003eMahatma Gandhi Medical College and Research Institute (MGMCRI), Puducherry\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eThis multisite study will be coordinated by SCARF India.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eParticipant eligibility criteria\u0026nbsp;\u003c/h3\u003e\n\u003ch4\u003eFor mental health professionals/clinicians\u003c/h4\u003e\n\u003cp\u003e\u003cem\u003eInclusion criteria:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe inclusion criteria for mental health professionals stipulate that eligible mental health professionals can be any mental health or healthcare professionals at the study sites (e.g., psychologists, psychiatrists, social workers) with a minimum of 6 months of experience in a healthcare facility, who meet \u0026nbsp; their patients on at least a monthly basis, having \u0026nbsp;experience in helping individuals with anxiety and depression, and have no intention of vacating their position within the next 6 months.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eExclusion criteria:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eMental health professionals who had previous exposure to DIALOG+ will not be considered eligible for participation in the study.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eFor patient participants\u003c/h4\u003e\n\u003cp\u003e\u003cem\u003eInclusion criteria:\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eAge: 18\u0026ndash;60 years.\u003c/li\u003e\n \u003cli\u003eDiagnosis: Depressive or anxiety disorders (ICD-10 F30-F39, F40-F49), excluding bipolar disorder.\u003c/li\u003e\n \u003cli\u003eTreatment: Receiving outpatient care for depression and/or anxiety at the study sites.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eQuality of Life: Score \u0026le; 5 on MANSA (Manchester Short Assessment of Quality of Life).\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eConsent: Capacity to provide informed consent.\u003c/li\u003e\n \u003cli\u003eLanguage: Ability to communicate in Tamil or English.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003eExclusion criteria:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eComorbidities: Major medical or psychiatric conditions.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSubstance Use: Current alcohol or substance use disorder (except nicotine).\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePregnancy: Pregnant or lactating mothers.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eConsent: Inability to provide informed consent.\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003eWho will take informed consent?\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eResearchers with training in good clinical practice and informed consent will screen eligible participants and obtain their consent to participate in the study.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eInformed consent for clinicians\u003c/h4\u003e\n\u003cp\u003ePost initial screening for eligibility criteria, trained researchers to set up a meeting with clinicians potentially interested to participate in the study. Researchers will go through the study procedure in detail and allow time for questions. Researchers will then check for understanding from the clinician. If the clinician agrees to take part in the study, they will be asked to sign two copies of the \u0026lsquo;Clinician Consent Form\u0026rsquo; (one copy will be kept by the clinician). Researchers will collect demographic details of the clinician\u0026rsquo;s post signing of consent form and inform them about upcoming steps such as intervention and technical training.\u0026nbsp;\u003c/p\u003e\n\u003ch4\u003eInformed consent for patient participants\u0026nbsp;\u003c/h4\u003e\n\u003cp\u003ePost screening for eligibility criteria, potential participants will be approached for consent by trained researchers. All details of the study including but not limited to its purpose, procedure, randomisation, expected time commitment, and compensation are to be communicated in a language the person is conversant with (either English or Tamil) using a flipchart. The informed consent form is to be read by the person. If they are unable to read, the researcher will read the same slowly and clearly in the language the person is conversant with. Comprehension of the same is to be probed and any questions the person has are to be clarified. This procedure is to be followed by the administration of the UBACC (UCSD Brief Assessment of Capacity to Consent) tool[25]. If the person scores \u0026ge;12 on the same, the researcher will enroll them into the study by asking them to sign two copies of the \u0026lsquo;Informed Consent Form\u0026rsquo; (one copy will be kept by the participant). In case the consent form was read by the researcher, a witness is to be present when signing and the witness will be required to sign as well.\u003c/p\u003e\n\u003ch3\u003eAdditional consent provisions for collection and use of participant data and biological specimens\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eParticipants and clinicians will be asked for additional agreement to record some sessions on audio and video in order to aid fidelity assessments. No biological samples are being collected for the investigation.\u003c/p\u003e\n\u003ch2\u003eInterventions\u003c/h2\u003e\n\u003ch3\u003eExplanation for the choice of comparators\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe comparator for this study is the DIALOG Scale administered alongside treatment as usual (TAU). This was selected because the DIALOG Scale provides an active control condition that assesses patient satisfaction without delivering the structured therapeutic components of DIALOG+. This allows clear identification of the additional therapeutic benefit offered by DIALOG+ compared with routine assessment and TAU. Monthly administration of the DIALOG Scale is consistent with standard monitoring practices in mental health services, enhancing feasibility and reducing bias.\u003c/p\u003e\n\u003ch3\u003eIntervention description\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eIntervention arm: DIALOG+ plus TAU\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;DIALOG+ is a therapeutic intervention which uses a solution focussed approach delivered monthly over six months using a digital application. \u0026nbsp;In the intervention arm, the process begins with an assessment of the patient\u0026apos;s level of satisfaction across eight areas of life domains (including mental health, physical health, employment status, housing, recreational activities, social connections, familial/partner relationships, and personal safety) and three aspects of treatment (such as medication, practical assistance, and consultations with professionals).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;DIALOG Scale uses a 7-point Likert scale to assess each life domain. The patient\u0026apos;s evaluations are compiled and analysed, allowing for comparison with prior assessments. This review encompasses favourable remarks and the identification of domains for subsequent discourse. The patient chooses up to three domains to address with the therapist.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA four-step approach is used to address the patient\u0026apos;s concerns and reach a consensus on the actions needed to resolve them. The patient is advised to complete assignments between sessions. The four-step strategy encompasses Understanding (What is the source of the patient\u0026apos;s dissatisfaction?) What went well nonetheless?; Anticipating the Future (What is the optimal outcome?) What constitutes the minimal advancement?; Evaluating Alternatives (What actions can the patient, doctor, or others undertake?); and ultimately, Reaching Consensus on Actions (e.g., assignments and referrals).\u0026nbsp;\u003cbr\u003e\u0026nbsp;At the beginning of the subsequent DIALOG+ session, the agreed actions will be presented, and the session will then proceed as in the first meeting. DIALOG+ is compatible with software that operates on iPads and Android tablets.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eControl arm: DIALOG Scale plus TAU\u003c/p\u003e\n\u003cp\u003eIn the control arm, the mental health professional administers the DIALOG Scale monthly and rates the patient level of satisfaction across the life and treatment domains No therapeutic steps or action-planning are carried out. Participants continue receiving TAU.\u003c/p\u003e\n\u003cp\u003eDIALOG+ and DIALOG scale apps were developed by the Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Service Development)which is part of Queen Mary University of London (QMUL) created DIALOG scale and DIALOG+ apps[19,26,27].\u003c/p\u003e\n\u003cp\u003eThe research was led by Professor Stefan Priebe with funding from the European Commission and the National Institute for Health and Care Research (NIHR)in the United Kingdom. Both the apps are available in Tamil and English and have been used \u0026nbsp;at SCARF in an international NIHR funded PIECEs project for improving quality of life of persons with psychosis[28].\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/h3\u003e\n\u003cp\u003eAlthough DIALOG+, the intervention which is being tested, has not been shown to pose risks in previous research, some participants may still experience anxiety when trying a new intervention. Participants will continue to receive their routine care, including medication and available psychosocial support, alongside the study intervention. The DIALOG+ sessions can be stopped at any point if needed. Participants may discontinue or modify the intervention if their mental health worsens and requires urgent care, if they choose to withdraw, or if participation causes significant distress. The intervention, delivered monthly over six months by trained clinicians, will be adjusted or stopped based on clinical judgement, and all changes will be recorded according to the study protocol.\u003c/p\u003e\n\u003ch3\u003eStrategies to improve adherence to interventions\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eAdherence to the intervention will be supported through several strategies within the context of routine care. Flexible appointment scheduling will be offered to accommodate participants\u0026rsquo; availability; telephone reminders will be sent prior to each session if needed. Follow-up contact will be made within one week for any missed sessions to re-engage participants. Clinicians delivering DIALOG+ will receive standardized training and fidelity monitoring to ensure the intervention is delivered consistently.\u003c/p\u003e\n\u003ch3\u003eRelevant concomitant care permitted or prohibited during the trail\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eDuring the study, participants will continue to receive their usual treatment, including pharmacological and psychosocial interventions. These treatments are permitted alongside DIALOG+. However, they will be prohibited from concurrent participation in other research studies during the trial.\u003c/p\u003e\n\u003ch3\u003eProvisions for post-trial care\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe risk of harm during the study is very low. If a participant shares information indicating immediate danger to themselves or others, their participation will be stopped, and the researcher will notify the appropriate safeguarding authority (e.g., clinic). All researchers will be trained in safeguarding procedures and supervised to ensure correct handling of risk. The study will be carried out only by trained and experienced mental health researchers.\u003c/p\u003e\n\u003cp\u003eAfter the six-month trial, all participants will continue receiving TAU. Any needs identified during the study will be shared with the treating team, and anyone showing deterioration will be managed according to the clinical guidelines. If \u0026nbsp;DIALOG+ is found helpful, the service may consider offering it more widely after the study, subject to institutional approval, and the clinicians in the control arm will then be trained to deliver DIALOG+.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eQuantitative outcome measures will be captured at 3 different time points: baseline, 3 months and 6 months of the cluster RCT. The primary outcome measures will include the Quality of Life which will be assessed using Manchester Short Assessment of Quality of Life(MANSA)[29] and the secondary outcome measures will include the Depression and Anxiety Stress Scale (DASS-21)[30], Hamilton Depression Rating Scale (HDRS)[31] and the Hamilton Anxiety Rating Scale (HAM-A)[32].\u003c/p\u003e\n\u003cp\u003eThe sociodemographic details will be collected at baseline. Clinical details will be collected at baseline, 3 months and 6 months post randomization.\u003c/p\u003e\n\u003ch3\u003eParticipant timeline\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe total duration of the study project is for 36 months. The study will be conducted in 3 phases. 1. Preparatory phase (6 months); 2. Data collection phase (24 months); and 3. Data analysis and report writing. A summary of the participant timeline during the data collection phase for screening,enrolment,intervention and assessments is shown below.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"569\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"10\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eParticipant Timeline \u0026ndash; DIALOG+ Cluster RCT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eScreening\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eBaseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"6\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003emonths\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCompletion\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003emonth\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTIMEPOINT\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eENROLMENT:\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eEligibility screen\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eInformed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMANSA Screening (patients)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAllocation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eINTERVENTIONS:\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDIALOG+\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDIALOG Scale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eASSESSMENTS:\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSociodemographic Questionnaire\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMANSA\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eHAM-D/HDRS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eHAM-A\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDASS-21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eQualitative Interviews\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFidelity checks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eMANSA - Manchester Short Assessment of Quality of Life\u003c/p\u003e\n\u003cp\u003eDASS-21 - Depression, Anxiety and Stress Scale - 21 items\u003c/p\u003e\n\u003cp\u003eHAM-D/HDRS - Hamilton Depression Rating Scale\u003c/p\u003e\n\u003cp\u003eHAM-A - Hamilton Anxiety Rating Scale\u003c/p\u003e\n\u003ch3\u003eSample size\u003c/h3\u003e\n\u003cp\u003eThe required sample size to show an effect size of 0.5 with 80% power, 5% level of significance, design effect of 2, and attrition rate of 20% was calculated to be 168 in each arm[33].\u0026nbsp;According to the above calculation, the ICC is 0.037. The cluster adjusted sample size is 336 and the number of clusters is 12 per arm. Therefore, the sample size for each cluster is approximately 14.The total number =12(# of clusters)*2(arms)*14=336 (168 per arm).\u003c/p\u003e\n\u003cp\u003eWe have used \u0026nbsp;MANSA tool, a continuous measure of quality of life as a primary outcome measure to calculate sample size. To detect a standardized effect size of 0.5 with 80% power at a two‑tailed significance level of 5%, an individually randomized trial would require approximately 134 participants. As this is a cluster randomized controlled trial, the required sample size accounting for the design effect (DE):DE=1+(m\u0026minus;1)\u0026times;ICC ,where \u003cem\u003em\u003c/em\u003e is the average cluster size and \u003cem\u003eICC\u003c/em\u003e is the intracluster correlation coefficient. With an assumed \u003cem\u003em\u003c/em\u003e = 14 participants per clinician and ICC = 0.037 (derived from similar DIALOG+ psychosocial interventions),DE \u0026asymp;1.5.We have used more conservative DE = 2 to safeguard power and adjusted for 20% attrition to arrive at a sample size of 336.\u003c/p\u003e\n\u003ch3\u003eRecruitment\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eTo support effective recruitment at all sites, posters with details of the study will be displayed to invite participants to contact the research team. Mental Health Professionals at each location will also be informed about the study criteria and requested \u0026nbsp;to refer eligible patients.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor individuals with limited time, the research team will adapt the screening and consenting process by dividing it across visits \u0026nbsp;as needed, ensuring that time constraints do not prevent participation.\u003c/p\u003e\n\u003ch2\u003eAssignment of interventions: allocation\u003c/h2\u003e\n\u003ch3\u003eSequence generation\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eRandomisation will be conducted by an independent statistician using sequential computer-generated random numbers in an allocation ratio of 1:1. Mental health professionals along with their eligible patient participants will be randomised as a cluster once 14 patients are recruited under each professional to the intervention or control arm.\u003c/p\u003e\n\u003ch3\u003eConcealment mechanism\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eAllocation concealment will be rigorously maintained through a centralized allocation system managed solely by the independent statistician. The project coordinator will be intimated by the treatment sites after the cluster is formed i.e mental health professional with 14 eligible consented patients are recruited. Then the project coordinator will contact the independent statistician, who will then provide the next pre-determined allocation (Intervention or Control) from the secure randomization sequence. The project co-ordinator will be the only designated contact for statistician, The randomization table will be stored exclusively on password-protected, encrypted computer, with access restricted only to the independent statistician. This procedure ensures that assignment is requested and revealed only after the commitment of the entire cluster, completely preventing selection bias based on foreknowledge of the treatment arm.\u003c/p\u003e\n\u003ch3\u003eImplementation\u003c/h3\u003e\n\u003cp\u003eEligible patient participants will be approached for consent, and those who provide written informed consent will undergo baseline assessments conducted by blinded research assistants at their respective sites.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe intervention mental health professionals and the control mental health professionals will be trained in using DIALOG+ app and DIALOG scale respectively by the unblinded researchers (SCARF Co I). The training will happen in person. The training will last approximately 3 to 4 hours. During the training, the issues of accidental unblinding will be discussed and the mental health professional will be encouraged not to discuss their randomisation status with other mental health professionals.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll the patients will receive routine care in both arms with the intervention arm patients additionally receiving DIALOG+ sessions once a month and the control arm professionals will complete the DIALOG scale with the patients in the monthly sessions. Sessions will happen once a month for 6 months. The mental health professionals in the DIALOG+ arm will be supported by the unblinded researchers to audio record some of the intervention sessions to evaluate for fidelity of intervention.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eAssignment of interventions: blinding\u003c/h2\u003e\n\u003ch3\u003eWho will be blinded\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eAll the patients will be assessed by blinded outcome raters at baseline, 3 months and 6 months.\u0026nbsp;The unblinded researchers will extract data from the tablets once a week and store the DIALOG and DIALOG+ data in password protected files that are accessible only to the unblinded researchers. Several attempts were made to minimise bias in this study. The study is a pragmatic, outcome assessor-blinded cluster RCT. An independent statistician, who is not part of the study team, will generate randomisation sequence using computer-generated random numbers. As this is a psycho-behavioural intervention, it is not possible to blind the participating clinicians or the patient participants to their group assignment. The Project Coordinator and the Co-Investigators (Co-Is) involved in clinician training, performing in-depth interviews, and conducting fidelity checks will not be blinded, as this is necessary to fulfil their roles.\u003c/p\u003e\n\u003cp\u003eParticipants may be able to identify whether they are receiving DIALOG Scale or DIALOG+ due to the nature of the interventions. However, they may not be unaware of the difference between the intervention and control arms. Meticulous procedures will be in place to ensure that the research assistants responsible for collecting outcome data remain blinded to group allocation. Furthermore, participants will be instructed not to disclose their group status during assessment sessions.\u003c/p\u003e\n\u003ch3\u003eProcedure for unblinding if needed\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eUnblinding will be considered when necessary for participant safety. Emergency unblinding will be considered in compliance with standard operating procedures (SOPs). In the rare event, such as in the case of a Serious Adverse Event (SAE),if the knowledge of participant allocation is deemed essential for clinical management, the treating clinician or the site\u0026apos;s Principal Investigator can formally request the unblinding of that specific participant. This \u0026nbsp;request will be directed to the project co-ordinator who is unblinded. If the request is approved, the allocation for only that individual will be revealed, and the event will be thoroughly documented. Every effort will be made to maintain the blind for the outcome assessors.\u003c/p\u003e\n\u003ch2\u003eData Collection and management\u0026nbsp;\u003c/h2\u003e\n\u003ch3\u003ePlans for assessment and collection of outcomes:\u003c/h3\u003e\n\u003cp\u003eAll the \u0026nbsp;tools used to assess outcomes have been translated into the local language, Tamil. Tamil translation of MANSA and DASS 21 was already available from a previous study[34,35].The study team has undergone training in good clinical practice in an online course. \u0026nbsp;Senior researchers and clinicians trained the research team in administering HAM-D, HAM\u0026ndash;A and DASS 21. \u0026nbsp;Paper case report forms (CRF) will be used to collect information from participants and subsequently the data will be entered into an electronic database, REDCap. The researchers are responsible for creating and managing the REDCap database, and data cleaning will happen once the data collection concludes. If interested anyone can request access to the data collection forms from the authors.\u003c/p\u003e\n\u003cp\u003eThe data assessment tools used in the study include:\u003c/p\u003e\n\u003ch4\u003ePrimary outcome measures:\u003c/h4\u003e\n\u003cp\u003e1.The Manchester Short Assessment of Quality of Life (MANSA): is utilized for evaluating quality of life. The instrument assesses overall life happiness as well as satisfaction across different life domains. The assessment comprises 16 items and is evaluated using a 7-point Likert scale. This tool has been validated and used in Indian settings. Cronbach\u0026apos;s alpha for satisfaction ratings was 0.74[29].\u003c/p\u003e\n\u003ch4\u003e\u0026nbsp;Secondary outcome measures:\u003c/h4\u003e\n\u003cp\u003e1. Depression and Anxiety Stress Scale (DASS-21): This instrument evaluates overall psychological suffering. It assesses depression, anxiety, and stress levels. The items are evaluated using a four-point Likert scale ranging from \u0026quot;never\u0026quot; (0) to \u0026quot;almost always\u0026quot; (3). It has been validated in the Indian setting and exhibited robust psychometric qualities with a strong correlation among subscales[35,36].\u003c/p\u003e\n\u003cp\u003e2. Hamilton Depression Rating Scale (HDRS):This is a widely employed clinician-administered instrument for evaluating depression. The assessment has 17 items, each rated on a scale from 0 to 4, evaluating depressive symptoms encountered in the preceding week. A score of 0\u0026ndash;7 is deemed to be \u0026nbsp;the normal range (or indicative of clinical remission), while higher numbers signify increased severity of depression[31,37].\u003c/p\u003e\n\u003cp\u003e3. Hamilton Anxiety Rating Scale (HAM-A):This is a clinician-administered tool for evaluating the degree of anxiety in clinical and research contexts, comprising 14 items, each rated on a scale from 0 (not present) to 4 (severe), yielding a total score range of 0\u0026ndash;56. A score below 17 signifies mild severity, 18\u0026ndash;24 denotes mild to moderate severity, and 25\u0026ndash;30 shows moderate to severe anxiety[32].\u003c/p\u003e\n\u003cp\u003eBoth HAM-A and HAM-D are clinician rating scales regularly used in clinical and research settings in India. Inter-rater reliability (IRR) will be conducted to ensure consistency among outcome assessors. Participants who discontinue the intervention or drop out will also \u0026nbsp;be invited to complete end-line and follow-up assessments, in accordance with the CONSORT and ICH E9 guidelines, which recommend minimizing missing data and collecting outcomes from all randomized participants to enable an intention-to-treat analysis. This approach helps reduce attrition bias and preserves the validity and generalizability of the study findings[38,39].\u003c/p\u003e\n\u003ch3\u003ePlans to promote participant retention and complete follow-up\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe site coordinators will reach out to each of the recruited patients for fixing appointments for the monthly sessions. This can help patient retention by offering flexible scheduling.\u0026nbsp;If a study participant misses a session, they will be contacted up to five times (via telephone or their preferred mode of contact) to re-engage them and facilitate rescheduling of the appointment. Additionally, to ensure intervention quality, clinicians will receive standardized training, and regular fidelity checks to ensure consistent intervention. All the patients will be invited to participate in the follow-up assessments of 3 and 6 months, irrespective of their level of participation in the intervention sessions.\u003c/p\u003e\n\u003ch3\u003eData Management\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eCase Report Forms (CRFs) in paper format will be stored securely in locked filing cabinets at each participating site. The project coordinator will review the completed CRFs for accuracy. If any errors are detected, the forms will be returned to the original assessor for correction. After CRF verification, the data will be entered into the REDCap electronic database. Co-investigators (CO-Is) will subsequently cross-verify the electronic entries with the original CRFs to ensure data accuracy. Full details of the data management procedures are available from the authors upon request.\u003c/p\u003e\n\u003ch3\u003eAssessing fidelity of DIALOG+ sessions\u003c/h3\u003e\n\u003cp\u003eAfter obtaining consent from the participants, some of the sessions (3-4 sessions per participant) will be audio recorded to assess fidelity of the intervention. The Co-PIs will rate the recordings and evaluate fidelity using the DIALOG+ fidelity scale. The 19-item DIALOG + Adherence Scale was created by the DIALOG+ implementation scale group to assist the wider implementation of DIALOG within routine clinical services[40]. The items will help assess the behaviour of the mental health professional and each of the 19 items is rated 0 or 1 depending on whether the action is in accordance with the DIALOG+ manual.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eConfidentiality\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eTo protect confidentiality, all identifiable participant information will be pseudonymized, with each participant assigned a unique identification number. The folder containing personal data (e.g., names and contact details) and the corresponding ID list will be password protected and the access will be limited to members of the study team. Physical documents, including case report forms, consent forms, patient receipts, and socio-demographic questionnaires, will be securely stored in locked file cabinets at each site. To further ensure confidentiality, evaluations will be conducted in separate rooms, isolated from both participants and researchers.\u003c/p\u003e\n\u003ch3\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThis study does not involve the collection of any biological samples; therefore, this section is not applicable.\u003c/p\u003e\n\u003ch2\u003eStatistical methods\u003c/h2\u003e\n\u003ch3\u003eQuantitative data analysis\u003c/h3\u003e\n\u003ch3\u003eStatistical methods for primary and secondary outcomes\u003c/h3\u003e\n\u003cp\u003eQuantitative data will be analysed using Statistical Package for Social Sciences (SPSS) Version\u003c/p\u003e\n\u003cp\u003e21.0(SPSS version 21. 0 )and R statistical program (Version 4. 4.3 or later). A two-tailed- value of less than 0.05 will be considered statistically significant for all inferential analyses. Descriptive characterization of the trial population will be done. The distribution of continuous variables will be checked for normality and summarised accordingly. The evaluation of the intervention\u0026apos; s effectiveness will be conducted using the intention-to-treat (ITT) analysis. All participants randomized to the DIALOG+ and DIALOG scale groups after the baseline assessment will be included in the ITT analysis.\u003c/p\u003e\n\u003cp\u003eThe primary and secondary continuous outcomes will be analysed using Linear Mixed Models (LMM). This accounts for the non- independence of observations due to clustering of patients within clinicians and repeated measurements within individual participants over time. To control for initial symptom severity, the baseline score of the respective outcome will be included as a covariate. A sensitivity analysis will be done on treatment completers to assess the effect of \u0026nbsp;fully adhering to the study intervention. We will also conduct sensitivity analysis on \u0026nbsp;participants who have attended at least 3 sessions, to estimate the intervention\u0026apos;s efficacy under ideal conditions. To address the potential impact of participant attrition, multiple imputation for missing data will be conducted.\u003c/p\u003e\n\u003ch3\u003eInterim analyses\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eNo interim analyses are planned due to the short intervention period, the small sample size, and the cluster-randomized design, which makes interim evaluation unlikely to provide meaningful or reliable information.\u003c/p\u003e\n\u003ch3\u003eMethod for additional analyses (e.g., subgroup analyses)\u003c/h3\u003e\n\u003cp\u003eA subgroup analysis will be carried out, by age and duration of illness if the data indicate potential effect modifiers\u003c/p\u003e\n\u003ch3\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eWe will employ a comprehensive analytic approach including ITT for protocol non-adherence, multiple imputation to manage missing data, and sensitivity analyses to examine the robustness of our findings.\u003c/p\u003e\n\u003ch3\u003ePlans to give access to the full protocol, participant level-data and statistical code\u003c/h3\u003e\n\u003cp\u003eAccess to full protocol, data and statistical analysis will be provided on reasonable request to the corresponding author on a case-by-case basis.\u003c/p\u003e\n\u003ch3\u003eQualitative data analysis\u003c/h3\u003e\n\u003cp\u003eThe Theoretical Domains Framework (TDF) has been specifically designed based on commonly used theories on behaviour change, documenting the various domains within which change occurs across various domains such as Knowledge, skills, social/professional role, beliefs about capabilities, beliefs about consequences, motivation and goals, memory, attention and decision processes, environmental context and resources, social influences, emotion, behavioural regulation[41],[42]. The TDF will be used to develop the interview topic guide, support the process of coding, analysis and in presenting the results. The coding process will encompass both descriptive and conceptual coding. Team members will collaboratively work on the coding framework to ensure intercoder validity and reliability.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe subsequent analysis will involve other study team members categorizing coding data related to each domain. Identified themes will be rigorously reviewed by researchers through multiple iterative processes, assessing internal consistency and theme appropriateness. Detailed memos maintained by both coders will facilitate the interpretative phase of the analysis.\u003c/p\u003e\n\u003cp\u003eQualitative data will be collected through in-depth interviews with 20 purposively selected participants from the intervention arm and all DIALOG+ mental health professionals (n=12). Participant selection will ensure maximum variation based on whether they completed the intervention as intended, whether there was an improvement in outcomes and participant characteristics such as gender and sociodemographic. Interviews will be facilitated using a semi-structured topic guide and audio-recorded, conducted immediately after the intervention to ensure accurate recollection without influencing primary outcome data, and participants will be encouraged to focus on their experience of participation.\u003c/p\u003e\n\u003ch2\u003eOversight and monitoring\u003c/h2\u003e\n\u003ch3\u003eComposition of the coordinating centre and trial steering committee\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eSCARF India where the Principal Investigator is associated is the primary site coordinating the study. The program manager will support the sites in day-to-day guidance and project related financial management support, technical support and training. A coordinator in Chennai for two of the sites and another in Pondicherry for the other two sites will support the details of recruitment, data collection, verification and session coordination in the sites. All four site have Co-investigators who oversee the daily progress of the trial. The funding agency will be the trial steering committee who will oversee the trial and will provide necessary strategies. The sites will provide annual reports to the steering committee and they will clarify any doubts or provide with additional information if and when necessary.\u003c/p\u003e\n\u003ch3\u003eComposition of the data monitoring committee, its role and reporting structure\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eAs the trial does not involve any use of medication, the ethics committee has determined that a data monitoring committee is not necessary for this trial.\u003c/p\u003e\n\u003ch3\u003eAdverse event reporting and harms\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe research team doesn\u0026rsquo;t expect any harm or any serious adverse event for the participants because of the intervention. But if the participants experience distress during the session the mental health professional who will be delivering the intervention will pause the intervention and will give time to the participant to recover from it. If they do not feel better, they will be given an option to terminate that session. As they will be under the clinical care continuously through the trial period and they will be provided with necessary clinical care if they need. All adverse events and serious adverse event are recorded in both the CRFs and Logs. The Project Coordinators will report every serious adverse event to the PI and necessary action will be taken. The event will also be notified to each site\u0026rsquo;s Ethics committee for their perusal.\u003c/p\u003e\n\u003ch3\u003eFrequency and plans for auditing trial conduct\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe audit inspection and monitoring can be carried out by the funding agency or the ethics committees of any of the four sites if required.\u003c/p\u003e\n\u003ch3\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees)\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eAny amendments to the protocol will be immediately reported to all four trial site ethics committees for their approvals and the approved amendments will be immediately informed to the funding agency.\u003c/p\u003e\n\u003ch3\u003eDissemination plans\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe study protocol will be published in a peer-reviewed journal in the first 6 months before data collection begins. To maximise the impact of the finding, publication will target high impact, open access, peer reviewed journals. Authorship guidelines will be drawn up and followed for publications. Based on the contributions to the study design, data collection, data analysis and writing up of the study authorships will be decided. Both senior and junior researchers will be encouraged to present findings of the study in suitable national and international conferences.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study will evaluate the feasibility, acceptability, and effectiveness of DIALOG+, a low cost, app-based, patient-centred intervention delivered during routine clinical meetings for individuals with anxiety and depressive disorders in four centres in Tamil Nadu and Pondicherry in South India. DIALOG\u0026thinsp;+\u0026thinsp;is an evidence based generic intervention that requires minimal training and it can be delivered by a range of clinical staff. Even though the centres are urban based, patients from rural settings also access these services. Use of a tablet in the clinical settings is likely to be novel for the participants. This is controlled by using an active control. The active control also ensures that additional time spent in the session is also accounted for.\u003c/p\u003e \u003cp\u003eBy combining structured need-based assessment with solution focused interaction, DIALOG\u0026thinsp;+\u0026thinsp;aims to strengthen clinician-patient communication and support recovery. The inclusion of an active control using the DIALOG scale, translated into Tamil, allows a clear assessment of the added therapeutic value of the structured DIALOG\u0026thinsp;+\u0026thinsp;components beyond routine monitoring. Both the DIALOG\u0026thinsp;+\u0026thinsp;intervention and DIALOG scale have been translated into Tamil to ensure cultural and linguistic appropriateness.\u003c/p\u003e \u003cp\u003eA key strength of this trial is its randomised controlled design, which helps control for confounding and allows direct comparison of outcomes between DIALOG\u0026thinsp;+\u0026thinsp;plus TAU and TAU plus DIALOG scale. Evaluating the intervention within real-world outpatient services will generate important evidence on its suitability for routine practice in low and middle income settings like India.\u003c/p\u003e \u003cp\u003eHowever, the study has some limitations. As the study sites are urban centres, there will be patients speaking multiple languages. However, the study is restricted to Tamil and English-speaking population avoiding the recruitment of participants who do not speak either of these languages. However, if the intervention is shown to be effective for persons with depression and anxiety, it is possible to translate the intervention into other languages and make it widely accessible in other Indian languages also. Attempts are made to ensure blinding of the researchers but blinding of the mental health professionals and patient participants will not be possible introducing potential bias and possible placebo effect. Its effectiveness may vary depending on the clinician\u0026rsquo;s skill and consistency in delivering the structured components, and the format may feel mechanical if not delivered flexibly. The intervention relies on patient engagement and reflective ability, which may be challenging for individuals with more severe symptoms. As a digital tool, its use may also be influenced by comfort with technology and availability of the functioning devices. To address these concerns and ensure methodological rigour, we plan to recruit 336 participants, anticipating up to a 20% dropout rate.\u003c/p\u003e \u003cp\u003eOverall, the study offers an opportunity to test and explore the effectiveness of a low cost resource oriented intervention for use in anxiety and depression in a LAMI country like India. If the results demonstrate effectiveness, DIALOG\u0026thinsp;+\u0026thinsp;can be implemented in routine care as it does not require new services.\u003c/p\u003e \u003cp\u003eTrial status\u003c/p\u003e \u003cp\u003eThe present study is conducted in accordance with protocol version 3.1 (dated 29 May 2025).The preparatory phase of the study commenced on 25 February 2025. All preparatory activities for the RCT including finalisation of SOPs and CRFs, ethics amendments across all participating sites, development and finalisation of the REDCap database, preparation of study materials, training of the research team, selection and recruitment of clinicians for the first batch has been completed and 8 clusters have been randomized as on submission date. The trial is expected to complete by September 2027.\u003c/p\u003e"},{"header":"Trial status","content":"\u003cp\u003eThe present study is conducted in accordance with protocol version 3.1 (dated 29 May 2025).The preparatory phase of the study commenced on 25 February 2025. All preparatory activities for the RCT including finalisation of SOPs and CRFs, ethics amendments across all participating sites, development and finalisation of the REDCap database, preparation of study materials, training of the research team, selection and recruitment of clinicians for the first batch has been completed and 8 clusters have been randomized as on submission date. The trial is expected to complete by September 2027.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eLMICs - Low and Middle Income Countries\u003c/p\u003e\n\u003cp\u003eCBT - Cognitive Behaviour Therapy\u003c/p\u003e\n\u003cp\u003eRCT - Randomized Control Trial\u003c/p\u003e\n\u003cp\u003eTAU - Treatment As Usual\u003c/p\u003e\n\u003cp\u003eMANSA - Manchester Short Assessment of Quality of Life\u003c/p\u003e\n\u003cp\u003eDASS-21 - Depression, Anxiety and Stress Scale - 21 items\u003c/p\u003e\n\u003cp\u003eHAM-D/HDRS - Hamilton Depression Rating Scale\u003c/p\u003e\n\u003cp\u003eHAM-A - Hamilton Anxiety Rating Scale\u003c/p\u003e\n\u003cp\u003eCTRI - Clinical Trial Registry - India\u003c/p\u003e\n\u003cp\u003eCMDs - Common Mental Disorders\u003c/p\u003e\n\u003cp\u003eSCARF - Schizophrenia Research Foundation(I)\u003c/p\u003e\n\u003cp\u003eSRIHER - Sri Ramachandra Institute of Higher Education and Research\u003c/p\u003e\n\u003cp\u003eJIPMER - Jawaharlal Institute of Postgraduate Medical Education and Research\u003c/p\u003e\n\u003cp\u003eMGMCRI - Mahatma Gandhi Medical College and Research Institute\u003c/p\u003e\n\u003cp\u003eICD - International Classification of Diseases\u003c/p\u003e\n\u003cp\u003eUBACC - UCSD Brief Assessment of Capacity to Consent\u003c/p\u003e\n\u003cp\u003eWHO - World Health Organisation\u003c/p\u003e\n\u003cp\u003eQMUL - Queen Mary University, London\u003c/p\u003e\n\u003cp\u003eNIHR - National Institute of Health and Care Research\u003c/p\u003e\n\u003cp\u003ePIECEs -\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePI- Principal investigator\u003c/p\u003e\n\u003cp\u003eCO-I- Co-investigator\u003c/p\u003e\n\u003cp\u003eSPSS - Statistical Package for Social Sciences\u003c/p\u003e\n\u003cp\u003eLMM - Linear Mixed Models\u003c/p\u003e\n\u003cp\u003eITT - Intention-to-treat\u003c/p\u003e\n\u003cp\u003eTDF - Theoretical Domains Framework\u003c/p\u003e\n\u003cp\u003eICC - Intraclass Correlation Coefficient\u003c/p\u003e\n\u003cp\u003eDE - Design Effect\u003c/p\u003e\n\u003cp\u003eSOP - Standard Operating Procedures\u003c/p\u003e\n\u003cp\u003eSAE - Serious Adverse Event\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCRF - Case Report Form\u003c/p\u003e\n\u003cp\u003eREDCap - Research Electronic Data Capture\u003c/p\u003e\n\u003cp\u003eCONSORT - Consolidated Standards of Reporting Trials\u003c/p\u003e\n\u003cp\u003eICH - International Conference on Harmonization\u003c/p\u003e\n\u003cp\u003eIRR - Inter Rater Reliability\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch4\u003eEthics approval and consent to participate\u0026nbsp;\u003c/h4\u003e\n\u003cp\u003eThis RCT study has been approved by each study site\u0026apos;s Ethics Committee. Informed consent will be obtained from all participants at each study site. SCARF - Ethics Committee, registered under the Department of Health Research (DHR) bearing registration no: EC/NEW/INST/2023/TN/0329\u003c/p\u003e\n\u003cp\u003eSRIHER - Ethics committee registered under DHR IEC/NEW/INST/2023/TN/0293\u003c/p\u003e\n\u003cp\u003eJIPMER - Ethics committee registered under DHR ECR/342/INST/PY/2013/RR-19\u003c/p\u003e\n\u003cp\u003eMGMCRI - Ethics committee registered under DHR EC/NEW/INST/2022/PY/0169\u003c/p\u003e\n\u003ch4\u003eConsent for publication\u003c/h4\u003e\n\u003cp\u003eNot applicable- no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trail results.\u003c/p\u003e\n\u003ch4\u003eCompeting interests\u0026nbsp;\u003c/h4\u003e\n\u003cp\u003eThere is no competing interest for principal investigators for the overall trial and each study site.\u003c/p\u003e\n\u003ch4\u003eFunding\u003c/h4\u003e\n\u003cp\u003eThe research is funded by the Indian Council of Medical Research, ICMR, via its Investigator Initiated Research Proposals-Intermediate Grant (IIRP-IG) initiatives. Grant number: IIRPIG-2024-01-01457. The views expressed in this publication are those of the author(s) and not necessarily those of ICMR. The funder plays no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.\u003c/p\u003e\n\u003ch4\u003eAuthors\u0026rsquo; Contribution\u003c/h4\u003e\n\u003cp\u003eThe Principal Investigator (P.R.) and the Co-Investigators (H.O.J., L.V., S.J.K., V.M., R.G., N.V., Ka.S.) conceived the study and led the study proposal and protocol development. All authors (H.O.J., S.D., S.J.K., A.M., G.E., J.G., K.D.G., Ka.S., Kr.S., L.V., N.V., R.G., R.V., R.A., V.M., V.R., and P.R.) provided substantial intellectual contributions, reviewed the manuscript, and approved the final version for publication.\u003c/p\u003e\n\u003ch4\u003eAuthor details\u003c/h4\u003e\n\u003cp\u003eSchizophrenia Research Foundation (I), Chennai, India. SRMC \u0026amp; RI, Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai, India. Jawaharlal Institute Of Postgraduate Medical Education and Research (JIPMER), Pondicherry, India. Mahatma Gandhi Medical College and Research Institute (MGMCRI), Pondicherry, India.\u003c/p\u003e\n\u003ch4\u003eAcknowledgements\u003c/h4\u003e\n\u003cp\u003eProf. Victoria Jane Bird, Institute of Public Health and Wellbeing, University of Essex for her contribution to conceptualise this project.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGBD Results [Internet]. Inst. Health Metr. Eval. [cited 2025 Sept 21]. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://vizhub.healthdata.org/gbd-results\u003c/span\u003e\u003cspan address=\"https://vizhub.healthdata.org/gbd-results\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 21 Sept 2025\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMeghrajani VR, Marathe M, Sharma R, Potdukhe A, Wanjari MB, Taksande AB. A Comprehensive Analysis of Mental Health Problems in India and the Role of Mental Asylums. Cureus. 2023;15:e42559. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.7759/cureus.42559\u003c/span\u003e\u003cspan address=\"10.7759/cureus.42559\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHossain MM, Purohit N. Improving child and adolescent mental health in India: Status, services, policies, and way forward. Indian J Psychiatry. 2019;61:415\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4103/psychiatry.IndianJPsychiatry_217_18\u003c/span\u003e\u003cspan address=\"10.4103/psychiatry.IndianJPsychiatry_217_18\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMath SB, Srinivasaraju R. Indian Psychiatric epidemiological studies: Learning from the past. Indian J Psychiatry. 2010;52:S95\u0026ndash;103. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4103/0019-5545.69220\u003c/span\u003e\u003cspan address=\"10.4103/0019-5545.69220\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBloom, D.E., Cafiero, E.T., Jan\u0026eacute;-Llopis, E., Abrahams-Gessel, S., Bloom, L.R., Fathima, S., Feigl,A.B., Gaziano, T., Mowafi, M., Pandya, A., Prettner, K., Rosenberg, L., Seligman, B., Stein, A.Z., \u0026amp; Weinstein, C. (2011). The Global Economic Burden of Noncommunicable Diseases. Geneva: World Economic Forum.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGururaj G, Varghese M, Benegal V, Rao GN, Pathak K, Singh LK, Mehta RY, Ram D, Shibukumar TM, Kokane A, Lenin Singh RK, Chavan BS, Sharma P, Ramasubramanian C, Dalal PK, Saha PK, Deuri SP, Giri AK, Kavishvar AB, Sinha VK, Thavody J, Chatterji R, Akoijam BS, Das S, Kashyap A, Ragavan VS, Singh SK, Misra R and NMHS collaborators group. National Mental Health Survey of India, 2015-16: Prevalence, patterns and outcomes. Bengaluru, National Institute of Mental Health and Neuro Sciences, NIMHANS Publication No. 129, 2016.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDinakaran D, Krishna A, Elangovan AR, Amudhan S, Muthuswamy S, Ramasubramanian C, et al. Epidemiological analysis of mental health morbidity in Tamil Nadu. Indian J Psychiatry. 2023;65:1275\u0026ndash;81. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4103/indianjpsychiatry.indianjpsychiatry_829_23\u003c/span\u003e\u003cspan address=\"10.4103/indianjpsychiatry.indianjpsychiatry_829_23\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKnapp M, Wong G. Economics and mental health: the current scenario. World Psychiatry Off J World Psychiatr Assoc WPA. 2020;19:3\u0026ndash;14. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1002/wps.20692\u003c/span\u003e\u003cspan address=\"10.1002/wps.20692\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTungpunkom P, Maayan N, Soares-Weiser K. Life skills programmes for chronic mental illnesses. Cochrane Database Syst Rev. 2012;1:CD000381. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1002/14651858.CD000381.pub3\u003c/span\u003e\u003cspan address=\"10.1002/14651858.CD000381.pub3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFekadu W, Mihiretu A, Craig TKJ, Fekadu A. Multidimensional impact of severe mental illness on family members: systematic review. BMJ Open. 2019;9:e032391. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/bmjopen-2019-032391\u003c/span\u003e\u003cspan address=\"10.1136/bmjopen-2019-032391\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAnthony WA. Recovery from mental illness: The guiding vision of the mental health service system in the 1990s. Psychosoc Rehabil J. 1993;16:11\u0026ndash;23. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1037/h0095655\u003c/span\u003e\u003cspan address=\"10.1037/h0095655\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDavidson L, O\u0026rsquo;Connell M, Tondora J, Styron T, Kangas K. The top ten concerns about recovery encountered in mental health system transformation. Psychiatr Serv Wash DC. 2006;57:640\u0026ndash;5. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1176/ps.2006.57.5.640\u003c/span\u003e\u003cspan address=\"10.1176/ps.2006.57.5.640\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShepherd G, Boardman J, Slade M (2008) Making recovery a reality. London: Sainsbury Centre for mental health.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJuliet SHO, Joseph J, Sims S, Annamalai K, Venkatraman L, Raghavan V, et al. Does Telephone Based Intervention Combined with Face to Face Contact Improve Socio-Occupational Functioning of Persons with Schizophrenia? A Retrospective Chart Review. J Psychosoc Rehabil Ment Health. 2022;9:99\u0026ndash;105. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s40737-021-00240-w\u003c/span\u003e\u003cspan address=\"10.1007/s40737-021-00240-w\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePatel V, Saxena S, Lund C, Thornicroft G, Baingana F, Bolton P, et al. The Lancet Commission on global mental health and sustainable development. Lancet Lond Engl. 2018;392:1553\u0026ndash;98. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/S0140-6736(18)31612-X\u003c/span\u003e\u003cspan address=\"10.1016/S0140-6736(18)31612-X\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWorld Health Organization. (2021, May 26). Guidance and technical packages on community mental health services. Retrieved September 21, 2025, from \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.who.int/publications/i/item/guidance-and-technical-packages-on-community-mental-health-services\u003c/span\u003e\u003cspan address=\"https://www.who.int/publications/i/item/guidance-and-technical-packages-on-community-mental-health-services\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIndia State-Level Disease Burden Initiative Mental Disorders Collaborators. The burden of mental disorders across the states of India: the Global Burden of Disease Study 1990\u0026ndash;2017. Lancet Psychiatry. 2020;7:148\u0026ndash;61. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/S2215-0366(19)30475-4\u003c/span\u003e\u003cspan address=\"10.1016/S2215-0366(19)30475-4\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePatel V, Araya R, Chatterjee S, Chisholm D, Cohen A, De Silva M, et al. Treatment and prevention of mental disorders in low-income and middle-income countries. Lancet Lond Engl. England; 2007;370:991\u0026ndash;1005. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/S0140-6736(07)61240-9\u003c/span\u003e\u003cspan address=\"10.1016/S0140-6736(07)61240-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePriebe S, Kelley L, Omer S, Golden E, Walsh S, Khanom H, et al. The Effectiveness of a Patient-Centred Assessment with a Solution-Focused Approach (DIALOG+) for Patients with Psychosis: A Pragmatic Cluster-Randomised Controlled Trial in Community Care. Psychother Psychosom. 2015;84:304\u0026ndash;13. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1159/000430991\u003c/span\u003e\u003cspan address=\"10.1159/000430991\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJovanović N, Russo M, Pemovska T, Francis JJ, Arenliu A, Bajraktarov S, et al. Improving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: Results from a hybrid effectiveness-implementation, pragmatic, cluster-randomized clinical trial (IMPULSE). Eur Psychiatry. 2022;65:e50. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1192/j.eurpsy.2022.2302\u003c/span\u003e\u003cspan address=\"10.1192/j.eurpsy.2022.2302\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcNamee P, Matanov A, Jerome L, Kerry S, Walker N, Feng Y, et al. Clinical- and cost-effectiveness of a technology-supported and solution-focused intervention (DIALOG+) in treatment of patients with chronic depression-study protocol for a multi-site, cluster randomised controlled trial [TACK]. Trials. 2022;23:237. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13063-022-06181-4\u003c/span\u003e\u003cspan address=\"10.1186/s13063-022-06181-4\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003evan Loggerenberg F, Akena D, Alinaitwe R, Birabwa-Oketcho H, M\u0026eacute;ndez CAC, G\u0026oacute;mez-Restrepo C, et al. Feasibility and outcomes of using DIALOG\u0026thinsp;+\u0026thinsp;in primary care to improve quality of life and mental distress of patients with long-term physical conditions: an exploratory non-controlled study in Bosnia and Herzegovina, Colombia and Uganda. BMC Prim Care. 2023;24:241. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s12875-023-02197-0\u003c/span\u003e\u003cspan address=\"10.1186/s12875-023-02197-0\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSlatina Murga S, Janković S, Muhić M, Sikira H, Burn E, Priebe S, et al. Effectiveness of a structured intervention to make routine clinical meetings therapeutically effective (DIALOG+) for patients with depressive and anxiety disorders in Bosnia and Herzegovina: A cluster randomised controlled trial. Psychiatry Res Commun. 2021;1:None. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.psycom.2021.100010\u003c/span\u003e\u003cspan address=\"10.1016/j.psycom.2021.100010\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQureshi O, Divya K, Dawood M, Davis S, Venkatraman L, Baig M, et al. Exploring the feasibility and acceptability of DIALOG+ (a structured digital communication tool) in strengthening psychiatric care in India and Pakistan: a qualitative pilot study. BMJ Open. 2025;15:e091852. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/bmjopen-2024-091852\u003c/span\u003e\u003cspan address=\"10.1136/bmjopen-2024-091852\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, et al. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007;64:966\u0026ndash;74. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1001/archpsyc.64.8.966\u003c/span\u003e\u003cspan address=\"10.1001/archpsyc.64.8.966\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eApplication and results of the Manchester Short Assessment of Quality of Life (MANSA) - PubMed [Internet]. [cited 2025 Dec 2]. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pubmed.ncbi.nlm.nih.gov/10443245/\u003c/span\u003e\u003cspan address=\"https://pubmed.ncbi.nlm.nih.gov/10443245/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 2 Dec 2025\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePriebe S, Golden E, Kingdon D, Omer S, Walsh S, Katevas K, et al. Effective patient\u0026ndash;clinician interaction to improve treatment outcomes for patients with psychosis: a mixed-methods design [Internet]. Southampton (UK): NIHR Journals Library; 2017 [cited 2025 Dec 2]. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.ncbi.nlm.nih.gov/books/NBK424433/\u003c/span\u003e\u003cspan address=\"http://www.ncbi.nlm.nih.gov/books/NBK424433/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 2 Dec 2025\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBird VJ, Sajun SZ, Peppl R, Evans-Lacko S, Priebe S, Singh S, et al. Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan\u0026mdash;a cluster RCT. Trials. 2023;24:59. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13063-022-07032-y\u003c/span\u003e\u003cspan address=\"10.1186/s13063-022-07032-y\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePriebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999;45:7\u0026ndash;12. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1177/002076409904500102\u003c/span\u003e\u003cspan address=\"10.1177/002076409904500102\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLovibond PF, Lovibond SH. Depression Anxiety and Stress Scales [Internet]. 2015 [cited 2025 Sept 21]. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1037/t39835-000\u003c/span\u003e\u003cspan address=\"10.1037/t39835-000\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHamilton M. A Rating Scale for Depression. J Neurol Neurosurg Psychiatry. BMJ Publishing Group Ltd; 1960;23:56\u0026ndash;62. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/jnnp.23.1.56\u003c/span\u003e\u003cspan address=\"10.1136/jnnp.23.1.56\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988;14:61\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/0165-0327(88)90072-9\u003c/span\u003e\u003cspan address=\"10.1016/0165-0327(88)90072-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020;49:979\u0026ndash;95. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1093/ije/dyz237\u003c/span\u003e\u003cspan address=\"10.1093/ije/dyz237\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBird VJ, Sajun SZ, Peppl R, Evans-Lacko S, Priebe S, Singh S, et al. Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan-a cluster RCT. Trials. 2023;24:59. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13063-022-07032-y\u003c/span\u003e\u003cspan address=\"10.1186/s13063-022-07032-y\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAlagarsamy S, Sugirthan N, Mehrolia S, Elangovan N. Translation and validation of the Tamil version of depression anxiety stress scales-21. J Affect Disord Rep. 2022;10:100398. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.jadr.2022.100398\u003c/span\u003e\u003cspan address=\"10.1016/j.jadr.2022.100398\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSharma MK, Hallford DJ, Anand N. Confirmatory factor analysis of the Depression, Anxiety, and Stress Scale among Indian adults. Indian J Psychiatry. 2020;62:379\u0026ndash;83. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4103/psychiatry.IndianJPsychiatry_313_19\u003c/span\u003e\u003cspan address=\"10.4103/psychiatry.IndianJPsychiatry_313_19\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePrasad MK, Udupa K, Kishore KR, Thirthalli J, Sathyaprabha TN, Gangadhar BN. Inter-rater reliability of Hamilton depression rating scale using video- recorded interviews - Focus on rater-blinding. Indian J Psychiatry. 2009;51:191\u0026ndash;4. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.4103/0019-5545.55085\u003c/span\u003e\u003cspan address=\"10.4103/0019-5545.55085\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbraham J. International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. In: Tietje C, Brouder A, editors. Handb Transnatl Econ Gov Regimes [Internet]. Brill | Nijhoff; 2010 [cited 2025 Sept 21]. p. 1041\u0026ndash;53. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1163/ej.9789004163300.i-1081.897\u003c/span\u003e\u003cspan address=\"10.1163/ej.9789004163300.i-1081.897\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/bmj.e7586\u003c/span\u003e\u003cspan address=\"10.1136/bmj.e7586\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eResources | East London NHS Foundation Trust [Internet]. [cited 2025 Sept 21]. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.elft.nhs.uk/dialog/resources\u003c/span\u003e\u003cspan address=\"https://www.elft.nhs.uk/dialog/resources\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 21 Sept 2025\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMichie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A, et al. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005;14:26\u0026ndash;33. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1136/qshc.2004.011155\u003c/span\u003e\u003cspan address=\"10.1136/qshc.2004.011155\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAtkins L, Francis J, Islam R, O\u0026rsquo;Connor D, Patey A, Ivers N, et al. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017;12:77. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1186/s13012-017-0605-9\u003c/span\u003e\u003cspan address=\"10.1186/s13012-017-0605-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"DIALOG+, Psychosocial intervention, Quality of Life, Solution-focused, Cluster randomised trial, Patient Satisfaction, Common mental disorders, Mental health, Outpatient setting, Routine treatment","lastPublishedDoi":"10.21203/rs.3.rs-8416024/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8416024/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eClinically diagnosed anxiety, and depressive disorders are widely recognised as the most common mental health issues in India, affecting approximately 15% of the population. With notable gender disparities, Tamil Nadu has some of the highest rates of depression in the nation. Despite the growing burden, countries such as India that fall within the low and middle-income countries (LMICs) continue to struggle with mental health services due to challenges in funding, a lack of qualified practitioners, and obstacles to putting evidence-based treatments like Cognitive Behaviour Therapy (CBT) into practice. Innovative, low-cost, and scalable approaches are needed to address this gap. This multisite, pragmatic randomized controlled trial (RCT) seeks to assess the feasibility, acceptability, and evaluate the effectiveness of DIALOG+, a low-cost, app-based, solution-focused intervention designed to enhance quality of life and reduce mental distress. While previously validated for psychosis and other chronic psychiatric conditions, this study aims to evaluate its potential for individuals with anxiety and depression in outpatient psychiatric services in India.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA pragmatic, multisite randomized controlled trial will be conducted across four outpatient psychiatric settings in Chennai and Puducherry to assess the feasibility, acceptability, and effectiveness of DIALOG+, a low-cost app-based intervention. Adults (18\u0026ndash;65 years) with anxiety and/or depressive disorders will be randomly allocated to receive either DIALOG\u0026thinsp;+\u0026thinsp;together with treatment as usual (TAU) or DIALOG Scale alongside treatment as usual (TAU) over a 6-month period. The key outcome of this study is improvement in quality of life, evaluated through the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcomes will include changes in depression and anxiety measured by the Depression, Anxiety and Stress Scale (DASS-21), Hamilton Depression Rating Scale (HDRS), and Hamilton Anxiety Rating Scale (HAM-A). Feasibility will be assessed through recruitment, retention, and intervention fidelity rates, while acceptability will be explored through interviews with participants and clinicians. Assessments at follow-up will be carried out at 3 and 6 months, and analyses will follow an intention-to-treat approach.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eIf feasible, acceptable, and effective, DIALOG\u0026thinsp;+\u0026thinsp;for clinically diagnosed persons with anxiety and depressive disorders could represent a transformative, scalable solution to improve mental health outcomes in India and similar LMIC contexts.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eThe study is registered under Clinical trial registry-India (CTRI), and the registration number is CTRI/2025/08/092477.The registration was done on 6th August 2025.The URL of the trial registry record is \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=133110\u0026amp;EncHid=16149.91763\u0026amp;modid=1\u0026amp;compid=19\u003c/span\u003e\u003cspan address=\"https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=133110\u0026amp;EncHid=16149.91763\u0026amp;modid=1\u0026amp;compid=19\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/p\u003e","manuscriptTitle":"Study Protocol Low Cost App-Based Intervention Dialog+ for Depression and Anxiety in Outpatient Psychiatric Settings: A Study Protocol for a Pragmatic Multisite Cluster Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-23 07:46:29","doi":"10.21203/rs.3.rs-8416024/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"282220430669018469499539024070515049499","date":"2026-05-14T20:02:28+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-05-13T18:34:17+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-05-04T04:03:33+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-22T11:35:02+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2026-01-20T07:49:38+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7a443874-d729-4492-8dae-7f291866cc16","owner":[],"postedDate":"January 23rd, 2026","published":true,"recentEditorialEvents":[{"type":"reviewerAgreed","content":"282220430669018469499539024070515049499","date":"2026-05-14T20:02:28+00:00","index":17,"fulltext":""},{"type":"reviewersInvited","content":"1","date":"2026-05-13T18:34:17+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-05-04T04:03:33+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-13T18:38:24+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-23 07:46:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8416024","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8416024","identity":"rs-8416024","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}