Adaptation of an integrated Behavioural Activation and physical activity intervention for women with depression and type 2 diabetes mellitus in Pakistan

Adaptation of an integrated Behavioural Activation and physical activity intervention for women with depression and type 2 diabetes mellitus in Pakistan | 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 Research Article Adaptation of an integrated Behavioural Activation and physical activity intervention for women with depression and type 2 diabetes mellitus in Pakistan Aatik Arsh, Saima Afaq, Claire Carswell, Najma Siddiqi This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7480009/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background Integrated Behavioural Activation and physical activity interventions (BAcPAc) have the potential to tackle depression and type 2 diabetes mellitus (T2DM) multimorbidity. However, such interventions, developed in high-income countries, may need to be adapted and contextualized to be appropriate for use in low and middle-income countries. The objective of this study was to adapt a BAcPAc intervention to tailor it for women with depression and T2DM living in Pakistan. Methods Two co-design informed workshops with key stakeholders (people with depression and T2DM, carers, healthcare workers, and social workers) were conducted. The purpose of workshop 1 was to identify facilitators and barriers to the delivery of the original BAcPAc intervention as per the domains of the Bernal cultural adaptation framework (language, persons, metaphors, content, concepts, goals, methods, context). Based on the findings of workshop 1, changes were made to the original intervention. Stirman’s adaptation classification was used to map the changes. In workshop 2, participants’ feedback was used to refine and finalise the contents of the adapted intervention. Results A total of 21 participants attended workshop 1, while 16 participants attended workshop 2. Barriers and enablers were identified in all domains of the Bernal’s framework. Changes were made in the language, pictures/illustrations, intervention dose and delivery, training intensity, and evaluation measures. Conclusion This study produced a theoretically informed, culturally adapted BAcPAc intervention for women with depression and T2DM living in Pakistan. Behavioural Activation Depression Diabetes Mellitus Type 2 Physical activity Women Figures Figure 1 1. INTRODUCTION Depression and type 2 diabetes mellitus (T2DM) multimorbidity is highly prevalent as 14.5–28% of people with T2DM suffer from depression (Farooqi et al., 2022 ; Khaledi et al., 2019 ; Wang et al., 2019 ). Evidence suggests that women with T2DM have a higher prevalence of depression compared to their male counterparts (Barbosa et al., 2022 ; Pan et al., 2010 ). The prevalence of depression among women with T2DM ranges from 24–34%, while its prevalence among men ranges from 15.8–23% (Farooqi et al., 2022 ; Khaledi et al., 2019 ; Wang et al., 2019 ). In low and middle-income countries (LMICs), although the prevalence of depression among women with T2DM has not been studied, it is reported that estimates of depression prevalence might be considerably higher in this population (Mendenhall & Weaver, 2014 ). Physical activity has been shown to not only improve glycaemic control but also to be effective in managing depression (Kandola et al., 2019 ; Narita et al., 2019 ; van der Feltz-Cornelis et al., 2021 ). However, women with depression and T2DM mostly remain physically inactive (Koopmans et al., 2009 ; Lee et al., 2020 ). This is a particular challenge in Pakistan where due to cultural values, women face additional barriers to physical activity compared to men (Arsh et al., 2023 )). According to conservative estimates, 27–80% of women in Pakistan are physically inactive (Guthold et al., 2008 ; Hoodbhoy et al., 2018 ; Mawani, 2017 ; Memon et al., 2018 ; Pengpid et al., 2015 ; Samir et al., 2011 ). While the statistics regarding physical inactivity among women with T2DM and depression living in Pakistan are not available, it is likely that physical inactivity is significantly higher in this population compared to the level of physical inactivity observed in the general population. Literature suggests that the use of rewarding activities can improve people’s motivation and compliance to adhere to specific exercise protocols (Bullard et al., 2019 ). Behavioural Activation (BA) is based on identifying and engaging in rewarding activities to improve symptoms of depression (Janssen et al., 2021 ; Turner & Leach, 2012 ). While increasing daily activities is the goal of BA, it does not specifically employ strategies to promote physical activity. With a slight change in the emphasis, there is a possibility to focus BA on physical activity. This can be achieved by selective reinforcement of activities that demand high energy expenditure (Michie et al., 2009 ; Pentecost et al., 2015 ). Adapting BA to focus specifically on physical activity could potentially improve uptake of physical activity in women with depression and T2DM, leading to better glycaemic control, in addition to improving depression symptoms. Some studies have either discussed the possibility of using BA along with physical activity (Farrand et al., 2014 ; Lambert et al., 2017 ; Schneider et al., 2011 ; Turner et al., 2019 ), or evaluated the feasibility of combined BA and physical activity interventions for the management of depression (Lambert et al., 2018 ; Pentecost et al., 2015 ; Schneider et al., 2016 ). The only study available in the literature that specifically assessed the effects of a combined BA and physical activity intervention for the management of depression in people with T2DM was conducted by Schneider et al. ( 2011 , 2016 ) (Schneider et al., 2011 ; Schneider et al., 2016 ), although they did not describe the intervention development process. The development of an intervention to integrate BA with physical activity for adults with depression has previously been described by Farrand et al. ( 2014 ), followed by a pilot RCT to assess the feasibility and acceptability of the intervention (Farrand et al., 2014 ; Pentecost et al., 2015 ). The feasibility trial suggested that the integrated BA and physical activity (BAcPAc) intervention is feasible and acceptable. Farrand and his colleagues derived principles from self-determination theory to adapt the BA protocol proposed by Richards ( 2010 ) to emphasize physical activity (Richards, 2010 ). According to self-determination theory, behaviour results from intrinsic motivation (the pleasure one experiences when engaging in a behaviour). Self-determination theory argues that intrinsic motivation can be achieved if three core psychological needs (autonomy, competence, and relatedness) are attained. Self-determination theory emphasizes that meeting these psychological needs is crucial for the initiation and maintenance of behaviour. The fundamental concept of self-determination theory is that a person’s psychological needs must be met (autonomy, competence, and relatedness) within an activity for them to be optimally motivated to engage (Deci & Ryan, 1985 , 2000 , 2008 ; Ryan et al., 2009 ). Evidence suggests that interventions based on self-determination theory which focus on patient preferences could result in more enduring changes in physical activity by fostering autonomy and concentrating on more enduring, intrinsically driven changes (Nyström et al., 2015 ; Teixeira et al., 2012 ). Lambert et al. ( 2017 ) adapted the concepts of Farrand et al. ( 2014 ) to develop a web-based BA and physical activity intervention (Lambert et al., 2017 ). They also conducted a pilot RCT and reported that a web-based BA and physical activity intervention is feasible for adults with depression (Lambert et al., 2018 ). To sum up, there are good arguments for integrating BA with physical activity and there is emerging evidence for the effectiveness of this approach. Moreover, it is evident that integrated BA and physical activity interventions have the potential to promote physical activity and thus tackle depression and T2DM multimorbidity (Lambert et al., 2018 ; Pentecost et al., 2015 ; Schneider et al., 2016 ). However, to date, this work has been carried out in high income countries and may not translate to LMIC contexts. Therefore, integrated BA and physical activity interventions developed in high-income countries need to be adapted and contextualized in LMICs. This is particularly important for women with depression and T2DM living in Pakistan because the existing BA and physical activity interventions may not be feasible for them. Therefore, the current study was designed to adapt an integrated BA and physical activity intervention for women with depression and T2DM living in Pakistan. 2. MATERIAL AND METHODS 2.1. Intervention for adaptation BAcPAc, developed by Farrand et al. ( 2014 ) is the only theoretically informed intervention we found that integrates BA and physical activity for people with depression (Farrand et al., 2014 ). Therefore, we chose to adapt this intervention for women with depression and T2DM in Pakistan. 2.2. Adaptation framework The Bernal’s cultural adaptation framework was used to guide the choice of intervention aspects that needed adaptation (Bernal et al., 1995 ). The adaptation matrix from the Stirman adaptation classification was used to map and describe the changes made to the original intervention (Stirman et al., 2013 )). An initial logic model was developed to visualize the process of intervention adaptation (Fig. 1 ). 2.3. Participants Patient participants, carers, healthcare staff, and social workers/representatives of the public were recruited into the consultative workshops. 2.3.1. Patient-participants Individuals, aged ≥ 18 years, with a physician-confirmed diagnosis of T2DM, and a diagnosis of major depressive disorder as defined by the Structured Clinical Interview for DSM-V disorders and who were able to provide informed consent, were eligible. 2.3.2. Carers Individuals, aged ≥ 18 years, nominated by the patient participants as a carer, who provide care to a family member with the clinical diagnosis of depression and T2DM, and who could provide informed consent, were eligible. 2.3.3. Healthcare staff Diabetes specialists, mental health specialists (psychiatrists/psychologists), and other healthcare staff and managers (nutritionists, and paramedical staff), involved in primary or secondary care of people with depression and T2DM, were eligible. In addition, professionals with relevant knowledge or experience of physical activity interventions (such as physical therapists and public health experts) were eligible. 2.3.4. Social workers/representatives of the public Individuals, aged ≥ 18 years, working for the social welfare of the community, were eligible. 2.4. Participants identification Participants were identified from three main sources: 2.4.1. Participants of qualitative study Individuals (people with depression and T2DM, their carers, and healthcare staff) who participated in the qualitative study (Arsh et al., 2023 ), conducted prior to this study, were invited to join the consultative workshops. These individuals were invited to the current study to gain insights from their experiences for the adaptation of integrated BA and physical activity intervention. 2.4.2. Participants from DiaDeM study Patients and healthcare staff (psychologists (supervisors), and non-mental health specialists (facilitators) with experience of delivering BA) who participated in the DiaDeM (management of depression in diabetes) programme, an ongoing National Institute of Health Research (NIHR) funded research project, which aims to develop and test a culturally appropriate approach to the recognition and treatment of depression in people with diabetes in Bangladesh and Pakistan based on BA (Aslam et al., 2022 ; Zavala et al., 2023 ), were also invited. These individuals had either received or delivered BA, so they were targeted to gain insights from their experiences. 2.4.3. Referral New participants, who did not take part in the qualitative study, or the DiaDeM programme were also recruited. They were identified with the help of participants who either participated in the qualitative study or in the DiaDeM study. 2.5. Recruitment The research team provided leaflets and participant information sheets, containing information about the research study and information on how to get involved in the study to potential participants. A contact number and email address were provided for the participants to use if they wished to participate. A self-addressed envelope was also provided which potential participants may return if they wish to participate in the study but do not want to call or email. When potential participants made contact, a researcher scheduled meetings with them to re-confirm their eligibility and answer any queries about the study. Written informed consent (either thumbprints or signatures) was obtained on the day of the workshop before the commencement of the workshop by the workshop facilitator. 2.6. Data collection Two consultative workshops were conducted at Khyber Medical University Peshawar in May and June 2023. Each workshop lasted 4 hours with a 30-minute break after the first 120 minutes. Each workshop began with a formal welcome to the participants followed by the introduction of facilitators and participants. The aims and objectives of the workshops and a summary of the intervention adaptation process were communicated to the participants. The content and activities of the workshop were then presented. 2.6.1. Workshop 1 The objective of workshop 1 was to identify changes needed in the original intervention. Hard copies of the BAcPAc intervention were provided to participants. The workshop facilitators presented the core components of original BAcPAc intervention to the participants and explained the need for an adapted intervention. Participants were given enough time to review and understand the core components of the original intervention. Four personas were presented. Persona characteristics varied in age, marital status/number of children, area (urban/rural), profession, and socioeconomic status. The workshop participants were divided into four groups and one persona was assigned to each group. Each group was asked to identify factors as per the domains of Bernal’s framework (language, persons, metaphors, content, concepts, goals, methods, context), specific to the persona that could affect participation and/or adherence to the original BAcPAc intervention. A 30-minute break was announced after completion of this activity. During break time, workshop facilitators displayed the personas along with the factors identified by each group for their assigned persona. After break time, participants were requested to suggest changes that could be made to the original BAcPAc intervention to overcome constraints identified by participants for the personas. The suggestions presented by participants were noted. The factors identified by participants that could affect participation and/or adherence to the original BAcPAc intervention and the suggestions to overcome these constraints were compiled according to Bernal’s framework. The changes in the original BAcPAc intervention proposed by workshop participants were made. The Stirman adaptation classification was used to map the changes made to the original intervention (Stirman et al., 2013 ). 2.6.2. Workshop 2 The objective of the 2nd workshop was to present the adapted intervention materials to the stakeholders and refine it. Before the workshop, the adapted intervention materials were provided to the participants of workshop 1 (either in soft copy or hard copy depending on participant preference) for review and feedback. Sections of the adapted intervention were presented to participants of workshop 2, and they were asked to give their feedback after each section of the presentation. This feedback was used to refine and finalise the adapted intervention materials. 2.7. Ethics approval Ethics approval was obtained from the Health Sciences Research Governance Committee University of York United Kingdom (Reference No. HSRGC/2022/498/A, dated 6th May 2022) and Ethics Board of Khyber Medical University Pakistan (Reference No. DIR/KMU-EB/CB/00115, dated 23rd May 2022). 3. RESULTS 3.1. Participants A total of 21 participants attended the first consultative workshop including 7 patient participants (5 female and 2 male), 9 healthcare staff (5 female and 4 male), 2 carers (1 female and 1 male), and 3 social workers/representatives of public (1 female and 2 male).The second workshop was attended by 16 participants including 6 patient participants (5 female and 1 male), 7 healthcare staff (4 female and 3 male), 2 carers (1 female and 1 male), and 1 female social worker. Of the workshop 2 participants, 11 attended workshop 1 (Supplementary file 1) . 3.2. Intervention adaptation The original BAcPAc intervention comprised of a self-help workbook (Get Active_layout_1 (exeter.ac.uk)), training manual (Microsoft Word - Additional file 3.docx (springer.com)) and case studies Get Active_layout_1 (exeter.ac.uk). The participants carried out a detailed review of the intervention to identify barriers and enablers to delivery within the domains of the Bernal cultural adaptation framework (Supplementary file 2) . 3.2.1. Language The original BAcPAc intervention was delivered in the English language and therefore it was not possible to use it in Pakistani settings. However, participants highlighted the possibility of translating the intervention content into the Urdu language. Participants emphasized that written Urdu is much easier to understand as compared to other local languages (such as Pashto), therefore, the consensus was that the intervention materials should be translated into Urdu. 3.2.2. Persons (patient and therapist) In the BAcPAc intervention, there was no consideration of the patient’s and therapist’s gender, however, the participants in the consultative workshops felt that women patients and their carers might prefer female therapists. Workshop participants highlighted the comparatively negative attitude of patients and their carers towards healthcare staff other than the treating physician (diabetologist). 3.2.3. Metaphors (using signs and symbols) The original intervention did not include signs or symbols in the self-help workbook. Participants suggested providing signs and symbols to guide patients and their carers. For example, when explaining routine activities, the symbol of a clock can be incorporated in the intervention material to denote 24-hour routine activities. Similarly, to explain pleasurable activities, a smiley emoji can be used. 3.2.4. Content Participants highlighted that the case studies, activities, images, and illustrations used in the original intervention are not appropriate for Pakistani settings. Moreover, participants were concerned that patients may face difficulties reading and understanding lengthy written scripts, instructions, and explanations present in the original intervention manuals. Participants discussed that case studies specific to local context need to be developed. Similarly, participants emphasized the addition of cultural and religious-specific images and illustrations in the intervention manual. Moreover, participants recognised the need to replace certain textual information with images and illustrations. 3.2.5. Concepts Participants highlighted that patients and their carers often have limited awareness about the positive effects of physical activity on mental health and this might be a barrier to intervention delivery. Participants added that generally people consider rest as more beneficial for people with depression and there could be concerns that physical activities might aggravate their depression symptoms. Nonetheless, participants stated that patients and their carers are generally aware of the positive effects of physical activity on physical health (weight loss, body appearance, general health) and thus this could help promote engagement in physical activity. 3.2.6. Goals The goal of both original BAcPAc intervention and the adapted intervention was to promote physical activity and reduce depressive symptoms. In addition, the adapted intervention also aims to manage blood glucose levels in women with depression and T2DM. 3.2.7. Methods The BAcPAc intervention was delivered by psychological well-being practitioners. In the UK, psychological well-being practitioners treat and support individuals with common mental health issues such as depression and anxiety. Psychological well-being practitioners receive British Psychological Society accredited training (45 days of academic work alongside supervised practice for one year) based upon the curriculum developed for the Improving Access to Psychological Therapies (IAPT) program (NHS, 2023 ; Richards, 2009 ). The psychological well-being practitioners involved in delivering BAcPAc intervention received one day of additional training related to BAcPAc intervention. Participants discussed different possibilities for delivering the adapted intervention in the diabetes care facilities because there is no psychological well-being practitioners role in Pakistan. Similarly, other mental health workers are generally not available in diabetes care facilities. In addition to this, participants highlighted that patients might face difficulties in visiting healthcare facilities for treatment sessions due to financial constraints, long distances to travel and restrictions to solo travel of women with depression and T2DM. Furthermore, participants emphasized that patients might not be able to fill their worksheets without assistance. Workshop participants discussed the possibility of training non-mental health specialists who would be available at diabetes care facilities such as nutritionists and nurses to deliver the adapted intervention. Participants emphasized that one-day training might be insufficient to understand the intervention components, therefore non-mental health specialists who are supposed to deliver the adapted intervention should receive at least 3 days of face-to-face training. Participants also advised that follow-up intervention sessions need to be scheduled alongside follow-up diabetic check-ups and these follow-up sessions need to be flexible to accommodate patient needs. Similarly, participants recommended involving family members/ friends to assist patients in completing their worksheets and helping them achieve the goals of the intervention. 3.2.8. Context Participants highlighted that patients might be dependent on carers as in Pakistan women often do not travel alone. Patients might also need permission from husbands/ other male family members to attend sessions. Participants discussed the possibility of the therapist meeting with carers/family members. Participants highlighted that carers could support therapists in the successful delivery of the intervention and thus it may be necessary to involve family members/carers along with the patient. 3.3. Intervention production 3.3.1. Content modifications 3.3.1.1 Curricula and components (inclusion or exclusion of elements) : The original intervention was designed for adults with depression only, therefore, we added T2DM along with depression when referring to the target population. Moreover, activities mentioned in the case studies were relevant to people in the UK, therefore, we changed the examples of activities in the case studies to be culturally relevant, particularly we focused on activities that are commonly performed by women in Pakistan such as performing household chores, children’s care, visiting neighbours and relatives, care for cattle, helping male partners in farming related activities, gardening in home, and walk within home or in open space. The adapted intervention was named the BE-ACTIVE intervention. (Supplementary file 3) . 3.3.1.2 Change in pictures or illustrations : In the BAcPAc intervention manual, there were only a few pictures of people from the UK on the initial pages of the booklet. In addition to replacing the existing pictures, we included some additional pictures presenting the local context to illustrate the activities pictorially. We have added symbols and emojis to the self-help workbook to guide participants about certain components. Moreover, in the original intervention manual, a visual scale from 0 to 6 was used to evaluate difficulties in performing activities, however, we replaced it with a visual scale from 0 to 10. Participants highlighted that it would be easier to explain a 0 to 10 visual scale to patients and their carers. 3.3.1.3 Intervention dose : The original intervention consisted of one assessment session, followed by 12 support sessions. Each session was 25 to 35 minutes. The adapted intervention consists of one assessment session followed by 5 support sessions and each session is 30 to 45 minutes. The six sessions will be delivered in 6 to 12 weeks duration to ensure flexibility in the intervention sessions. Participants highlighted that 12 sessions might not be feasible for the target population. They added that DiaDeM (BA intervention for people with depression and T2DM delivered in Pakistan and Bangladesh (Aslam et al., 2022 ; Zavala et al., 2023 )) and BEACON (BA intervention for people with non-communicable diseases delivered in India (Zainab et al., 2022 )) comprised 6 interventions sessions. Participants anticipated that 6 sessions will be feasible for patients, therefore they suggested that the adapted intervention should have 6 intervention sessions. 3.3.2. Contextual modifications 3.3.2.1 Inclusion and exclusion criteria : The original intervention was focused on individuals with depression living in the UK while the adapted intervention is focused on women with depression and T2DM living in Pakistan. 3.3.2.2 Intervention delivery : The original intervention manual was lengthy with most of the instructions in written format. In the adapted intervention, the self-help materials are more brief with increased verbal input from the therapists. Where possible, written text is replaced with images and illustrations. Similarly, in the original intervention, instructions about support from family/friends were mentioned only a few times. In the adapted intervention, a stronger social support component is advised to ask patients to involve family or friends if possible. The original intervention was delivered by trained psychological well-being practitioners; however, the adapted intervention will be delivered by non-mental health specialists working in diabetes care services who will be trained on the delivery of the adapted intervention. Moreover, an initial verbal/written description of the intervention will be provided by the treating physician, who will also be responsible for referring patients to the intervention. 3.3.3. Modifications to the training and evaluation process 3.3.3.1 Training : In the original intervention, trained psychological well-being practitioners received one day of training. For the adapted intervention, non-mental health specialists will receive 3 days of face-to-face training. Moreover, relevant reading materials and/or online resources will be provided to therapists to gain insights about concepts of BA, physical activity and original BAcPAc intervention. 3.3.3.2 Evaluation measures : Physical activity and depression were the main outcomes for the original intervention while we will also evaluate glycaemic control, in addition to physical activity and depression. Moreover, after the treatment, we will also evaluate activities in which patients face difficulties at the start of the treatment, to determine whether engagement in physical activity becomes easier after receiving the intervention. 4. DISCUSSION BAcPAc, an integrated BA and physical activity intervention was adapted for women with depression and T2DM living in Pakistan. Two consultative workshops were conducted to facilitate the process of intervention adaptation. Modifications were made to the original intervention based on the findings of the consultative workshops, to make the intervention culturally appropriate for the target population. The changes made during the adaptation process were mapped according to the Adaptation matrix from the Stirman adaptation classification (Stirman et al., 2013 ). The workshop participants emphasised that the uptake of the adapted intervention might depend on the involvement of family members and the treating physicians in the intervention delivery. The main reasons for including family members and carers in the delivery of the adapted intervention are the dependence of women in Pakistan on family members for treatment-related decisions, and difficulties women experience travelling alone to healthcare facilities. In Pakistan, important decisions are usually made by male members of the family and some reports showed that even women’s health-related decisions are usually made by male family members (Memon et al., 2023 ; Rowther et al., 2020 ; Tariq et al., 2022 ). On average, 48% of women in Pakistan have no say in decisions relating to their healthcare. Compared to urban areas, women in rural areas are 1.3 times more likely to report having no say in decisions regarding their health matters. The statistics are more alarming for women of Pashtun ethnicity because the report revealed that about 65% of women in the Pashtun belt had no right to make decisions about their health (Ilyas, 2018 ; Ismail & Dagia, 2018 ). Despite improvements in legislation related to women’s rights in the last two decades, a major proportion of women remain deprived of their fundamental right to make decisions about their healthcare (Habib et al., 2021 ; Hussain et al., 2019 ). That might be one of the reasons that Pakistan was ranked 145 out of 146 countries in a recent gender gap report (WEF, 2022 ). The fact that women rely on family for treatment-related decisions is of utmost importance as it shows that uptake of the intervention is directly dependent on family involvement. Therefore, the involvement of family members and their carers is essential in the delivery of the adapted intervention. Despite the risk of reinforcing the inequalities for women in decision-making about their health by involving male family members, focusing on depression in women and women’s participation in physical activity should contribute to addressing some of these health disparities. There may also be potential to empower women through the intervention to negotiate with family members. There is high-quality evidence that supports the inclusion of family members in the treatment of people with depression and T2DM. Some of the benefits presented in the literature for including family members in the treatment of people with depression and T2DM include assistance in dietary control, prevention of stigma and isolation, and assistance in the identification of condition-specific symptoms (Bukhsh et al., 2020 ; Gilliss et al., 2019 ; Gupta et al., 2019 ; Mayberry et al., 2021 ). There is agreement between the findings of the current study and the literature that family members need to be considered while designing, delivering, and upscaling the intervention for people with depression and T2DM. In addition to the factors presented above, family members can support people with depression and T2DM by interpreting intervention materials and supporting them to effectively use the intervention. Similarly, family members can facilitate communication between patients and therapists. During the consultative workshops, participants particularly emphasized the importance of the role of treating physicians in intervention delivery. From the findings of the current study, it appeared that generally people with depression and T2DM and their carers follow the advice and prescription of the treating physician while having a more negative attitude towards other healthcare professionals (might be due to limited understanding of their training and role). Participants added that people with depression and T2DM and their carers do not visit other healthcare professionals, follow their instructions, or take their advice seriously until and unless they are referred by the treating physician. During the workshop, participants discussed that treating physicians have busy schedules and due to workload and workforce shortages, it will be implausible for treating physicians to deliver a physical activity intervention in clinical settings. However, keeping in mind the importance of the treating physician’s advice for the uptake of intervention, it was incorporated in the intervention material that the treating physician will provide a verbal/written description of the intervention and refer patients to the intervention. The role of healthcare professionals in physical activity promotion to a broad segment of the population is evident from the literature (Brooks et al., 2019 ; Cantwell et al., 2018 ; Lobelo et al., 2018 ; Netherway et al., 2021 ; Vishnubala & Pringle, 2021 ). However, most healthcare professionals, particularly busy clinicians do not formally advise and/or prescribe physical activity in routine clinical practice. Despite this, from the participant’s discussion during the workshop, it appeared that the sustainability of the adapted intervention is linked with referral to the intervention by the treating physicians. Therefore, the treating physician’s verbal and/or written advice/prescription is particularly mentioned in the adapted intervention. The study has important implications. At present, physical activity is not formally advised or prescribed in routine clinical practice. Healthcare professionals including treating physicians, other medical doctors, nurses, nutritionists, and paramedics can be trained to deliver the adapted intervention. Moreover, there is the possibility to train lay workers (non-healthcare professionals) for the delivery of the adapted intervention, but this needs further exploration as the focus of the current study was on healthcare professionals who are already present in the diabetes care facilities. The adapted intervention focuses on women with depression and T2DM, however, there is the possibility to further adapt this intervention for other populations. The current study provides preliminary work related to the adaptation of an BA and physical activity intervention, however, we need more evidence to guide policy and practice. There is a need to conduct clinical trials to test the feasibility, acceptance, and effectiveness of the adapted intervention. Moreover, the economic implications of the adapted intervention need to be assessed. The current study has several limitations. It was conducted in Khyber Pakhtunkhwa and the focus of the adapted intervention was on women of Pashtun ethnicity, therefore generalisability of the adapted intervention to other regions of Pakistan is questionable. We recruited a diverse group of participants (patient-participants, carers, healthcare staff, social workers) to capture a wide range of views and opinions. However, due to power imbalances, some participants (particularly patient participants) might not have been able to express their views efficiently during consultative workshops. Moreover, due to time constraints and resource limitations, we conducted only two consultative workshops. Despite these limitations, the study involved key stakeholders with diverse backgrounds in the adaptation process. Similarly, in-between workshops, we provided the adapted intervention materials to the stakeholders for review and feedback. Together with the feedback received in-between workshops, we think we were able to identify the most salient adaptations needed. The use of evidence-informed persona to facilitate the workshop discussions, followed good practice guidance, helped to orientate participants to the task. Insights provided by the wide range of stakeholders assisted in identifying factors that can affect the feasibility of the intervention in real-world practice. Similarly, the utilization of the cultural adaptation framework assisted in systematically identifying aspects of the intervention to tailor it to the cultural needs of women with depression and T2DM in the region. 5. CONCLUSION The study reports the cultural adaptation of an integrated BA and physical activity intervention for women with depression and T2DM living in Pakistan. The adapted intervention was named the BE-ACTIVE intervention. The adapted intervention is novel in attempting to offer a solution for physical inactivity among women with depression and T2DM. However, there is a need to assess the feasibility of the adapted intervention and its effectiveness in improving physical activity levels, depressive symptoms, and glycaemic control. Declarations Declaration of interest: None. Author Contribution A.A., S.A., C.C., and N.S. designed the study. A.A. collected data and wrote the initial draft of the paper. S.A., C.C., and N.S. critically revised the manuscript. All authors contributed to and have approved the final manuscript. Acknowledgement We would like to thank Professor Paul Farrand (CEDAR; University of Exeter) for providing BAcPAc intervention materials and for allowing us to adapt BAcPAc intervention. We would also like to thank Brendon Stubbs (King’s College London), Jeffrey Lambert (University of Bath), Joy Adamson (University of York) and Liz Newbronner (University of York) for their expert consultation and guidance. References Arsh, A., Afaq, S., Carswell, C., Coales, K., & Siddiqi, N. (2023). Barriers & facilitators to physical activity in people with depression and type 2 diabetes mellitus in Pakistan: A qualitative study to explore perspectives of patient participants, carers and healthcare staff. 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Adaptation of a Behavioural Activation Intervention for Depression in People with Diabetes in Bangladesh and Pakistan: DiaDeM Intervention. Global Implementation Research and Applications , 3 (1), 44–55. https://doi.org/10.1007/s43477-023-00072-9 Additional Declarations No competing interests reported. Supplementary Files 3.Supplementaryfile1.docx 4.Supplementaryfile2.docx 5.Supplementaryfile3.docx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 01 Sep, 2025 Editor assigned by journal 29 Aug, 2025 Submission checks completed at journal 29 Aug, 2025 First submitted to journal 28 Aug, 2025 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. 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01:03:30","extension":"html","order_by":9,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":166642,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7480009/v1/3237e1d59edc8ba9c2d5c1b7.html"},{"id":92680281,"identity":"ce63e517-8073-405c-94bf-d338410d8431","added_by":"auto","created_at":"2025-10-03 01:03:30","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":200157,"visible":true,"origin":"","legend":"\u003cp\u003eLogic model for adaptation of integrated Behavioural Activation and Physical Activity intervention\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7480009/v1/a30a1d3ace55f174ed7a4b1a.jpeg"},{"id":92682647,"identity":"aa3f2f48-0f4f-4d8c-96a8-510bcd3032b4","added_by":"auto","created_at":"2025-10-03 01:19:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1116360,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7480009/v1/2fa51057-f626-4c60-9556-95da64d74df3.pdf"},{"id":92680277,"identity":"4eac41b9-41a2-4638-b868-60f16e5bd441","added_by":"auto","created_at":"2025-10-03 01:03:30","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":19945,"visible":true,"origin":"","legend":"","description":"","filename":"3.Supplementaryfile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7480009/v1/a352d909ac4e79b6ae025ade.docx"},{"id":92680283,"identity":"20c3b3bd-a58d-4b94-9be2-afdb4d430cc7","added_by":"auto","created_at":"2025-10-03 01:03:30","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":18595,"visible":true,"origin":"","legend":"","description":"","filename":"4.Supplementaryfile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-7480009/v1/19501665af2572783cb1b03b.docx"},{"id":92680286,"identity":"a268e525-6cc6-4305-8207-bcfdfb95ed50","added_by":"auto","created_at":"2025-10-03 01:03:30","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":19521,"visible":true,"origin":"","legend":"","description":"","filename":"5.Supplementaryfile3.docx","url":"https://assets-eu.researchsquare.com/files/rs-7480009/v1/a1c100e9b8e8401f94a5b820.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Adaptation of an integrated Behavioural Activation and physical activity intervention for women with depression and type 2 diabetes mellitus in Pakistan","fulltext":[{"header":"1. INTRODUCTION","content":"\u003cp\u003eDepression and type 2 diabetes mellitus (T2DM) multimorbidity is highly prevalent as 14.5\u0026ndash;28% of people with T2DM suffer from depression (Farooqi et al., \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Khaledi et al., \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Wang et al., \u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). Evidence suggests that women with T2DM have a higher prevalence of depression compared to their male counterparts (Barbosa et al., \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Pan et al., \u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e2010\u003c/span\u003e). The prevalence of depression among women with T2DM ranges from 24\u0026ndash;34%, while its prevalence among men ranges from 15.8\u0026ndash;23% (Farooqi et al., \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Khaledi et al., \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Wang et al., \u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). In low and middle-income countries (LMICs), although the prevalence of depression among women with T2DM has not been studied, it is reported that estimates of depression prevalence might be considerably higher in this population (Mendenhall \u0026amp; Weaver, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e2014\u003c/span\u003e).\u003c/p\u003e\u003cp\u003ePhysical activity has been shown to not only improve glycaemic control but also to be effective in managing depression (Kandola et al., \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Narita et al., \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; van der Feltz-Cornelis et al., \u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). However, women with depression and T2DM mostly remain physically inactive (Koopmans et al., \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2009\u003c/span\u003e; Lee et al., \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e2020\u003c/span\u003e). This is a particular challenge in Pakistan where due to cultural values, women face additional barriers to physical activity compared to men (Arsh et al., \u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e2023\u003c/span\u003e)). According to conservative estimates, 27\u0026ndash;80% of women in Pakistan are physically inactive (Guthold et al., \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e2008\u003c/span\u003e; Hoodbhoy et al., \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Mawani, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Memon et al., \u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Pengpid et al., \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Samir et al., \u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e2011\u003c/span\u003e). While the statistics regarding physical inactivity among women with T2DM and depression living in Pakistan are not available, it is likely that physical inactivity is significantly higher in this population compared to the level of physical inactivity observed in the general population.\u003c/p\u003e\u003cp\u003eLiterature suggests that the use of rewarding activities can improve people\u0026rsquo;s motivation and compliance to adhere to specific exercise protocols (Bullard et al., \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). Behavioural Activation (BA) is based on identifying and engaging in rewarding activities to improve symptoms of depression (Janssen et al., \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e2021\u003c/span\u003e; Turner \u0026amp; Leach, \u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e2012\u003c/span\u003e). While increasing daily activities is the goal of BA, it does not specifically employ strategies to promote physical activity. With a slight change in the emphasis, there is a possibility to focus BA on physical activity. This can be achieved by selective reinforcement of activities that demand high energy expenditure (Michie et al., \u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e2009\u003c/span\u003e; Pentecost et al., \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e2015\u003c/span\u003e). Adapting BA to focus specifically on physical activity could potentially improve uptake of physical activity in women with depression and T2DM, leading to better glycaemic control, in addition to improving depression symptoms.\u003c/p\u003e\u003cp\u003eSome studies have either discussed the possibility of using BA along with physical activity (Farrand et al., \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2014\u003c/span\u003e; Lambert et al., \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2017\u003c/span\u003e; Schneider et al., \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e2011\u003c/span\u003e; Turner et al., \u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e2019\u003c/span\u003e), or evaluated the feasibility of combined BA and physical activity interventions for the management of depression (Lambert et al., \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Pentecost et al., \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Schneider et al., \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e2016\u003c/span\u003e). The only study available in the literature that specifically assessed the effects of a combined BA and physical activity intervention for the management of depression in people with T2DM was conducted by Schneider et al. (\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e2011\u003c/span\u003e, \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e2016\u003c/span\u003e) (Schneider et al., \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e2011\u003c/span\u003e; Schneider et al., \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e2016\u003c/span\u003e), although they did not describe the intervention development process. The development of an intervention to integrate BA with physical activity for adults with depression has previously been described by Farrand et al. (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2014\u003c/span\u003e), followed by a pilot RCT to assess the feasibility and acceptability of the intervention (Farrand et al., \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2014\u003c/span\u003e; Pentecost et al., \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e2015\u003c/span\u003e). The feasibility trial suggested that the integrated BA and physical activity (BAcPAc) intervention is feasible and acceptable.\u003c/p\u003e\u003cp\u003eFarrand and his colleagues derived principles from self-determination theory to adapt the BA protocol proposed by Richards (\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e2010\u003c/span\u003e) to emphasize physical activity (Richards, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e2010\u003c/span\u003e). According to self-determination theory, behaviour results from intrinsic motivation (the pleasure one experiences when engaging in a behaviour). Self-determination theory argues that intrinsic motivation can be achieved if three core psychological needs (autonomy, competence, and relatedness) are attained. Self-determination theory emphasizes that meeting these psychological needs is crucial for the initiation and maintenance of behaviour. The fundamental concept of self-determination theory is that a person\u0026rsquo;s psychological needs must be met (autonomy, competence, and relatedness) within an activity for them to be optimally motivated to engage (Deci \u0026amp; Ryan, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e1985\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e2000\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e2008\u003c/span\u003e; Ryan et al., \u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e2009\u003c/span\u003e). Evidence suggests that interventions based on self-determination theory which focus on patient preferences could result in more enduring changes in physical activity by fostering autonomy and concentrating on more enduring, intrinsically driven changes (Nystr\u0026ouml;m et al., \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Teixeira et al., \u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e2012\u003c/span\u003e). Lambert et al. (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2017\u003c/span\u003e) adapted the concepts of Farrand et al. (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2014\u003c/span\u003e) to develop a web-based BA and physical activity intervention (Lambert et al., \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2017\u003c/span\u003e). They also conducted a pilot RCT and reported that a web-based BA and physical activity intervention is feasible for adults with depression (Lambert et al., \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2018\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eTo sum up, there are good arguments for integrating BA with physical activity and there is emerging evidence for the effectiveness of this approach. Moreover, it is evident that integrated BA and physical activity interventions have the potential to promote physical activity and thus tackle depression and T2DM multimorbidity (Lambert et al., \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Pentecost et al., \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Schneider et al., \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e2016\u003c/span\u003e). However, to date, this work has been carried out in high income countries and may not translate to LMIC contexts. Therefore, integrated BA and physical activity interventions developed in high-income countries need to be adapted and contextualized in LMICs. This is particularly important for women with depression and T2DM living in Pakistan because the existing BA and physical activity interventions may not be feasible for them. Therefore, the current study was designed to adapt an integrated BA and physical activity intervention for women with depression and T2DM living in Pakistan.\u003c/p\u003e"},{"header":"2. MATERIAL AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003e2.1. Intervention for adaptation\u003c/h2\u003e\n \u003cp\u003eBAcPAc, developed by Farrand et al. (\u003cspan class=\"CitationRef\"\u003e2014\u003c/span\u003e) is the only theoretically informed intervention we found that integrates BA and physical activity for people with depression (Farrand et al., \u003cspan class=\"CitationRef\"\u003e2014\u003c/span\u003e). Therefore, we chose to adapt this intervention for women with depression and T2DM in Pakistan.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n \u003ch2\u003e2.2. Adaptation framework\u003c/h2\u003e\n \u003cp\u003eThe Bernal\u0026rsquo;s cultural adaptation framework was used to guide the choice of intervention aspects that needed adaptation (Bernal et al., \u003cspan class=\"CitationRef\"\u003e1995\u003c/span\u003e). The adaptation matrix from the Stirman adaptation classification was used to map and describe the changes made to the original intervention (Stirman et al., \u003cspan class=\"CitationRef\"\u003e2013\u003c/span\u003e)). An initial logic model was developed to visualize the process of intervention adaptation (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n \u003ch2\u003e2.3. Participants\u003c/h2\u003e\n \u003cp\u003ePatient participants, carers, healthcare staff, and social workers/representatives of the public were recruited into the consultative workshops.\u003c/p\u003e\n \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e\n \u003ch2\u003e2.3.1. Patient-participants\u003c/h2\u003e\n \u003cp\u003eIndividuals, aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years, with a physician-confirmed diagnosis of T2DM, and a diagnosis of major depressive disorder as defined by the Structured Clinical Interview for DSM-V disorders and who were able to provide informed consent, were eligible.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e\n \u003ch2\u003e2.3.2. Carers\u003c/h2\u003e\n \u003cp\u003eIndividuals, aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years, nominated by the patient participants as a carer, who provide care to a family member with the clinical diagnosis of depression and T2DM, and who could provide informed consent, were eligible.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e\n \u003ch2\u003e2.3.3. Healthcare staff\u003c/h2\u003e\n \u003cp\u003eDiabetes specialists, mental health specialists (psychiatrists/psychologists), and other healthcare staff and managers (nutritionists, and paramedical staff), involved in primary or secondary care of people with depression and T2DM, were eligible. In addition, professionals with relevant knowledge or experience of physical activity interventions (such as physical therapists and public health experts) were eligible.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e\n \u003ch2\u003e2.3.4. Social workers/representatives of the public\u003c/h2\u003e\n \u003cp\u003eIndividuals, aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years, working for the social welfare of the community, were eligible.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003e2.4. Participants identification\u003c/h2\u003e\n \u003cp\u003eParticipants were identified from three main sources:\u003c/p\u003e\n \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e\n \u003ch2\u003e2.4.1. Participants of qualitative study\u003c/h2\u003e\n \u003cp\u003eIndividuals (people with depression and T2DM, their carers, and healthcare staff) who participated in the qualitative study (Arsh et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e), conducted prior to this study, were invited to join the consultative workshops. These individuals were invited to the current study to gain insights from their experiences for the adaptation of integrated BA and physical activity intervention.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e\n \u003ch2\u003e2.4.2. Participants from DiaDeM study\u003c/h2\u003e\n \u003cp\u003ePatients and healthcare staff (psychologists (supervisors), and non-mental health specialists (facilitators) with experience of delivering BA) who participated in the DiaDeM (management of depression in diabetes) programme, an ongoing National Institute of Health Research (NIHR) funded research project, which aims to develop and test a culturally appropriate approach to the recognition and treatment of depression in people with diabetes in Bangladesh and Pakistan based on BA (Aslam et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Zavala et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e), were also invited. These individuals had either received or delivered BA, so they were targeted to gain insights from their experiences.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e\n \u003ch2\u003e2.4.3. Referral\u003c/h2\u003e\n \u003cp\u003eNew participants, who did not take part in the qualitative study, or the DiaDeM programme were also recruited. They were identified with the help of participants who either participated in the qualitative study or in the DiaDeM study.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n \u003ch2\u003e2.5. Recruitment\u003c/h2\u003e\n \u003cp\u003eThe research team provided leaflets and participant information sheets, containing information about the research study and information on how to get involved in the study to potential participants. A contact number and email address were provided for the participants to use if they wished to participate. A self-addressed envelope was also provided which potential participants may return if they wish to participate in the study but do not want to call or email. When potential participants made contact, a researcher scheduled meetings with them to re-confirm their eligibility and answer any queries about the study. Written informed consent (either thumbprints or signatures) was obtained on the day of the workshop before the commencement of the workshop by the workshop facilitator.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n \u003ch2\u003e2.6. Data collection\u003c/h2\u003e\n \u003cp\u003eTwo consultative workshops were conducted at Khyber Medical University Peshawar in May and June 2023. Each workshop lasted 4 hours with a 30-minute break after the first 120 minutes. Each workshop began with a formal welcome to the participants followed by the introduction of facilitators and participants. The aims and objectives of the workshops and a summary of the intervention adaptation process were communicated to the participants. The content and activities of the workshop were then presented.\u003c/p\u003e\n \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e\n \u003ch2\u003e2.6.1. Workshop 1\u003c/h2\u003e\n \u003cp\u003eThe objective of workshop 1 was to identify changes needed in the original intervention. Hard copies of the BAcPAc intervention were provided to participants. The workshop facilitators presented the core components of original BAcPAc intervention to the participants and explained the need for an adapted intervention. Participants were given enough time to review and understand the core components of the original intervention.\u003c/p\u003e\n \u003cp\u003eFour personas were presented. Persona characteristics varied in age, marital status/number of children, area (urban/rural), profession, and socioeconomic status. The workshop participants were divided into four groups and one persona was assigned to each group. Each group was asked to identify factors as per the domains of Bernal\u0026rsquo;s framework (language, persons, metaphors, content, concepts, goals, methods, context), specific to the persona that could affect participation and/or adherence to the original BAcPAc intervention. A 30-minute break was announced after completion of this activity. During break time, workshop facilitators displayed the personas along with the factors identified by each group for their assigned persona. After break time, participants were requested to suggest changes that could be made to the original BAcPAc intervention to overcome constraints identified by participants for the personas. The suggestions presented by participants were noted.\u003c/p\u003e\n \u003cp\u003eThe factors identified by participants that could affect participation and/or adherence to the original BAcPAc intervention and the suggestions to overcome these constraints were compiled according to Bernal\u0026rsquo;s framework. The changes in the original BAcPAc intervention proposed by workshop participants were made. The Stirman adaptation classification was used to map the changes made to the original intervention (Stirman et al., \u003cspan class=\"CitationRef\"\u003e2013\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e\n \u003ch2\u003e2.6.2. Workshop 2\u003c/h2\u003e\n \u003cp\u003eThe objective of the 2nd workshop was to present the adapted intervention materials to the stakeholders and refine it. Before the workshop, the adapted intervention materials were provided to the participants of workshop 1 (either in soft copy or hard copy depending on participant preference) for review and feedback. Sections of the adapted intervention were presented to participants of workshop 2, and they were asked to give their feedback after each section of the presentation. This feedback was used to refine and finalise the adapted intervention materials.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n \u003ch2\u003e2.7. Ethics approval\u003c/h2\u003e\n \u003cp\u003e\u003cstrong\u003eEthics approval\u0026nbsp;\u003c/strong\u003ewas obtained from the Health Sciences Research Governance Committee University of York United Kingdom (Reference No. HSRGC/2022/498/A, dated 6th May 2022) and Ethics Board of Khyber Medical University Pakistan (Reference No. DIR/KMU-EB/CB/00115, dated 23rd May 2022).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"3. RESULTS","content":"\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\n \u003ch2\u003e3.1. Participants\u003c/h2\u003e\n \u003cp\u003eA total of 21 participants attended the first consultative workshop including 7 patient participants (5 female and 2 male), 9 healthcare staff (5 female and 4 male), 2 carers (1 female and 1 male), and 3 social workers/representatives of public (1 female and 2 male).The second workshop was attended by 16 participants including 6 patient participants (5 female and 1 male), 7 healthcare staff (4 female and 3 male), 2 carers (1 female and 1 male), and 1 female social worker. Of the workshop 2 participants, 11 attended workshop 1 \u003cstrong\u003e(Supplementary file 1)\u003c/strong\u003e.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\n \u003ch2\u003e3.2. Intervention adaptation\u003c/h2\u003e\n \u003cp\u003eThe original BAcPAc intervention comprised of a self-help workbook (Get Active_layout_1 (exeter.ac.uk)), training manual (Microsoft Word - Additional file 3.docx (springer.com)) and case studies Get Active_layout_1 (exeter.ac.uk). The participants carried out a detailed review of the intervention to identify barriers and enablers to delivery within the domains of the Bernal cultural adaptation framework \u003cstrong\u003e(Supplementary file 2)\u003c/strong\u003e.\u003c/p\u003e\n \u003cdiv id=\"Sec22\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.1. Language\u003c/h2\u003e\n \u003cp\u003eThe original BAcPAc intervention was delivered in the English language and therefore it was not possible to use it in Pakistani settings. However, participants highlighted the possibility of translating the intervention content into the Urdu language. Participants emphasized that written Urdu is much easier to understand as compared to other local languages (such as Pashto), therefore, the consensus was that the intervention materials should be translated into Urdu.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.2. Persons (patient and therapist)\u003c/h2\u003e\n \u003cp\u003eIn the BAcPAc intervention, there was no consideration of the patient\u0026rsquo;s and therapist\u0026rsquo;s gender, however, the participants in the consultative workshops felt that women patients and their carers might prefer female therapists. Workshop participants highlighted the comparatively negative attitude of patients and their carers towards healthcare staff other than the treating physician (diabetologist).\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec24\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.3. Metaphors (using signs and symbols)\u003c/h2\u003e\n \u003cp\u003eThe original intervention did not include signs or symbols in the self-help workbook. Participants suggested providing signs and symbols to guide patients and their carers. For example, when explaining routine activities, the symbol of a clock can be incorporated in the intervention material to denote 24-hour routine activities. Similarly, to explain pleasurable activities, a smiley emoji can be used.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.4. Content\u003c/h2\u003e\n \u003cp\u003eParticipants highlighted that the case studies, activities, images, and illustrations used in the original intervention are not appropriate for Pakistani settings. Moreover, participants were concerned that patients may face difficulties reading and understanding lengthy written scripts, instructions, and explanations present in the original intervention manuals.\u003c/p\u003e\n \u003cp\u003eParticipants discussed that case studies specific to local context need to be developed. Similarly, participants emphasized the addition of cultural and religious-specific images and illustrations in the intervention manual. Moreover, participants recognised the need to replace certain textual information with images and illustrations.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.5. Concepts\u003c/h2\u003e\n \u003cp\u003eParticipants highlighted that patients and their carers often have limited awareness about the positive effects of physical activity on mental health and this might be a barrier to intervention delivery. Participants added that generally people consider rest as more beneficial for people with depression and there could be concerns that physical activities might aggravate their depression symptoms.\u003c/p\u003e\n \u003cp\u003eNonetheless, participants stated that patients and their carers are generally aware of the positive effects of physical activity on physical health (weight loss, body appearance, general health) and thus this could help promote engagement in physical activity.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.6. Goals\u003c/h2\u003e\n \u003cp\u003eThe goal of both original BAcPAc intervention and the adapted intervention was to promote physical activity and reduce depressive symptoms. In addition, the adapted intervention also aims to manage blood glucose levels in women with depression and T2DM.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec28\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.7. Methods\u003c/h2\u003e\n \u003cp\u003eThe BAcPAc intervention was delivered by psychological well-being practitioners. In the UK, psychological well-being practitioners treat and support individuals with common mental health issues such as depression and anxiety. Psychological well-being practitioners receive British Psychological Society accredited training (45 days of academic work alongside supervised practice for one year) based upon the curriculum developed for the Improving Access to Psychological Therapies (IAPT) program (NHS, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; Richards, \u003cspan class=\"CitationRef\"\u003e2009\u003c/span\u003e). The psychological well-being practitioners involved in delivering BAcPAc intervention received one day of additional training related to BAcPAc intervention.\u003c/p\u003e\n \u003cp\u003eParticipants discussed different possibilities for delivering the adapted intervention in the diabetes care facilities because there is no psychological well-being practitioners role in Pakistan. Similarly, other mental health workers are generally not available in diabetes care facilities. In addition to this, participants highlighted that patients might face difficulties in visiting healthcare facilities for treatment sessions due to financial constraints, long distances to travel and restrictions to solo travel of women with depression and T2DM. Furthermore, participants emphasized that patients might not be able to fill their worksheets without assistance.\u003c/p\u003e\n \u003cp\u003eWorkshop participants discussed the possibility of training non-mental health specialists who would be available at diabetes care facilities such as nutritionists and nurses to deliver the adapted intervention. Participants emphasized that one-day training might be insufficient to understand the intervention components, therefore non-mental health specialists who are supposed to deliver the adapted intervention should receive at least 3 days of face-to-face training. Participants also advised that follow-up intervention sessions need to be scheduled alongside follow-up diabetic check-ups and these follow-up sessions need to be flexible to accommodate patient needs. Similarly, participants recommended involving family members/ friends to assist patients in completing their worksheets and helping them achieve the goals of the intervention.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec29\" class=\"Section3\"\u003e\n \u003ch2\u003e3.2.8. Context\u003c/h2\u003e\n \u003cp\u003eParticipants highlighted that patients might be dependent on carers as in Pakistan women often do not travel alone. Patients might also need permission from husbands/ other male family members to attend sessions.\u003c/p\u003e\n \u003cp\u003eParticipants discussed the possibility of the therapist meeting with carers/family members. Participants highlighted that carers could support therapists in the successful delivery of the intervention and thus it may be necessary to involve family members/carers along with the patient.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec30\" class=\"Section2\"\u003e\n \u003ch2\u003e3.3. Intervention production\u003c/h2\u003e\n \u003cdiv id=\"Sec31\" class=\"Section3\"\u003e\n \u003ch2\u003e3.3.1. Content modifications\u003c/h2\u003e\n \u003cp\u003e3.3.1.1\u0026nbsp;\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003eCurricula and components (inclusion or exclusion of elements)\u003c/span\u003e: The original intervention was designed for adults with depression only, therefore, we added T2DM along with depression when referring to the target population. Moreover, activities mentioned in the case studies were relevant to people in the UK, therefore, we changed the examples of activities in the case studies to be culturally relevant, particularly we focused on activities that are commonly performed by women in Pakistan such as performing household chores, children\u0026rsquo;s care, visiting neighbours and relatives, care for cattle, helping male partners in farming related activities, gardening in home, and walk within home or in open space. The adapted intervention was named the BE-ACTIVE intervention. \u003cstrong\u003e(Supplementary file 3)\u003c/strong\u003e.\u003c/p\u003e\u003cspan\u003e\n \u003cp\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e3.3.1.2 Change in pictures or illustrations\u003c/span\u003e: In the BAcPAc intervention manual, there were only a few pictures of people from the UK on the initial pages of the booklet. In addition to replacing the existing pictures, we included some additional pictures presenting the local context to illustrate the activities pictorially. We have added symbols and emojis to the self-help workbook to guide participants about certain components. Moreover, in the original intervention manual, a visual scale from 0 to 6 was used to evaluate difficulties in performing activities, however, we replaced it with a visual scale from 0 to 10. Participants highlighted that it would be easier to explain a 0 to 10 visual scale to patients and their carers.\u003c/p\u003e\n \u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e3.3.1.3 Intervention dose\u003c/span\u003e: The original intervention consisted of one assessment session, followed by 12 support sessions. Each session was 25 to 35 minutes. The adapted intervention consists of one assessment session followed by 5 support sessions and each session is 30 to 45 minutes. The six sessions will be delivered in 6 to 12 weeks duration to ensure flexibility in the intervention sessions.\u003c/p\u003e\n \u003c/span\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eParticipants highlighted that 12 sessions might not be feasible for the target population. They added that DiaDeM (BA intervention for people with depression and T2DM delivered in Pakistan and Bangladesh (Aslam et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Zavala et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e)) and BEACON (BA intervention for people with non-communicable diseases delivered in India (Zainab et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e)) comprised 6 interventions sessions. Participants anticipated that 6 sessions will be feasible for patients, therefore they suggested that the adapted intervention should have 6 intervention sessions.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec32\" class=\"Section3\"\u003e\n \u003ch2\u003e3.3.2. Contextual modifications\u003c/h2\u003e\u003cspan\u003e\n \u003cp\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e3.3.2.1 Inclusion and exclusion criteria\u003c/span\u003e: The original intervention was focused on individuals with depression living in the UK while the adapted intervention is focused on women with depression and T2DM living in Pakistan.\u003c/p\u003e\n \u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e3.3.2.2\u0026nbsp;\u003c/span\u003eIntervention delivery\u003c/span\u003e: The original intervention manual was lengthy with most of the instructions in written format. In the adapted intervention, the self-help materials are more brief with increased verbal input from the therapists. Where possible, written text is replaced with images and illustrations. Similarly, in the original intervention, instructions about support from family/friends were mentioned only a few times. In the adapted intervention, a stronger social support component is advised to ask patients to involve family or friends if possible.\u003c/p\u003e\n \u003c/span\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe original intervention was delivered by trained psychological well-being practitioners; however, the adapted intervention will be delivered by non-mental health specialists working in diabetes care services who will be trained on the delivery of the adapted intervention. Moreover, an initial verbal/written description of the intervention will be provided by the treating physician, who will also be responsible for referring patients to the intervention.\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec33\" class=\"Section3\"\u003e\n \u003ch2\u003e3.3.3. Modifications to the training and evaluation process\u003c/h2\u003e\u003cspan\u003e\n \u003cp\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e3.3.3.1 Training\u003c/span\u003e: In the original intervention, trained psychological well-being practitioners received one day of training. For the adapted intervention, non-mental health specialists will receive 3 days of face-to-face training. Moreover, relevant reading materials and/or online resources will be provided to therapists to gain insights about concepts of BA, physical activity and original BAcPAc intervention.\u003c/p\u003e\n \u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e\u003cspan type=\"BoldItalicUnderline\" class=\"BoldItalicUnderline\" name=\"Emphasis\"\u003e3.3.3.2 Evaluation measures\u003c/span\u003e: Physical activity and depression were the main outcomes for the original intervention while we will also evaluate glycaemic control, in addition to physical activity and depression. Moreover, after the treatment, we will also evaluate activities in which patients face difficulties at the start of the treatment, to determine whether engagement in physical activity becomes easier after receiving the intervention.\u003c/p\u003e\n \u003c/span\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e"},{"header":"4. DISCUSSION","content":"\u003cp\u003eBAcPAc, an integrated BA and physical activity intervention was adapted for women with depression and T2DM living in Pakistan. Two consultative workshops were conducted to facilitate the process of intervention adaptation. Modifications were made to the original intervention based on the findings of the consultative workshops, to make the intervention culturally appropriate for the target population. The changes made during the adaptation process were mapped according to the Adaptation matrix from the Stirman adaptation classification (Stirman et al., \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e2013\u003c/span\u003e). The workshop participants emphasised that the uptake of the adapted intervention might depend on the involvement of family members and the treating physicians in the intervention delivery.\u003c/p\u003e\u003cp\u003eThe main reasons for including family members and carers in the delivery of the adapted intervention are the dependence of women in Pakistan on family members for treatment-related decisions, and difficulties women experience travelling alone to healthcare facilities. In Pakistan, important decisions are usually made by male members of the family and some reports showed that even women\u0026rsquo;s health-related decisions are usually made by male family members (Memon et al., \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Rowther et al., \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Tariq et al., \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e2022\u003c/span\u003e). On average, 48% of women in Pakistan have no say in decisions relating to their healthcare. Compared to urban areas, women in rural areas are 1.3 times more likely to report having no say in decisions regarding their health matters. The statistics are more alarming for women of Pashtun ethnicity because the report revealed that about 65% of women in the Pashtun belt had no right to make decisions about their health (Ilyas, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Ismail \u0026amp; Dagia, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). Despite improvements in legislation related to women\u0026rsquo;s rights in the last two decades, a major proportion of women remain deprived of their fundamental right to make decisions about their healthcare (Habib et al., \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e2021\u003c/span\u003e; Hussain et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). That might be one of the reasons that Pakistan was ranked 145 out of 146 countries in a recent gender gap report (WEF, \u003cspan citationid=\"CR58\" class=\"CitationRef\"\u003e2022\u003c/span\u003e). The fact that women rely on family for treatment-related decisions is of utmost importance as it shows that uptake of the intervention is directly dependent on family involvement. Therefore, the involvement of family members and their carers is essential in the delivery of the adapted intervention. Despite the risk of reinforcing the inequalities for women in decision-making about their health by involving male family members, focusing on depression in women and women\u0026rsquo;s participation in physical activity should contribute to addressing some of these health disparities. There may also be potential to empower women through the intervention to negotiate with family members.\u003c/p\u003e\u003cp\u003eThere is high-quality evidence that supports the inclusion of family members in the treatment of people with depression and T2DM. Some of the benefits presented in the literature for including family members in the treatment of people with depression and T2DM include assistance in dietary control, prevention of stigma and isolation, and assistance in the identification of condition-specific symptoms (Bukhsh et al., \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Gilliss et al., \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Gupta et al., \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Mayberry et al., \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). There is agreement between the findings of the current study and the literature that family members need to be considered while designing, delivering, and upscaling the intervention for people with depression and T2DM. In addition to the factors presented above, family members can support people with depression and T2DM by interpreting intervention materials and supporting them to effectively use the intervention. Similarly, family members can facilitate communication between patients and therapists.\u003c/p\u003e\u003cp\u003eDuring the consultative workshops, participants particularly emphasized the importance of the role of treating physicians in intervention delivery. From the findings of the current study, it appeared that generally people with depression and T2DM and their carers follow the advice and prescription of the treating physician while having a more negative attitude towards other healthcare professionals (might be due to limited understanding of their training and role). Participants added that people with depression and T2DM and their carers do not visit other healthcare professionals, follow their instructions, or take their advice seriously until and unless they are referred by the treating physician. During the workshop, participants discussed that treating physicians have busy schedules and due to workload and workforce shortages, it will be implausible for treating physicians to deliver a physical activity intervention in clinical settings. However, keeping in mind the importance of the treating physician\u0026rsquo;s advice for the uptake of intervention, it was incorporated in the intervention material that the treating physician will provide a verbal/written description of the intervention and refer patients to the intervention. The role of healthcare professionals in physical activity promotion to a broad segment of the population is evident from the literature (Brooks et al., \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e2019\u003c/span\u003e; Cantwell et al., \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Lobelo et al., \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Netherway et al., \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e2021\u003c/span\u003e; Vishnubala \u0026amp; Pringle, \u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). However, most healthcare professionals, particularly busy clinicians do not formally advise and/or prescribe physical activity in routine clinical practice. Despite this, from the participant\u0026rsquo;s discussion during the workshop, it appeared that the sustainability of the adapted intervention is linked with referral to the intervention by the treating physicians. Therefore, the treating physician\u0026rsquo;s verbal and/or written advice/prescription is particularly mentioned in the adapted intervention.\u003c/p\u003e\u003cp\u003eThe study has important implications. At present, physical activity is not formally advised or prescribed in routine clinical practice. Healthcare professionals including treating physicians, other medical doctors, nurses, nutritionists, and paramedics can be trained to deliver the adapted intervention. Moreover, there is the possibility to train lay workers (non-healthcare professionals) for the delivery of the adapted intervention, but this needs further exploration as the focus of the current study was on healthcare professionals who are already present in the diabetes care facilities. The adapted intervention focuses on women with depression and T2DM, however, there is the possibility to further adapt this intervention for other populations. The current study provides preliminary work related to the adaptation of an BA and physical activity intervention, however, we need more evidence to guide policy and practice. There is a need to conduct clinical trials to test the feasibility, acceptance, and effectiveness of the adapted intervention. Moreover, the economic implications of the adapted intervention need to be assessed.\u003c/p\u003e\u003cp\u003eThe current study has several limitations. It was conducted in Khyber Pakhtunkhwa and the focus of the adapted intervention was on women of Pashtun ethnicity, therefore generalisability of the adapted intervention to other regions of Pakistan is questionable. We recruited a diverse group of participants (patient-participants, carers, healthcare staff, social workers) to capture a wide range of views and opinions. However, due to power imbalances, some participants (particularly patient participants) might not have been able to express their views efficiently during consultative workshops. Moreover, due to time constraints and resource limitations, we conducted only two consultative workshops. Despite these limitations, the study involved key stakeholders with diverse backgrounds in the adaptation process. Similarly, in-between workshops, we provided the adapted intervention materials to the stakeholders for review and feedback. Together with the feedback received in-between workshops, we think we were able to identify the most salient adaptations needed. The use of evidence-informed persona to facilitate the workshop discussions, followed good practice guidance, helped to orientate participants to the task. Insights provided by the wide range of stakeholders assisted in identifying factors that can affect the feasibility of the intervention in real-world practice. Similarly, the utilization of the cultural adaptation framework assisted in systematically identifying aspects of the intervention to tailor it to the cultural needs of women with depression and T2DM in the region.\u003c/p\u003e"},{"header":"5. CONCLUSION","content":"\u003cp\u003eThe study reports the cultural adaptation of an integrated BA and physical activity intervention for women with depression and T2DM living in Pakistan. The adapted intervention was named the BE-ACTIVE intervention. The adapted intervention is novel in attempting to offer a solution for physical inactivity among women with depression and T2DM. However, there is a need to assess the feasibility of the adapted intervention and its effectiveness in improving physical activity levels, depressive symptoms, and glycaemic control.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003ch2\u003eDeclaration of interest:\u003c/h2\u003e\u003cp\u003eNone.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eA.A., S.A., C.C., and N.S. designed the study. A.A. collected data and wrote the initial draft of the paper. S.A., C.C., and N.S. critically revised the manuscript. All authors contributed to and have approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe would like to thank Professor Paul Farrand (CEDAR; University of Exeter) for providing BAcPAc intervention materials and for allowing us to adapt BAcPAc intervention. We would also like to thank Brendon Stubbs (King\u0026rsquo;s College London), Jeffrey Lambert (University of Bath), Joy Adamson (University of York) and Liz Newbronner (University of York) for their expert consultation and guidance.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eArsh, A., Afaq, S., Carswell, C., Coales, K., \u0026amp; Siddiqi, N. (2023). Barriers \u0026amp; facilitators to physical activity in people with depression and type 2 diabetes mellitus in Pakistan: A qualitative study to explore perspectives of patient participants, carers and healthcare staff. \u003cem\u003eMental Health and Physical Activity\u003c/em\u003e,\u003cem\u003e 25\u003c/em\u003e, 100542. https://doi.org/https://doi.org/10.1016/j.mhpa.2023.100542 \u003c/li\u003e\n\u003cli\u003eAslam, F., Afaq, S., Siddiqui, F., Zavala, G., Ahmed, N., Walker, S., Maria Jennings, H., Fottrell, E., Ul Haq, Z., Siddiqi, N., Hewitt, C., \u0026amp; DiaDe, M. G. H. R. G. (2022). 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V., Jennings, H., Jackson, C., Mazumdar, P., Hewitt, C., Ekers, D., \u0026amp; Narayanan, G. (2022). Behavioural activation for co-morbid depression in people with non-communicable disease in India: Protocol for a randomised controlled feasibility trial (BEACON). \u003cem\u003emedRxiv\u003c/em\u003e, 2022.2005. 2025.22275556. https://doi.org/https://doi.org/10.1101/2022.05.25.22275556 \u003c/li\u003e\n\u003cli\u003eZavala, G. A., Afaq, S., Anas, A., Ahmed, N., Aslam, F., Benkalkar, S., Coales, K., Jennings, H. M., Kellar, I., Nabi, M., Naz, A., Shakoor, H., Siddiqi, N., \u0026amp; Ekers, D. (2023). Adaptation of a Behavioural Activation Intervention for Depression in People with Diabetes in Bangladesh and Pakistan: DiaDeM Intervention. \u003cem\u003eGlobal Implementation Research and Applications\u003c/em\u003e,\u003cem\u003e 3\u003c/em\u003e(1), 44\u0026ndash;55. https://doi.org/10.1007/s43477-023-00072-9 \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"global-implementation-research-and-applications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"gira","sideBox":"Learn more about [Global Implementation Research and Applications](http://link.springer.com/journal/43477)","snPcode":"43477","submissionUrl":"https://submission.springernature.com/new-submission/43477/3","title":"Global Implementation Research and Applications","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Behavioural Activation, Depression, Diabetes Mellitus Type 2, Physical activity, Women","lastPublishedDoi":"10.21203/rs.3.rs-7480009/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7480009/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eIntegrated Behavioural Activation and physical activity interventions (BAcPAc) have the potential to tackle depression and type 2 diabetes mellitus (T2DM) multimorbidity. However, such interventions, developed in high-income countries, may need to be adapted and contextualized to be appropriate for use in low and middle-income countries. The objective of this study was to adapt a BAcPAc intervention to tailor it for women with depression and T2DM living in Pakistan.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eTwo co-design informed workshops with key stakeholders (people with depression and T2DM, carers, healthcare workers, and social workers) were conducted. The purpose of workshop 1 was to identify facilitators and barriers to the delivery of the original BAcPAc intervention as per the domains of the Bernal cultural adaptation framework (language, persons, metaphors, content, concepts, goals, methods, context). Based on the findings of workshop 1, changes were made to the original intervention. Stirman\u0026rsquo;s adaptation classification was used to map the changes. In workshop 2, participants\u0026rsquo; feedback was used to refine and finalise the contents of the adapted intervention.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eA total of 21 participants attended workshop 1, while 16 participants attended workshop 2. Barriers and enablers were identified in all domains of the Bernal\u0026rsquo;s framework. Changes were made in the language, pictures/illustrations, intervention dose and delivery, training intensity, and evaluation measures.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThis study produced a theoretically informed, culturally adapted BAcPAc intervention for women with depression and T2DM living in Pakistan.\u003c/p\u003e","manuscriptTitle":"Adaptation of an integrated Behavioural Activation and physical activity intervention for women with depression and type 2 diabetes mellitus in Pakistan","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-03 01:03:25","doi":"10.21203/rs.3.rs-7480009/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-09-02T00:10:10+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-29T06:54:55+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-29T06:53:02+00:00","index":"","fulltext":""},{"type":"submitted","content":"Global Implementation Research and Applications","date":"2025-08-28T11:49:05+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"global-implementation-research-and-applications","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"gira","sideBox":"Learn more about [Global Implementation Research and Applications](http://link.springer.com/journal/43477)","snPcode":"43477","submissionUrl":"https://submission.springernature.com/new-submission/43477/3","title":"Global Implementation Research and Applications","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"2db31bcb-058c-44fc-ae84-cff44752785b","owner":[],"postedDate":"October 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-05T18:24:05+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-03 01:03:25","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7480009","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7480009","identity":"rs-7480009","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}