Development of Modified Cognitive Behaviour Therapy in Sri Lanka: a feasibility study

Development of Modified Cognitive Behaviour Therapy in Sri Lanka: a feasibility study | 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 Development of Modified Cognitive Behaviour Therapy in Sri Lanka: a feasibility study Asiri Rodrigo, Harry Minas, Richard Newton, Piyanjali de Zoysa This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1803510/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction- Depression is an important public health issue in Sri Lanka with a high prevalence and significant burden. Depression is under-treated in Sri Lanka. Psychotherapy, an integral part of the treatment, is rarely practiced in the country, partly due to lack of culturally sensitive psychotherapies. Method- An experimental prospective study design was adopted to evaluate the feasibility and safety of modified cognitive behavioural therapy (CBT). Twelve consenting adult patients with depressive disorder received 6 sessions of modified CBT over 10 weeks and were followed-up for 16 weeks thereafter. Participants were assessed with Hamilton Depression (HRSD) and Beck Depression (BDI) and Global Assessment of Function (GAF) scales. Interviews were conducted with patients and clinicians regarding the acceptability of treatment. Results- Eleven out of 12 patients completed the treatment. HRSD, BDI and GAF scores improved significantly (p>0.05) from baseline to both week 10 and 26. All the patients believed that the psychotherapy was useful while all the clinicians reported modified CBT as being feasible and easily deliverable. Conclusion- Culturally modified CBT for depression is acceptable, feasible and probably effective. Introduction Depression is a burdensome health issue in Sri Lanka with a point prevalence of 6.1–22.1%. It is associated with important health and social issues such as suicide, non-communicable diseases and poverty. [ 1 , 2 ] Yet, many people with depression do not receive adequate treatment. [ 2 – 6 ] Poor provision of psychotherapy, an integral component of the treatment, in Sri Lanka may have contributed to the treatment gap. [ 7 – 10 ] Cognitive behaviour therapy (CBT) is the most effective and widely practiced psychotherapy for depression. [ 11 ] Psychotherapies including CBT are based on Western cultural values and ideals and better suited for Western societies. [ 12 ] The most frequently cited reasons for non-provision of psychotherapy include lack of time and inadequate training for clinicians and poor acceptability and accessibility for patients. Consequently, it is of foremost importance that Sri Lankans are provided with psychotherapy for depression that strive to overcome the above-mentioned barriers. Sri Lankan stakeholders including patients, carers, mental health professionals and traditional healers suggested a modified CBT with fewer and shorter sessions, more didactic style,greater emphasis on physical symptoms, activity scheduling and problem solving may address some of these issues. Consequently, a culturally modified CBT manual was formulated with six 30-minutemodified CBT sessions embedded with necessary culturally modified components, techniques and strategies. Methodology An experimental prospective study design was adopted to evaluate the feasibility and safety of modified CBT for patients with depressive disorder. Patients were recruited from the psychiatry outpatient clinic at Colombo North Teaching Hospital, Ragama. Consenting adult patients satisfying DSM-V criteria for major depression with a score of at least 20 on the 24-item Hamilton Rating Scale for Depression (HRSD) and 18 on the Sinhalese version of Beck Depression Inventory II (BDI) and who have received treatment for depression for at least 6 months were recruited. Patients with a history of bipolar disorder, psychosis, persistent antisocial behaviour, borderline personality disorder, learning disability (estimated IQ < 70) or organic brain damage were excluded from the study. Patients were selected by purposive sampling. The number of participants for the study was decided after studying previous feasibility studies. Those studies found 10 participants is adequate to gather necessary information and 12 participants were recruited making allowance for 20% attrition. [ 13 ] The period of study comprised of 10 weeks of treatment and six months of follow-up from the initiation of treatment. During the treatment phase patients received six fortnightly sessions of modified CBT in addition to treatment as usual, including medications and supportive measures such as psychoeducation and social interventions. The modified CBT was delivered by clinical psychologists and a consultant psychiatrist according to the modified CBT manual. Clinicians held regular meetings to ensure the intervention was done according to the manual. Treatment as usual was provided by the treating psychiatrists’ team. Participants were assessed at baseline, at ten weeks (completion of treatment), and at six months from the start of treatment by an independent assessor. Baseline assessments included history of present episode, previous history, recent treatment and the scores of the HRSD, BDI and Global Assessment of Function (GAF) scales. The rating scales used in the assessments have been translated and validated for use in the Sinhala speaking population of Sri Lanka. [ 14 , 15 ] In subsequent assessments HRSD, BDI and GAF scores, details of allopathic and traditional mental health treatment received from the time of study enrolment, including change of psychotropic medications and electro-convulsive therapy (ECT), and details of any attempts at self-harm and hospitalisations were gathered. Treatment adherence to medication was assessed through self-reporting on a 5-point scale. The semi-structured individual interviews were conducted with patients who had modified CBT soon after they completed the last session and clinicians who provided CBT within ??? days of completing therapy with all the patients. Interviews with patients were focused on acceptability of modified CBT, obstacles to treatment, benefits and drawbacks of the therapy in general and of specific components. Clinicians’ interviews were focused on perceived efficacy of modified CBT, obstacles to delivery, benefits and drawbacks of the therapy in general and of specific components. All these interviews were audio-recorded, transcribed and translated when interviews were conducted in Sinhalese. Thereafter transcripts were coded, anonymised and analysed for categories and themes. Ethics approval was obtained from ethics review committees of University of Melbourne, Australia and University of Kelaniya, Sri Lanka. Results Out of 12 patients recruited, 11 completed the treatment. One patient was admitted to the hospital with exacerbation of depressive symptoms after 4 sessions and she was lost to follow-up. Most of the patients (67%; 8/12) were females and average age was 42 (range 22–66) years. Majority (58%; 7/12) had previous episodes of depression and mean duration of treatment was 3.1 years. At the baseline, all were on antidepressant medications and eight were on adjunct medications. Table 1 presents the scores of the scales at baseline, post-treatment (10 weeks) and at 6 months follow-up. The table also presents changes to treatment and treatment adherence during the study. Although the HRSD, BDI and GAF scores have improved significantly at both points with better scores at week 10, differences between the outcome scores at weeks 10 and 26 were not significant. Treatment compliance did not show any significant difference from baseline at the two assessment points. Table 1 Assessment scores at baseline, week 10 and week 26 Mean score at baseline Mean score at week 10 Change from baseline at Week 10 Mean score at Week 26 Change from baseline at Week 26 HRSD 26.3 21.4 4.9 ( p < 0.01 ) 22.2 4.1 ( p < 0.05 ) BDI 22 17.9 4.1 ( p < 0.05 ) 18.5 3.7 ( p = 0.05 ) GAF 51 60 9 ( p < 0.01 ) 58 7 ( p < 0.05 ) TC 4.4 4.5 0.1 ( p = 0.17 ) 4.45 0.05 ( p = 0.58) HRSD - Hamilton Rating Scale for Depression; BDI - Beck Depression Inventory II; GAF- Global Assessment of Function Scale; TC - Treatment compliance on a 5-point Likert Scale Patients’ And Clinicians’ Perceptions And Content Analysis All the patients believed that the psychotherapy was useful and practical. Majority (73%, 8/11) reported psychotherapy was able to give them something significantly different to treatment as usual. All the clinicians reported modified CBT as being ‘feasible’ and ‘easily deliverable’. Codes were categorised to demonstrate broad representative themes (Table 2 ). Table 2 Codes, categories and themes identified in the interviews Codes Categories Themes Assessment Formulation Familiarisation Assessment and formulation Training on familiarisation to CBT Assessment and formulation was not given adequate weightage. There should be more explicit discussion about the assessment. Training on familiarisation to the CBT model should be more robust. Homework In-sessions Leaflets Problems with homework Improvement to leaflets More lenient approach on homework promotes patients attendance. Patients do homework during the session which reduces the time for other things. Patients find it difficult to do homework and they need guidance and support. They did not get much support from family members to do the homework. So a different and better approach may help. Eye-catching, easy-to-read leaflets given to patients as reading material at home could serve as useful reminders and attract more family support. Mindfulness Assertiveness Activity scheduling Relaxation Somatic symptoms Not-so-helpful techniques Helpful techniques Mindfulness and assertiveness are not very beneficial. So less emphasis should be placed on those. Activity scheduling, relaxation techniques and addressing physical symptoms are helpful and more focus should be placed on them. Duration No of sessions Approach Advantages and disadvantages of process Duration and number of sessions keep clinicians and patients focused. Patients find duration and number practical and feasible. It makes clinicians time conscious thereby more task oriented and focused. At times it is stressful for the clinicians. Patients were comfortable with direct approach and it was easier to keep to time because of that Satisfaction Feasibility At the end Perceptions of patients Perceptions of clinicians Patients were satisfied with the therapy. They felt it had done something medication could not or did not do. Clinicians felt it was feasible. At the end of sessions some patients feel empowered and they have wrestled back the control of their life. But others felt they will not know what to do. Discussion We conducted our study to evaluate the feasibility and acceptability of modified CBT. Our study was designed to determine the acceptability of interventions, test the integrity of the study protocol, gain initial estimates for sample size calculation, test data collection forms or questionnaires, estimate rates of recruitment and consent and to select the most appropriate primary outcome measure [ 16 ]. We were able to achieve all those objectives. Further, we were able to test the practicality (exploration of whether modified CBT can be delivered when resources, time or some combination thereof are constrained in some way), adaptation (exploration of further changes in contents or format of CBT to be appropriate in Sri Lankan context) and integration (assessment whether a new program or process could integrate into an existing system or infrastructure). While this study evaluated the feasibility and acceptability of modified CBT, we did not attempt to conclude the efficacy of this intervention. But the results we saw with the outcome measures were very encouraging. Although efficacy and effectiveness are usually not evaluated in a pilot study it may give some indication that the new intervention will work [ 17 ]. Patients who participated in the study demonstrated clear improvement in their symptoms and functionality as suggested by improvements of HRSD, BDI and GAF scores. Those improvements are too significant to be ignored as natural progression seen with treatment as usual in patients who were treated for a mean duration of 3.1 years. Further, the fact that those changes were more marked soon after the completion of therapy at week 10 when compared 6 months afterwards also gives credence to the possibility that improvements were due to modified psychotherapy. On the other hand, this observation may question the sustainability of symptom resolution. However, it should be noted that better response in immediacy of treatment completion is a well-known phenomenon. [ 18 ] There was an improvement, though statistically not significant, in treatment compliance with modified CBT. This would also confirm the widely held view that psychotherapies are not only supplementary but also complementary in treatment. [ 19 ] More significant symptom improvement may suggest mildly improved treatment compliance alone is not the reason for the previous. Symptom improvement is combined with subjective acceptance of the therapy by the patients. It is important to note that all, but one patient attended all the therapy sessions. Benuto and O’Donohue identified improvements in access, acceptability of the treatment, engagement with the treatment, reduction of symptoms as markers of success of a culturally modified intervention. [ 20 ] Our intervention has achieved the last three objectives. We believe that as this is a manualised and relatively uncomplicated therapy, training clinicians including nurses to deliver this would be possible. If such training and subsequent treatment delivery are possible it may certainly increase the access to such treatment that would be available to patients. Sri Lanka has been able to successfully eradicate menacing infectious diseases such as polio and malaria; it was the 11th country in the world to eradicate polio and the second country in Southeast Asia to eliminate malaria [ 21 ]. Conversely, Sri Lanka’s struggle against noncommunicable diseases has been far less noteworthy [ 22 ]. We may be able to emulate the success against communicable disease if we could find an effective, inexpensive and widely accepted treatment such as immunisation for noncommunicable diseases [ 23 ]. The success of immunisation lies not only in it being inexpensive and widely available, but its ability to prevent future occurrences of the illness [ 24 ]. Further, no treatment would be of any use, unless people are willing to utilise it. Mental health is laden with unique issues such as stigma and cultural relevance, particularly in a country like Sri Lanka [ 25 , 26 ]. This is one of the reasons why people seek traditional treatment for mental illness as they feel these therapies are much more attuned with their culture [ 27 ]. Human resources are scarce in the field of mental health in Sri Lanka [ 28 ]. Therefore, treatment should be easily deliverable by available health staff. Considering the above factors, the ideal treatment for mental health in Sri Lanka should be inexpensive, easily deliverable, culturally sensitive and effective in symptom control and prevent future relapses. If one could achieve this feat, preventing or minimising relapses with psychotherapy consisting of fewer sessions, it would be a truly effective and inexpensive way to reduce the burden of the illness considering the cost of antidepressant medications and high degree of non-compliance or partial non-compliance of medication once the acute phase is resolved. Results of this feasibility study suggest that we have developed a psychotherapy that could be easily delivered in a culturally sensitive, acceptable and effective manner. The clinicians who delivered modified CBT felt that case formulation was not given adequate weightage. While, case formulation improves the outcome of CBT, Jacobson et al showed that detailed formulation will not change the outcome of therapy at termination, although detailed formulation may lead to maintaining improved gains at six-month follow-up [ 29 ]. Pre-prepared illustrations and strategies for developing case conceptualizations based on Beck’s cognitive model have been used to make formulation less time consuming and more user-friendly [ 30 ]. We will use those in the future. We found behavioural activation, relaxation techniques and addressing somatic symptoms are more helpful than other strategies. Similar findings were noted in Indian patients with moderate to severe depression [ 31 ]. Behavioural activation has been found to be a helpful technique in treating and preventing depression in non-Western settings [ 32 , 33 ]. We believe relative success of behavioural activation may be due to it being action oriented, focused on somatic functions, easily deliverable by health professionals with less training [ 33 , 34 ]. The last factor will augur well with Sri Lankan psychotherapy delivery due to scarcity of trained therapist. Dealing with physical or somatic symptoms in depressed patients with psychotherapy appears to be important in Sri Lankan context due to prominence of somatic symptoms in these patients. Conclusions And Limitations These encouraging results of the feasibility study should be evaluated with a randomised clinical trial (RCT) for the clinical effectiveness of the therapy. As discussed before findings of the feasibility study should be used to improve the CBT manual further. This study did not compare treatment as usual (TAU) or standard CBT with modified CBT. Authors acknowledge that intervention with CBT implies closer follow-up and regular appointments than usually expected in TAU. The better therapeutic relationship may have influenced outcome. In this study, intervention was delivered by ‘highly trained’ clinicians which may question the wider applicability of these interventions. Further studies are required to addressed this by using nurses with short training in modified CBT as clinicians along with psychiatrists and psychologists to compare whether there will be a difference in outcome depending on the professional background of the therapist. This study contributes to the growing evidence pointing to the need for adaptation of evidenced based interventions; the efficacy and acceptability of such culturally adapted CBT as a treatment option for depression is suggested by the results. Declarations Ethics approval and consent to participate Ethics approval was obtained from ethics review committees of University of Melbourne, Australia and University of Kelaniya, Sri Lanka. Informed written consent was obtained from all the participants. Consent for publication No identifiable information or photographs of the participants are included. Written informed consent included consent for publication Availability of data and material Authors are happy to provide data and material at request Competing interests- None Funding - Self funded Authors' contributions – All authors contributed to the study conception and design. AR conducted the study, collected and analyzed data under the supervision of HM, RN and PZ. AR prepared the draft manuscript. All authors reviewed the results and approved the final version of the manuscript. Acknowledgements Authors would like to acknowledge Dr Ritz Kakuma. References Ball HA, Siribaddana SH, Kovas Y, Glozier N, McGuffin P, Sumathipala A, et al. Epidemiology and symptomatology of depression in Sri Lanka: a cross-sectional population-based survey in Colombo District. J Affect Disord. 2010;123(1–3):188–96. Egede LE, Ellis C. Diabetes and depression: global perspectives. Diabetes Res Clin Pract. 2010;87(3):302–12. Perera B TM, Jayawardana G, Pallethanna N. Depressive Symptoms among Adolescents in Sri Lanka: Prevalence and Behavioural Correlates. J Adolesc Health. 2006;123 (1–3):188–96. Husain F, Anderson M, Lopes Cardozo B, Becknell K, Blanton C, Araki D, et al. Prevalence of war-related mental health conditions and association with displacement status in postwar Jaffna District, Sri Lanka. JAMA. 2011;306(5):522–31. Abeyasinghe R, Gunnell D. Psychological autopsy study of suicide in three rural and semi-rural districts of Sri Lanka. Soc Psychiatry Psychiatr Epidemiol. 2008;43(4):280–5. Samaraweera S SA, Siribaddana S, Sivayogan S, Bhugra D. Completed suicide among Sinhalese in Sri Lanka: a psychological autopsy study. Suicide Life Threat Behav. 2008;38(2):221–8. Fernando SM, Deane FP, McLeod HJ. Sri Lankan doctors' and medical undergraduates' attitudes towards mental illness. Soc Psychiatry Psychiatr Epidemiol. 2010;45(7):733–9 Ediriweera HW FS, Pai NB. Mental health literacy survey among Sri Lankan carers of patients with schizophrenia and depression. Asian J Psychiatr. 2012 5(3):246–50. Samarasekara N DM, Siribaddana S. The stigma of mental illness in Sri Lanka: the perspectives of community mental health workers. Stigma research and action. 2012;2(2). Vogt B. Skill and Trust: The Tovil Healing Ritual of Sri Lanka As Culture-Specific Psychotherapy. Amsterdam: Amsterdam: University Press 1999. Cuijpers P, Cristea IA, Karyotaki E, Reijnders M, Huibers MJ. How effective are cognitive behavior therapies for major depression and anxiety disorders? A meta-analytic update of the evidence. World Psychiatry. 2016 Oct;15(3):245–258. Sue S, Zane N, Nagayama Hall GC, Berger LK. The case for cultural competency in psychotherapeutic interventions. Annu Rev Psychol. 2009;60:525–48. Billingham SA, Whitehead AL, Julious SA. 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Prevention and control of selected Chronic NCDs in Sri Lanka: policy options and action. Washington (DC): The World Bank; 2009. Doherty M, Buchy P, Standaert B, Giaquinto C, Prado-Cohrs D. Vaccine impact: Benefits for human health. Vaccine. 2016 Dec 20;34(52):6707–6714. Fernando SM, Deane FP, McLeod HJ. Sri Lankan doctors' and medical undergraduates' attitudes towards mental illness. Soc Psychiatry Psychiatr Epidemiol. 2010;45(7):733–9. Samarasekara N DM, Siribaddana S. The stigma of mental illness in Sri Lanka: the perspectives of community mental health workers. Stigma research and action. 2012;2(2). Choudhry FR, Mani V, Ming LC, Khan TM. Beliefs and perception about mental health issues: a meta-synthesis. Neuropsychiatr Dis Treat. 2016 Oct 31; 12:2807–2818. Minas, H. A mental health human resources strategy for Sri Lanka. Sri Lanka Journal of Psychiatry. 2015; 6(1): 1–3. Jacobson NS, Schmaling KB, Holtzworth-Munroe A, Katt JL, Wood LF, Follette VM. Research-structured vs clinically flexible versions of social learning-based marital therapy. Behav Res Ther. 1989;27(2):173–80. Needleman LD. Cognitive case conceptualization: A guidebook for practitioners. Mahwah, NJ; Lawrence Erlbaum Associates: 1999. Chowdhary N, et al. The Healthy Activity Program lay counsellor delivered treatment for severe depression in India: systematic development and randomised evaluation Br J Psychiatry. 2016 Apr; 208(4): 381–388. Hirayama T, Ogawa Y, Yanai Y, Suzuki SI, Shimizu K. Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. Biopsychosoc Med. 2019 Apr 29;13:9. Wong SYS, Sun YY, Chan ATY, Leung MKW, Chao DVK, Li CCK, Chan KKH, Tang WK, Mazzucchelli T, Au AML, Yip BHK. Treating subthreshold depression in primary care: A randomized controlled trial of behavioral activation with mindfulness. Ann Fam Med. 2018 Mar;16(2):111–119. Ekers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011; 198(1): 66–72. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-1803510","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":117272670,"identity":"da614822-c741-41eb-925f-2d363b54ebff","order_by":0,"name":"Asiri Rodrigo","email":"data:image/png;base64,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","orcid":"","institution":"Victorian Institute of Forensic Mental Health;","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Asiri","middleName":"","lastName":"Rodrigo","suffix":""},{"id":117272671,"identity":"99d10509-991f-4123-ac51-cddd894629b5","order_by":1,"name":"Harry Minas","email":"","orcid":"","institution":"University of Melbourne","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Harry","middleName":"","lastName":"Minas","suffix":""},{"id":117272672,"identity":"7fb9467d-7b53-428f-b478-d0903921b192","order_by":2,"name":"Richard Newton","email":"","orcid":"","institution":"University of Melbourne","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Richard","middleName":"","lastName":"Newton","suffix":""},{"id":117272673,"identity":"a60a2d3c-1681-45f4-acfb-a22464b859a1","order_by":3,"name":"Piyanjali de Zoysa","email":"","orcid":"","institution":"University of Colombo","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Piyanjali","middleName":"","lastName":"de Zoysa","suffix":""}],"badges":[],"createdAt":"2022-06-28 11:14:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1803510/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1803510/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":25956118,"identity":"16327afd-2862-49e0-be08-1216f6701e42","added_by":"auto","created_at":"2022-09-01 22:29:27","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":273995,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1803510/v1/bbee2ecb-d6c1-4f8e-ba9e-bc522f0b18d5.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Development of Modified Cognitive Behaviour Therapy in Sri Lanka: a feasibility study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eDepression is a burdensome health issue in Sri Lanka with a point prevalence of 6.1\u0026ndash;22.1%. It is associated with important health and social issues such as suicide, non-communicable diseases and poverty. [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] Yet, many people with depression do not receive adequate treatment. [\u003cspan additionalcitationids=\"CR3 CR4 CR5\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] Poor provision of psychotherapy, an integral component of the treatment, in Sri Lanka may have contributed to the treatment gap. [\u003cspan additionalcitationids=\"CR8 CR9\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eCognitive behaviour therapy (CBT) is the most effective and widely practiced psychotherapy for depression. [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] Psychotherapies including CBT are based on Western cultural values and ideals and better suited for Western societies. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] The most frequently cited reasons for non-provision of psychotherapy include lack of time and inadequate training for clinicians and poor acceptability and accessibility for patients. Consequently, it is of foremost importance that Sri Lankans are provided with psychotherapy for depression that strive to overcome the above-mentioned barriers. Sri Lankan stakeholders including patients, carers, mental health professionals and traditional healers suggested a modified CBT with fewer and shorter sessions, more didactic style,greater emphasis on physical symptoms, activity scheduling and problem solving may address some of these issues. Consequently, a culturally modified CBT manual was formulated with six 30-minutemodified CBT sessions embedded with necessary culturally modified components, techniques and strategies.\u003c/p\u003e"},{"header":"Methodology","content":"\u003cp\u003eAn experimental prospective study design was adopted to evaluate the feasibility and safety of modified CBT for patients with depressive disorder. Patients were recruited from the psychiatry outpatient clinic at Colombo North Teaching Hospital, Ragama. Consenting adult patients satisfying DSM-V criteria for major depression with a score of at least 20 on the 24-item Hamilton Rating Scale for Depression (HRSD) and 18 on the Sinhalese version of Beck Depression Inventory II (BDI) and who have received treatment for depression for at least 6 months were recruited. Patients with a history of bipolar disorder, psychosis, persistent antisocial behaviour, borderline personality disorder, learning disability (estimated IQ\u0026thinsp;\u0026lt;\u0026thinsp;70) or organic brain damage were excluded from the study.\u003c/p\u003e \u003cp\u003ePatients were selected by purposive sampling. The number of participants for the study was decided after studying previous feasibility studies. Those studies found 10 participants is adequate to gather necessary information and 12 participants were recruited making allowance for 20% attrition. [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThe period of study comprised of 10 weeks of treatment and six months of follow-up from the initiation of treatment. During the treatment phase patients received six fortnightly sessions of modified CBT in addition to treatment as usual, including medications and supportive measures such as psychoeducation and social interventions. The modified CBT was delivered by clinical psychologists and a consultant psychiatrist according to the modified CBT manual. Clinicians held regular meetings to ensure the intervention was done according to the manual. Treatment as usual was provided by the treating psychiatrists\u0026rsquo; team.\u003c/p\u003e \u003cp\u003eParticipants were assessed at baseline, at ten weeks (completion of treatment), and at six months from the start of treatment by an independent assessor. Baseline assessments included history of present episode, previous history, recent treatment and the scores of the HRSD, BDI and Global Assessment of Function (GAF) scales. The rating scales used in the assessments have been translated and validated for use in the Sinhala speaking population of Sri Lanka. [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] In subsequent assessments HRSD, BDI and GAF scores, details of allopathic and traditional mental health treatment received from the time of study enrolment, including change of psychotropic medications and electro-convulsive therapy (ECT), and details of any attempts at self-harm and hospitalisations were gathered. Treatment adherence to medication was assessed through self-reporting on a 5-point scale.\u003c/p\u003e \u003cp\u003eThe semi-structured individual interviews were conducted with patients who had modified CBT soon after they completed the last session and clinicians who provided CBT within ??? days of completing therapy with all the patients. Interviews with patients were focused on acceptability of modified CBT, obstacles to treatment, benefits and drawbacks of the therapy in general and of specific components. Clinicians\u0026rsquo; interviews were focused on perceived efficacy of modified CBT, obstacles to delivery, benefits and drawbacks of the therapy in general and of specific components.\u003c/p\u003e \u003cp\u003eAll these interviews were audio-recorded, transcribed and translated when interviews were conducted in Sinhalese. Thereafter transcripts were coded, anonymised and analysed for categories and themes.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eEthics approval\u003c/strong\u003e \u003cp\u003e was obtained from ethics review committees of University of Melbourne, Australia and University of Kelaniya, Sri Lanka.\u003c/p\u003e \u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eOut of 12 patients recruited, 11 completed the treatment. One patient was admitted to the hospital with exacerbation of depressive symptoms after 4 sessions and she was lost to follow-up. Most of the patients (67%; 8/12) were females and average age was 42 (range 22\u0026ndash;66) years. Majority (58%; 7/12) had previous episodes of depression and mean duration of treatment was 3.1 years. At the baseline, all were on antidepressant medications and eight were on adjunct medications.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the scores of the scales at baseline, post-treatment (10 weeks) and at 6 months follow-up. The table also presents changes to treatment and treatment adherence during the study. Although the HRSD, BDI and GAF scores have improved significantly at both points with better scores at week 10, differences between the outcome scores at weeks 10 and 26 were not significant. Treatment compliance did not show any significant difference from baseline at the two assessment points.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAssessment scores at baseline, week 10 and week 26\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean score at baseline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMean score at week 10\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eChange from baseline at Week 10\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMean score at Week 26\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eChange from baseline at Week 26\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHRSD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.9 (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.01\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4.1 (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBDI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.1 (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e18.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3.7 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.05\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGAF\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.01\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7 (\u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.1 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.17\u003c/em\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.05 (\u003cem\u003ep\u0026thinsp;=\u0026thinsp;0.58)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003e\u003cb\u003eHRSD\u003c/b\u003e - Hamilton Rating Scale for Depression; \u003cb\u003eBDI\u003c/b\u003e - Beck Depression Inventory II; \u003cb\u003eGAF-\u003c/b\u003e Global Assessment of Function Scale; \u003cb\u003eTC\u003c/b\u003e- Treatment compliance on a 5-point Likert Scale\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch2\u003ePatients’ And Clinicians’ Perceptions And Content Analysis\u003c/h2\u003e\n\u003cp\u003eAll the patients believed that the psychotherapy was useful and practical. Majority (73%, 8/11) reported psychotherapy was able to give them something significantly different to treatment as usual. All the clinicians reported modified CBT as being \u0026lsquo;feasible\u0026rsquo; and \u0026lsquo;easily deliverable\u0026rsquo;. Codes were categorised to demonstrate broad representative themes (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCodes, categories and themes identified in the interviews\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCodes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCategories\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eThemes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAssessment\u003c/p\u003e \u003cp\u003eFormulation\u003c/p\u003e \u003cp\u003eFamiliarisation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAssessment and formulation\u003c/p\u003e \u003cp\u003eTraining on familiarisation to CBT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAssessment and formulation was not given adequate weightage. There should be more explicit discussion about the assessment.\u003c/p\u003e \u003cp\u003eTraining on familiarisation to the CBT model should be more robust.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHomework\u003c/p\u003e \u003cp\u003eIn-sessions\u003c/p\u003e \u003cp\u003eLeaflets\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eProblems with homework\u003c/p\u003e \u003cp\u003eImprovement to leaflets\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMore lenient approach on homework promotes patients attendance. Patients do homework during the session which reduces the time for other things. Patients find it difficult to do homework and they need guidance and support. They did not get much support from family members to do the homework. So a different and better approach may help. Eye-catching, easy-to-read leaflets given to patients as reading material at home could serve as useful reminders and attract more family support.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMindfulness\u003c/p\u003e \u003cp\u003eAssertiveness\u003c/p\u003e \u003cp\u003eActivity scheduling\u003c/p\u003e \u003cp\u003eRelaxation\u003c/p\u003e \u003cp\u003eSomatic symptoms\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot-so-helpful techniques\u003c/p\u003e \u003cp\u003eHelpful techniques\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMindfulness and assertiveness are not very beneficial. So less emphasis should be placed on those.\u003c/p\u003e \u003cp\u003eActivity scheduling, relaxation techniques and addressing physical symptoms are helpful and more focus should be placed on them.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration\u003c/p\u003e \u003cp\u003eNo of sessions\u003c/p\u003e \u003cp\u003eApproach\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAdvantages and disadvantages of process\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDuration and number of sessions keep clinicians and patients focused. Patients find duration and number practical and feasible. It makes clinicians time conscious thereby more task oriented and focused. At times it is stressful for the clinicians.\u003c/p\u003e \u003cp\u003ePatients were comfortable with direct approach and it was easier to keep to time because of that\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSatisfaction\u003c/p\u003e \u003cp\u003eFeasibility\u003c/p\u003e \u003cp\u003eAt the end\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePerceptions of patients\u003c/p\u003e \u003cp\u003ePerceptions of clinicians\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePatients were satisfied with the therapy. They felt it had done something medication could not or did not do. Clinicians felt it was feasible.\u003c/p\u003e \u003cp\u003eAt the end of sessions some patients feel empowered and they have wrestled back the control of their life. But others felt they will not know what to do.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eWe conducted our study to evaluate the feasibility and acceptability of modified CBT. Our study was designed to determine the acceptability of interventions, test the integrity of the study protocol, gain initial estimates for sample size calculation, test data collection forms or questionnaires, estimate rates of recruitment and consent and to select the most appropriate primary outcome measure [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. We were able to achieve all those objectives. Further, we were able to test the practicality (exploration of whether modified CBT can be delivered when resources, time or some combination thereof are constrained in some way), adaptation (exploration of further changes in contents or format of CBT to be appropriate in Sri Lankan context) and integration (assessment whether a new program or process could integrate into an existing system or infrastructure). While this study evaluated the feasibility and acceptability of modified CBT, we did not attempt to conclude the efficacy of this intervention. But the results we saw with the outcome measures were very encouraging. Although efficacy and effectiveness are usually not evaluated in a pilot study it may give some indication that the new intervention will work [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePatients who participated in the study demonstrated clear improvement in their symptoms and functionality as suggested by improvements of HRSD, BDI and GAF scores. Those improvements are too significant to be ignored as natural progression seen with treatment as usual in patients who were treated for a mean duration of 3.1 years. Further, the fact that those changes were more marked soon after the completion of therapy at week 10 when compared 6 months afterwards also gives credence to the possibility that improvements were due to modified psychotherapy. On the other hand, this observation may question the sustainability of symptom resolution. However, it should be noted that better response in immediacy of treatment completion is a well-known phenomenon. [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] There was an improvement, though statistically not significant, in treatment compliance with modified CBT. This would also confirm the widely held view that psychotherapies are not only supplementary but also complementary in treatment. [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] More significant symptom improvement may suggest mildly improved treatment compliance alone is not the reason for the previous. Symptom improvement is combined with subjective acceptance of the therapy by the patients. It is important to note that all, but one patient attended all the therapy sessions.\u003c/p\u003e \u003cp\u003eBenuto and O\u0026rsquo;Donohue identified improvements in access, acceptability of the treatment, engagement with the treatment, reduction of symptoms as markers of success of a culturally modified intervention. [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] Our intervention has achieved the last three objectives. We believe that as this is a manualised and relatively uncomplicated therapy, training clinicians including nurses to deliver this would be possible. If such training and subsequent treatment delivery are possible it may certainly increase the access to such treatment that would be available to patients.\u003c/p\u003e \u003cp\u003eSri Lanka has been able to successfully eradicate menacing infectious diseases such as polio and malaria; it was the 11th country in the world to eradicate polio and the second country in Southeast Asia to eliminate malaria [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Conversely, Sri Lanka\u0026rsquo;s struggle against noncommunicable diseases has been far less noteworthy [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. We may be able to emulate the success against communicable disease if we could find an effective, inexpensive and widely accepted treatment such as immunisation for noncommunicable diseases [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The success of immunisation lies not only in it being inexpensive and widely available, but its ability to prevent future occurrences of the illness [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Further, no treatment would be of any use, unless people are willing to utilise it. Mental health is laden with unique issues such as stigma and cultural relevance, particularly in a country like Sri Lanka [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. This is one of the reasons why people seek traditional treatment for mental illness as they feel these therapies are much more attuned with their culture [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Human resources are scarce in the field of mental health in Sri Lanka [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Therefore, treatment should be easily deliverable by available health staff. Considering the above factors, the ideal treatment for mental health in Sri Lanka should be inexpensive, easily deliverable, culturally sensitive and effective in symptom control and prevent future relapses. If one could achieve this feat, preventing or minimising relapses with psychotherapy consisting of fewer sessions, it would be a truly effective and inexpensive way to reduce the burden of the illness considering the cost of antidepressant medications and high degree of non-compliance or partial non-compliance of medication once the acute phase is resolved. Results of this feasibility study suggest that we have developed a psychotherapy that could be easily delivered in a culturally sensitive, acceptable and effective manner.\u003c/p\u003e \u003cp\u003eThe clinicians who delivered modified CBT felt that case formulation was not given adequate weightage. While, case formulation improves the outcome of CBT, Jacobson et al showed that detailed formulation will not change the outcome of therapy at termination, although detailed formulation may lead to maintaining improved gains at six-month follow-up [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Pre-prepared illustrations and strategies for developing case conceptualizations based on Beck\u0026rsquo;s cognitive model have been used to make formulation less time consuming and more user-friendly [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. We will use those in the future.\u003c/p\u003e \u003cp\u003eWe found behavioural activation, relaxation techniques and addressing somatic symptoms are more helpful than other strategies. Similar findings were noted in Indian patients with moderate to severe depression [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. Behavioural activation has been found to be a helpful technique in treating and preventing depression in non-Western settings [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. We believe relative success of behavioural activation may be due to it being action oriented, focused on somatic functions, easily deliverable by health professionals with less training [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. The last factor will augur well with Sri Lankan psychotherapy delivery due to scarcity of trained therapist. Dealing with physical or somatic symptoms in depressed patients with psychotherapy appears to be important in Sri Lankan context due to prominence of somatic symptoms in these patients.\u003c/p\u003e"},{"header":"Conclusions And Limitations","content":"\u003cp\u003eThese encouraging results of the feasibility study should be evaluated with a randomised clinical trial (RCT) for the clinical effectiveness of the therapy. As discussed before findings of the feasibility study should be used to improve the CBT manual further.\u003c/p\u003e \u003cp\u003eThis study did not compare treatment as usual (TAU) or standard CBT with modified CBT. Authors acknowledge that intervention with CBT implies closer follow-up and regular appointments than usually expected in TAU. The better therapeutic relationship may have influenced outcome. In this study, intervention was delivered by \u0026lsquo;highly trained\u0026rsquo; clinicians which may question the wider applicability of these interventions. Further studies are required to addressed this by using nurses with short training in modified CBT as clinicians along with psychiatrists and psychologists to compare whether there will be a difference in outcome depending on the professional background of the therapist.\u003c/p\u003e \u003cp\u003eThis study contributes to the growing evidence pointing to the need for adaptation of evidenced based interventions; the efficacy and acceptability of such culturally adapted CBT as a treatment option for depression is suggested by the results.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval was obtained from ethics review committees of University of Melbourne, Australia and University of Kelaniya, Sri Lanka. Informed written consent was obtained from all the participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo identifiable information or photographs of the participants are included. Written informed consent included consent for publication\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors are happy to provide data and material at request\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests-\u0026nbsp;\u003c/strong\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding \u0026nbsp;-\u0026nbsp;\u003c/strong\u003eSelf funded\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions \u0026ndash;\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors contributed to the study conception and design. AR conducted the study, collected and analyzed data under the supervision of HM, RN and PZ. AR prepared the draft manuscript. All authors reviewed the results and approved the final version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors would like to acknowledge Dr Ritz Kakuma.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003e\u003cspan\u003eBall HA, Siribaddana SH, Kovas Y, Glozier N, McGuffin P, Sumathipala A, et al. Epidemiology and symptomatology of depression in Sri Lanka: a cross-sectional population-based survey in Colombo District. J Affect Disord. 2010;123(1\u0026ndash;3):188\u0026ndash;96.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eEgede LE, Ellis C. Diabetes and depression: global perspectives. Diabetes Res Clin Pract. 2010;87(3):302\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003ePerera B TM, Jayawardana G, Pallethanna N. Depressive Symptoms among Adolescents in Sri Lanka: Prevalence and Behavioural Correlates. J Adolesc Health. 2006;123 (1\u0026ndash;3):188\u0026ndash;96.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eHusain F, Anderson M, Lopes Cardozo B, Becknell K, Blanton C, Araki D, et al. Prevalence of war-related mental health conditions and association with displacement status in postwar Jaffna District, Sri Lanka. JAMA. 2011;306(5):522\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eAbeyasinghe R, Gunnell D. Psychological autopsy study of suicide in three rural and semi-rural districts of Sri Lanka. Soc Psychiatry Psychiatr Epidemiol. 2008;43(4):280\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eSamaraweera S SA, Siribaddana S, Sivayogan S, Bhugra D. 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Skill and Trust: The Tovil Healing Ritual of Sri Lanka As Culture-Specific Psychotherapy. Amsterdam: Amsterdam: University Press 1999.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eCuijpers P, Cristea IA, Karyotaki E, Reijnders M, Huibers MJ. How effective are cognitive behavior therapies for major depression and anxiety disorders? A meta-analytic update of the evidence. World Psychiatry. 2016 Oct;15(3):245\u0026ndash;258.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eSue S, Zane N, Nagayama Hall GC, Berger LK. The case for cultural competency in psychotherapeutic interventions. Annu Rev Psychol. 2009;60:525\u0026ndash;48.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eBillingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eSuraweera C, Hanwella R, Sivayokan S, de Silva, V. Rating Scales validated for Sri Lankan populations. Sri Lanka Journal of Psychiatry 2013; 4(2): 16\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eRodrigo A, Kuruppuarachchi KALA, Pathmeswaran A. Validation of the Beck Depression Inventory II among the Sinhalese speaking population in Sri Lanka. Sri Lanka Journal of Psychiatry. 2015; 6(2): 20\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eLancaster GA, Dodd SR, Williamson PR: Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract2004,10(2):307\u0026ndash;312. 10.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eLeon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eMayotte-Blum J, Slavin-Mulford J, Lehmann M, Pesale F, Becker-Matero N, Hilsenroth M. Therapeutic immediacy across long-term psychodynamic psychotherapy: an evidence-based case study. J Couns Psychol. 2012 Jan;59(1):27\u0026ndash;40.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eKaryotaki E, Smit Y, Holdt Henningsen K, Huibers MJ, Robays J, de Beurs D, Cuijpers P. Combining pharmacotherapy and psychotherapy or monotherapy for major depression? A meta-analysis on the long-term effects. J Affect Disord. 2016;194:144\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eBenuto LT, O\u0026rsquo;Donohue W. Is Culturally Sensitive Cognitive Behavioral Therapy an Empirically Supported Treatment?: The Case for Hispanics. Rev Int Psicol Ter Psicol. 2015;15(3): 405\u0026ndash;42\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eAbeyasinghe RR, Galappaththy GN, Gueye C Smith, Kahn J G, Feachem R G. Malaria Control and Elimination in Sri Lanka: Documenting Progress and Success Factors in a Conflict Setting. PLoS One 2012. 7 (8): e43162.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eMehta FR. Addressing the challenge of noncommunicable diseases: some key issues and a country case study. Asia-Pacific Journal of Public Health 2016; 28(1S): 111S\u0026ndash;4S.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eEngelgau M, Okamoto K, Navaratne KM, Gopalan S. Prevention and control of selected Chronic NCDs in Sri Lanka: policy options and action. Washington (DC): The World Bank; 2009.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eDoherty M, Buchy P, Standaert B, Giaquinto C, Prado-Cohrs D. Vaccine impact: Benefits for human health. Vaccine. 2016 Dec 20;34(52):6707\u0026ndash;6714.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eFernando SM, Deane FP, McLeod HJ. Sri Lankan doctors\u0026apos; and medical undergraduates\u0026apos; attitudes towards mental illness. Soc Psychiatry Psychiatr Epidemiol. 2010;45(7):733\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eSamarasekara N DM, Siribaddana S. The stigma of mental illness in Sri Lanka: the perspectives of community mental health workers. Stigma research and action. 2012;2(2).\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eChoudhry FR, Mani V, Ming LC, Khan TM. Beliefs and perception about mental health issues: a meta-synthesis. Neuropsychiatr Dis Treat. 2016 Oct 31; 12:2807\u0026ndash;2818.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eMinas, H. A mental health human resources strategy for Sri Lanka. Sri Lanka Journal of Psychiatry. 2015; 6(1): 1\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eJacobson NS, Schmaling KB, Holtzworth-Munroe A, Katt JL, Wood LF, Follette VM. Research-structured vs clinically flexible versions of social learning-based marital therapy. Behav Res Ther. 1989;27(2):173\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eNeedleman LD. Cognitive case conceptualization: A guidebook for practitioners. Mahwah, NJ; Lawrence Erlbaum Associates: 1999.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eChowdhary N, et al. The Healthy Activity Program lay counsellor delivered treatment for severe depression in India: systematic development and randomised evaluation Br J Psychiatry. 2016 Apr; 208(4): 381\u0026ndash;388.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eHirayama T, Ogawa Y, Yanai Y, Suzuki SI, Shimizu K. Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. Biopsychosoc Med. 2019 Apr 29;13:9.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eWong SYS, Sun YY, Chan ATY, Leung MKW, Chao DVK, Li CCK, Chan KKH, Tang WK, Mazzucchelli T, Au AML, Yip BHK. Treating subthreshold depression in primary care: A randomized controlled trial of behavioral activation with mindfulness. Ann Fam Med. 2018 Mar;16(2):111\u0026ndash;119.\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003eEkers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011; 198(1): 66\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-1803510/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1803510/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction-\u003c/strong\u003e Depression is an important public health issue in Sri Lanka with a high prevalence and significant burden. Depression is under-treated in Sri Lanka. Psychotherapy, an integral part of the treatment, is rarely practiced in the country, partly due to lack of culturally sensitive psychotherapies. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethod- \u003c/strong\u003eAn experimental prospective study design was adopted to evaluate the feasibility and safety of modified cognitive behavioural therapy (CBT). Twelve consenting adult patients with depressive disorder received 6 sessions of modified CBT over 10 weeks and were followed-up for 16 weeks thereafter. \u0026nbsp;Participants were assessed with Hamilton Depression (HRSD) and Beck Depression (BDI) and Global Assessment of Function (GAF) scales. Interviews were conducted with patients and clinicians regarding the acceptability of treatment. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults- \u003c/strong\u003eEleven out of 12 patients completed the treatment. HRSD, BDI and GAF scores improved significantly (p\u0026gt;0.05) from baseline to both week 10 and 26. All the patients believed that the psychotherapy was useful while all the clinicians reported modified CBT as being feasible and easily deliverable. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion- \u003c/strong\u003eCulturally modified CBT for depression is acceptable, feasible and probably effective.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"Development of Modified Cognitive Behaviour Therapy in Sri Lanka: a feasibility study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-07-01 20:29:55","doi":"10.21203/rs.3.rs-1803510/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"62e5cd5b-1cad-4765-9e39-4fec01ba2a81","owner":[],"postedDate":"July 1st, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2022-09-01T22:29:20+00:00","versionOfRecord":[],"versionCreatedAt":"2022-07-01 20:29:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-1803510","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1803510","identity":"rs-1803510","version":["v1"]},"buildId":"cBFmMYwuxLRRLfASyISRj","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}