Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial

Laura K Murray, Emily E Haroz, Benjamin Doty, Namrita S Singh, Sergey Bogdanov, Judith Bass, Shannon Dorsey, Paul Bolton, Laura K Murray, Emily E Haroz, Benjamin Doty, Namrita S Singh, Sergey Bogdanov, Judith Bass, Shannon Dorsey, Paul Bolton

Abstract

Background: Mental illness is a major public health concern. Despite progress understanding which treatments work, a significant treatment gap remains. An ongoing concern is treatment length. Modular, flexible, transdiagnostic approaches have been offered as one solution to scalability challenges. The Common Elements Treatment Approach (CETA) is one such approach and offers the ability to treat a wide range of common mental health problems. CETA is supported by two randomized trials from low- and middle-income countries showing strong effectiveness and implementation outcomes.

Methods/design: This trial evaluates the effectiveness and implementation of two versions of CETA using a non-inferiority design to test two primary hypotheses: (1) a brief five-session version of CETA (Brief CETA) will provide similar effectiveness for reducing the severity of common mental health problems such as depression, post-traumatic stress, impaired functioning, anxiety, and substance use problems compared with the standard 8-12-session version of CETA (Standard CETA); and (2) both Brief and Standard CETA will have superior impact on the outcomes compared to a wait-list control condition. For both hypotheses, the main effect will be assessed using longitudinal data and mixed-effects regression models over a 6-month period post baseline. A secondary aim includes exploration of implementation factors. Additional planned analyses will include exploration of: moderators of treatment impact by disorder severity and comorbidity; the impact of individual therapeutic components; and trends in symptom change between end of treatment and 6-month assessment for all participants.

Discussion: This trial is the first rigorous study comparing a standard-length (8-12 sessions) modular, flexible, transdiagnostic, cognitive-behavioral approach to a shortened version of the approach (five sessions). Brief CETA entails "front-loading" with elements that research suggests are strong mechanisms of change. The study design will allow us to draw conclusions about the effects of both Brief and Standard CETA as well as which elements are integral to their mechanisms of action, informing future implementation and fidelity efforts. The results from this trial will inform future dissemination, implementation and scale-up of CETA in Ukraine and contribute to our understanding of the effects of modular, flexible, transdiagnostic approaches in similar contexts.

Trial registration: ClinicalTrials.gov, ID: NCT03058302 (U.S. National Library of Medicine). Registered on 20 February 2017.

Keywords: Cognitive-behavioral therapy; Depression; Global mental health; Implementation research; Internally displaced persons; Transdiagnostic; Trauma; Veterans.

Conflict of interest statement

The study design and all study procedures were approved by the Institutional Review Boards at both Johns Hopkins University and the National University of Kyiv-Mohyla Academy. We will obtain informed consent from all participants in the study.

Not applicable

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure; schedule of enrollment, interventions, and assessments
Fig. 2
Fig. 2
Study protocol flow
Fig. 3
Fig. 3
Example Common Elements Treatment Approach (CETA)-Brief flows

References

    1. Whiteford HA, Ferrari AJ, Degenhardt L, Feigin V, Vos T. The global burden of mental, neurological and substance use disorders: an analysis from the Global Burden of Disease Study 2010. PLoS One. 2015;10:e0116820. doi: 10.1371/journal.pone.0116820.
    1. Bolton P, Bass JK, Zangana GAS, Kamal T, Murray SM, Kaysen D, et al. A randomized controlled trial of mental health interventions for survivors of systematic violence in Kurdistan. Northern Iraq BMC Psychiatry. 2014;14:360. doi: 10.1186/s12888-014-0360-2.
    1. Bass JK, Annan J, McIvor Murray S, Kaysen D, Griffiths S, Cetinoglu T, et al. Controlled trial of psychotherapy for Congolese survivors of sexual violence. N Engl J Med. 2013;368:2182–2191. doi: 10.1056/NEJMoa1211853.
    1. Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008;372:902–909. doi: 10.1016/S0140-6736(08)61400-2.
    1. Neuner F, Onyut PL, Ertl V, Odenwald M, Schauer E, Elbert T. Treatment of posttraumatic stress disorder by trained lay counselors in an African refugee settlement: a randomized controlled trial. J Consult Clin Psychol. 2008;76:686–694. doi: 10.1037/0022-006X.76.4.686.
    1. Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011;306:503–512. doi: 10.1001/jama.2011.1060.
    1. Bolton P, Bass J, Neugebauer R, Verdeli H, Clougherty KF, Wickramaratne P, et al. Group interpersonal psychotherapy for depression in rural Uganda: a randomized controlled trial. JAMA. 2003;289:3117–3124. doi: 10.1001/jama.289.23.3117.
    1. Patel V, Weiss HA, Chowdhary N, Naik S, Pednekar S, Chatterjee S, et al. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010;376:2086–2095. doi: 10.1016/S0140-6736(10)61508-5.
    1. Murray LK, Skavenski S, Kane JC, Mayeya J, Dorsey S, Cohen JA, et al. Trauma-focused cognitive behavioral therapy among trauma-affected children in Lusaka, Zambia: a randomized clinical trial. JAMA Pediatr. 2015;169:761–769. doi: 10.1001/jamapediatrics.2015.0580.
    1. Hensel-Dittmann D, Schauer M, Ruf M, Catani C, Odenwald M, Elbert T, et al. Treatment of traumatized victims of war and torture: a randomized controlled comparison of narrative exposure therapy and stress inoculation training. Psychother Psychosom. 2011;80:345–352. doi: 10.1159/000327253.
    1. Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007;370:878–889. doi: 10.1016/S0140-6736(07)61239-2.
    1. Patel V, Chowdhary N, Rahman A, Verdeli H. Improving access to psychological treatments: lessons from developing countries. Behav Res Ther. 2011;49:523–528. doi: 10.1016/j.brat.2011.06.012.
    1. Kohn R, Saxena S, Levav I, Saraceno B. The treatment gap in mental health care. Bull World Health Organ. 2004;82:858–866.
    1. McHugh RK, Barlow DH. Dissemination and implementation of evidence-based psychological interventions. Oxford: Oxford University Press; 2012.
    1. Norton PJ, Barrera TL, Mathew AR, Chamberlain LD, Szafranski DD, Reddy R, et al. Effect of transdiagnostic CBT for anxiety disorders on comorbid diagnoses. J Depress Anxiety. 2013;30:168–173. doi: 10.1002/da.22018.
    1. Norton PJ, Barrera TL. Transdiagnostic versus diagnosis-specific cbt for anxiety disorders: a preliminary randomized controlled noninferiority trial. J Depress Anxiety. 2012;29:874–882. doi: 10.1002/da.21974.
    1. Dear BF, Staples LG, Terides MD, Karin E, Zou J, Johnston L, et al. Transdiagnostic versus disorder-specific and clinician-guided versus self-guided Internet-delivered treatment for generalized anxiety disorder and comorbid disorders: a randomized controlled trial. J Anxiety Disord. 2015;36:63–77. doi: 10.1016/j.janxdis.2015.09.003.
    1. Weisz JR, Chorpita BF, Palinkas LA, Schoenwald SK, Miranda J, Bearman SK, et al. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: a randomized effectiveness trial. Arch Gen Psychiatry. 2012;69:274–282. doi: 10.1001/archgenpsychiatry.2011.147.
    1. Sauer-Zavala S, Gutner CA, Farchione TJ, Boettcher HT, Bullis JR, Barlow DH. Current definitions of “Transdiagnostic” in treatment development: a search for consensus. Behav Ther. 2017;48:128–138. doi: 10.1016/j.beth.2016.09.004.
    1. Boustani MM, Gellatly R, Westman JG, Chorpita BF. Advances in cognitive behavioral treatment design: time for a glossary. Behav Ther (N Y N Y) 2017;40:199–208.
    1. Murray LK, Dorsey S, Haroz E, Lee C, Alsiary MM, Haydary A, et al. A common elements treatment approach for adult mental health problems in low- and middle-income countries. Cogn Behav Pract. 2014;21:111–123. doi: 10.1016/j.cbpra.2013.06.005.
    1. Weisz JR, Krumholz LS, Santucci L, Thomassin K, Ng MY. Shrinking the gap between research and practice: tailoring and testing youth psychotherapies in clinical care contexts. Annu Rev Clin Psychol. 2015;11:139–163. doi: 10.1146/annurev-clinpsy-032814-112820.
    1. Chorpita BF, Weisz JR, Daleiden EL, Schoenwald SK, Palinkas LA, Miranda J, et al. Long-term outcomes for the Child STEPs randomized effectiveness trial: a comparison of modular and standard treatment designs with usual care. J Consult Clin Psychol. 2013;81:999–1009. doi: 10.1037/a0034200.
    1. Chorpita BF, Daleiden EL, Weisz JR. Identifying and selecting the common elements of evidence based interventions: a distillation and matching model. Ment Health Serv Res. 2005;7:5–20. doi: 10.1007/s11020-005-1962-6.
    1. Chorpita BF, Daleiden EL, Weisz JR. Modularity in the design and application of therapeutic interventions. Appl Prev Psychol. 2005;11(3):141–56.
    1. Weiss WM, Murray LK, Zangana GAS, Mahmooth Z, Kaysen D, Dorsey S, et al. Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial. BMC Psychiatry. 2015;15:249. doi: 10.1186/s12888-015-0622-7.
    1. Glasgow RE, Fisher L, Strycker LA, Hessler D, Toobert DJ, King DK, et al. Minimal intervention needed for change: definition, use, and value for improving health and health research. Transl Behav Med. 2014;4:26–33. doi: 10.1007/s13142-013-0232-1.
    1. Bolton P, Lee C, Haroz EE, Murray L, Dorsey S, Robinson C, et al. A transdiagnostic community-based mental health treatment for comorbid disorders: development and outcomes of a randomized controlled trial among Burmese refugees in Thailand. PLoS Med. 2014;11:e1001757. doi: 10.1371/journal.pmed.1001757.
    1. Sijbrandij M, Bryant RA, Schafer A, Dawson KS, Anjuri D, Ndogoni L, et al. Problem Management Plus (PM+) in the treatment of common mental disorders in women affected by gender-based violence and urban adversity in Kenya: study protocol for a randomized controlled trial. Int J Ment Health Syst. 2016;10:44. doi: 10.1186/s13033-016-0075-5.
    1. Chorpita BF, Daleiden EL. Mapping evidence-based treatments for children and adolescents: application of the distillation and matching model to 615 treatments from 322 randomized trials. J Consult Clin Psychol. 2009;77:566–579. doi: 10.1037/a0014565.
    1. Internal Displacement Monitoring Center. IDMC: Ukraine Update. (2007). Accessed 5 July 2017.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50:217–226. doi: 10.1097/MLR.0b013e3182408812.
    1. Chatfield A, Javetski G, Lesh N. CommCare evidence base 2015. . Accessed 5 July 2018.
    1. Haroz EE, Bass J, Lee C, Oo SS, Lin K, Kohrt B, Bolton P. Development and cross-cultural testing of the International Depression Symptom Scale (IDSS): a measurement instrument designed to represent global presentations of depression. Glob Ment Health. 2017;4:e17. 10.1017/gmh.2017.16. eCollection 2017.
    1. Haroz EE, Michalopolous L, Bolton PA, Bass JK. Development of new global instruments for assessing depression and post-traumatic stress related to torture and trauma. Washington, DC: Report to United States Agency for International Development; 2015.
    1. WHO ASSIST Working Group The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002;97:1183–1194. doi: 10.1046/j.1360-0443.2002.00185.x.
    1. World Health Organization. The ASSIST Project—Alcohol, Smoking and Substance Involvement Screening Test. World Health Organization. . Accessed 5 July 2018.
    1. Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19:1–15. doi: 10.1002/bs.3830190102.
    1. Cardozo BL. Mental health, social functioning, and attitudes of Kosovar Albanians following the war in Kosovo. JAMA. 2000;284:569. doi: 10.1001/jama.284.5.569.
    1. Kleijn WC, Hovens JE, Rodenburg JJ. Posttraumatic stress symptoms in refugees: assessments with the Harvard Trauma Questionnaire and the Hopkins Symptom Checklist-25 in different languages. Psychol Rep. 2001;88:527–532. doi: 10.2466/pr0.2001.88.2.527.
    1. Lhewa D, Banu S, Rosenfeld B, Keller A. Validation of a Tibetan translation of the Hopkins Symptom Checklist 25 and the Harvard Trauma Questionnaire. Assessment. 2007;14:223–230. doi: 10.1177/1073191106298876.
    1. Thapa SB, Hauff E. Psychological distress among displaced persons during an armed conflict in Nepal. Soc Psychiatry Psychiatr Epidemiol. 2005;40:672–679. doi: 10.1007/s00127-005-0943-9.
    1. Ustun TB, Kostanjesek N, Chatterji S, Rehm J, World Health Organization. Measuring Health and Disability: Manual for WHO Disability Assessment Schedule (WHODAS 2.0). Geneva: World Health Organization; 2010. . Accessed 5 July 2018.
    1. Bolton P, Tang AM. An alternative approach to cross-cultural function assessment. Soc Psychiatry Psychiatr Epidemiol. 2002;37:537–543. doi: 10.1007/s00127-002-0580-5.
    1. Doty SB, Haroz EE, Singh NS, Bogdanov S, Bass JK, Murray LK, et al. Adaptation and testing of an assessment for mental health and alcohol use problems among conflict-affected adults in Ukraine. Confl Heal. 2018. 10.1186/s13031-018-0169-6.
    1. First MB, Spitzer RL, Gibbon M, JBW W. Structured Clinical Interview for DSM­IV­TR Axis I Disorders, Research Version, Patient Edition. Revision: January 2010 [Internet]. Biometrics Research. New York: New York State Psychiatric Institute; 2002. Available from: . Accessed 5 July 2018.
    1. Liu X. Classification accuracy and cut point selection. Stat Med. 2012;31:2676–2686. doi: 10.1002/sim.4509.
    1. World Population Review: Ukraine. World Population Review, Walnut, CA, USA. 2017. . Accessed 5 July 2018.
    1. Murray LK, Dorsey S, Bolton P, Jordans MJ, Rahman A, Bass J, et al. Building capacity in mental health interventions in low resource countries: an apprenticeship model for training local providers. Int J Ment Health Syst. 2011;5:30. doi: 10.1186/1752-4458-5-30.
    1. Foa EB. Prolonged exposure therapy: past, present, and future. J Depress Anxiety. 2011;28:1043–1047. doi: 10.1002/da.20907.
    1. Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002;70:867–879. doi: 10.1037/0022-006X.70.4.867.
    1. Murray LK, Jordans MJD. Rethinking the service delivery system of psychological interventions in low and middle income countries. BMC Psychiatry. 2016;16:234. doi: 10.1186/s12888-016-0938-y.
    1. Sloan JA. Assessing the minimally clinically significant difference: scientific considerations, challenges and solutions. COPD. 2009;2:57–62. doi: 10.1081/COPD-200053374.
    1. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371–383. doi: 10.4065/77.4.371.
    1. Azur MJ, Stuart EA, Frangakis C, Leaf PJ. Multiple imputation by chained equations: what is it and how does it work? Int J Methods Psychiatr Res. 2011;20:40–49. doi: 10.1002/mpr.329.
    1. Rubin DB. Multiple imputation for nonresponse in surveys. Hoboken: Wiley; 2004.
    1. Applied Mental Health Research Group. Design, implementation, monitoring and evaluation of cross-cultural trauma-related mental health and psychosocial assistance programs: A user's manual for researchers and program implementers. AMHR. 2013. Available from: . Accessed 1 Nov 2016.
    1. Singer JD, Willett JB. Applied longitudinal data analysis. Oxford: Oxford University Press; 2003.
    1. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12–19. doi: 10.1037/0022-006X.59.1.12.
    1. NICE: The National Institute for Health and Care Excellence. London. 2017. . Accessed 5 July 2018.
    1. Cohen JA, Mannarino AP. A treatment study for sexually abused preschool children: outcome during a one-year follow-up. J Am Acad Child Adolesc Psychiatry. 1997;36:1228–1235. doi: 10.1097/00004583-199709000-00015.
    1. Kaysen D, Lindgren K, Zangana GAS, Murray L, Bass J, Bolton P. Adaptation of cognitive processing therapy for treatment of torture victims: Experience in Kurdistan, Iraq. Psychol Trauma. 2013;5:184–192. doi: 10.1037/a0026053.
    1. Emmelkamp PMG, Bellack AS, Herson M, Kazdin AE, Kazdin A. International handbook of behavior modification and therapy. 1990. Anxiety and fear; pp. 283–305.
    1. Olatunji BO, Deacon BJ, Abramowitz JS. The cruelest cure? Ethical issues in the implementation of exposure-based treatments. Cogn Behav Pract. 2009;16:172–180. doi: 10.1016/j.cbpra.2008.07.003.
    1. Tryon W. Possible mechanisms for why desensitization and exposure therapy work. Clin Psychol Rev. 2005;25:67–95. doi: 10.1016/j.cpr.2004.08.005.
    1. Barrera TL, Mott JM, Hofstein RF, Teng EJ. A meta-analytic review of exposure in group cognitive behavioral therapy for posttraumatic stress disorder. Clin Psychol Rev. 2013;33:24–32. doi: 10.1016/j.cpr.2012.09.005.
    1. Robjant K, Fazel M. The emerging evidence for Narrative Exposure Therapy: a review. Clin Psychol Rev. 2010;30:1030–1039. doi: 10.1016/j.cpr.2010.07.004.
    1. Frueh BC, Turner SM, Beidel DC. Exposure therapy for combat-related PTSD: a critical review. Clin Psychol Rev. 1995;15:799–817. doi: 10.1016/0272-7358(95)00049-6.

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