ASHA Bangladesh--An Integrated Intervention to Address Poverty and Depression

Официальное название

ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women

Обзор

The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are whether adding poverty alleviation to depression treatment in an integrated intervention: 1) improves depression outcomes at 6 months post baseline as measured by changes in the PHQ-9 from baseline--compared to depression treatment alone; 2) reduces the chance of relapse (PHQ-9 \>=5) at 18 months among patients who remitted (PHQ-9\<5) at six months--compared to depression treatment alone; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention--compared to depression treatment alone. Other outcomes that will be studied include economic vulnerability and psychosocial variables such as anxiety, culturally specific symptoms, quality of life, and function. Participants in both arms will participate in research interviews at 6,12 and 18 months. The project also includes a mixed methods implementation evaluation. Quantitative implementation outcomes to be examined include adoption/uptake; retention in the intervention, and fidelity of intervention delivery. A qualitative process evaluation will include interviews with 80 study participants and approximately 40 staff members, including research staff, agricultural officers, and interventionist staff.

Вмешательства

• Поведенческое Manualized Group Based Psychotherapy
  Participants in the control group will receive a 10-session 6-month manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: 1) problem solving; 2) increasing social support; 3) behavioral activation; and 4) relaxation through deep breathing. The intervention is delivered by trained non professional peers.
• Другое Poverty Alleviation
  In addition to the psychotherapy intervention described above, participants in the experimental group will receive a poverty alleviation intervention adapted from the well-known Graduation Program--a poverty alleviation intervention widely used in low income countries. The poverty alleviation intervention includes a) 4 sessions of financial literacy education; b) savings accounts; c) consumption support equal to the cost of 1kg of rice per day for six months; d) productive asset transfer of 3 go

Первичные конечные точки

• Change in Depressive symptoms at 6 Months [Срок оценки: 6 Months]

Вторичные конечные точки (7)

• 18-Month Relapse [Срок оценки: 18 months]
• Depression at 12 and 18 months [Срок оценки: 12 and 18 months]
• Economic vulnerability Index [Срок оценки: Baseline, 12, and 18 Months]
• Anxiety [Срок оценки: Baseline, 6 Months, 12 Months, and 18 Months]
• Function [Срок оценки: Baseline, 6 Months, 12 Months, and 18 Months]
• Change in Quality of Life [Срок оценки: Baseline, 6 Months, 12 Months, and 18 Months]
• Tension Scale [Срок оценки: Baseline, 6 Months, 12 Months, 18 months]

Критерии участия

Критерии включения

• Age 18-45
• Meets criteria for Economic Vulnerability as measured by: household income <= 15000 Taka per month; food insufficiency in household over previous six months; OR owning <= 10 decimals of land
• Family willingness to participate in the program
• Basic literacy as measured by ability to read a simple sentence;
• A score >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline

Критерии исключения

• Pregnancy at screen;
• Cognitive or physical impairment precluding participation
• Plans to relocate or to travel for > 1 month during 18 M period.
• Household debt greater than 70,000 Taka

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• International Centre for Diarrhoeal Disease Research — Dhaka

Публикации

• Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003 Dec;64(12):1465-75. doi: 10.4088/jcp.v64n1211. PMID 14728109
• Kessler RC, Akiskal HS, Ames M, Birnbaum H, Greenberg P, Hirschfeld RM, Jin R, Merikangas KR, Simon GE, Wang PS. Prevalence and effects of mood disorders on work performance in a nationally representative sample of U.S. workers. Am J Psychiatry. 2006 Sep;163(9):1561-8. doi: 10.1176/ajp.2006.163.9.1561. PMID 16946181
• Heflin CM, Iceland J. Poverty, Material Hardship and Depression. Soc Sci Q. 2009 Dec 1;90(5):1051-1071. doi: 10.1111/j.1540-6237.2009.00645.x. PMID 25530634
• Haushofer J, Fehr E. On the psychology of poverty. Science. 2014 May 23;344(6186):862-7. doi: 10.1126/science.1232491. PMID 24855262
• Patel V, Araya R, de Lima M, Ludermir A, Todd C. Women, poverty and common mental disorders in four restructuring societies. Soc Sci Med. 1999 Dec;49(11):1461-71. doi: 10.1016/s0277-9536(99)00208-7. PMID 10515629
• Lerman S. The syndemogenesis of depression Concepts and examples. depression. 2018.
• Lund C, De Silva M, Plagerson S, Cooper S, Chisholm D, Das J, Knapp M, Patel V. Poverty and mental disorders: breaking the cycle in low-income and middle-income countries. Lancet. 2011 Oct 22;378(9801):1502-14. doi: 10.1016/S0140-6736(11)60754-X. Epub 2011 Oct 16. PMID 22008425
• Lund C, Breen A, Flisher AJ, Kakuma R, Corrigall J, Joska JA, Swartz L, Patel V. Poverty and common mental disorders in low and middle income countries: A systematic review. Soc Sci Med. 2010 Aug;71(3):517-528. doi: 10.1016/j.socscimed.2010.04.027. Epub 2010 May 12. PMID 20621748

Идентификаторы

NCT: NCT06295250 · STUDY00001114 · 7R01MH127577

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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