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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment reduced: 680 → 600 participantsv6
  2. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 640 to 680
    • Site details revised
    v5
  3. Primary endpoints: 2 to 1v4 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 660 to confirmed 640
    • Primary and study completion dates: Nov 2027 to Dec 2026
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: 5 to 7
    • Site details revised
    • Collaborators: 4 to 3
  4. Primary completion date: Dec 30, 2026 to Nov 2027v3 Show 6 more changesShow less
    • Primary endpoints: 3 to 2
    • Study completion date: Dec 30, 2027 to Nov 2027
    • Start date: Mar 15, 2024 to Mar 1, 2024
    • Secondary endpoints revised (5)
    • Site details revised
    • Study title expanded, about 1 word
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 30, 2027 to Dec 30, 2026
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06295250
Lead Sponsor University of Massachusetts, Worcester
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh, Georgetown University, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Depression, Economic Vulnerability, Anxiety, Culture Specific Symptoms
Related terms Anxiety Disorders, Depression
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov