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

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Depression; Economic Vulnerability

Treatments: Behavioral: Manualized Group Based Psychotherapy; Other: Poverty Alleviation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06295250

7R01MH127577 (U.S. NIH Grant/Contract)

STUDY00001114

Details and patient eligibility

About

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; 2) reduces the chance of relapse (PHQ-9 >=10) at 24 months among patients who remitted (PHQ-9>=5) at six months; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in research interviews at 6,12 and 24 months.

Enrollment: 660 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. married women;
2. age 18-75;
3. fluent in Bengali);
4. Meets criteria on an Economic Vulnerability Index
5. >=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale at baseline

Exclusion criteria

1. Inability to provide informed consent;
2. Plans to travel for > 1 month during 24 M period.
3. Inability to participate in the study for any other reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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660 participants in 2 patient groups

Depression Treatment (DT)

Active Comparator group

Description:

Participants in the control group will receive a 10 session 6 month manualized group based psychotherapy treatment..

Treatment:

Behavioral: Manualized Group Based Psychotherapy

Integrated Intervention

Experimental group

Description:

The experimental arm includes 2 elements: 1. The psychotherapy intervention described above. 2. A poverty alleviation intervention

Treatment:

Other: Poverty Alleviation

Behavioral: Manualized Group Based Psychotherapy