ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression

Not Applicable

Recruiting

• Conditions: Economic Vulnerability; Depression
• Interventions: Behavioral: Manualized Group Based Psychotherapy; Other: Poverty Alleviation

• Registration Number: NCT06295250
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-06
• Study Start: 2024-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 660

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depression Treatment (DT)	Manualized Group Based Psychotherapy	Participants in the control group will receive a 6 month manualized group based psychotherapy treatment..
Integrated Intervention	Poverty Alleviation	The experimental arm includes 2 elements: 1. A poverty alleviation intervention 2. The psychotherapy intervention described above.
Integrated Intervention	Manualized Group Based Psychotherapy	The experimental arm includes 2 elements: 1. A poverty alleviation intervention 2. The psychotherapy intervention described above.

Primary Outcome Measures

Name	Time	Method
Change in Depressive symptoms at 24 Months	24 months	Change in Symptoms from Baseline to 24 months post baseline, as measured by the Patient Health Questionnaire, a 9 item questionnaire designed to assess depressive symptoms. The minimum score is 0; the maximum score is 27.
Change in Depressive symptoms at intermediate timepoints	6, 12, 18 months	Change in Symptoms from Baseline to 6, 12, and 18 months post baseline, as measured by the Patient Health Questionnaire, a 9 item questionnaire designed to assess depressive symptoms. The minimum score is 0; the maximum score is 27.
24 Month Relapse	24 months	Relapse is defined as A score of Patient Health Questionnaire\>= 10 among participants who achieved remission at 6 months. To assess relapse, the investigators will ask participants about the experience of depressive symptoms at any time since the previous data collection point. Data collection will focus on 24 month relapse, or the presence of relapse at any time since Time 2 (6 months).

Secondary Outcome Measures

Name	Time	Method
Anxiety	Baseline, 6 Months, 12 Months, and 24 Months	Anxiety symptoms as measured on the General Anxiety Disorder scale--a seven item questionnaire with scores from 0-231. HIgher scores indicate more anxiety.
Tension Scale	Baseline, 6 Months, 12 Months, 18 months and 24 Months	A questionnaire that measures both psychological symptoms as well as somatic cultural symptoms: a 39 item instrument measured from 0-3 with a minimum score of 0 and a maximum score of 117. with higher scores indicating higher levels of distress.
Economic vulnerability	Baseline, 12, and 24 Months	A composite index of economic vulnerability that includes income, assets, debt, food insecurity, financial worry. This measure does not have a fixed score but is composed using a pragmatic approach based on data collected in the field.
European Quality of Life Five Dimensions Five Level scale	Baseline, 6 Months, 12 Months, and 24 Months	Quality of life measure that includes five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression, scored from 0-100 with higher scores indicating better quality of life.
Function	Baseline, 6 Months, 12 Months, and 24 Months	Function and disability as measured by the World Health Organization Disability Assessment Schedule, a 12 item questionnaire that is scored from 12-60 with higher scores indicating greater disability.

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research; 🇧🇩 Dhaka, Bangladesh