ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression

February 27, 2024 updated by: Alison Karasz, University of Massachusetts, Worcester

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • International Centre for Diarrhoeal Disease Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Depression Treatment (DT)
Participants in the control group will receive a 6 month manualized group based psychotherapy treatment..
Behavioral: Manualized Group Based Psychotherapy
Manualized Group Based Psychotherapy. Adapted from the WHO Problem Management Plus (PM+) intervention, this intervention includes behavioral activation, enhancing social support, and problem managment.
Experimental: Integrated Intervention

The experimental arm includes 2 elements:

  1. A poverty alleviation intervention
  2. The psychotherapy intervention described above.
Behavioral: Manualized Group Based Psychotherapy
Manualized Group Based Psychotherapy. Adapted from the WHO Problem Management Plus (PM+) intervention, this intervention includes behavioral activation, enhancing social support, and problem managment.
Other: Poverty Alleviation
This intervention includes Asset transfer, skill transfer, financial literacy education, stipend, savings accounts, veterinary support, feed, and agricultural training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depressive symptoms at 24 Months
Time Frame: 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.
24 months
Change in Depressive symptoms at intermediate timepoints
Time Frame: 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.
6, 12, 18 months
24 Month Relapse
Time Frame: 24 months
Relapse is defined as A score of Patient Health Questionnaire>= 10 among participants who achieved remission at 6 months. To assess relapse, we will ask participants about the experience of depressive symptoms at any time since the previous data collection point. We will focus on 24 month relapse, or the presence of relapse at any time since Time 2 (6 months).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic vulnerability
Time Frame: 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.
Baseline, 12, and 24 Months
Anxiety
Time Frame: 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.
Baseline, 6 Months, 12 Months, and 24 Months
Function
Time Frame: 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.
Baseline, 6 Months, 12 Months, and 24 Months
European Quality of Life Five Dimensions Five Level scale
Time Frame: Baseline, 6 Months, 12 Months, and 24 Months
Quality of life measure that includes five dimensions: mobility, self care, usual actigities, pain/discomfort and anxiety/depression, scored from 0-100 with higher scores indicating better quality of life.
Baseline, 6 Months, 12 Months, and 24 Months
Tension Scale
Time Frame: 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.
Baseline, 6 Months, 12 Months, 18 months and 24 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation Outcomes--Adoption
Time Frame: Baseline + 30 days
The number of participants attending >-1 treatment session/# participants randomized. Based on recruitment and study records.
Baseline + 30 days
Implementation Outcomes--Feasibility
Time Frame: Six months
Percent of participants attending >= 75 percent of intervention sessions--based on study records
Six months
Implementation outcomes--fidelity
Time Frame: Intervention months 1, 3 and 6
Supervisor observations of sessions will be assessed for fidelity using a LIKERT scale that includes preparedness (0-3), Facilitation (0-11), Engagement (0-6) time management (0-1) and Documentation (0-1).
Intervention months 1, 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine
Georgetown University
International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

  • Principal Investigator: Alison Karasz, PhD, UMass Chan Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001114
  • 7R01MH127577 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will create a deidentified dataset and it is our intention that these data be readily accessible and used. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes. All such data requests will be approved though by the investigative team, including the ICDDRB, to help ensure ethical use of the data.

IPD Sharing Time Frame

Data will be available indefinitely following the completion of analyses

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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