NCT06295250

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 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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable depression

Timeline
6mo left

Started Mar 2024

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

February 27, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

February 27, 2024

Last Update Submit

March 5, 2026

Conditions

DepressionEconomic VulnerabilityAnxietyCulture Specific Symptoms

Keywords

Depression treatmentCash TransferProblem Management PlusPoverty Alleviation

Outcome Measures

Primary Outcomes (1)

  • Change in Depressive symptoms at 6 Months

    Change in Symptoms from Baseline to 6 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 Months

Secondary Outcomes (7)

  • 18-Month Relapse

    18 months

  • Depression at 12 and 18 months

    12 and 18 months

  • Economic vulnerability Index

    Baseline, 12, and 18 Months

  • Anxiety

    Baseline, 6 Months, 12 Months, and 18 Months

  • Function

    Baseline, 6 Months, 12 Months, and 18 Months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Implementation Outcomes--Adoption

    Baseline + 30 days

  • Implementation Outcomes--Feasibility

    6 months

  • Implementation outcomes--Fidelity

    At least once for each six month treatment group.

Study Arms (2)

Depression Treatment (DT)

ACTIVE COMPARATOR

Participants in the control group will receive: 1) 6-sessions of a manualized group based psychotherapy treatment. The treatment is adapted from a WHO program called Problem Management Plus (PM+). PM+ includes 4 evidence based strategies: problem solving; increasing social support; behavioral activation; and relaxation through deep breathing; 2) 4 support group meetings. The intervention is delivered by trained non professional peers.

Behavioral: Manualized Group Based Psychotherapy

Integrated Intervention

EXPERIMENTAL

The experimental arm includes 2 elements: 1. The 6-ssesion psychotherapy intervention described above. 2. A poverty alleviation intervention that 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 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building.

Behavioral: Manualized Group Based PsychotherapyOther: Poverty Alleviation

Interventions

Manualized Group Based PsychotherapyBEHAVIORAL

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.

Depression Treatment (DT)Integrated Intervention
Poverty AlleviationOTHER

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 goats; e) 12 months of animal feed and veterinary care; f) gardening supplies; g) agricultural skill building.

Integrated Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research

Dhaka, Dhaka Division, Bangladesh

RECRUITING

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MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Alison Karasz, PhD

    UMass Chan Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Karasz, PhD

CONTACT

3478435652alison.karasz@umassmed.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
In this trial, participants, interventionists, and outcome assessors will be blinded to details of the trial design, alternate interventions and randomization assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 6, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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 International Center for Diarrhoeal Disease Research (ICDDRB), to help ensure ethical use of the data.

Shared Documents
ANALYTIC CODE
Time Frame
Data will be available indefinitely following the completion of analyses
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).

Locations

BA(1)