ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295250
• Other study ID #: STUDY00001114
• Secondary ID: 7R01MH127577
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: Alison Karasz, PhD
• Phone: 3478435652
• Email: alison.karasz[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Manualized Group Based Psychotherapy
Manualized Group Based Psychotherapy. Adapted from the World Health Organization (WHO) Problem Management Plus (PM+) intervention, this intervention includes behavioral activation, enhancing social support, and problem management.

Other:
• Poverty Alleviation
This intervention includes Asset transfer, skill transfer, financial literacy education, stipend, savings accounts, veterinary support, feed, and agricultural training

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research	Dhaka

Sponsors (5)

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

Country where clinical trial is conducted

Bangladesh, 

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* Note: There are 163 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implementation Outcomes--Adoption	The number of participants attending >-1 treatment session/# participants randomized. Based on recruitment and study records.	Baseline + 30 days
Other	Implementation Outcomes--Feasibility	Percent of participants attending >= 75 percent of intervention sessions--based on study records	Six months
Other	Implementation outcomes--fidelity	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
Primary	Change in Depressive symptoms at 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
Primary	Change in Depressive symptoms at intermediate timepoints	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
Primary	24 Month Relapse	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).	24 months
Secondary	Economic vulnerability	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
Secondary	Anxiety	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
Secondary	Function	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
Secondary	European Quality of Life Five Dimensions Five Level scale	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.	Baseline, 6 Months, 12 Months, and 24 Months
Secondary	Tension Scale	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