- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532008
Depression Treatment and Economic Empowerment (ASHA)
August 28, 2020 updated by: Alison Karasz, Albert Einstein College of Medicine
The ASHA Project: Pilot Study of a Depression Treatment/Economic Empowerment
This pilot study randomized 48 depressed rural Bangladeshi housewives to either intervention or control groups.
The intervention groups received depression treatment and a financial empowerment intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was conducted in the rural Sirajganj region of Bangladesh.
Working with the International Centre for Diarrhoeal Disease Research, Bangladesh and a local NGO, we recruited 48 depressed rural housewives for the study.
Participants were randomized into intervention in control groups.
The intervention groups (n=24) received 12 sessions of evidence based depression treatment, financial literacy education, agricultural training and skill building.
They opened bank accounts and saved for six months.
At the end of the six month period, participants who had met savings and attendance requirements received a cash transfer of approximately $186, which was used to purchase a productive asset.
22 participants purchased an agricultural animal, usually a goat; 1 financed a small retail business, and 1 leased land to grow crops for sale.
Depression scores on the PHD-9 were sharply reduced.
The study had 100% retention.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 18-40
- PHQ greater than 10
- Able to save
- Able to read and write
Exclusion Criteria:
- Not in age range PhQ below 10 Unable to contribute to savings account Illiterate
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No intervention
|
|
|
Experimental: Treatment Group
Experimental group received 12 session of group based depression treatment, a matched savings program, financial literacy training, agricultural training, and a cash transfer.
|
12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms
Time Frame: 12 months post baseline
|
symptoms on the Patient Health Questionnaire (PHD-9), ranging from 0 to 27, with higher scores indicating worse outcomes
|
12 months post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention
Time Frame: Assessed at 12 Months post basline
|
Percentage of participants in the intervention group completing the intervention
|
Assessed at 12 Months post basline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alison Karasz, Albert Einstein College Of Medicine
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 (Actual)
September 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
August 15, 2020
Study Registration Dates
First Submitted
August 24, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Actual)
August 31, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-2320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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