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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04532008
Other study ID # 2013-2320
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2012
Est. completion date August 15, 2020

Study information

Verified date August 2020
Source Albert Einstein College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 15, 2020
Est. primary completion date September 1, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group based treatment
12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Albert Einstein College of Medicine International Centre for Diarrhoeal Disease Research, Bangladesh

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive Symptoms symptoms on the Patient Health Questionnaire (PHD-9), ranging from 0 to 27, with higher scores indicating worse outcomes 12 months post baseline
Secondary Retention Percentage of participants in the intervention group completing the intervention Assessed at 12 Months post basline
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