NCT04532008

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 24, 2020

Last Update Submit

August 28, 2020

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Retention

    Assessed at 12 Months post basline

Study Arms (2)

Control Group

NO INTERVENTION

No intervention

Treatment Group

EXPERIMENTAL

Experimental group received 12 session of group based depression treatment, a matched savings program, financial literacy training, agricultural training, and a cash transfer.

Behavioral: Group based treatment

Interventions

Group based treatmentBEHAVIORAL

12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy

Treatment Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40
  • PHQ greater than 10
  • Able to save
  • Able to read and write

You may not qualify if:

  • Not in age range PhQ below 10 Unable to contribute to savings account Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Alison Karasz

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 48 women randomized to either intervention or control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 31, 2020

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Study Completion

August 15, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share