Evaluation of an Integrated Microfinance and Depression Care Program for Women (LIFE-DM)
The study evaluates LIFE-DM, an integrated microfinance and collaborative care intervention by comparing it to enhanced treatment as usual (national guideline antidepressant care and referral to microfinance resources) in Vietnam. Intervention effects at baseline, 3 month, and 6 month follow-up on patient outcomes, including depression, anxiety, quality of life, functioning, self-efficacy, satisfaction, and income will be compared across the two conditions.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Development of an Integrated Microfinance and Depression Care Program for Women|
- Change in Patient Health Questionnaire-9 [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Reduction in depression symptoms from baseline (0), 3 month, and 6 month follow-up.
- Change in MINI Diagnostic Interview [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Recovery from Depression Diagnosis from baseline to 3 month to 6 month.
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. We are evaluating improvement in quality of life and satisfaction across baseline, to 3 month, to 6 months.
- Change in Self-Efficacy [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Improvement in patient self-reported self efficacy at 0, 3, and 6 months.
- Change in Medical Outcome Study (MOS)-Social Support Survey [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Improvement in patient reported social support at baseline, 3 month, and 6 months.
- Change in Medical Outcomes Study (MOS) 12-Item Short Form Health Survey (SF-12) [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Improvement in MOS SF-12 Health Functioning (composed of Physical and Mental Health Functioning factors) from baseline, 3, and 6 months follow-up.
- Change in Generalized Anxiety Disorder (GAD-7) [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Reduction in anxiety symptoms from baseline, 3 months, and 6 months follow-up.
- Change in Behavior Activation for Depression Scale (BADS) [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Improvement in behavior activation from baseline to 3 and 6 months.
- Change in income [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]Improvement in income from baseline to 3 and 6 months
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Depression and microfinance integrated program using behavior activation and problem solving therapy applied to livelihood
The goals of the LIFE-DM program (an integrated depression and microfinance program) are to provide economically disadvantaged women in Vietnam with:
Other Name: Livelihood Integration for Effective Depression Management (LIFE-DM).
Active Comparator: Treatment as Usual
Currently treatment as usual in this province includes guideline antidepressant care for depression and referral for microfinance/livelihood programs
Drug: Guideline Antidepressant Care
Guideline antidepressant care
Depression is one of the largest contributors to the world's health burden. Prior work in the Partners in Care study has shown that evidence-based service delivery programs for depression can improve health outcomes in depressed patients, and especially in minorities, largely overcoming disparities in outcomes from care between whites and minorities. Effective treatments exist, but they do not reach many depressed individuals, especially in resource-poor communities--ethnic minorities, rural residents in the United States, and individuals in most of the developing world.
Women, in particular, are at risk for depression and poverty. Integrating programs that treat depression and address livelihood concerns may improve engagement in depression treatment and improve mental health and functioning for patients in low-resource settings. The proposed study would integrate depression care with existing "microfinance" programs, which provide poverty-alleviation services including small loans, savings programs, and vocational training to women.
This project will (1) conduct qualitative studies of barriers and facilitators of women's successful use of existing depression care and microfinance programs; (2) adapt and integrate the depression care and microfinance services; (3) train Women's Union facilitators to deliver the integrated depression care and microfinance program; and conduct evaluation of LIFE-DM program to assess acceptability, feasibility, and preliminary effectiveness. The non-randomized control trial compares the integrated microfinance and collaborative care intervention with enhanced treatment as usual (national guideline antidepressant care and referral to microfinance resources) at the Women's Union in Danang city in Vietnam.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02069301
|Contact: Victoria K Ngo, PhD||626-780-7899 ext email@example.com|
|Contact: Trung Lam, MDfirstname.lastname@example.org|
|Commune Health Stations|
|Principal Investigator:||Victoria K Ngo, PhD||RAND|