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Evaluation of an Integrated Microfinance and Depression Care Program for Women (LIFE-DM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by RAND
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Victoria K. Ngo, PhD, RAND
ClinicalTrials.gov Identifier:
NCT02069301
First received: February 10, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Depression
Anxiety
Behavioral: LIFE-DM
Drug: Guideline Antidepressant Care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
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)
Arms Assigned Interventions
Experimental: LIFE-DM
Depression and microfinance integrated program using behavior activation and problem solving therapy applied to livelihood
Behavioral: LIFE-DM

The goals of the LIFE-DM program (an integrated depression and microfinance program) are to provide economically disadvantaged women in Vietnam with:

  1. Effective depression management skills to cope with and problem solve their stressors.
  2. Livelihood support, including group-based loans to develop small enterprise, personal finance management education, business management skills, vocational training, and rotating-credit savings program.
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
Other Names:
  • Fluoxetine
  • Amitrytaline
  • other antidepressants

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • depression, low-income

Exclusion Criteria:

  • psychosis, mania, substance abuse, high suicide risk, physical disabilities, significant cognitive impairments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069301

Contacts
Contact: Victoria K Ngo, PhD 626-780-7899 ext 6295 vngo@rand.org
Contact: Trung Lam, MD 0905123410 tutrung.lttrungdn@gmail.com

Locations
Vietnam
Commune Health Stations
Danang, Vietnam
Sponsors and Collaborators
RAND
Investigators
Principal Investigator: Victoria K Ngo, PhD RAND
  More Information

No publications provided

Responsible Party: Victoria K. Ngo, PhD, Behavior Scientist, RAND
ClinicalTrials.gov Identifier: NCT02069301     History of Changes
Other Study ID Numbers: 5R34MH094648-02, 5R34MH094648-02
Study First Received: February 10, 2014
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
Behavior Activation
Problem solving therapy
Depression Treatment
depression care integration
microfinance

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014