Clinical trial NCT02069301: Evaluation of an Integrated Microfinance and Depression Care Program for Women
Official title: Development of an Integrated Microfinance and Depression Care Program for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Behavior Activation
Problem solving therapy
Depression Treatment
depression care integration
microfinance
livelihood
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Danang Psychiatric Hospital
First posted: 2014-02-24
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, 6 month, and 12 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.

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 criteria: Inclusion Criteria:

* depression, low-income

Exclusion Criteria:

* psychosis, mania, substance abuse, high suicide risk, physical disabilities, significant cognitive impairments

Primary outcomes:
measure: Change in Depression Score from the Patient Health Questionnaire
timeFrame: 0, 6, 12 months
Secondary outcomes:
measure: Change in Quality of Life Score from Quality of Life and Enjoyment and Satisfaction Questionnaire
timeFrame: 0, 6, 12 months
measure: Change in Self-Efficacy Score from Self Efficacy Survey
timeFrame: 0, 6, 12 months
measure: Change in Social Support Index from Medical Outcome Study Social Support Survey
timeFrame: 0, 6, 12 months
measure: Change in health and mental health functioning scores from Medical Outcomes Study Short Form Health Survey (SF-12)
timeFrame: 0, 6, 12 months
measure: Change in Anxiety Symptom Score from Generalized Anxiety Disorder (GAD-7) Scale
timeFrame: 0, 6, 12 months
measure: Change in Behavior Activation Score from the Behavior Activation for Depression Scale Short Form (BADS-SF)
timeFrame: 0, 6, 12 months
measure: Change in household wealth indicators from Economic Well-Being Inventory
timeFrame: 0, 6, 12 months
measure: Change in number and type of income generating activities from the Employment and business Activities Questionnaire
timeFrame: 0, 6, 12 months
measure: Treatment Acceptability Score from Help-Seeking Behavior Questionnaire
timeFrame: 0, 6, 12 months
measure: Depression Stigma Score from the Depression Stigma Questionnaire
timeFrame: 0, 6, 12 months
measure: Social Capital Score from Social Capital Assessment Tool
timeFrame: 0, 6, 12 months
measure: Total Score Client Service Satisfaction Questionnaire
timeFrame: 0, 6, 12 months
measure: Number of Participants Demonstrating Mental Health Literacy with Depression Vignette
timeFrame: 0, 12 months
measure: Number of Participants with Depression Diagnosis - MINI International Neuropsychiatric Interview, Version 6.0 (MINI)
timeFrame: 0, 6, 12 months
Other outcomes:
Locations:
city: Da Nang
country: Vietnam
facility: Hoa Cuong Bac Commune Health Station
city: Da Nang
country: Vietnam
facility: Hoa Cuong Nam Commune Health Station
city: Da Nang
country: Vietnam
facility: Hoa Hiep Nam Commune Health Station
city: Da Nang
country: Vietnam
facility: Hoa Minh Commune Health Station
Study officials:
affiliation: RAND
name: Victoria K Ngo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo VK, Weiss B, Lam T, Dang T, Nguyen T, Nguyen MH. The Vietnam Multicomponent Collaborative Care for Depression Program: Development of Depression Care for Low- and Middle-Income Nations. J Cogn Psychother. 2014;28(3):156-167. doi: 10.1891/0889-8391.28.3.156.