Evaluation of an Integrated Microfinance and Depression Care Program for Women

Depression Clinical Trial

— LIFE-DM  

Official title:

Development of an Integrated Microfinance and Depression Care Program for Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069301
• Other study ID #: 5R34MH094648-02
• Secondary ID: 5R34MH094648-02
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: November 28, 2017
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2017
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• depression, low-income

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Integrated Depression/Microfinance Group
LIFE-DM Integrated Depression and Microfinance group, uses behavior activation and problem solving therapy skills to teach patients how to manage mood and reach livelihood goals.

Other:
• Treatment as Usual
National Guideline for antidepressant care
• Livelihood Support
Livelihood support, including group-based loans to develop small enterprise, personal finance management education, business management skills, vocational training, and rotating-credit savings program.

Locations

Country	Name	City	State
Vietnam	Hoa Cuong Bac Commune Health Station	Da Nang
Vietnam	Hoa Cuong Nam Commune Health Station	Da Nang
Vietnam	Hoa Hiep Nam Commune Health Station	Da Nang
Vietnam	Hoa Minh Commune Health Station	Da Nang

Sponsors (3)

Lead Sponsor	Collaborator
RAND	Danang Psychiatric Hospital, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depression Score from the Patient Health Questionnaire	The PHQ-9 is a nine-item validated tool measuring depressive symptoms based on DSM-IV criteria. The answers are rated on a scale from zero (not at all) to three (nearly every day). Total scores range from 0-27, subdivided into five categories of depression severity: 1 to 4 is minimal; 5 to 9 is mild; 10 to 14 is moderate; 15 to 19 is moderate-severe; and 20 and above is severe. The PHQ-9 has been widely used internationally including in Vietnam.	0, 6, 12 months
Secondary	Change in Quality of Life Score from Quality of Life and Enjoyment and Satisfaction Questionnaire	The Quality of Life Enjoyment and Satisfaction Questionnaire 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. The summary scores were found to be reliable and valid measures of these dimensions in a group of depressed outpatients. The Q-LES-Q measures were related to, but not redundant with, measures of overall severity of illness or severity of depression within this sample. These findings suggest that the Q-LES-Q measures may be sensitive to important differences among depressed patients that are not detected by the measures usually employed.	0, 6, 12 months
Secondary	Change in Self-Efficacy Score from Self Efficacy Survey	Items were developed to assess effectiveness of a goal-setting and planning intervention (Macleod et al., 2008). Self-efficacy is assessed via 4-items that measure locus of control, materials and skills to complete goals, confidence, and optimism. Self-efficacy is rated on a 9-point scale from 1 ("Not at all") to 9 ("To a great extent").	0, 6, 12 months
Secondary	Change in Social Support Index from Medical Outcome Study Social Support Survey	A brief, multidimensional, selfadministered, social support survey that was developed for patients in the Medical Outcomes Study (MOS), a two-year study of patients with chronic conditions. This survey was designed to be comprehensive in terms of recent thinking about the various dimensions of social support.	0, 6, 12 months
Secondary	Change in health and mental health functioning scores from Medical Outcomes Study Short Form Health Survey (SF-12)	The SF-12v2 is a 12-item survey that measures the same eight domains of health. The domains scores are summarized into two composite scores: Physical Component Summary and Mental Component Summary scores. The survey is a brief, reliable measure of overall health status. It is useful in large population health surveys and has been used in Vietnamese populations.	0, 6, 12 months
Secondary	Change in Anxiety Symptom Score from Generalized Anxiety Disorder (GAD-7) Scale	The GAD-7 is a 7-item anxiety scale used for screening and assessing symptom severity of GAD. GAD and depression symptoms frequently occurred together, but factor analysis confirmed them as distinct dimensions, and they had independent effects on functional impairment and disability. Self-report and interviewer-administered versions of GAD-7 were in good agreement.	0, 6, 12 months
Secondary	Change in Behavior Activation Score from the Behavior Activation for Depression Scale Short Form (BADS-SF)	The abbreviated BADS-SF is a nine-item scale measuring factors expected to change as a function of behavioral activation, including activation and avoidance	0, 6, 12 months
Secondary	Change in household wealth indicators from Economic Well-Being Inventory	The economic well-being inventory collect various indicators of self-reported household wealth: housing materials, land ownership, home ownership, and selling and purchasing of assets such as livestock and durable goods (car, bicycle, radio, TV), as well as income, savings, and debt. This economic well-being inventory was used in the Danang Household Mental Health Survey.	0, 6, 12 months
Secondary	Change in number and type of income generating activities from the Employment and business Activities Questionnaire	We developed questionnaire to measure income generating activities, which include questions about participation and number of hours in types of employment and income generating activities in Low-Income countries, including formal salaried employment, farming and planting food, selling goods and services, property rentals, etc.	0, 6, 12 months
Secondary	Treatment Acceptability Score from Help-Seeking Behavior Questionnaire	This measure consists of items that assesses 1) resources in the community, 2) participant's help seeking history, 3) perceived effectiveness, and 4) acceptability of a variety of strategies used for depression care.	0, 6, 12 months
Secondary	Depression Stigma Score from the Depression Stigma Questionnaire	18 item questionnaire about perceived and personal stigma related to depression.	0, 6, 12 months
Secondary	Social Capital Score from Social Capital Assessment Tool	The short version of the Adapted Social Capital Assessment Tool (SASCAT) is a nine-item tool measures the structural (quantity of social relationships) and cognitive (quality of social relationships) components of social capital as well as citizenship. The measure derived from the Adapted Social Capital Assessment Tool (A-SCAT) (Harpham et al., 2002). The measures has been used in many international settings, including developing countries.	0, 6, 12 months
Secondary	Total Score Client Service Satisfaction Questionnaire	A standardized measure with strong psychometric properties that could be used to assess general satisfaction across varied health and human services. The CSQ Scales® (CSQ) measure may be used to assess client satisfaction with mental health services, as a program evaluation tool, or to assess client satisfaction within and across programs (intra- or inter-program) and demographic groups.	0, 6, 12 months
Secondary	Number of Participants Demonstrating Mental Health Literacy with Depression Vignette	Vignette describes someone with the minimal number of symptoms necessary for major depression (according to DSM description). Respondents were asked an open-ended question, ``What would you say, if anything, is wrong with Mary?'' Only answers including " depression " are considered a correct response.	0, 12 months
Secondary	Number of Participants with Depression Diagnosis - MINI International Neuropsychiatric Interview, Version 6.0 (MINI)	The MINI is a brief structured psychiatric interview used to diagnose for multiple axis I DSM-IV mental disorders. In this study, the MINI is used to assess for major depressive episodes. Using DSM-IV criteria (at least 5 symptoms of depression over a 2 week period; endorsement of depressed mood or anhedonia were necessary for diagnosis) the interviewers can distinguish between past, current, and recurrent episodes of depression. The MINI is a reliable and valid alternative to the longer Structured Clinical Interview for Diagnostic. The MINI has been used widely in developing countries and administered by non-mental health providers.	0, 6, 12 months