Evaluation of an Integrated Microfinance and Depression Care Program for Women

NCT02069301 | Completed DMC

• 1 other identifier: 5R34MH094648-02
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression

Keywords

Behavior Activation; Problem solving therapy; Depression Treatment; depression care integration; microfinance; livelihood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change in Quality of Life Score from Quality of Life and Enjoyment and Satisfaction Questionnaire

  0, 6, 12 months

• Change in Self-Efficacy Score from Self Efficacy Survey

  0, 6, 12 months

• Change in Social Support Index from Medical Outcome Study Social Support Survey

  0, 6, 12 months

• Change in health and mental health functioning scores from Medical Outcomes Study Short Form Health Survey (SF-12)

  0, 6, 12 months

• Change in Anxiety Symptom Score from Generalized Anxiety Disorder (GAD-7) Scale

  0, 6, 12 months

Study Arms (2)

Integrated Depression/Microfinance Group

EXPERIMENTAL

LIFE-DM is a Depression and Microfinance integrated program using behavior activation and problem solving therapy applied to both depression and livelihood. Livelihood support include microfinance loans, personal finance, and income-generation skills.

Behavioral: Integrated Depression/Microfinance Group; Other: Treatment as Usual; Other: Livelihood Support

Treatment as Usual

OTHER

Currently treatment as usual in this province includes national guidelines for antidepressant care for depression and referral for microfinance/livelihood programs

Other: Treatment as Usual

Interventions

Integrated Depression/Microfinance Group BEHAVIORAL

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.

Also known as: LIFE-DM Group

Integrated Depression/Microfinance Group

Treatment as Usual OTHER

National Guideline for antidepressant care

Also known as: Guideline antidepressant care, Fluoxetine, Amitrytaline, other antidepressants

Integrated Depression/Microfinance Group; Treatment as Usual

Livelihood Support OTHER

Livelihood support, including group-based loans to develop small enterprise, personal finance management education, business management skills, vocational training, and rotating-credit savings program.

Also known as: Microfinance loans

Integrated Depression/Microfinance Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• depression, low-income

You may not qualify if:

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

Sponsors & Collaborators

• RAND: lead
• National Institute of Mental Health (NIMH): collaborator
• Danang Psychiatric Hospital: collaborator

Study Sites (4)

Hoa Cuong Bac Commune Health Station

Da Nang, Vietnam

Location

Hoa Cuong Nam Commune Health Station

Da Nang, Vietnam

Location

Hoa Hiep Nam Commune Health Station

Da Nang, Vietnam

Location

Hoa Minh Commune Health Station

Da Nang, Vietnam

Location

Related 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. doi: 10.1891/0889-8391.28.3.156.

  PMID: 25568593 RESULT

MeSH Terms

Conditions

Depression

Interventions

Therapeutics; Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Victoria K Ngo, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Behavior Scientist

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: November 30, 2017

Record last verified: 2017-11

Locations

VN (4)