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DepressionLIFE-DMNCT02069301

Evaluation of an Integrated Microfinance and Depression Care Program for Women

A study testing Integrated Depression/Microfinance Group, Treatment as Usual and Livelihood Support in people with Depression, run by RAND at 4 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Depression
What is being tested?
Integrated Depression/Microfinance Group, Treatment as Usual and Livelihood Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
4 sitesVietnam
Study dates
Feb 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • depression, low-income

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Vietnam4 sites
  • Hoa Cuong Bac Commune Health Station

    Da Nang

  • Hoa Cuong Nam Commune Health Station

    Da Nang

  • Hoa Hiep Nam Commune Health Station

    Da Nang

  • Hoa Minh Commune Health Station

    Da Nang

Other trials in Vietnam

About this study

Official title: Development of an Integrated Microfinance and Depression Care Program for Women

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.

Read the 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.

Conditions
Depression
Being tested
Integrated Depression/Microfinance Group, Treatment as Usual, Livelihood Support
Keywords
Behavior Activation, Problem solving therapy, Depression Treatment, depression care integration, microfinance, livelihood
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Depression/Microfinance GroupBehavioural

    Also called LIFE-DM 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.

  • Treatment as UsualOther

    Also called Guideline antidepressant care, Fluoxetine, Amitrytaline, other antidepressants

    National Guideline for antidepressant care

  • Livelihood SupportOther

    Also called Microfinance loans

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

Study groups in NCT02069301
Study groupRoleWhat they receive
Integrated Depression/Microfinance GroupExperimentalLIFE-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.
Receives: Behavioral: Integrated Depression/Microfinance Group; Other: Treatment as Usual; Other: Livelihood Support
Treatment as UsualOtherCurrently treatment as usual in this province includes national guidelines for antidepressant care for depression and referral for microfinance/livelihood programs
Receives: Other: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0, 6, 12 months

Secondary outcomes (14)
  1. 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.

    Measured: 0, 6, 12 months

  2. 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").

    Measured: 0, 6, 12 months

  3. 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.

    Measured: 0, 6, 12 months

  4. 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.

    Measured: 0, 6, 12 months

  5. 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.

    Measured: 0, 6, 12 months

  6. 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

    Measured: 0, 6, 12 months

  7. 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.

    Measured: 0, 6, 12 months

  8. 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.

    Measured: 0, 6, 12 months

  9. 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.

    Measured: 0, 6, 12 months

  10. Depression Stigma Score from the Depression Stigma Questionnaire

    18 item questionnaire about perceived and personal stigma related to depression.

    Measured: 0, 6, 12 months

  11. 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.

    Measured: 0, 6, 12 months

  12. 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.

    Measured: 0, 6, 12 months

  13. 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.

    Measured: 0, 12 months

  14. 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.

    Measured: 0, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionSep 2015
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02069301
Sponsor's protocol ID
5R34MH094648-02
Other IDs
5R34MH094648-02
Acronym
LIFE-DM
Status last verified
Nov 2017
First submitted
10 Feb 2014
Last updated
30 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25568593
  • Ngo VK, Vu TT, Sobowale K, Lam TT, Nguyen T, Linnemayr S, Huang W. Integrated Depression Care and Livelihood Interventions for Low-Income Women in Vietnam: Protocol for a Cluster Nonrandomized Controlled Trial (LIFE-DM). JMIR Res Protoc. 2026 Jun 5;15:e80546. doi: 10.2196/80546.

    PubMed 42247574

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Depression/Microfinance Group, Treatment as Usual and Livelihood Support in people with Depression, run by RAND at 4 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Score from the Patient Health Questionnaire (time frame: 0, 6, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02069301, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.

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LIFE-DM Clinical Trial NCT02069301 | AzTrials