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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
Depression Stigma Score from the Depression Stigma Questionnaire
18 item questionnaire about perceived and personal stigma related to depression.
Measured: 0, 6, 12 months
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
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
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
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.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Danang Psychiatric Hospital
- Responsible party
- Principal investigator, Victoria K. Ngo, PhD, RAND
- Investigators
- Victoria K Ngo, PhD, Principal investigator, RAND
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 25568593Ngo 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Integrated Microfinance and Depression Care Program for Women
- ClinicalTrials.gov ID
- NCT02069301
- Acronym / sponsor ID
- LIFE-DM / 5R34MH094648-02
- Conditions
- Depression
- Keywords
- Behavior Activation, Problem solving therapy, Depression Treatment, depression care integration, microfinance, livelihood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Danang Psychiatric Hospital
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Depression/Microfinance Group | Experimental | Behavioral: Integrated Depression/Microfinance Group, Other: Treatment as Usual, Other: Livelihood SupportLIFE-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. |
| Treatment as Usual | Other | Other: Treatment as UsualCurrently treatment as usual in this province includes national guidelines for antidepressant care for depression and referral for microfinance/livelihood programs |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- depression, low-income
Key exclusion criteria (1 listed)
- psychosis, mania, substance abuse, high suicide risk, physical disabilities, significant cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Depression/Microfinance GroupAlso: LIFE-DM GroupLIFE-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. | Behavioural | Integrated Depression/Microfinance Group |
| Treatment as UsualAlso: Guideline antidepressant care, Fluoxetine, Amitrytaline, other antidepressantsNational Guideline for antidepressant care | Other | Integrated Depression/Microfinance Group, Treatment as Usual |
| Livelihood SupportAlso: Microfinance loansLivelihood support, including group-based loans to develop small enterprise, personal finance management education, business management skills, vocational training, and rotating-credit savings program. | Other | Integrated Depression/Microfinance Group |
Primary outcome
Change in Depression Score from the Patient Health Questionnaire
Time frame: 0, 6, 12 months
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.
14 secondary outcomes
Change in Quality of Life Score from Quality of Life and Enjoyment and Satisfaction Questionnaire
Time frame: 0, 6, 12 months
Change in Self-Efficacy Score from Self Efficacy Survey
Time frame: 0, 6, 12 months
Change in Social Support Index from Medical Outcome Study Social Support Survey
Time frame: 0, 6, 12 months
Change in health and mental health functioning scores from Medical Outcomes Study Short Form Health Survey (SF-12)
Time frame: 0, 6, 12 months
Change in Anxiety Symptom Score from Generalized Anxiety Disorder (GAD-7) Scale
Time frame: 0, 6, 12 months
Change in Behavior Activation Score from the Behavior Activation for Depression Scale Short Form (BADS-SF)
Time frame: 0, 6, 12 months
Change in household wealth indicators from Economic Well-Being Inventory
Time frame: 0, 6, 12 months
Change in number and type of income generating activities from the Employment and business Activities Questionnaire
Time frame: 0, 6, 12 months
Treatment Acceptability Score from Help-Seeking Behavior Questionnaire
Time frame: 0, 6, 12 months
Depression Stigma Score from the Depression Stigma Questionnaire
Time frame: 0, 6, 12 months
Social Capital Score from Social Capital Assessment Tool
Time frame: 0, 6, 12 months
Total Score Client Service Satisfaction Questionnaire
Time frame: 0, 6, 12 months
Number of Participants Demonstrating Mental Health Literacy with Depression Vignette
Time frame: 0, 12 months
Number of Participants with Depression Diagnosis - MINI International Neuropsychiatric Interview, Version 6.0 (MINI)
Time frame: 0, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Results publication: PubMed 25568593Ngo 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.
- Derived from this study: PubMed 42247574Ngo 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.
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria K Ngo, PhD principal investigator
RAND
4 sites in 1 country: see every site and its status.
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.