DepressionLIFE-DMNCT04218214
Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
An observational study of Depression, run by RAND at 2 sites in Vietnam.
Trial summary
This is an implementation project to develop a model to support implementation of LIFE-DM, an evidence-based practice (EBP) program that integrates depression management with microfinance services to address both poverty and depression among low-income women in Vietnam. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)
- How many people
- 141 participants
- Where
- 2 sitesVietnam
- Study dates
- 7 Dec 2017to 31 Mar 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Study participants are recruited from community health clinics that are implementing LIFE-DM and depression care services in the GCC funded transition to scale grant. These participants are 18-60 years old, have elevated depressive symptoms (PHQ 9 > 9), have economic disadvantage, and are interested in participating in an integrated depression and livelihood program. Patients with severe mental illness, such as psychosis, mania, substance abuse, or high risk of suicide are also excluded and referred to psychiatric hospital for higher level of care. Those who have disabilities, significant cognitive impairments, and chronic illness that may interfere with their ability to participate in group therapy are also excluded and referred to other more individualized support.
Who may be able to join
- depression - based on Patient Health Questionnaire Total Score = > 9
- low-income
- female
- ages 18 - 60
Who cannot join
- psychosis risk
- mania risk
- substance abuse risk
- high suicide risk
- physical disabilities
- significant cognitive impairments
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Commune Health Stations
Da Nang
Commune Health Stations
Huế, Thừa Thiên Huế Province
About this study
Official title: LIFE-DM Implementation Study: A Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
This is an implementation project to develop a model to support implementation of LIFE-DM, an evidence-based practice (EBP) program that integrates depression management with microfinance services to address both poverty and depression among low-income women in Vietnam. This evaluation is a mixed methods study that will 1) describe the development of community-partnered implementation process, 2) study the effectiveness of the training and implementation support plan on provider and patient outcomes, and 3) identify factors that impact implementation success.
Read the detailed description
Livelihood Integration for Effective Depression Management (LIFE-DM) aims to address the dual challenges of poverty and depression faced by women in Vietnam by integrating evidence-based treatment for depression management and microfinance services. With funding from NIMH, the investigators established initial evidence for the effectiveness of LIFE-DM in reducing depression and improving functioning, social support, self-efficacy, and income at six months. These treatment effects were maintained at twelve months, suggesting that the LIFE-DM program may be an effective strategy to break the cycle of depression and poverty in low-income women.
For the Grand Challenges of Canada (GCC) Transition to Scale Grant, the investigators developed a model to scale up the program in the public health and social system across two provinces, Danang and Thua Thien Hue through 1) the training of local trainers from the psychiatric hospital to support local implementation, 2) development of a supervision model, and 3) use of a learning collaborative.
To evaluate the success of the model, the investigators will conduct a mixed methods implementation study that will assess implementation and patient outcomes according to the RE-AIM framework, as well as identify barriers and facilitators to implementation.
- Conditions
- Depression
- Being tested
- LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)
- Keywords
- depression, poverty
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)Other
Also called Livelihood Integration for Effective Depression Management, behavior activation, problem solving, microfinance
Livelihood Integration for Effective Depression Management (LIFE-DM) program aims to address the dual challenges of poverty and depression by integrating evidence-based treatment for depression management and microfinance services. The LIFE-DM group is a 12-session based on Behavior Activation and Problem Solving therapy for depression applied to both mood problems and livelihood stressors. Livelihood supports includes training on personal finance, referrals to vocational training, and access to microfinance loans. The group is provided at the local commune health stations, and facilitated by primary care health provider and a lay community provider from the Women's Union. The intervention generally lasts about 3-4 months.
| Study group | Role | What they receive |
|---|---|---|
| LIFE-DM Group | The LIFE-DM group is a 12-session based on Behavior Activation and Problem Solving therapy for depression applied to both mood problems and livelihood stressors. Livelihood supports includes training on personal finance, referrals to vocational training, and microfinance loans of 2 million VND. The group is provided at the local commune health stations, and facilitated by primary care health provider and a lay community provider from the Women's Union. Receives: Other: LIFE-DM Group (Integrated Depression and Livelihood Group Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Adoption of LIFE-DM and Depression Care - Count
Delivery of LIFE-DM and depression care components (Counts of depression care components delivered - # of screening, assessment, LIFEDM, individual therapy, medication, loans)
Measured: one year
Provider Adoption of LIFE-DM and Depression Care - Percentage
Delivery of LIFE-DM and depression care components (% of depression care components delivered - screening, assessment, LIFEDM, individual therapy, medication, loans based on eligible cases)
Measured: one year
Patient Depression Scores (PHQ) Change from Baseline to 6 month
Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: 0, 6 months
Secondary outcomes (5)
Provider Participation
Provider Participation in Training Activities (Count / % of workshop attendance, supervision meetings, and learning collaborative meetings)
Measured: 0-12 months
Provider Implementation Quality
Supervisor Rated LIFE-DM session adherence and quality. Supervision of groups involve observation of group facilitation by supervisors, who provide adherence and quality ratings of sessions. Each item is assessed on a 4 point scale - 0 (did not do), 1 (delivered but poor), 2 (average), and 3 (excellent). The items are averaged to provide a session specific score of adherence and quality. Session adherence / quality scores are used to compute provider level adherence and quality averages. Each supervisor was expected to provide ratings for a minimum of 3 assessments out of the 12 group sessions. These session ratings are used to compute the average adherence and quality score for each provider.
Measured: throughout the study implementation period, about 1 year
Implementation Barriers and Facilitators
Qualitative Interviews of Providers and Program Staff to Assess Barriers and Facilitators of Implementation
Measured: one year
Change in Patient Functioning
Patient - SF-12 - Change in functioning from baseline to 6 months. The SF-12 Health Survey is a 12-item subset of the SF-36v2™ that measures the same eight domains of health (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health). It is a brief, reliable measure of overall health status. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years
Measured: 0 and 6 months
Change in Patient Family Functioning
Patient - McMaster Family Functioning Scale - Change from baseline to 6 months. This is a 12 item scale (on a 4 point scale). the average score across items is used to determine the degree of problematic family functioning. A score of 2.00 or above indicates problematic family functioning. The higher the score, the more problematic the family member perceives the family's overall functioning.
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start7 Dec 2017
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Basic Needs Vietnam, Danang Psychiatric Hospital
- Responsible party
- Principal investigator, Victoria K. Ngo, PhD, RAND
- Investigators
- Victoria Ngo, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218214
- Sponsor's protocol ID
- 2017-0716
- Acronym
- LIFE-DM
- Status last verified
- Nov 2019
- First submitted
- 11 May 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFE-DM Implementation Study: A Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
- ClinicalTrials.gov ID
- NCT04218214
- Acronym / sponsor ID
- LIFE-DM / 2017-0716
- Conditions
- Depression
- Keywords
- depression, poverty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Basic Needs Vietnam, Danang Psychiatric Hospital
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 6 Jan 2020 (actual)
- 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.
This is an implementation project to develop a model to support implementation of LIFE-DM, an evidence-based practice (EBP) program that integrates depression management with microfinance services to address both poverty and depression among low-income women in Vietnam. This evaluation is a mixed methods study that will 1) describe the development of community-partnered implementation process, 2) study the effectiveness of the training and implementation support plan on provider and patient outcomes, and 3) identify factors that impact implementation success.
Detailed description
Livelihood Integration for Effective Depression Management (LIFE-DM) aims to address the dual challenges of poverty and depression faced by women in Vietnam by integrating evidence-based treatment for depression management and microfinance services. With funding from NIMH, the investigators established initial evidence for the effectiveness of LIFE-DM in reducing depression and improving functioning, social support, self-efficacy, and income at six months. These treatment effects were maintained at twelve months, suggesting that the LIFE-DM program may be an effective strategy to break the cycle of depression and poverty in low-income women.
For the Grand Challenges of Canada (GCC) Transition to Scale Grant, the investigators developed a model to scale up the program in the public health and social system across two provinces, Danang and Thua Thien Hue through 1) the training of local trainers from the psychiatric hospital to support local implementation, 2) development of a supervision model, and 3) use of a learning collaborative.
To evaluate the success of the model, the investigators will conduct a mixed methods implementation study that will assess implementation and patient outcomes according to the RE-AIM framework, as well as identify barriers and facilitators to implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFE-DM Group | – | Other: LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)The LIFE-DM group is a 12-session based on Behavior Activation and Problem Solving therapy for depression applied to both mood problems and livelihood stressors. Livelihood supports includes training on personal finance, referrals to vocational training, and microfinance loans of 2 million VND. The group is provided at the local commune health stations, and facilitated by primary care health provider and a lay community provider from the Women's Union. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study participants are recruited from community health clinics that are implementing LIFE-DM and depression care services in the GCC funded transition to scale grant. These participants are 18-60 years old, have elevated depressive symptoms (PHQ 9 > 9), have economic disadvantage, and are interested in participating in an integrated depression and livelihood program. Patients with severe mental illness, such as psychosis, mania, substance abuse, or high risk of suicide are also excluded and referred to psychiatric hospital for higher level of care. Those who have disabilities, significant cognitive impairments, and chronic illness that may interfere with their ability to participate in group therapy are also excluded and referred to other more individualized support.
Key inclusion criteria (4 listed)
- depression - based on Patient Health Questionnaire Total Score = > 9
- low-income
- female
- ages 18 - 60
Key exclusion criteria (6 listed)
- psychosis risk
- mania risk
- substance abuse risk
- high suicide risk
- physical disabilities
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 |
|---|---|---|
| LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)Also: Livelihood Integration for Effective Depression Management, behavior activation, problem solving, microfinanceLivelihood Integration for Effective Depression Management (LIFE-DM) program aims to address the dual challenges of poverty and depression by integrating evidence-based treatment for depression management and microfinance services. The LIFE-DM group is a 12-session based on Behavior Activation and Problem Solving therapy for depression applied to both mood problems and livelihood stressors. Livelihood supports includes training on personal finance, referrals to vocational training, and access to microfinance loans. The group is provided at the local commune health stations, and facilitated by primary care health provider and a lay community provider from the Women's Union. The intervention generally lasts about 3-4 months. | Other | LIFE-DM Group |
Primary outcome
Provider Adoption of LIFE-DM and Depression Care - Count
Time frame: one year
Delivery of LIFE-DM and depression care components (Counts of depression care components delivered - # of screening, assessment, LIFEDM, individual therapy, medication, loans)
Provider Adoption of LIFE-DM and Depression Care - Percentage
Time frame: one year
Delivery of LIFE-DM and depression care components (% of depression care components delivered - screening, assessment, LIFEDM, individual therapy, medication, loans based on eligible cases)
Patient Depression Scores (PHQ) Change from Baseline to 6 month
Time frame: 0, 6 months
Patients will be assessed for depression using self-reported depression measure (PHQ). The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores are used and they range from 0 to 27, with PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
5 secondary outcomes
Provider Participation
Time frame: 0-12 months
Provider Implementation Quality
Time frame: throughout the study implementation period, about 1 year
Implementation Barriers and Facilitators
Time frame: one year
Change in Patient Functioning
Time frame: 0 and 6 months
Change in Patient Family Functioning
Time frame: 0 and 6 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 6 Jan 2020.
- Individual participant dataSharing planned: No
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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 Ngo, PhD principal investigator
RAND
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by RAND at 2 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 4 inclusion and 6 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Provider Adoption of LIFE-DM and Depression Care - Count (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2020.