Clinical trial NCT04218214: Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
Official title: LIFE-DM Implementation Study: A Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: depression
poverty
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Basic Needs Vietnam
name: Danang Psychiatric Hospital
First posted: 2020-01-06
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* depression - based on Patient Health Questionnaire Total Score = \> 9
* low-income
* female
* ages 18 - 60

Exclusion Criteria:

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

Primary outcomes:
measure: Provider Adoption of LIFE-DM and Depression Care - Count
timeFrame: one year
measure: Provider Adoption of LIFE-DM and Depression Care - Percentage
timeFrame: one year
measure: Patient Depression Scores (PHQ) Change from Baseline to 6 month
timeFrame: 0, 6 months
Secondary outcomes:
measure: Provider Participation
timeFrame: 0-12 months
measure: Provider Implementation Quality
timeFrame: throughout the study implementation period, about 1 year
measure: Implementation Barriers and Facilitators
timeFrame: one year
measure: Change in Patient Functioning
timeFrame: 0 and 6 months
measure: Change in Patient Family Functioning
timeFrame: 0 and 6 months
Other outcomes:
Locations:
city: Huế
country: Vietnam
facility: Commune Health Stations
state: Thua Thien Hue
city: Da Nang
country: Vietnam
facility: Commune Health Stations
Study officials:
affiliation: RAND
name: Victoria Ngo, PhD
role: PRINCIPAL_INVESTIGATOR
References: