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Completed

NCT Number: NCT04218214

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Commune Health Stations, Huế, Thừa Thiên Huế Province, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)

Other

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.

Other names: Livelihood Integration for Effective Depression Management, behavior activation, problem solving, microfinance

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

Secondary outcomes

  1. Provider Participation

    Time frame: 0-12 months

    Provider Participation in Training Activities (Count / % of workshop attendance, supervision meetings, and learning collaborative meetings)

  2. Provider Implementation Quality

    Time frame: throughout the study implementation period, about 1 year

    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.

  3. Implementation Barriers and Facilitators

    Time frame: one year

    Qualitative Interviews of Providers and Program Staff to Assess Barriers and Facilitators of Implementation

  4. Change in Patient Functioning

    Time frame: 0 and 6 months

    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

  5. Change in Patient Family Functioning

    Time frame: 0 and 6 months

    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.

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Basic Needs Vietnam
  • Danang Psychiatric Hospital
  • Grand Challenges Canada

Registry information

Official study title

LIFE-DM Implementation Study: A Mixed Methods Implementation Evaluation of an Integrated Depression and Microfinance Program for Women in Vietnam

Acronym: LIFE-DM

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 6, 2020
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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