Paraprofessional Treatment of Depression in Vietnam

Study Overview
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Brief Summary
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Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.

Detailed Description
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This project focuses on evaluation of a collaborative care system for treatment of depression in Vietnam. This system involves training para-professional health care workers in a stepped-care model system of depression care to be implemented in commune health stations in Vietnam.

Official Title
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Paraprofessional Treatment of Depression in Vietnam

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Other: Behavioral Activation + Medication
* Drug: Guideline Antidepressant Medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 Depression Diagnosis Exclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guideline Antidepressant Medication<br>Guideline Antidepressant Medication, following the VN National Mental Health plan. | Drug: Guideline Antidepressant Medication<br>* Guideline Antidepressant Medication, following the VN National Mental Health plan.<br>|
| Experimental: Behavioral Activation + Medication<br>Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model. | Other: Behavioral Activation + Medication<br>* Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.<br>* Other names: BA + SSRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire | The PHQ-9 (Patient Health Questionnaire-9) assesses depressive symptoms, over the last two weeks. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points. | 0, 6, 12, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change across time (random effects slope) in anxiety symptoms, as assessed by the GAD-7 questionnaire | The GAD-7 (General Anxiety Disorder-7) assesses anxiety symptoms, over the last two weeks. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points. | 0, 6, 12, 24 weeks | 
| Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale | The SF-12 questionnaire, Physical Health subscale, assesses physical health functioning. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points. | 0, 6, 12, 24 weeks | 
| Change across time (random effects slope) in mental health, as assessed by the SF-12 questionnaire, Mental Health subscale | The SF-12 questionnaire, Mental Health subscale, assesses mental health functioning. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points. | 0, 6, 12, 24 weeks | 
| Change across time (random effects slope) in behavioral activation skills and behaviors, as assessed by the BADS questionnaire. | The BADS (Behavioral Activation for Depression Scale) questionnaire assesses behavioral activation-related skills and behaviors. It is assessed at 0, 6, 12, 24 weeks. The outcome target is the linear and quadratic change slopes across these 4 time points. | 0, 6, 12, 24 weeks | 
| Substantial improvement in depressive symptoms, as assessed by the PHQ-9 | Rates of substantial symptomatic improvement (50% or greater reduction in PHQ-9 scores from baseline), to (a) 6 weeks, (b) 12 weeks, (c) 24 weeks. | 6, 12, 24 weeks | 
| Depression remission, as assessed by the PHQ-9 | Depression remission (PHQ-9<5), at (a) 6 weeks, (b) 12 weeks, (c) 24 weeks. | 6, 12, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, collaborative care, Vietnam, behavioral activation