Paraprofessional Treatment of Depression in Vietnam

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

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Drug: Guideline Antidepressant Medication; Other: Behavioral Activation + Medication

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 473
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Danang, Vietnam
    • Danang Psychiatric Hospital
  • Khanh Hoa
    • Nha Trang, Khanh Hoa, Vietnam
      • Khanh Hoa Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >=18
2. Depression Diagnosis

Exclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vietnam Veterans of America Foundation
• Collaborators: Vanderbilt University; RAND

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 3, 2009

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: depression; behavioral activation; Vietnam; collaborative care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: 20090928.1