Back to resultsParaprofessional Treatment of Depression in Vietnam
Primary Purpose
Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Behavioral Activation + Medication
Guideline Antidepressant Medication
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Symptoms focused on measuring depression, collaborative care, Vietnam, behavioral activation
Eligibility Criteria
Inclusion Criteria:
- Age >=18
- Depression Diagnosis
Exclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.
Sites / Locations
- Khanh Hoa Provincial Hospital
- Danang Psychiatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Guideline Antidepressant Medication
Behavioral Activation + Medication
Arm Description
Guideline Antidepressant Medication, following the VN National Mental Health plan.
Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
"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.
"Depression remission", as assessed by the PHQ-9
Depression remission (PHQ-9<5), at (a) 6 weeks, (b) 12 weeks, (c) 24 weeks.
Full Information
NCT ID
NCT01006694
First Posted
November 2, 2009
Last Updated
March 4, 2015
Sponsor
Vietnam Veterans of America Foundation
Collaborators
RAND, Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT01006694
Brief Title
Paraprofessional Treatment of Depression in Vietnam
Official Title
Paraprofessional Treatment of Depression in Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam Veterans of America Foundation
Collaborators
RAND, Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
depression, collaborative care, Vietnam, behavioral activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
473 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guideline Antidepressant Medication
Arm Type
Active Comparator
Arm Description
Guideline Antidepressant Medication, following the VN National Mental Health plan.
Arm Title
Behavioral Activation + Medication
Arm Type
Experimental
Arm Description
Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
Intervention Type
Other
Intervention Name(s)
Behavioral Activation + Medication
Other Intervention Name(s)
BA + SSRI
Intervention Description
Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
Intervention Type
Drug
Intervention Name(s)
Guideline Antidepressant Medication
Intervention Description
Guideline Antidepressant Medication, following the VN National Mental Health plan.
Primary Outcome Measure Information:
Title
Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire
Description
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.
Time Frame
0, 6, 12, 24 weeks
Secondary Outcome Measure Information:
Title
Change across time (random effects slope) in anxiety symptoms, as assessed by the GAD-7 questionnaire
Description
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.
Time Frame
0, 6, 12, 24 weeks
Title
Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale
Description
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.
Time Frame
0, 6, 12, 24 weeks
Title
Change across time (random effects slope) in mental health, as assessed by the SF-12 questionnaire, Mental Health subscale
Description
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.
Time Frame
0, 6, 12, 24 weeks
Title
Change across time (random effects slope) in behavioral activation skills and behaviors, as assessed by the BADS questionnaire.
Description
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.
Time Frame
0, 6, 12, 24 weeks
Title
"Substantial improvement" in depressive symptoms, as assessed by the PHQ-9
Description
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.
Time Frame
6, 12, 24 weeks
Title
"Depression remission", as assessed by the PHQ-9
Description
Depression remission (PHQ-9<5), at (a) 6 weeks, (b) 12 weeks, (c) 24 weeks.
Time Frame
6, 12, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >=18
Depression Diagnosis
Exclusion Criteria: active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
victoria ngo, phd
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khanh Hoa Provincial Hospital
City
Nha Trang
State/Province
Khanh Hoa
Country
Vietnam
Facility Name
Danang Psychiatric Hospital
City
Danang
Country
Vietnam
12. IPD Sharing Statement
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Paraprofessional Treatment of Depression in Vietnam
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