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Paraprofessional Treatment of Depression in Vietnam

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01006694
First Posted: November 3, 2009
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
RAND
Vanderbilt University
Information provided by (Responsible Party):
Bahr Weiss, Vanderbilt University
  Purpose
Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.

Condition Intervention
Depressive Symptoms Other: Behavioral Activation + Medication Drug: Guideline Antidepressant Medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paraprofessional Treatment of Depression in Vietnam

Resource links provided by NLM:


Further study details as provided by Bahr Weiss, Vanderbilt University:

Primary Outcome Measures:
  • Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire [ Time Frame: 0, 6, 12, 24 weeks ]
    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 [ Time Frame: 0, 6, 12, 24 weeks ]
    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 [ Time Frame: 0, 6, 12, 24 weeks ]
    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 [ Time Frame: 0, 6, 12, 24 weeks ]
    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. [ Time Frame: 0, 6, 12, 24 weeks ]
    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 [ Time Frame: 6, 12, 24 weeks ]
    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 [ Time Frame: 6, 12, 24 weeks ]
    Depression remission (PHQ-9<5), at (a) 6 weeks, (b) 12 weeks, (c) 24 weeks.


Enrollment: 473
Study Start Date: March 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: BA + SSRI

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >=18
  2. Depression Diagnosis

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006694


Locations
Vietnam
Khanh Hoa Provincial Hospital
Nha Trang, Khanh Hoa, Vietnam
Danang Psychiatric Hospital
Danang, Vietnam
Sponsors and Collaborators
Vietnam Veterans of America Foundation
RAND
Vanderbilt University
Investigators
Principal Investigator: victoria ngo, phd RAND
  More Information

Responsible Party: Bahr Weiss, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01006694     History of Changes
Other Study ID Numbers: 20090928.1
First Submitted: November 2, 2009
First Posted: November 3, 2009
Last Update Posted: March 5, 2015
Last Verified: March 2015

Keywords provided by Bahr Weiss, Vanderbilt University:
depression
collaborative care
Vietnam
behavioral activation

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs