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Paraprofessional Treatment of Depression in Vietnam

This study has been completed.
Sponsor:
Collaborators:
RAND
Vanderbilt University
Information provided by (Responsible Party):
Bahr Weiss, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01006694
First received: November 2, 2009
Last updated: August 17, 2014
Last verified: August 2014
  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: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paraprofessional Treatment of Depression in Vietnam

Resource links provided by NLM:


Further study details as provided by Vietnam Veterans of America Foundation:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Corporation
  More Information

No publications provided

Responsible Party: Bahr Weiss, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01006694     History of Changes
Other Study ID Numbers: 20090928.1
Study First Received: November 2, 2009
Last Updated: August 17, 2014
Health Authority: Vietnam: Ministry of Health

Keywords provided by Vietnam Veterans of America Foundation:
depression
collaborative care
Vietnam
behavioral activation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014