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Completed

NCT Number: NCT01006694

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khanh Hoa Provincial Hospital, Nha Trang, Khanh Hoa, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >=18
  • Depression Diagnosis

Exclusion criteria

active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.

Treatment and study plan

Behavioral Activation + Medication

Other

Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.

Other names: BA + SSRI

Guideline Antidepressant Medication

Drug

Guideline Antidepressant Medication, following the VN National Mental Health plan.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. "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.

  6. "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.

Sponsors and collaborators

Lead sponsor

Vietnam Veterans of America Foundation

Other

Collaborators

  • RAND
  • Vanderbilt University

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 3, 2009
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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