Paraprofessional Treatment of Depression in Vietnam

Depressive Symptoms Clinical Trial

Official title:

Paraprofessional Treatment of Depression in Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006694
• Other study ID #: 20090928.1
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: March 4, 2015
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Vietnam Veterans of America Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >=18

2. Depression Diagnosis

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Symptoms

Intervention

Other:
• Behavioral Activation + Medication
Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.

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

Locations

Country	Name	City	State
Vietnam	Danang Psychiatric Hospital	Danang
Vietnam	Khanh Hoa Provincial Hospital	Nha Trang	Khanh Hoa

Sponsors (3)

Lead Sponsor	Collaborator
Vietnam Veterans of America Foundation	RAND, Vanderbilt University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	"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	No
Secondary	"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	No