Paraprofessional Treatment of Depression in Vietnam
1 other identifier
interventional
473
1 country
2
Brief Summary
Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 5, 2015
March 1, 2015
2.2 years
November 2, 2009
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Change across time (random effects slope) in anxiety symptoms, as assessed by the GAD-7 questionnaire
0, 6, 12, 24 weeks
Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale
0, 6, 12, 24 weeks
Change across time (random effects slope) in mental health, as assessed by the SF-12 questionnaire, Mental Health subscale
0, 6, 12, 24 weeks
Change across time (random effects slope) in behavioral activation skills and behaviors, as assessed by the BADS questionnaire.
0, 6, 12, 24 weeks
"Substantial improvement" in depressive symptoms, as assessed by the PHQ-9
6, 12, 24 weeks
- +1 more secondary outcomes
Study Arms (2)
Guideline Antidepressant Medication
ACTIVE COMPARATORGuideline Antidepressant Medication, following the VN National Mental Health plan.
Behavioral Activation + Medication
EXPERIMENTALPsychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
Interventions
Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
Guideline Antidepressant Medication, following the VN National Mental Health plan.
Eligibility Criteria
You may qualify if:
- Age \>=18
- Depression Diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vietnam Veterans of America Foundationlead
- RANDcollaborator
- Vanderbilt Universitycollaborator
Study Sites (2)
Khanh Hoa Provincial Hospital
Nha Trang, Khanh Hoa, Vietnam
Danang Psychiatric Hospital
Da Nang, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
victoria ngo, phd
RAND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
March 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 5, 2015
Record last verified: 2015-03