Depressive Symptoms
Conditions
Keywords
depression, collaborative care, Vietnam, behavioral activation
Brief summary
Trained para-professional health care workers will implement a stepped-care model of depression care in commune health stations in Vietnam.
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.
Interventions
OTHERBehavioral Activation + Medication
Psychoeducation, behavioral activation therapy, and medication delivered within a collaborative care model.
DRUGGuideline Antidepressant Medication
Guideline Antidepressant Medication, following the VN National Mental Health plan.
Sponsors
RAND
Vanderbilt University
Vietnam Veterans of America Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 2. Depression Diagnosis
Exclusion criteria
active psychosis, mania, substance abuse, suicidal behaviors, cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change across time (random effects slope) in depressive symptoms, as assessed by the PHQ-9 questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Change across time (random effects slope) in physical health, as assessed by the SF-12 questionnaire, Physical Health subscale | 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 | 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 anxiety symptoms, as assessed by the GAD-7 questionnaire | 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. |
| Substantial improvement in depressive symptoms, as assessed by the PHQ-9 | 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 | 6, 12, 24 weeks | Depression remission (PHQ-9\<5), at (a) 6 weeks, (b) 12 weeks, (c) 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 | 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. |
Countries
Vietnam
Outcome results
None listed