Depression Disorders, HIV (Human Immunodeficiency Virus)
Conditions
Brief summary
Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness. This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.
Detailed description
Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness. This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks. The specific co-primary aims of this proposed study are to: 1. Test the effectiveness COMBEX (with its additional ERIC strategies) compared to COMB on the implementation outcomes of adoption, fidelity, and sustainability. 2. Evaluate, using a cluster randomized design, the impact of COMBEX compared to COMB in improving real-world effectiveness of reducing indices of depression (e.g., symptoms, treatment response, remission) and decreasing the viral load (VL) among 130 YWH in eight HIV care clinics over 72 weeks. 3. Use an explanatory, sequential, mixed-method approach to evaluate the context of implementation, for both COMB and COMBEX, guided by the sustainability framework with data from staff/clinicians (n=64).
Interventions
Sponsors
Rhode Island Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Hybrid Type 2 Cluster Randomized Trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* aged 15- 24 years * engaged in care at a participating HIV care site * have documented HIV-1 confirmed by medical records * a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment \[either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) * significant symptomatology at Entry (as defined by the PHQ-9) * aware of their HIV status as determined by site staff * English-speaking * able and willing to provide written informed assent/consent and written parental or guardian permission
Exclusion criteria
* by site review, have a history of any psychotic disorders and/or Bipolar I or II Disorder * have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment * have depression and/or suicidal ideation requiring more intensive services * intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist) * if they are in imminent danger to themselves or others. If wards of the state meet all eligibility requirements, they will be eligible if the state allows them to participate in research. Otherwise, they will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | Assessed at baseline and Weeks 12, 24, 36, 48, 60, and 72 | Self-reported depression symptoms score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV viral load | Measured at baseline and Weeks 12, 24, 36, 48, 60, and 72 | Quantitative VL levels (copies/mL) will be abstracted from the medical records |
Contacts
CONTACTLarry K Brown, MD
CONTACTGraham Emslie, MD
PRINCIPAL_INVESTIGATORLarry K Brown, MD
Rhode Island Hospital
Outcome results
None listed