About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- COMBEX
- COMB
Treatment groups
Locations
Sponsors and collaborators
Rhode Island Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator