impaact 2002: cognitive behavioral therapy and medication management for treatment of depression in us youth with hiv

Conditions: HIV; Depression

Summary: impaact 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate whether a health and wellness cognitive behavioral therapy and medication management (comb-r) intervention for depression demonstrates improved depression and medical outcomes for hiv-infected youth in the united states (us) compared to enhanced standard care (esc).

impaact 2002 was a prospective, multi-site, two-arm, cluster-randomized study that evaluated whether a health and wellness cognitive behavioral therapy and medication management (comb-r) intervention for depression demonstrated improved depression outcomes (e.g., decreased depressive symptoms and greater remission and response rates) and medical outcomes (e.g., increased cluster of differentiation 4 (cd4) t-cell count, decreased hiv rna level) among hiv-infected youth in the us compared to enhanced standard care (esc). sites were randomized to either the comb-r intervention or the esc control arm. youth enrolled in the study attended a screening/entry visit and study visits at weeks 1, 6, 12, and 24. they had two additional follow-up visits at weeks 36 and 48 for the study team to evaluate if observed effects of the intervention were maintained. the intervention was a treatment for depression that included a manualized health and wellness cognitive behavioral therapy and an algorithm-driven medication management designed to address the unique challenges faced by this population.

Eligibility criteria:
inclusion criteria: * receiving mental health or hiv-related care at participating us impaact site * confirmed hiv-1 infection * aware of his or her hiv infection * per clinician assessment, primary diagnosis of nonpsychotic depression, including major depressive disorder, depression not otherwise specified (nos), or dysthymia, as defined by diagnostic and statistical manual of mental disorders (dsm)-iv or dsm-v criteria * current depressive symptoms that warrant intervention as determined by a score of ≥ 11 on the quick inventory of depressive symptomatology - clinician (qids-c) * able to communicate in spoken and written english * able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required, as specified in site standard operating procedure (sop), by state law, and/or institutional review board (irb) policy) to be screened for and to enroll in impaact 2002 exclusion criteria: * known or self-reported history of any psychotic disorder and/or bipolar i or ii disorder * severe disorders (more than 6 symptoms) based on dsm-v criteria related to alcohol, cannabis or other substances; or those with moderate symptoms (4 or 5 symptoms) who are also currently experiencing withdrawal or dependence symptoms; within the past month prior to enrollment * per clinician assessment at screening, depression and/or suicidal ideation requiring more intensive treatment than the study provides or at immediate risk of being a danger to themselves or others * per participant report at screening, intends to relocate away from the study site during study participation * currently in therapy with a non-study provider, unless willing to switch to a study-trained provider * has any other condition that, in the opinion of the investigator of record (ior)/designee, would preclude informed assent/consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Keywords: cognitive behavioral therapy medication management