IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV
Completed · Not applicable
Conditions studied: HIV, Depression
In brief
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).
Key facts
- Study ID
- NCT02939131
- Run by
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- People needed
- 156
- Starts
- 2017-03-06
- Expected to finish
- 2020-01-21
- Last updated by the study team
- 2021-03-03
Who can join
Age: 12 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Southern California - MCA Center (CRS 5048), — Alhambra, California, United States
- University California, San Diego (CRS 4601) — La Jolla, California, United States
- David Geffen School of Medicine at UCLA (CRS 5112) — Los Angeles, California, United States
- Children's Hospital of Colorado (CRS 5052) — Aurora, Colorado, United States
- Children's Diagnostic and Treatment Center (CRS 5055) — Fort Lauderdale, Florida, United States
- Emory University School of Medicine (CRS 5030) — Atlanta, Georgia, United States
- Rush University Medical Center (CRS 5083) — Chicago, Illinois, United States
- Johns Hopkins University School of Medicine (CRS 5092) — Baltimore, Maryland, United States
- Stony Brook University Medical Center (CRS 5040) — Stony Brook, New York, United States
- Bronx-Lebanon Hospital Center (CRS 5114) — The Bronx, New York, United States
- Jacobi Medical Center (CRS 5013) — The Bronx, New York, United States
- St Jude Children's Research Hospital (CRS 6501) — Memphis, Tennessee, United States
- Texas Children's/Baylor (CRS 3801) — Houston, Texas, United States
Full record on ClinicalTrials.gov
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