IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV
NCT ID: NCT02939131
Last Updated: 2021-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2017-03-06
2020-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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COMB-R
Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention
Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm
Behavioral therapy based on a manualized approach developed specifically for youth living with both HIV and depression, using problem-solving, motivational interviewing and cognitive-behavioral strategies to decrease adherence obstacles and increase wellness. The medication management algorithm includes guidance for clinicians on strategies and tactics to treat depression in this population, including factors to consider when deciding on treatments (i.e., drug-drug interactions, side effects).
Enhanced Standard of Care
Enhanced Standard of Care (ESC)
Enhanced Standard of Care
Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training on current principles for use of medication and psychotherapy in the treatment of depression.
Interventions
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Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm
Behavioral therapy based on a manualized approach developed specifically for youth living with both HIV and depression, using problem-solving, motivational interviewing and cognitive-behavioral strategies to decrease adherence obstacles and increase wellness. The medication management algorithm includes guidance for clinicians on strategies and tactics to treat depression in this population, including factors to consider when deciding on treatments (i.e., drug-drug interactions, side effects).
Enhanced Standard of Care
Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training on current principles for use of medication and psychotherapy in the treatment of depression.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
24 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Larry Brown, MD
Role: STUDY_CHAIR
Rhode Island Hospital; Brown University
Locations
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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
Countries
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References
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Brown LK, Kennard BD, Emslie GJ, Mayes TL, Whiteley LB, Bethel J, Xu J, Thornton S, Tanney MR, Hawkins LA, Garvie PA, Subramaniam GA, Worrell CJ, Stoff LW; Adolescent Trials Network for HIVAIDS Interventions. Effective Treatment of Depressive Disorders in Medical Clinics for Adolescents and Young Adults Living With HIV: A Controlled Trial. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):38-46. doi: 10.1097/QAI.0000000000000803.
Bernstein IH, Rush AJ, Trivedi MH, Hughes CW, Macleod L, Witte BP, Jain S, Mayes TL, Emslie GJ. Psychometric properties of the Quick Inventory of Depressive Symptomatology in adolescents. Int J Methods Psychiatr Res. 2010 Dec;19(4):185-94. doi: 10.1002/mpr.321.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol and Informed Consent Form
Related Links
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The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (AE) (DAIDS AE Grading Table), Corrected Version 2.1, July 2017
Richard M Selik, Eve D Mokotoff, Bernard Branson, et al. Revised Surveillance Case Definition for HIV Infection - United States, 2014. Morbidity and Mortality Weekly Report (MMWR) 2014; 63 (No. 3):7
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS Expedited Adverse Events (EAE) Manual), Version 2.0, January 2010
Other Identifiers
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