IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Status: Completed

Conditions: HIV; Depression

Treatments: Behavioral: Enhanced Standard of Care; Behavioral: Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT02939131

UM1AI068632 (U.S. NIH Grant/Contract)

UM1AI106716 (U.S. NIH Grant/Contract)

IMPAACT 2002

UM1AI068616 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

COMB-R

Experimental group

Description:

Health and Wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention

Treatment:

Behavioral: Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm

Enhanced Standard of Care

Active Comparator group

Description:

Enhanced Standard of Care (ESC)

Treatment:

Behavioral: Enhanced Standard of Care