NCT02939131

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

IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living With HIV in the United States

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: 12 Years – 24 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• HIV
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	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).
BEHAVIORAL	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.

Timeline

• Start date: 2017-03-06
• Primary completion: 2019-09-12
• Completion: 2020-01-21
• First posted: 2016-10-19
• Last updated: 2021-03-03
• Results posted: 2020-09-22

Locations

13 sites across 1 country: United States