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

Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group

About this trial

Last updated 4 years ago

Study ID

IMPAACT 2002

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
12 to 24 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial 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).

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status