Summary

for people ages 12-24 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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 US compared to enhanced standard care (ESC).

Official Title

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

Details

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 outcomes (e.g., decreased depressive symptoms and greater remission and response rates) and medical outcomes (e.g., increased CD4 T-cell count, decreased HIV RNA level) among HIV-infected youth in the US compared to enhanced standard care (ESC). Youth enrolled in the study will attend a Screening/Entry Visit and study visits at Weeks 1, 6, 12, and 24. They will have two additional follow-up visits at Weeks 36 and 48 for the study team to evaluate if observed effects of the intervention are maintained. The intervention is a treatment for depression that includes manualized Health and Wellness Cognitive Behavioral Therapy and algorithm-driven Medication Management designed to address the unique challenges faced by this population.

Keywords

HIV Depression Cognitive Behavioral Therapy Medication Management Depressive Disorder Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm Enhanced Standard of Care COMB-R ESC

Eligibility

You can join if…

Open to people ages 12-24

  • Receiving mental health or HIV-related care at participating US IMPAACT site
  • Confirmed of HIV-1 Infection
  • Aware of his or her HIV infection
  • Per clinician assessment, primary diagnosis of nonpsychotic depression, including Major Depressive Disorder, Depression NOS, or Dysthymia, as defined by 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 SOP, by State law,and/or IRB policy) to be screened for and to enroll in IMPAACT 2002

You CAN'T join 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

Locations

  • University California, San Diego (CRS 4601)
    La Jolla California 92093 United States
  • University of Southern California - MCA Center (CRS 5048),
    Alhambra California 91803 United States
  • David Geffen School of Medicine at UCLA (CRS 5112)
    Los Angeles California 90095 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ID
NCT02939131
Study Type
Interventional
Last Updated
November 15, 2017