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NCT01049789 · ClinicalTrials.gov registry record · NA
Treatment for Depression Among HIV-Infected Youth
A NA study of Depression and HIV Infections, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 4
- Study locations
NCT01049789 is a NA study of Depression and HIV Infections that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 42 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01049789, a NA study of Depression and HIV Infections, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication Management (COMB) treatment group or the Treatment as Usual (TAU) group. Phase I involves pilot testing of a 24-week intervention consisting of Cognitive Behavioral Therapy (CBT) and Medication Management (MM) manuals at sites assigned to the COMB treatment group. Participants enrolled at TAU sites will receive treatment for depression that is typical at that site, which may include medication management, psychosocial therapy, or a combination of the two. Psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Study coordinators and site clinicians, regardless of group assignment, will document depression symptoms and treatment regimens for all participants for 24 weeks. In addition, site staff and participants at COMB sites will participate in an exit interview. The findings from these interviews will be used to revise both CBT and MM intervention manuals at the end of Phase I. Phase II is a feasibility study of the revised CBT and MM manuals. Phase II involves similar procedures as Phase I; sites assigned to COMB will implement the revised CBT and MM manuals. Participants at TAU sites will receive treatment for depression that is typical at that site. As in Phase I, psychopharmacological and psychosocial interventions will not be standardized and participants may receive any depression treatment recommended by the site clinicians while on study. Depression symptoms and treatment regimens for all participants will be documented for 24 weeks. Additionally, all Phase II participants will have 2 follow-up visits at weeks 36 and 48. Again, site st
Conditions Studied
Interventions
- BEHAVIORAL COMB - Combination Cognitive Behavioral Therapy and Medication Management
- BEHAVIORAL TAU - Treatment as Usual
Study Locations (4)
Florida
- USF College of Medicine - Tampa
New York
- Montefiore Medical Center - The Bronx
Pennsylvania
- The Childrens Hospital of Philadelphia - Philadelphia
Tennessee
- St. Jude Children's Research Center - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01049789
The ClinicalTrials.gov registry entry for NCT01049789 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (95% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which COMB - Combination Cognitive Behavioral Therapy and Medication Management is the first listed.
NCT01049789 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01049789 about?
NCT01049789 is a clinical study titled "Treatment for Depression Among HIV-Infected Youth". This is a two-phase study that is designed to test a novel behavioral intervention to treat depression in Human Immunodeficiency Virus (HIV) adolescents and young adults. Four Adolescent Trials Network (ATN) sites will be assigned to either the Combination Cognitive Behavioral Therapy and Medication...
What is the current status of trial NCT01049789?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2010-06. Estimated completion is 2013-10.
What conditions does trial NCT01049789 study?
This clinical trial studies the following conditions: Depression, HIV Infections, HIV.
What interventions are being tested in trial NCT01049789?
The interventions under investigation include: COMB - Combination Cognitive Behavioral Therapy and Medication Management (BEHAVIORAL), TAU - Treatment as Usual (BEHAVIORAL).
Who is sponsoring clinical trial NCT01049789?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01049789 being conducted?
This trial has 4 study locations across Florida, New York, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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