CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
CBT-AD +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • HIV seropositive
  • Currently enrolled in methadone maintenance treatment for at least one month
  • Current major or subsyndromal depression (subsyndromal = major depression without full diagnostic criteria but CGI-S of 2 [mildly ill])
  • Prescribed antiretroviral therapy for HIV and under care of a primary care provider
Key exclusion· 4
  • Active untreated, unstable major mental illness (untreated psychosis or mania)
  • Other Axis I psychiatric disorders (besides depression) that would interfere with ability to participate (CGI-S >6)
  • Unable or unwilling to provide informed consent
  • Currently in cognitive behavioral therapy for depression

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00218634
NCT00218634N/ACompleted

CBT for Depression & Adherence in HIV Methadone Patients

Massachusetts General Hospital·interventional·Posted Sep 22, 2005·Updated Jan 2, 2018

In Brief

A clinical study evaluating CBT-AD and ETAU for Adherence and 5 related conditions. Completed, enrolled 89 participants across 1 site.

Detailed Summary

Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatment. The project is based on our pilot work with close attention to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et al., 2001). Depression is highly comorbid with both HIV infection and with opioid dependence. Depression and substance abuse are both associated with poor adherence to antiretroviral medications. Patients with HIV, depression, and opioid dependence are at high risk for poor health outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression; and research by the PI and others has shown that cognitive-behavioral interventions have been successful in promoting adherence to HIV medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartFeb 1, 2005
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.8 years ago

Interventions

CBT-ADbehavioral

Cognitive behavioral therapy for adherence and depression consisting of 1 session focusing on adherence and 8 sessions consisting of cognitive behavioral therapy for medication adherence and depression.

ETAUbehavioral

Enhanced treatment as usual consisting of 1 session focused on adherence (the same session as the CBT-AD intervention) and 8 sessions for participants to complete self-reports and collect adherence data.