Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

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.

Conditions

• Adherence
• Depression
• Heroin Dependence
• Methadone
• Motivational Interviewing
• Substance-Related Disorders

Interventions

BEHAVIORAL

CBT-AD

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.

BEHAVIORAL

ETAU

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Steven Safren, Ph.D. · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-02-28

Primary Completion

2009-07-31

Completion

2009-07-31

Countries

• United States

Study Locations