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

NCT00218634 | Completed Results

• 2 other identifiers: NIDA-18603-1R01DA018603
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Percent Medication Adherence at 3-month Follow-up Assessment

  Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

  3-month assessment

• Percent Medication Adherence at 12-month Follow-up Assessment

  Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

  12-month follow-up assessment

Secondary Outcomes (6)

• Clinician-assessed Depression Rating at 3 Month Follow-up Assessment

  3 month follow-up

• HIV Viral Load at 12-month Follow-up Assessment

  12-month follow-up assessment

• CD4+ Lymphocyte Count at 12-month Follow-up Assessment.

  12-month follow-up assessment

• Clinician-assessed Depression at 12-month Follow-up Assessment

  12-month follow-up assessment

• HIV Viral Load at 3-month Follow-up Assessment

  3-month assessment

Study Arms (2)

CBT-AD

EXPERIMENTAL

Cognitive behavioral therapy for adherence and depression

Behavioral: CBT-AD

ETAU

ACTIVE COMPARATOR

Enhanced treatment as usual

Behavioral: ETAU

Interventions

CBT-AD BEHAVIORAL

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.

CBT-AD

ETAU BEHAVIORAL

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.

ETAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV seropositive
• Currently enrolled in methadone maintenance treatment for at least one month
• Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))
• Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.
• Between the ages of 18 and 65.

You may not qualify if:

• Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S \>6)
• Unable or unwilling to provide informed consent.
• Currently in cognitive behavioral therapy for depression.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Safren SA, O'Cleirigh CM, Bullis JR, Otto MW, Stein MD, Pollack MH. Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):404-15. doi: 10.1037/a0028208. Epub 2012 Apr 30.

  PMID: 22545737 DERIVED

MeSH Terms

Conditions

Depression; Heroin Dependence; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Opioid-Related Disorders; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Steven Safren
• Organization: Mass General Hospital

ssafren@partners.org

617 724 0817

Study Officials

• Steven Safren, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Behavioral Medicine

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 2, 2018
• Results First Posted: July 30, 2012

Record last verified: 2017-12

Locations

US (1)