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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00218634
First received: September 20, 2005
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Adherence
Depression
Heroin Dependence
Methadone
Motivational Interviewing
Substance-Related Disorders
Behavioral: CBT-AD
Behavioral: ETAU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for Depression & Adherence in HIV Methadone Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Percent Medication Adherence at 3-month Follow-up Assessment [ Time Frame: 3-month assessment ] [ Designated as safety issue: No ]
    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.

  • Percent Medication Adherence at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinician-assessed Depression Rating at 3 Month Follow-up Assessment [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
    Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.

  • HIV Viral Load at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
    HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.

  • CD4+ Lymphocyte Count at 12-month Follow-up Assessment. [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
    CD4+ lymphocyte cell count at 12-month follow-up assessment.

  • Clinician-assessed Depression at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
    Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.

  • HIV Viral Load at 3-month Follow-up Assessment [ Time Frame: 3-month assessment ] [ Designated as safety issue: No ]
    HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.

  • CD4+ Lymphocyte Count at 3-month Follow-up Assessment. [ Time Frame: 3-month assessment ] [ Designated as safety issue: No ]
    CD4+ lymphocyte cell count at 3-month follow-up assessment.


Enrollment: 89
Study Start Date: February 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-AD
Cognitive behavioral therapy for adherence and depression
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.
Active Comparator: ETAU
Enhanced treatment as usual
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.

Detailed Description:

Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood, suicidal ideation) that occur in the context of substance abuse or dependence can interfere with self-care behaviors necessary for maintaining HIV care, as well as interfere with potential benefit from an intervention that focuses on adherence alone. We hypothesize that teaching skills to cope with depression will improve the outcome from an adherence intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in methadone maintenance treatment.

Overview of Research Plan. Patients who are HIV positive and who are receiving methadone maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a combination of CBT for depression and HIV medication adherence, including a single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments or (2) the single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments. Participants will be followed for one-year post-randomization.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218634

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven Safren, Ph.D. Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00218634     History of Changes
Other Study ID Numbers: NIDA-18603-1, R01DA018603
Study First Received: September 20, 2005
Results First Received: January 3, 2012
Last Updated: June 22, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heroin Dependence
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Opioid-Related Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 21, 2014