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

September 20, 2005
June 22, 2012
February 2005
July 2009   (final data collection date for primary outcome measure)
  • 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.
Medication compliance
Complete list of historical versions of study NCT00218634 on ClinicalTrials.gov Archive Site
  • 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.
  • Medication compliance
  • Depression
  • HIV viral load and CD4 count
Not Provided
Not Provided
 
Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
CBT for Depression & Adherence in HIV Methadone Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Adherence
  • Depression
  • Heroin Dependence
  • Methadone
  • Motivational Interviewing
  • Substance-Related Disorders
  • 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.
  • Experimental: CBT-AD
    Cognitive behavioral therapy for adherence and depression
    Intervention: Behavioral: CBT-AD
  • Active Comparator: ETAU
    Enhanced treatment as usual
    Intervention: Behavioral: ETAU
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218634
NIDA-18603-1, R01DA018603
No
Steven A. Safren, Massachusetts General Hospital
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven Safren, Ph.D. Massachusetts General Hospital
Massachusetts General Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP