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Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
This study is currently recruiting participants.
Study NCT00218634   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 20, 2005   Last Updated: December 18, 2007   History of Changes

September 20, 2005
December 18, 2007
February 2005
 
Medication compliance
Same as current
Complete list of historical versions of study NCT00218634 on ClinicalTrials.gov Archive Site
  • Medication compliance
  • Depression
  • HIV viral load and CD4 count
Same as current
 
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
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Adherence
  • Behavior Therapy
  • Depression
  • Heroin Dependence
  • Methadone
  • Motivational Interviewing
  • Substance-Related Disorders
Behavioral: Adherence
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
 

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 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-severity >6)
  • Unable or unwilling to provide informed consent.
  • Currently in cognitive behavioral therapy for depression.
Both
18 Years to 65 Years
No
Contact: Pamela R Handelsman, B.A. (617)643-2147 phandelsman@partners.org
United States
 
NCT00218634
 
NIDA-18603-1, R01-18603-1
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: Steven Safren, Ph.D. Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
December 2007

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