Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
Condition: Adherence; Depression; Heroin Dependence; Methadone; Motivational Interviewing; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Heroin Dependence; Depression; Depressive Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): CBT-AD; ETAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment