Depression Clinical Trial
Official title:
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.
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