Skills Based Counseling for Adherence & Depression in HIV+ Methadone

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00218634
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	N/A
Start date	February 2005
Completion date	July 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms