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

Completed · Not applicable

Conditions studied: Adherence, Depression, Heroin Dependence, Methadone, Motivational Interviewing, Substance-Related Disorders

In brief

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.

Key facts

Study ID

NCT00218634

Run by

Massachusetts General Hospital

People needed

89

Starts

2005-02-01

Expected to finish

2009-07-01

Last updated by the study team

2018-01-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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