Clinical trial NCT00218634: Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
Official title: CBT for Depression & Adherence in HIV Methadone Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
Depression
Heroin Dependence
Methadone
Motivational Interviewing
Substance-Related Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 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.

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-S \>6)
* Unable or unwilling to provide informed consent.
* Currently in cognitive behavioral therapy for depression.

Primary outcomes:
measure: Percent Medication Adherence at 3-month Follow-up Assessment
timeFrame: 3-month assessment
measure: Percent Medication Adherence at 12-month Follow-up Assessment
timeFrame: 12-month follow-up assessment
Secondary outcomes:
measure: Clinician-assessed Depression Rating at 3 Month Follow-up Assessment
timeFrame: 3 month follow-up
measure: HIV Viral Load at 12-month Follow-up Assessment
timeFrame: 12-month follow-up assessment
measure: CD4+ Lymphocyte Count at 12-month Follow-up Assessment.
timeFrame: 12-month follow-up assessment
measure: Clinician-assessed Depression at 12-month Follow-up Assessment
timeFrame: 12-month follow-up assessment
measure: HIV Viral Load at 3-month Follow-up Assessment
timeFrame: 3-month assessment
measure: CD4+ Lymphocyte Count at 3-month Follow-up Assessment.
timeFrame: 3-month assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Safren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Safren SA, O'Cleirigh CM, Bullis JR, Otto MW, Stein MD, Pollack MH. Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):404-15. doi: 10.1037/a0028208. Epub 2012 Apr 30.