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

Condition(s) targeted: Adherence; Behavior Therapy; Depression; Heroin Dependence; Methadone; Motivational Interviewing; Substance-Related Disorders

Intervention: Adherence (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Steven Safren, Ph.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Pamela R Handelsman, B.A., Phone: (617)643-2147, Email: phandelsman@partners.org

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.

Official title: CBT for Depression & Adherence in HIV Methadone Patients

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Medication compliance

Secondary outcome:

Medication compliance

Depression

HIV viral load and CD4 count

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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 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-severity >6)

- Unable or unwilling to provide informed consent.

- Currently in cognitive behavioral therapy for depression.

Pamela R Handelsman, B.A., Phone: (617)643-2147, Email: phandelsman@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Pamela R Handelsman, BA, Phone: 617-643-2147, Email: phandelsman@partners.org
Nafisseh Soroudi, Ph.D., Phone: 617 726 7458, Email: nsoroudi@partners.org

Starting date: February 2005
Last updated: December 18, 2007