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

Study Overview
=================
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.

Official Title
-----------------
CBT for Depression & Adherence in HIV Methadone Patients

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

Intervention / Treatment
-----------------
* Behavioral: CBT-AD
* Behavioral: ETAU


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-AD<br>Cognitive behavioral therapy for adherence and depression | Behavioral: CBT-AD<br>* Cognitive behavioral therapy for adherence and depression consisting of 1 session focusing on adherence and 8 sessions consisting of cognitive behavioral therapy for medication adherence and depression.<br>|
| Active Comparator: ETAU<br>Enhanced treatment as usual | Behavioral: ETAU<br>* Enhanced treatment as usual consisting of 1 session focused on adherence (the same session as the CBT-AD intervention) and 8 sessions for participants to complete self-reports and collect adherence data.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Medication Adherence at 3-month Follow-up Assessment | Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed. | 3-month assessment | 
| Percent Medication Adherence at 12-month Follow-up Assessment | Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed. | 12-month follow-up assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-assessed Depression Rating at 3 Month Follow-up Assessment | Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression. | 3 month follow-up | 
| HIV Viral Load at 12-month Follow-up Assessment | HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment. | 12-month follow-up assessment | 
| CD4+ Lymphocyte Count at 12-month Follow-up Assessment. | CD4+ lymphocyte cell count at 12-month follow-up assessment. | 12-month follow-up assessment | 
| Clinician-assessed Depression at 12-month Follow-up Assessment | Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression. | 12-month follow-up assessment | 
| HIV Viral Load at 3-month Follow-up Assessment | HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment. | 3-month assessment | 
| CD4+ Lymphocyte Count at 3-month Follow-up Assessment. | CD4+ lymphocyte cell count at 3-month follow-up assessment. | 3-month assessment |