Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
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ClinicalTrials.gov Identifier: NCT00218634 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Results First Posted
: July 30, 2012
Last Update Posted
: January 2, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adherence Depression Heroin Dependence Methadone Motivational Interviewing Substance-Related Disorders | Behavioral: CBT-AD Behavioral: ETAU | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | CBT for Depression & Adherence in HIV Methadone Patients |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: CBT-AD
Cognitive behavioral therapy for adherence and depression
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Behavioral: CBT-AD
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.
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Active Comparator: ETAU
Enhanced treatment as usual
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Behavioral: ETAU
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.
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- Percent Medication Adherence at 3-month Follow-up Assessment [ Time Frame: 3-month 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.
- Percent Medication Adherence at 12-month Follow-up Assessment [ Time Frame: 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.
- Clinician-assessed Depression Rating at 3 Month Follow-up Assessment [ Time Frame: 3 month follow-up ]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.
- HIV Viral Load at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ]HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.
- CD4+ Lymphocyte Count at 12-month Follow-up Assessment. [ Time Frame: 12-month follow-up assessment ]CD4+ lymphocyte cell count at 12-month follow-up assessment.
- Clinician-assessed Depression at 12-month Follow-up Assessment [ Time Frame: 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.
- HIV Viral Load at 3-month Follow-up Assessment [ Time Frame: 3-month assessment ]HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.
- CD4+ Lymphocyte Count at 3-month Follow-up Assessment. [ Time Frame: 3-month assessment ]CD4+ lymphocyte cell count at 3-month follow-up assessment.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218634
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven Safren, Ph.D. | Massachusetts General Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00218634 History of Changes |
Other Study ID Numbers: |
NIDA-18603-1 R01DA018603 ( U.S. NIH Grant/Contract ) |
First Posted: | September 22, 2005 Key Record Dates |
Results First Posted: | July 30, 2012 |
Last Update Posted: | January 2, 2018 |
Last Verified: | December 2017 |
Additional relevant MeSH terms:
Depression Depressive Disorder Substance-Related Disorders Heroin Dependence Behavioral Symptoms Mood Disorders Mental Disorders Chemically-Induced Disorders Opioid-Related Disorders Methadone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |