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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Adherence Depression Heroin Dependence Methadone Motivational Interviewing Substance-Related Disorders Behavioral: CBT-AD Behavioral: ETAU Not Applicable

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.


Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CBT-AD
Cognitive behavioral therapy for adherence and depression
 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.
Active Comparator: ETAU
Enhanced treatment as usual
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. CD4+ Lymphocyte Count at 3-month Follow-up Assessment. [ Time Frame: 3-month assessment ]
    CD4+ lymphocyte cell count at 3-month follow-up assessment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Steven Safren, Ph.D. Massachusetts General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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