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Completed

NCT Number: NCT00218634

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

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.

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Key information

Conditions

Adherence Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Heroin Dependence Mental Disorders Methadone Motivational Interviewing Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-AD

Behavioral

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.

ETAU

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

CBT for Depression & Adherence in HIV Methadone Patients

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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