N/A
N=89
Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
Adherence · Depression · Heroin Dependence · Methadone · Motivational Interviewing
Bottom Line
View on ClinicalTrials.gov: NCT00218634 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Percent Medication Adherence at 3-month Follow-up Assessment — 79.02; 73.66 percent (doses taken/doses prescribed) — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT-AD (Behavioral); ETAU (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Medication Adherence at 3-month Follow-up Assessment |
79.02; 73.66 | <.05 sig |
| PRIMARY Percent Medication Adherence at 12-month Follow-up Assessment |
64.49; 61.11 | — |
| SECONDARY Clinician-assessed Depression Rating at 3 Month Follow-up Assessment |
17.02; 22.7 | <.05 sig |
| SECONDARY HIV Viral Load at 12-month Follow-up Assessment |
2.203; 2.177 | — |
| SECONDARY CD4+ Lymphocyte Count at 12-month Follow-up Assessment. |
452.94; 502.33 | <.05 sig |
| SECONDARY Clinician-assessed Depression at 12-month Follow-up Assessment |
15.28; 20.00 | — |
| SECONDARY HIV Viral Load at 3-month Follow-up Assessment |
2.349; 2.044 | — |
| SECONDARY CD4+ Lymphocyte Count at 3-month Follow-up Assessment. |
380.97; 539.29 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00218634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.