Depression Clinical Trial
Official title:
CBT for Depression & Adherence in HIV Methadone Patients
Verified date | December 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | CD4+ Lymphocyte Count at 12-month Follow-up Assessment. | CD4+ lymphocyte cell count at 12-month follow-up assessment. | 12-month follow-up assessment | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | CD4+ Lymphocyte Count at 3-month Follow-up Assessment. | CD4+ lymphocyte cell count at 3-month follow-up assessment. | 3-month assessment |
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