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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA018603 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-AD | Experimental | Cognitive behavioral therapy for adherence and depression |
|
| ETAU | Active Comparator | Enhanced treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Safren, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22545737 | Derived | Safren SA, O'Cleirigh CM, Bullis JR, Otto MW, Stein MD, Pollack MH. Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected injection drug users: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):404-15. doi: 10.1037/a0028208. Epub 2012 Apr 30. |
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Participants had to screen for study inclusion/exclusion criteria before randomization.
First participants from methadone clinics, remainder from MGH or RIH clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT-AD | Cognitive behavioral therapy for adherence and depression |
| FG001 | ETAU | Enhanced Treatment as Usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT-AD | Cognitive behavioral therapy for adherence and depression |
| BG001 | ETAU | Enhanced Treatment as Usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants. | Posted | Mean | Standard Deviation | percent (doses taken/doses prescribed) | 3-month assessment |
|
Adverse events are reported for a given participant for the time that participant was enrolled in the trial (roughly 1 year).
Serious adverse events reported include those that were study related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT-AD | Cognitive behavioral therapy for adherence and depression |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Safren | Mass General Hospital | 617 724 0817 | ssafren@partners.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D006556 | Heroin Dependence |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
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| 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. |
|
| 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 |
| CD4+ Lymphocyte Count at 12-month Follow-up Assessment. | CD4+ lymphocyte cell count at 12-month follow-up assessment. | 12-month follow-up assessment |
| 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 |
| 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 |
| CD4+ Lymphocyte Count at 3-month Follow-up Assessment. | CD4+ lymphocyte cell count at 3-month follow-up assessment. | 3-month assessment |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Enhanced treatment as usual
|
|
|
| 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. | We used intent to treat for all data analysis. | Posted | Mean | Standard Deviation | Units on scale | 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. | We used intent to treat for all data analysis. | Posted | Log Mean | Standard Deviation | log10 copies/mL | 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. | We used intent to treat for all data analysis. | Posted | Mean | Standard Deviation | cells/mm^3 | 12-month follow-up 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. | We used intent to treat for all data analysis. | Posted | Mean | Standard Deviation | percent (doses taken/doses prescribed) | 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. | We used intent to treat for all data analysis. | Posted | Mean | Standard Deviation | Units on scale | 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. | We used intent to treat for all data analysis. | Posted | Mean | Standard Deviation | log10 copies/mL" | 3-month assessment |
|
|
|
| Secondary | CD4+ Lymphocyte Count at 3-month Follow-up Assessment. | CD4+ lymphocyte cell count at 3-month follow-up assessment. | We used intent to treat for all analysis. | Posted | Mean | Standard Deviation | cells/mm3 | 3-month assessment |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | ETAU | Enhanced Treatment as Usual | 0 | 45 | 0 | 45 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |