An interventional study of CBT-AD and ETAU in Adherence, Depression and Heroin Dependence, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 89 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive behavioral therapy for adherence and depression
Behavioral: CBT-AD
Enhanced treatment as usual
Behavioral: ETAU
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.
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.
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.
Time frame: 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.
Time frame: 12-month follow-up assessment
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.
Time frame: 3 month follow-up
HIV Viral Load at 12-month Follow-up Assessment
HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.
Time frame: 12-month follow-up assessment
CD4+ Lymphocyte Count at 12-month Follow-up Assessment.
CD4+ lymphocyte cell count at 12-month follow-up assessment.
Time frame: 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.
Time frame: 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.
Time frame: 3-month assessment
CD4+ Lymphocyte Count at 3-month Follow-up Assessment.
CD4+ lymphocyte cell count at 3-month follow-up assessment.
Time frame: 3-month assessment
First participants from methadone clinics, remainder from MGH or RIH clinics.
| Milestone | CBT-AD | ETAU |
|---|---|---|
| Started | 44 | 45 |
| Completed | 36 | 30 |
| Not completed | 8 | 15 |
| Withdrew: Lost to follow-up | 8 | 15 |
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.
| percent (doses taken/doses prescribed) | CBT-AD | ETAU |
|---|---|---|
| Percent Medication Adherence at 3-month Follow-up Assessment | 79.02 ± 23.23 | 73.66 ± 25.15 |
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.
| Units on scale | Cognitive Behavioral Therapy for Adherence and Depression | Enhanced Treatment as Usual |
|---|---|---|
| Clinician-assessed Depression Rating at 3 Month Follow-up Assessment | 17.02 ± 10.62 | 22.7 ± 10.19 |
HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.
| log10 copies/mL | CBT-AD | ETAU |
|---|---|---|
| HIV Viral Load at 12-month Follow-up Assessment | 2.203 ± 0.687 | 2.177 ± 0.820 |
CD4+ lymphocyte cell count at 12-month follow-up assessment.
| cells/mm^3 | CBT-AD | ETAU |
|---|---|---|
| CD4+ Lymphocyte Count at 12-month Follow-up Assessment. | 452.94 ± 235.00 | 502.33 ± 314.19 |
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.
| percent (doses taken/doses prescribed) | CBT-AD | ETAU |
|---|---|---|
| Percent Medication Adherence at 12-month Follow-up Assessment | 64.49 ± 31.34 | 61.11 ± 34.94 |
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.
| Units on scale | CBT-AD | ETAU |
|---|---|---|
| Clinician-assessed Depression at 12-month Follow-up Assessment | 15.28 ± 9.22 | 20.00 ± 10.97 |
HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.
| log10 copies/mL" | CBT-AD | ETAU |
|---|---|---|
| HIV Viral Load at 3-month Follow-up Assessment | 2.349 ± 0.928 | 2.044 ± 0.509 |
CD4+ lymphocyte cell count at 3-month follow-up assessment.
| cells/mm3 | CBT-AD | ETAU |
|---|---|---|
| CD4+ Lymphocyte Count at 3-month Follow-up Assessment. | 380.97 ± 266.62 | 539.29 ± 293.61 |
Collected over Adverse events are reported for a given participant for the time that participant was enrolled in the trial (roughly 1 year).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBT-AD | — | 0/44 (0%) | 0/44 (0%) |
| ETAU | — | 0/45 (0%) | 0/45 (0%) |
| Age, Categorical(Participants) | CBT-AD | ETAU | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 44 | 45 | 89 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | CBT-AD | ETAU | Total |
|---|---|---|---|
| Mean | 47.05 ± 7.34 | 46.67 ± 7.05 | 46.85 ± 7.15 |
| Sex: Female, Male(Participants) | CBT-AD | ETAU | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 27 | 27 | 54 |
| Region of Enrollment(participants) | CBT-AD | ETAU | Total |
|---|---|---|---|
| United States | 44 | 45 | 89 |
The record gives a start of Feb 2005, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2012, 3 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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