Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00218634
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D006556', 'term': 'Heroin Dependence'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssafren@partners.org', 'phone': '617 724 0817', 'title': 'Steven Safren', 'organization': 'Mass General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported for a given participant for the time that participant was enrolled in the trial (roughly 1 year).', 'description': 'Serious adverse events reported include those that were study related.', 'eventGroups': [{'id': 'EG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Medication Adherence at 3-month Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced treatment as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '79.02', 'spread': '23.23', 'groupId': 'OG000'}, {'value': '73.66', 'spread': '25.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.', 'statisticalMethod': 'HLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3-month assessment', 'description': '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.', 'unitOfMeasure': 'percent (doses taken/doses prescribed)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Clinician-assessed Depression Rating at 3 Month Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy for Adherence and Depression', 'description': 'Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).'}, {'id': 'OG001', 'title': 'Enhanced Treatment as Usual', 'description': 'Enhanced treatment as usual (ETAU).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.02', 'spread': '10.62', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '10.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.', 'statisticalMethod': 'GLM and HLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': "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.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all data analysis.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load at 12-month Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced treatment as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '2.203', 'spread': '0.687', 'groupId': 'OG000'}, {'value': '2.177', 'spread': '0.820', 'groupId': 'OG001'}]}]}], 'paramType': 'LOG_MEAN', 'timeFrame': '12-month follow-up assessment', 'description': 'HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all data analysis.'}, {'type': 'SECONDARY', 'title': 'CD4+ Lymphocyte Count at 12-month Follow-up Assessment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced treatment as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '452.94', 'spread': '235.00', 'groupId': 'OG000'}, {'value': '502.33', 'spread': '314.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'CD4 would be more improved in the treatment condition', 'groupDescription': 'follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.', 'statisticalMethod': 'HLM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12-month follow-up assessment', 'description': 'CD4+ lymphocyte cell count at 12-month follow-up assessment.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all data analysis.'}, {'type': 'PRIMARY', 'title': 'Percent Medication Adherence at 12-month Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual'}], 'classes': [{'categories': [{'measurements': [{'value': '64.49', 'spread': '31.34', 'groupId': 'OG000'}, {'value': '61.11', 'spread': '34.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-month follow-up assessment', 'description': '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.', 'unitOfMeasure': 'percent (doses taken/doses prescribed)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all data analysis.'}, {'type': 'SECONDARY', 'title': 'Clinician-assessed Depression at 12-month Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual'}], 'classes': [{'categories': [{'measurements': [{'value': '15.28', 'spread': '9.22', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '10.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-month follow-up assessment', 'description': "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.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all data analysis.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load at 3-month Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual'}], 'classes': [{'categories': [{'measurements': [{'value': '2.349', 'spread': '0.928', 'groupId': 'OG000'}, {'value': '2.044', 'spread': '0.509', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month assessment', 'description': 'HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.', 'unitOfMeasure': 'log10 copies/mL"', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all data analysis.'}, {'type': 'SECONDARY', 'title': 'CD4+ Lymphocyte Count at 3-month Follow-up Assessment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'OG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual'}], 'classes': [{'categories': [{'measurements': [{'value': '380.97', 'spread': '266.62', 'groupId': 'OG000'}, {'value': '539.29', 'spread': '293.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month assessment', 'description': 'CD4+ lymphocyte cell count at 3-month follow-up assessment.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used intent to treat for all analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'FG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'First participants from methadone clinics, remainder from MGH or RIH clinics.', 'preAssignmentDetails': 'Participants had to screen for study inclusion/exclusion criteria before randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression'}, {'id': 'BG001', 'title': 'ETAU', 'description': 'Enhanced Treatment as Usual'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.05', 'spread': '7.34', 'groupId': 'BG000'}, {'value': '46.67', 'spread': '7.05', 'groupId': 'BG001'}, {'value': '46.85', 'spread': '7.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-07', 'studyFirstSubmitDate': '2005-09-20', 'resultsFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-06-22', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Medication Adherence at 3-month Follow-up Assessment', 'timeFrame': '3-month assessment', 'description': '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.'}, {'measure': 'Percent Medication Adherence at 12-month Follow-up Assessment', 'timeFrame': '12-month follow-up assessment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Clinician-assessed Depression Rating at 3 Month Follow-up Assessment', 'timeFrame': '3 month follow-up', 'description': "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."}, {'measure': 'HIV Viral Load at 12-month Follow-up Assessment', 'timeFrame': '12-month follow-up assessment', 'description': 'HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.'}, {'measure': 'CD4+ Lymphocyte Count at 12-month Follow-up Assessment.', 'timeFrame': '12-month follow-up assessment', 'description': 'CD4+ lymphocyte cell count at 12-month follow-up assessment.'}, {'measure': 'Clinician-assessed Depression at 12-month Follow-up Assessment', 'timeFrame': '12-month follow-up assessment', 'description': "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."}, {'measure': 'HIV Viral Load at 3-month Follow-up Assessment', 'timeFrame': '3-month assessment', 'description': 'HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.'}, {'measure': 'CD4+ Lymphocyte Count at 3-month Follow-up Assessment.', 'timeFrame': '3-month assessment', 'description': 'CD4+ lymphocyte cell count at 3-month follow-up assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adherence', 'Depression', 'Heroin Dependence', 'Methadone', 'Motivational Interviewing', 'Substance-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '22545737', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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).\n\nDepression 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.', 'detailedDescription': '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.\n\nOverview 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV seropositive\n* Currently enrolled in methadone maintenance treatment for at least one month\n* 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))\n* Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.\n* Between the ages of 18 and 65.\n\nExclusion Criteria:\n\n* 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)\n* Unable or unwilling to provide informed consent.\n* Currently in cognitive behavioral therapy for depression.'}, 'identificationModule': {'nctId': 'NCT00218634', 'briefTitle': 'Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'CBT for Depression & Adherence in HIV Methadone Patients', 'orgStudyIdInfo': {'id': 'NIDA-18603-1'}, 'secondaryIdInfos': [{'id': 'R01DA018603', 'link': 'https://reporter.nih.gov/quickSearch/R01DA018603', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-AD', 'description': 'Cognitive behavioral therapy for adherence and depression', 'interventionNames': ['Behavioral: CBT-AD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ETAU', 'description': 'Enhanced treatment as usual', 'interventionNames': ['Behavioral: ETAU']}], 'interventions': [{'name': 'CBT-AD', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['CBT-AD']}, {'name': 'ETAU', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['ETAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven Safren, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Behavioral Medicine', 'investigatorFullName': 'Steven A. Safren', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}