Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-05 @ 8:13 PM
Study NCT ID:
NCT02886234
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Health Improvement Project - Providence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael_carey@brown.edu', 'phone': '401793-8218', 'title': 'Dr. Michael Carey', 'organization': 'The Miriam Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored throughout the trial, starting at baseline and continuing through the initial pill count phase of baseline (2 months), the intervention period (2 months), and during the 3-month follow-up period (3 months). Thus, adverse events were monitored for a total of 7 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post-intervention, 9 to 10 weeks after baseline', 'description': 'Feasibility - as indicated by the number of patients attending at least 50% of sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post-intervention, 9 to 10 weeks after baseline', 'description': 'Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants in the MT arm did not complete the acceptability rating at the post-intervention assessment'}, {'type': 'SECONDARY', 'title': 'Antiretroviral Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.20', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '3.15', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention', 'categories': [{'measurements': [{'value': '3.41', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '3.30', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow-up', 'categories': [{'measurements': [{'value': '2.70', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '1.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Self-reported number of missed days of medication', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Sexual Risk Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '57', 'spread': '44', 'groupId': 'OG000'}, {'value': '32', 'spread': '44', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '100', 'spread': '236', 'groupId': 'OG000'}, {'value': '49', 'spread': '71', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow-up', 'categories': [{'measurements': [{'value': '71', 'spread': '49', 'groupId': 'OG000'}, {'value': '43', 'spread': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome', 'unitOfMeasure': 'percentage of sexual events condom used', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47.70', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '49.09', 'spread': '8.09', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention', 'categories': [{'measurements': [{'value': '53.06', 'spread': '10.32', 'groupId': 'OG000'}, {'value': '52.73', 'spread': '8.98', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow-up', 'categories': [{'measurements': [{'value': '53.05', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '52.18', 'spread': '7.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.90', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '5.86', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'post-Intervention', 'categories': [{'measurements': [{'value': '6.06', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow-up', 'categories': [{'measurements': [{'value': '5.80', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '5.73', 'spread': '3.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Barratt Impulsiveness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '18.15', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '17.50', 'spread': '4.36', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '17.76', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '15.68', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow-up', 'categories': [{'measurements': [{'value': '16.05', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '16.50', 'spread': '4.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'OG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.80', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '8.55', 'spread': '5.54', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention', 'categories': [{'measurements': [{'value': '8.82', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '5.68', 'spread': '4.82', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow-up', 'categories': [{'measurements': [{'value': '6.90', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '5.18', 'spread': '3.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'FG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Prior to being randomized, patients had to complete all baseline activities, which included two months of counting to establish a baseline adherence measure. During this interval, 6 patients withdrew from the study. Thus, 44 patients were randomized (24 to health coaching arm, and 20 to the mindfulness training arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindfulness Training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks\n\nMindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.'}, {'id': 'BG001', 'title': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks\n\nHealth Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-27', 'size': 690306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-02T12:44', 'hasProtocol': True}, {'date': '2017-03-27', 'size': 347425, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-12-02T12:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-23', 'studyFirstSubmitDate': '2016-08-18', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-23', 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention', 'timeFrame': 'post-intervention, 9 to 10 weeks after baseline', 'description': 'Feasibility - as indicated by the number of patients attending at least 50% of sessions'}], 'secondaryOutcomes': [{'measure': 'Acceptability of the Intervention', 'timeFrame': 'post-intervention, 9 to 10 weeks after baseline', 'description': 'Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention'}, {'measure': 'Antiretroviral Medication Adherence', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Self-reported number of missed days of medication'}, {'measure': 'Self-reported Sexual Risk Behavior', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome'}, {'measure': 'Barratt Impulsiveness Scale', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome'}, {'measure': 'Patient Health Questionnaire', 'timeFrame': 'Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline', 'description': 'Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Mindfulness', 'Adherence behaviors', 'Stress', 'Depression'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with HIV and whether it may help them improve adherence to medications and reduce risky sexual behaviors.', 'detailedDescription': 'Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. In this trial, the investigators will examine the utility of phone-delivered mindfulness training (MT) for people living with HIV. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents.\n\nFifty participants will be enrolled in this parallel-group randomized clinical trial (RCT). Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either MT or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* Sub-optimal adherence to ART (Less than "always" taking ART medication and/or viral load \\> 20 copies/mL);\n* Psychological distress (PHQ-4 score ≥ 2);\n* Recent risky sexual behavior (any unprotected sex OR \\> 1 sexual partner over the past 6 months)\n* Access to a telephone or cell phone\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent\n* Cognitive impairment\n* Non-English speaking\n* Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them\n* Enrolled in another behavioral trials\n* Prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year\n* Severe hearing impairment not allowing phone delivery\n* Suicidal ideation\n* Planning to move out of the area within the study period\n* Clinic provider advising against recruitment in the study.'}, 'identificationModule': {'nctId': 'NCT02886234', 'acronym': 'HIP', 'briefTitle': 'Health Improvement Project - Providence', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Mindfulness Training to Improve ART Adherence and Reduce Risk Behavior Among Persons Living With HIV', 'orgStudyIdInfo': {'id': 'R34AT008930', 'link': 'https://reporter.nih.gov/quickSearch/R34AT008930', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34AT008930', 'link': 'https://reporter.nih.gov/quickSearch/R34AT008930', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness training (MT)', 'description': 'Eight, 30-minute phone delivered MT sessions once a week for 8 weeks', 'interventionNames': ['Behavioral: Mindfulness Training (MT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Coaching (HC)', 'description': 'Eight, 30-minute phone delivered HC sessions once a week for 8 weeks', 'interventionNames': ['Behavioral: Health Coaching (HC)']}], 'interventions': [{'name': 'Mindfulness Training (MT)', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.', 'armGroupLabels': ['Mindfulness training (MT)']}, {'name': 'Health Coaching (HC)', 'type': 'BEHAVIORAL', 'description': 'The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics', 'armGroupLabels': ['Health Coaching (HC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'MIchael P Carey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital'}, {'name': 'Elena Salmoirago-Blotcher, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Centers for Preventive and Behavioral Medicine, The Miriam Hospital', 'investigatorFullName': 'Michael P. Carey', 'investigatorAffiliation': 'The Miriam Hospital'}}}}