Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-28 @ 7:15 AM
Study NCT ID:
NCT04938492
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Association Between Loneliness and Substance Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lisham_ashrafioun@urmc.rochester.edu', 'phone': '585-430-2026', 'title': 'Dr. Lisham Ashrafioun', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 1, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 1, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'increase in psychiatric distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'drug withdrawal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Loneliness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.'}, {'id': 'OG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '12.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.08', 'statisticalMethod': 'Latent growth modeling', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 2 months post-treatment', 'description': "Loneliness will be measured using the University of California-Los Angeles (UCLA) Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Percent Days Abstinent From Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.'}, {'id': 'OG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '43', 'groupId': 'OG000'}, {'value': '20', 'spread': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.19', 'statisticalMethod': 'Latent growth modeling', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 2 months post-treatment', 'description': 'Participants will complete a calendar indicating the type and frequency of drug use.', 'unitOfMeasure': 'percentage of days (abstinent/total)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Percent Days Abstinent From Other Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.'}, {'id': 'OG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '42', 'groupId': 'OG000'}, {'value': '14', 'spread': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.22', 'statisticalMethod': 'Latent growth modeling', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 2 months', 'description': 'Participants will complete a calendar indicating the type and frequency of drug use.', 'unitOfMeasure': 'percentage of days (abstinent/total)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.'}, {'id': 'OG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.23', 'statisticalMethod': 'Latent growth modeling', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 2 months post-treatment', 'description': 'Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions or perceived social support. Scores range from 6 to 18.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.'}, {'id': 'FG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Potential participants were recruited from social networking platforms. Recruitment started 08/2021.', 'preAssignmentDetails': 'Participants in both conditions receive a baseline assessment and then are randomized to either CBT or Health Education.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nCognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.'}, {'id': 'BG001', 'title': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.\n\nPhysical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '42.2', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', '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': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'UCLA Loneliness Scale', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.", 'unitOfMeasure': 'units on a scale - loneliness', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duke Social Support Index-Perceived Social Support', 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '11.5', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Duke Social Support Index-Perceived Social Support subscale assesses perceived social support. Higher scores indicate a higher perceived social support. Scores range from 6 to 18.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent days abstinent from opioids', 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '36.6', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '34.6', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '35.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants will complete a calendar indicating the type and frequency of drug use. Percent days abstinent from opioids is calculated by the number of days in which opioids were not used divided by the number of days in the assessment (i.e., 60).', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-22', 'size': 428778, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-07T17:11', 'hasProtocol': True}, {'date': '2022-07-25', 'size': 485228, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-10T14:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2021-06-16', 'resultsFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-03', 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Loneliness', 'timeFrame': 'baseline to 2 months post-treatment', 'description': "Loneliness will be measured using the University of California-Los Angeles (UCLA) Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome."}], 'secondaryOutcomes': [{'measure': 'Mean Change in Percent Days Abstinent From Opioids', 'timeFrame': 'baseline to 2 months post-treatment', 'description': 'Participants will complete a calendar indicating the type and frequency of drug use.'}, {'measure': 'Mean Change in Percent Days Abstinent From Other Drugs', 'timeFrame': 'baseline to 2 months', 'description': 'Participants will complete a calendar indicating the type and frequency of drug use.'}, {'measure': 'Mean Change in Social Support', 'timeFrame': 'baseline to 2 months post-treatment', 'description': 'Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions or perceived social support. Scores range from 6 to 18.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Loneliness']}, 'descriptionModule': {'briefSummary': 'The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.', 'detailedDescription': 'The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be ages 18+\n* Understand English\n* Have internet access\n* Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 (Diagnostic \\& Statistical Manual of Mental Disorder, 5th edition) Research Version (SCID-5-RV)\n* Screen positive for loneliness by scoring at least a T-score \\> 60 on the NIH Toolbox Loneliness Scale\n\nExclusion Criteria:\n\n* Consistent with previously used telehealth-delivered assessments, we will exclude any participant with cognitive impairment as measured by the Blessed Orientation-Memory-Concentration Test (BOMC)\n* Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded'}, 'identificationModule': {'nctId': 'NCT04938492', 'briefTitle': 'The Association Between Loneliness and Substance Use', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'The Association Between Loneliness and Substance Use', 'orgStudyIdInfo': {'id': 'STUDY00005387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy (CBT)', 'description': 'CBT delivered over the course of 6, \\~45 minute sessions delivered via telehealth.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for loneliness (CBT-L)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education', 'description': 'Health education sessions delivered over the course of 6, \\~45 minute sessions delivered via telehealth.', 'interventionNames': ['Behavioral: Physical Health Education Training (PHET)']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy for loneliness (CBT-L)', 'type': 'BEHAVIORAL', 'description': '6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT)']}, {'name': 'Physical Health Education Training (PHET)', 'type': 'BEHAVIORAL', 'description': 'Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.', 'armGroupLabels': ['Health Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Participant data is available upon request as part of scientific collaboration.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lisham Ashrafioun', 'investigatorAffiliation': 'University of Rochester'}}}}