Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT04349033
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Virtual Human Technology for Patients With Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mlumley@wayne.edu', 'phone': '3135772247', 'title': 'Dr. Mark A. Lumley, Professor', 'organization': 'Wayne State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patient debriefing was conducted at the end of the VH session and before the follow-up assessment.'}}, 'adverseEventsModule': {'timeFrame': 'During the 1-hour virtual interview with the patients, which was held remotely (via telehealth) with a research assistant, and then during the 1-month follow-up period, through the completion of on-line questionnaires.', 'eventGroups': [{'id': 'EG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain.", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'OG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'OG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Brief Pain Inventory (average of the 4 pain intensity rating items: highest, lowest, average, now). Range: 0.0 to 10.0 (higher = more severe pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'OG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'OG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Stages of Change Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'OG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'OG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Pain Stages of Change Questionnaire assesses readiness / motivation to engage in pain self-management. Sum of subscales of Contemplation + Action + Maintenance - Precontemplation; Range = 0 to 12; higher scores = more readiness to change', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Catastrophizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'OG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'OG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emotional Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'OG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'OG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Self-rating of how "depressed," "anxious," "angry," and "guilty" participant was during last week on 0 to 4 scale. Ratings averaged; higher means = more distress', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'FG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress, psychosocial risk factors, and other emotional issues, but with no feedback or brain-related education.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'FG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment started on February 10, 2021, and the study concluded on August 1, 2021'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Emotional Disclosure and Brain Education ("Educational Interview")', 'description': "Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.\n\nEmotional Disclosure and Brain Education: Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain."}, {'id': 'BG001', 'title': 'Emotional Disclosure Only ("Psychosocial Interview")', 'description': 'Patients are interviewed about stress and other emotional issues only.\n\nEmotional Disclosure Only: Patients are interviewed about a number of aspects of their lives, but without brain education'}, {'id': 'BG002', 'title': 'Pain Information Control ("Standard Interview")', 'description': 'Patients are interviewed about their pain history and experience.\n\nPain Information Control: Patients are interviewed about their pain history and other basic, non-disclosure information about their health.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.03', 'spread': '14.99', 'groupId': 'BG000'}, {'value': '56.65', 'spread': '13.68', 'groupId': 'BG001'}, {'value': '45.84', 'spread': '13.21', 'groupId': 'BG002'}, {'value': '51.04', 'spread': '14.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-22', 'size': 152232, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-11T15:25', 'hasProtocol': True}, {'date': '2021-10-15', 'size': 121404, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-11T15:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2020-04-13', 'resultsFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-11', 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Brief Pain Inventory (average of the 4 pain intensity rating items: highest, lowest, average, now). Range: 0.0 to 10.0 (higher = more severe pain)'}], 'secondaryOutcomes': [{'measure': 'Pain Interference', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Brief Pain Inventory (7 interference items; range: 0.0 to 10.0; higher = more interference)'}, {'measure': 'Pain Stages of Change Questionnaire', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Pain Stages of Change Questionnaire assesses readiness / motivation to engage in pain self-management. Sum of subscales of Contemplation + Action + Maintenance - Precontemplation; Range = 0 to 12; higher scores = more readiness to change'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Pain catastrophizing (range: 0.0 to 4.0; higher scores = more catastrophizing)'}, {'measure': 'Emotional Distress', 'timeFrame': 'Change from Baseline to 1-month follow-up', 'description': 'Self-rating of how "depressed," "anxious," "angry," and "guilty" participant was during last week on 0 to 4 scale. Ratings averaged; higher means = more distress'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Musculoskeletal Pain']}, 'referencesModule': {'references': [{'pmid': '37363989', 'type': 'DERIVED', 'citation': 'Junghaenel DU, Schneider S, Lucas G, Boberg J, Weinstein FM, Richeimer SH, Stone AA, Lumley MA. Virtual Human-Delivered Interviews for Patients With Chronic Pain: Feasibility, Acceptability, and a Pilot Randomized Trial of Standard Medical, Psychosocial, and Educational Interviews. Psychosom Med. 2023 Sep 1;85(7):627-638. doi: 10.1097/PSY.0000000000001228. Epub 2023 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'The experimental study compares three virtual human interviews of patients with chronic musculoskeletal pain: Emotional disclosure and brain, emotional disclosure only, basic information control. Effects on attitudes and clinical outcomes at 1-month follow-up are assessed.', 'detailedDescription': 'Emotional disclosure about stressors and other private experiences has been found to be helpful for some people with chronic musculoskeletal pain. Also, helping patients understand the role of the brain in pain has been helpful. We have developed a virtual human interviewer to help patients talk about their pain and their lives. We will conduct an experimental study to compare the effects of several different types of VH interviews. Patients with chronic pain will be randomized to receive one of three VH interviews: emotional disclosure and brain education; emotional disclosure alone; or a control basic pain interview. Patients will be assessed at baseline and 1-month follow-up on a range of attitudinal and clinical measures to determine how these different interviews affect outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic musculoskeletal Pain\n\nExclusion Criteria:\n\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT04349033', 'briefTitle': 'Virtual Human Technology for Patients With Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Virtual Human Technology for Patients With Chronic Pain: Experimental Study of Pain Neuroscience and Emotional Disclosure', 'orgStudyIdInfo': {'id': 'UP-19-00230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotional Disclosure and Brain Education', 'description': 'Patients are interviewed about stress and other emotional issues and are educated about how emotions and the brain influence pain.', 'interventionNames': ['Behavioral: Emotional Disclosure and Brain Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Emotional Disclosure only', 'description': 'Patients are interviewed about stress and other emotional issues only.', 'interventionNames': ['Behavioral: Emotional Disclosure Only']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pain Information Control', 'description': 'Patients are interviewed about their pain history and experience.', 'interventionNames': ['Behavioral: Pain Information Control']}], 'interventions': [{'name': 'Emotional Disclosure and Brain Education', 'type': 'BEHAVIORAL', 'description': "Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain.", 'armGroupLabels': ['Emotional Disclosure and Brain Education']}, {'name': 'Emotional Disclosure Only', 'type': 'BEHAVIORAL', 'description': 'Patients are interviewed about a number of aspects of their lives, but without brain education', 'armGroupLabels': ['Emotional Disclosure only']}, {'name': 'Pain Information Control', 'type': 'BEHAVIORAL', 'description': 'Patients are interviewed about their pain history and other basic, non-disclosure information about their health.', 'armGroupLabels': ['Pain Information Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089-3332', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Center for Self-report Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Doerte U Junghaenel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Mark A Lumley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Starting 1 year after study end, for 5 years.', 'ipdSharing': 'YES', 'description': 'Full, anonymized data set', 'accessCriteria': 'Contact the study PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark A. Lumley', 'investigatorAffiliation': 'Wayne State University'}}}}