Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-02-03 @ 12:56 AM
Study NCT ID:
NCT03828461
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2019-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hoarding Disorder Treatment With Virtual Reality
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067836', 'term': 'Hoarding Disorder'}, {'id': 'D060845', 'term': 'Hoarding'}, {'id': 'D013064', 'term': 'Speech Disorders'}], 'ancestors': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cr2163@stanford.edu', 'phone': '650-723-4095', 'title': 'Carolyn Rodriguez, MD, PhD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'BITS + VR', 'description': 'Facilitated group therapy with behavioral practice; 16 weeks\n\nFacilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dizziness', 'notes': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'general discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'eye strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty focusing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'salivation increasing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty concentrating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fullness of head', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'veritgo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stomach awareness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BITS + VR', 'description': 'Facilitated group therapy with behavioral practice; 16 weeks\n\nFacilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '7.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 16 weeks after treatment', 'description': 'The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.\n\nThe total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.\n\nFor the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition.\n\nFor the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding.\n\nFor the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BITS + VR', 'description': 'Facilitated group therapy with behavioral practice; 16 weeks\n\nFacilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 16 weeks after treatment', 'description': 'Clutter Imaging Rating (CIR) Scale consists of three sets of photographs of a room, each containing nine photos with varying levels of clutter. This scale assesses the clutter levels in the bedroom, living room and kitchen. Patients were asked to select the picture "that most accurately reflects the amount of clutter in your room". Scores on range from 1 (least cluttered) to 9 (most cluttered). A mean composite score ranging from 1 to 9 was calculated across the three rooms for each individual. A cut-off score of 4 or higher indicate significant clutter.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BITS + VR', 'description': 'Facilitated group therapy with behavioral practice; 16 weeks\n\nFacilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BITS + VR', 'description': 'Facilitated group therapy with behavioral practice; 16 weeks\n\nFacilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-17', 'size': 139158, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-17T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2019-01-31', 'resultsFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-08', 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)', 'timeFrame': 'Change from baseline to 16 weeks after treatment', 'description': 'The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.\n\nThe total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.\n\nFor the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition.\n\nFor the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding.\n\nFor the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter.'}], 'secondaryOutcomes': [{'measure': 'Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale', 'timeFrame': 'Change from baseline to 16 weeks after treatment', 'description': 'Clutter Imaging Rating (CIR) Scale consists of three sets of photographs of a room, each containing nine photos with varying levels of clutter. This scale assesses the clutter levels in the bedroom, living room and kitchen. Patients were asked to select the picture "that most accurately reflects the amount of clutter in your room". Scores on range from 1 (least cluttered) to 9 (most cluttered). A mean composite score ranging from 1 to 9 was calculated across the three rooms for each individual. A cut-off score of 4 or higher indicate significant clutter.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hoarding disorder', 'hoarding', 'clutter'], 'conditions': ['Hoarding Disorder', 'Hoarding', 'Clutter']}, 'referencesModule': {'references': [{'pmid': '37716272', 'type': 'BACKGROUND', 'citation': 'Raila H, Avanesyan T, Valentine KE, Koo B, Huang C, Tsutsumi Y, Andreeff E, Qiu T, Munoz Rodriguez PA, Varias A, Filippou-Frye M, van Roessel P, Bullock K, Periyakoil VS, Rodriguez CI. Augmenting group hoarding disorder treatment with virtual reality discarding: A pilot study in older adults. J Psychiatr Res. 2023 Oct;166:25-31. doi: 10.1016/j.jpsychires.2023.08.002. Epub 2023 Aug 9.'}], 'seeAlsoLinks': [{'url': 'http://med.stanford.edu/rodriguezlab.html', 'label': 'Rodriguez Lab Website'}, {'url': 'https://med.stanford.edu/profiles/carolyn-rodriguez?tab=bio', 'label': 'Dr. Carolyn Rodriguez Faculty Page'}]}, 'descriptionModule': {'briefSummary': 'This study explores whether a facilitated peer support group called Buried in Treasures (BIT) and a virtual reality decluttering practice can help individuals with clutter challenges.', 'detailedDescription': 'Individuals with clutter challenges participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. The investigators hypothesize that adding virtual reality decluttering practice to the BIT workshop will decrease hoarding symptoms and level of clutter over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '56 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age greater than 55\n2. Either gender and all ethno-racial groups\n3. Physically healthy male or non-pregnant female.\n4. Hoarding Disorder primary condition\n5. Willing and able to understand and complete consent and study procedures\n6. English speaking\n7. Participant should have the technology to host Zoom calls\n\nExclusion Criteria:\n\n1. Current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year.\n2. Clinically at risk of suicide with Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Subscale of 4 or higher (i.e. suicidal intent without specific plan)\n3. Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.\n4. Unable or unwilling to allow study staff into home for home assessment\n5. Currently at high risk for eviction\n6. Animal hoarding or squalor'}, 'identificationModule': {'nctId': 'NCT03828461', 'acronym': 'HDVR', 'briefTitle': 'Hoarding Disorder Treatment With Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality', 'orgStudyIdInfo': {'id': '41899'}, 'secondaryIdInfos': [{'id': '1P30AG059307', 'link': 'https://reporter.nih.gov/quickSearch/1P30AG059307', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BITS + VR', 'description': 'Facilitated group therapy with behavioral practice; 16 weeks', 'interventionNames': ['Behavioral: Facilitated group therapy with behavioral practice; 16 weeks']}], 'interventions': [{'name': 'Facilitated group therapy with behavioral practice; 16 weeks', 'type': 'BEHAVIORAL', 'description': 'Facilitated group therapy for hoarding disorder with behavioral practice', 'armGroupLabels': ['BITS + VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Psychiatry Department', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Carolyn I Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carolyn Rodriguez', 'investigatorAffiliation': 'Stanford University'}}}}