Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02040805
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2014-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Treatment for Hoarding Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067836', 'term': 'Hoarding Disorder'}, {'id': 'D013064', 'term': 'Speech Disorders'}], 'ancestors': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'kevin.delucchi@ucsf.edu', 'phone': '415-476-4180', 'title': 'Dr. Kevin L. Delucchi', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The primary limitation in this study was loss to follow up. Additionally, the longitudinal follow-up assessment was post-hoc rather than being planned prior to study initiation.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 1, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 2, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Voluntary hospitalization due to "alcohol detox" "possible suicidality"', 'notes': "Unanticipated hospitalization due events occurring in participant's life (event possibly related to study, but alternative cause is more likely)", 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality', 'notes': 'Participant became transiently suicidal while completing a homework assignment related to study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Participant Fell', 'notes': 'During a group session, a participant unintentionally walked into an obstruction and fell onto a chair.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Saving Inventory-Revised (SI-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.'}, {'id': 'OG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.5', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '66.4', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment: 20 weeks later', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.9', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '14.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test of non-inferiority.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Margin based on clinically meaningful change of \\>= 5 points.'}], 'paramType': 'MEAN', 'timeFrame': 'Administered at screening before start of treatment groups and after last treatment group (20 weeks later).', 'description': 'This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. The SI-R is scored on a scale of 0-92. Higher scores indicate more severe hoarding, and scores of 42 and over are considered clinically significant hoarding. Although subscale scores can be calculated, this study uses total scores as the primary outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were not lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Activities of Daily Living Scale, Hoarding (ADL-H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.'}, {'id': 'OG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.9', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '32.0', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment: 20 weeks later', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Test of non-inferiority.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Margin based on clinically meaningful change of \\>= 2.5 points.'}], 'paramType': 'MEAN', 'timeFrame': 'Administered at baseline and after last treatment group (20 weeks later).', 'description': 'The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. For this study, the score on each ADL-H item was summed to create a total score ranging from 0 to 75. Higher scores indicate more severe functional impairment due to hoarding.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were not lost to follow-up.'}, {'type': 'POST_HOC', 'title': 'Longitudinal Follow-Up: Saving Inventory-Revised (SI-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.'}, {'id': 'OG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '13.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'df=1', 'nonInferiorityComment': 'linear mixed models analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The post-hoc longitudinal data were collected at varying time points, but at least three months after the treatment ended. The range was 3 months to 25 months, with a mean of 14 months after treatment end.', 'description': 'This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. Using the SI-R, we obtained longitudinal follow-up data (defined as a second post-treatment assessment of hoarding symptom severity at least three months following completion of treatment). The total SI-R score was used, which ranges from 0-92, higher scores indicating more severe hoarding.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were not lost to follow-up.'}, {'type': 'POST_HOC', 'title': 'Longitudinal Follow-Up: Activities of Daily Living Scale, Hoarding (ADL-H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.'}, {'id': 'OG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'df=1', 'nonInferiorityComment': 'linear mixed model'}], 'paramType': 'MEAN', 'timeFrame': "Post-hoc longitudinal analyses were conducted at three or more months' following the end of treatment. The range was 3-25 months, and the mean time to longitudinal follow up was 14 months.", 'description': 'The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. Using the ADL-H, we obtained longitudinal follow-up data (defined as a second post-treatment assessment of hoarding specific difficulties or problems that may impact daily functioning at least three months following completion of treatment). For this study, a total score using the sum of all of the items was created, ranging from 0 to a total possible of 75. Higher scores indicate more severe impairment due to hoarding.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were not lost to follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.'}, {'id': 'FG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '41'}]}]}], 'recruitmentDetails': 'Recruitment occurred during April 2014 through February 2016. Participants were individuals with Hoarding Disorder recruited primarily through the Mental Health Association - San Francisco and flyers in the bay area (e.g. community center boards, coffee shops, laundry mats, libraries).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.\n\nGroup Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.'}, {'id': 'BG001', 'title': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.\n\nPeer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59.0', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian/Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Other or Multiracial', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '322 of the 323 randomized participants provided race/ethnicity information.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel clinical trial with assessments pre- and post-treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2014-01-16', 'resultsFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-04', 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Saving Inventory-Revised (SI-R)', 'timeFrame': 'Administered at screening before start of treatment groups and after last treatment group (20 weeks later).', 'description': 'This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. The SI-R is scored on a scale of 0-92. Higher scores indicate more severe hoarding, and scores of 42 and over are considered clinically significant hoarding. Although subscale scores can be calculated, this study uses total scores as the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Activities of Daily Living Scale, Hoarding (ADL-H)', 'timeFrame': 'Administered at baseline and after last treatment group (20 weeks later).', 'description': 'The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. For this study, the score on each ADL-H item was summed to create a total score ranging from 0 to 75. Higher scores indicate more severe functional impairment due to hoarding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['compulsive hoarding', 'clutter', 'hoarding disorder'], 'conditions': ['Hoarding Disorder']}, 'descriptionModule': {'briefSummary': 'This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common and impairing neuropsychiatric syndrome that has a profound impact on the lives and functioning of individuals, families, and society. Specifically, we will compare a novel community-based group treatment led by individuals from the community who are not mental health professionals to the current standard of care treatment for Hoarding Disorder, Cognitive Behavioral Therapy, conducted by psychologists in a group setting. We hypothesized that both treatment types will be similarly effective in reducing hoarding severity.', 'detailedDescription': 'The study design for this proposal is a stratified, randomized, single-blind, non- inferiority trial comparing the current standard of care for treatment of Hoarding Disorder (HD), Group Cognitive Behavioral Therapy (G-CBT), to an innovative and promising community-based treatment, Group Buried in Treasures (G-BiT). Participants will be stratified by gender, psychiatric status (high vs. low burden of psychiatric symptoms) and insurance status (insured vs. under- or un-insured) so that equal numbers of individuals with each of these characteristics are randomized to each treatment arm. They will then be randomly assigned (randomized) to either G-CBT or G-BiT. Participants will know which treatment group they are assigned to, but those members of the research team who are conducting clinical or neuropsychological assessments or analyzing the data will not; they will be blinded to participant group assignment, and group leaders will be blinded to the psychiatric status, neurocognitive status, insurance status, etc, of participants. The study is a non-inferiority trial, that is, the hypothesis to be tested is that G-BiT is as effective, or no less effective, than G-CBT. We chose a non-inferiority design because we have no reason to believe G-BiT is better than G-CBT and our preliminary data, as well as outcomes previously reported for G- CBT and G-BiT, suggest that these treatments may have similar efficacies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Hoarding Disorder\n\nExclusion Criteria:\n\n* Individuals with active psychosis, schizophrenia, intellectual disability, or known dementia will be excluded\n* Individuals who have participated in either cognitive-behavioral therapy for hoarding (group or individual) or in group Buried in Treasures in the past year'}, 'identificationModule': {'nctId': 'NCT02040805', 'briefTitle': 'Comparison of Treatment for Hoarding Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder', 'orgStudyIdInfo': {'id': 'CE-1304-6000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Cognitive-Behavioral Therapy', 'description': 'Sixteen sessions of group therapy facilitated by a psychologist.', 'interventionNames': ['Behavioral: Group Cognitive Behavioral Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Peer Facilitated Support Group', 'description': 'Fifteen sessions of peer-facilitated group support.', 'interventionNames': ['Behavioral: Peer Facilitated Support Group']}], 'interventions': [{'name': 'Group Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one\'s hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.', 'armGroupLabels': ['Group Cognitive-Behavioral Therapy']}, {'name': 'Peer Facilitated Support Group', 'type': 'BEHAVIORAL', 'description': 'Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.', 'armGroupLabels': ['Peer Facilitated Support Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Mental Health Association', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Carol A. Mathews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}, {'name': 'Kevin L. Delucchi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}