Viewing Study NCT01227057


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Study NCT ID: NCT01227057
Status: COMPLETED
Last Update Posted: 2018-07-24
First Post: 2010-10-20
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Hoarding Older Adults
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D007171', 'term': 'Implosive Therapy'}, {'id': 'D019090', 'term': 'Case Management'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'catherine.ayers1@va.gov', 'phone': '8585528585', 'title': 'Catherine Ayers', 'phoneExt': '2976', 'organization': 'VASDHS'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was under-powered to fully detect the differences between CREST and Case Management.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding\n\nCognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Case Management', 'description': 'Case Management: Case management', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding\n\nCognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.'}, {'id': 'OG001', 'title': 'Arm 2: Case Management', 'description': 'Case Management: Case management'}], 'classes': [{'categories': [{'measurements': [{'value': '35.44', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '44.68', 'spread': '13.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.029', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value is for the group x time interaction.', 'groupDescription': 'Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.', 'nonInferiorityComment': 'Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Activities of Daily Living in Hoarding (ADL-H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding\n\nCognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.'}, {'id': 'OG001', 'title': 'Arm 2: Case Management', 'description': 'Case management\n\nCase Management: Case management'}], 'classes': [{'categories': [{'measurements': [{'value': '21.09', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '27.81', 'spread': '14.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value is for the group x time interaction.', 'groupDescription': 'Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.', 'nonInferiorityComment': 'Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment. Higher scores represent increased impairment. Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding\n\nCognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.'}, {'id': 'OG001', 'title': 'Arm 2: Case Management', 'description': 'Case management\n\nCase Management: Case management'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '3.67', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '3.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.1', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P value is for the group x time interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding\n\nCognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.'}, {'id': 'FG001', 'title': 'Arm 2: Case Management', 'description': 'Case Management: Case management'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding\n\nCognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.'}, {'id': 'BG001', 'title': 'Arm 2: Case Management', 'description': 'Case Management: Case management'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.35', 'spread': '6.49', 'groupId': 'BG000'}, {'value': '64.19', 'spread': '5.35', 'groupId': 'BG001'}, {'value': '66.95', 'spread': '6.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Saving Inventory Revised', 'classes': [{'categories': [{'measurements': [{'value': '57.35', 'spread': '10.23', 'groupId': 'BG000'}, {'value': '59.48', 'spread': '14.01', 'groupId': 'BG001'}, {'value': '58.34', 'spread': '12.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score is 0-92, with higher scores indicating worse hoarding severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clutter Image Rating', 'classes': [{'categories': [{'measurements': [{'value': '4.15', 'spread': '1.71', 'groupId': 'BG000'}, {'value': '4.33', 'spread': '2.11', 'groupId': 'BG001'}, {'value': '4.24', 'spread': '1.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean score is 1-9, with higher scores indicating worse clutter severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'University of California, Los Angeles Hoarding Severity Scale', 'classes': [{'categories': [{'measurements': [{'value': '26.35', 'spread': '5.31', 'groupId': 'BG000'}, {'value': '28.85', 'spread': '5.82', 'groupId': 'BG001'}, {'value': '27.52', 'spread': '5.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score is 0-40, with higher scores indicating worse hoarding severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Activities of Daily Living - Hoarding', 'classes': [{'categories': [{'measurements': [{'value': '30.85', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '31.90', 'spread': '13.53', 'groupId': 'BG001'}, {'value': '31.31', 'spread': '11.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression', 'classes': [{'title': 'Hospital Anxiety and Depression - Anxiety', 'categories': [{'measurements': [{'value': '9.06', 'spread': '4.39', 'groupId': 'BG000'}, {'value': '10.15', 'spread': '3.41', 'groupId': 'BG001'}, {'value': '9.56', 'spread': '3.98', 'groupId': 'BG002'}]}]}, {'title': 'Hospital Anxiety and Depression - Depression', 'categories': [{'measurements': [{'value': '7.13', 'spread': '3.23', 'groupId': 'BG000'}, {'value': '8.56', 'spread': '4.97', 'groupId': 'BG001'}, {'value': '7.79', 'spread': '4.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score for each subscale is 0-21, with higher scores indicating worse anxiety or depression severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinician Global Improvement - Severity scale', 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '.92', 'groupId': 'BG000'}, {'value': '3.96', 'spread': '1.19', 'groupId': 'BG001'}, {'value': '3.81', 'spread': '1.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total score is 1-7, with higher scores indicating worse severity of mental illness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2010-10-20', 'resultsFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-27', 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months', 'timeFrame': '6 months', 'description': 'Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.'}], 'secondaryOutcomes': [{'measure': 'The Activities of Daily Living in Hoarding (ADL-H)', 'timeFrame': '6 months', 'description': 'The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment. Higher scores represent increased impairment. Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.'}, {'measure': 'Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months', 'timeFrame': '6 months', 'description': 'The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['exposure therapy', 'case management', 'older adults', 'cognitive rehabilitation'], 'conditions': ['Compulsive Hoarding']}, 'referencesModule': {'references': [{'pmid': '28541646', 'type': 'DERIVED', 'citation': 'Ayers CR, Dozier ME, Twamley EW, Saxena S, Granholm E, Mayes TL, Wetherell JL. Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) for Hoarding Disorder in Older Adults: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11072. doi: 10.4088/JCP.16m11072.'}], 'seeAlsoLinks': [{'url': 'http://ayerslab.wordpress.com/', 'label': 'Click here for more information about this study: Treatment of Late Life Compulsive Hoarding'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to examine treatment outcome of a new intervention for hoarding in older adults compared to standard case management for hoarding. The new intervention combines exposure therapy and cognitive remediation.', 'detailedDescription': "Research has shown that hoarding disorder (HD) is debilitating chronic and progressive condition that has significant public health implications. Older adults represent the largest group of HD suffers due to increasing severity with age. Often, Veterans with HD are seen in the VA system and the status of their hoarding is never assessed. Providers are treating patients for other health and social service issues yet missing an important source of disability and distress. This insidious, often undetected condition leads to greater medical and social disability and is costly to the VA system as patients continue to decompensate. When HD is even detected, patients in the VA receive indefinite case management and inadequate treatment. The cases the investigators know about have caused significant financial burden to the investigators' system. Most importantly, HD causes significant impairment and poor quality of life for the Veterans, particularly older Veterans. Unfortunately, the investigators know nothing about how to treat late life HD. Nor do the investigators know how neurocognitive features impact treatment response, which the investigators strongly suspect influence treatment outcome. HD is a potentially treatable source of disability in the VA system - one that the VA must research and treat. This study represents the first randomized controlled trial of a novel intervention for the treatment of HD in older Veterans. The main objective of this proposal is to further refine and test a new treatment for hoarding in older Veterans (age 60-85) which will be accomplished through a series of treatment development phases (case series, open labeled trial) and a randomized controlled trial. The new treatment (Cognitive Remediation and Exposure Therapy for hoarding; CogRET) is hypothesis driven and based on late life anxiety literature, consultation with mentors, results of the pilot study using a standard cognitive-behavioral intervention, and several case series that will be completed prior to the start of the Career Development Award (CDA). The first draft of CogRET is complete and is currently being used with several case studies. The research and training plan is divided into 5 phases; 1) training and preparation 2) training, further case studies using CogRET, further modification of CogRET 3)training, open label trial of CogRET, further modification of CogRET 4) randomized controlled trial and 5) presenting, publishing, dissemination of results and submission of a VA Merit grant. Primary hypotheses include 1) when randomized to CogRET, older Veterans with HD will show significant decreases in acquisition, difficulty discarding, and excessive clutter compared to those randomized to case management and 2) executive functioning (EF) is a significant moderator of treatment response. Other mediators and moderates of treatment response (psychiatric, medical, demographic, etc.) will be explored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must be between the ages of 60 - 85 years old and meet clinical criteria for Compulsive Hoarding (CH) developed by the Steketee and Frost (2000) research group. These criteria include:\n\n* significant amount of clutter in active living spaces\n* the urge to collect, buy, or acquire things\n* an extreme reluctance to part with items\n* clutter accumulation that causes distress or interferes with functioning\n* symptom duration of at least 6 months\n* the reluctance to part with items is not accounted for by other psychiatric conditions.\n\nTo be enrolled, patients must have:\n\n* a score of 20 or greater on the University of California, Los Angeles Hoarding Severity Scale (UHSS)\n* 40 or greater on the Savings Inventory-Revised (SI-R)\n* severity rating of 4 or higher on the Anxiety Disorders Interview Schedule (ADIS-IV) rating scales for clutter and difficulty discarding\n* and diagnosis confirmed at a consensus conference including at least two licensed professionals with expertise in CH (myself and at least one mentor).\n\nExclusion Criteria:\n\n* Individuals with moderate to severe cognitive deficits (scores below 23 on the MMSE) will be excluded.\n* Prospective participants must not have active substance abuse problems.\n* Participants will also be excluded if they are currently in other forms of psychotherapy.\n* Participants must have no change in any psychotropic medications for at least three months prior to the initial assessment.\n* Patients with current psychosis or mania will be excluded.\n* Mood and anxiety disorders are permitted as long as compulsive hoarding is the primary diagnosis.\n* Participants will are not eligible if they have active suicidal ideation, those participants will be given immediate medical or mental health attention.'}, 'identificationModule': {'nctId': 'NCT01227057', 'briefTitle': 'Hoarding Older Adults', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Treatment of Late Life Compulsive Hoarding', 'orgStudyIdInfo': {'id': 'CSRD-068-10S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Cognitive Rehabilitation', 'description': 'Cognitive rehabilitation and exposure therapy for hoarding', 'interventionNames': ['Behavioral: Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Case Management', 'description': 'Case management', 'interventionNames': ['Behavioral: Case Management']}], 'interventions': [{'name': 'Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding', 'type': 'BEHAVIORAL', 'description': 'The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.', 'armGroupLabels': ['Arm 1: Cognitive Rehabilitation']}, {'name': 'Case Management', 'type': 'BEHAVIORAL', 'description': 'Case management', 'armGroupLabels': ['Arm 2: Case Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Catherine R Ayers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}