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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Cognitive Rehabilitation | Experimental | Cognitive rehabilitation and exposure therapy for hoarding |
|
| Arm 2: Case Management | Active Comparator | Case management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding | Behavioral | The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring. |
| Measure | Description | Time Frame |
|---|---|---|
| Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Activities of Daily Living in Hoarding (ADL-H) | 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. | 6 months |
| Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months |
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Inclusion Criteria:
Participants 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:
To be enrolled, patients must have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine R Ayers, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28541646 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for more information about this study: Treatment of Late Life Compulsive Hoarding | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Cognitive Rehabilitation | Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring. |
| FG001 | Arm 2: Case Management | Case Management: Case management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Cognitive Rehabilitation | Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Cognitive Rehabilitation | Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring. |
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The study was under-powered to fully detect the differences between CREST and Case Management.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Ayers | VASDHS | 8585528585 | 2976 | catherine.ayers1@va.gov |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D007171 | Implosive Therapy |
| D019090 | Case Management |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Case Management | Behavioral | Case management |
|
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. |
| 6 months |
| Arm 2: Case Management |
Case Management: Case management |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Saving Inventory Revised | Total score is 0-92, with higher scores indicating worse hoarding severity. | Mean | Standard Deviation | units on a scale |
|
| Clutter Image Rating | Mean score is 1-9, with higher scores indicating worse clutter severity. | Mean | Standard Deviation | units on a scale |
|
| University of California, Los Angeles Hoarding Severity Scale | Total score is 0-40, with higher scores indicating worse hoarding severity. | Mean | Standard Deviation | units on a scale |
|
| Activities of Daily Living - Hoarding | Mean score is 1-75, with higher scores indicating worse impairment due to hoarding. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression | Total score for each subscale is 0-21, with higher scores indicating worse anxiety or depression severity. | Mean | Standard Deviation | units on a scale |
|
| Clinician Global Improvement - Severity scale | Total score is 1-7, with higher scores indicating worse severity of mental illness. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Arm 2: Case Management | Case Management: Case management |
|
|
|
| Secondary | The Activities of Daily Living in Hoarding (ADL-H) | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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|
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| Secondary | Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Arm 2: Case Management | Case Management: Case management | 0 | 27 | 0 | 27 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| Non-Inferiority or Equivalence |
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. |