Functional and Cognitive Rehabilitation of Hoarding Disorder
CREST
1 other identifier
interventional
60
1 country
1
Brief Summary
Hoarding Disorder (HD) is serious and disabling in Veterans. Present in up to 7% of Veterans and even higher symptom rates in older Veterans; HD contributes to functional impairment and poor quality of life. Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) has shown promising functional improvement and symptom reduction. To reduce burdens and barriers to implementation of CREST, the proposed project will individualize CREST based on cognitive testing and participant preferences, provide all care in the participant's home through telemedicine and home visits, and shorten the timeframe of treatment. A randomized controlled trial comparing 24 sessions of Personalized-CREST to case management for 130 adult Veterans with HD is proposed. Multifaceted functional and recovery outcomes including quality of life, HD severity, and sustained recovery outcomes will be examined throughout treatment and follow-up. By advancing the knowledge of the rehabilitative care of HD, we can interrupt the trajectory of this chronic and debilitating condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedDecember 10, 2025
December 1, 2025
3.2 years
December 28, 2020
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
World Health Organization Disability Assessment Schedule (WHODAS 2.0) Change
World Health Organization Disability Assessment Schedule (WHODAS 2.0) A 36-item, six domain (Cognitive, Mobility, Self-Care, Getting Along, Household, Work, Participation) assessment instrument developed by the World Health Organization (WHO) to provide a standardized method for measuring health and disability across cultures. The WHODAS has demonstrated high internal consistency, domain-specific reliability, and concurrent validity with similar disability measures. Total scores range from 0-100. Change is being assessed from baseline to post-treatment and again at follow-up.
Baseline, 1.5 months, 3 months, and 9 months
Activities of Daily Living in Hoarding Scale Change
The Activities of Daily Living in Hoarding Scale is a 15-item measure that assesses functional impairments in daily activities due to hoarding behavior. The ADL-H assesses a respondents' ability to fulfill basic needs such as prepare meals, utilize appliances and furniture, move around the home, and exit the home. The ADL-H has demonstrated good test-retest reliability, internal and inter-rater reliability, and convergent and discriminant validity. Total scores range from 0-75. Change is being assessed from baseline to post-treatment and again at follow-up.
Baseline, 1.5 months, 3 months, and 9 months
PROMIS-43 Profile v2.1 Change
The PROMIS-43 Profile v2.1 consists of a fixed collection of 6-item sets to assess global health and functioning (in physical, mental, and social domains). The PROMIS-43 assesses anxiety, depression, fatigue, pain interference, pain intensity (1-item), physical functioning, sleep disturbance, and ability to participate in social roles and activities. Substantial evidence supports the validity, reliability, and responsiveness to change of the PROMIS measures among adults with and without medical and mental health conditions. Total scores range from 0-275. Change is being assessed from baseline to post-treatment and again at follow-up.
Baseline, 1.5 months, 3 months, and 9 months
Quality of Life in Neurological Disorders (Neuro-QoL) Positive Affect and Well-Being Short form Change
Quality of Life will be assessed using the Quality of Life in Neurological Disorders (Neuro-QoL) Positive Affect and Well-Being Short form, a 9-item self-report measure that assesses sense of well-being, life satisfaction, purpose, and learning. The Neuro-QoL has demonstrated good internal consistency, test-retest reliability, and convergent and discriminant validity. A total score will be used for analyses and scores range from 0-9. Change is being assessed from baseline to post-treatment and again at follow-up.
Baseline, 1.5 months, 3 months, and 9 months
Secondary Outcomes (2)
Savings Inventory-Revised (SI-R) Change
Baseline, 1.5 months, 3 months, and 9 months
Clutter Image Rating Scale (CIR) Change
Baseline, 1.5 months, 3 months, and 9 months
Study Arms (2)
CREST
EXPERIMENTALCognitive Rehabilitation and Exposure/Sorting Therapy (CREST) provides training in compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, then helps reduce the distress associated with discarding items via exposure therapy.
Case Management
ACTIVE COMPARATORCase Management (CM). CM is the most widely available and utilized intervention for HD and is considered standard of care. This form of treatment involves managing the functional, housing, and legal ramifications of HD. Additionally, CM often involves assistance with economic, health, and social resources while providing support for the client.
Interventions
Case Management (CM). CM is the most widely available and utilized intervention for HD and is considered standard of care. This form of treatment involves managing the functional, housing, and legal ramifications of HD. Additionally, CM often involves assistance with economic, health, and social resources while providing support for the client.
Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) provides training in compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, then helps reduce the distress associated with discarding items via exposure therapy.
Eligibility Criteria
You may qualify if:
- Veterans age 18 and older
- voluntary informed consent for participation
- DSM-5 diagnosis of HD as measured by the Structured Interview for Hoarding Disorder
- HD as a primary diagnosis, and 5) stable on medications for at least 6 weeks
You may not qualify if:
- current psychosis or mania as measured by the Mini-International Neuropsychiatric Interview
- current or history of any neurodegenerative disease
- concurrent participation in any form of exposure-based psychotherapy
- suicide ideation will be monitored by the clinicians during sessions and VA standard suicide measure will be completed at all assessment points
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine R Ayers, PhD
VA San Diego Healthcare System, San Diego, CA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessor will be blind to treatment condition. Statistician to create randomization table.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2020
First Posted
January 6, 2021
Study Start
June 1, 2022
Primary Completion
August 1, 2025
Study Completion
September 1, 2025
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data will be available in 2024 for a minimum of 7 years.
- Access Criteria
- Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the PI leave the VASDHS the requests may be sent to the Associate Chief of Staff for Research. Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be redacted from this data. Any proprietary information will also be redacted from this data. This plan does not include any access to individually identifiable data. The request must include an email address for delivery and a written assurance that the recipient will not attempt to identify or re-identify any individual whose data are included in the data set.
Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the PI leave the VASDHS the requests may be sent to the Associate Chief of Staff for Research. One or more data sets without personal identifiers will be generated during the data analysis phase of the study. The data sets will include all data underlying any publications generated by this study and therefore these will be sufficient to reproduce or verify any published findings. Publications will specify the statistical analytic methods used, thereby enabling recipients to analyze the same data and validate study results.