Compulsive HoardingNCT01227057
Hoarding Older Adults
A study testing Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding and Case Management in people with Compulsive Hoarding, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Compulsive Hoarding
- What is being tested?
- Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding and Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- significant amount of clutter in active living spaces
- the urge to collect, buy, or acquire things
- an extreme reluctance to part with items
- clutter accumulation that causes distress or interferes with functioning
- symptom duration of at least 6 months
Show all 12Show fewer
- the reluctance to part with items is not accounted for by other psychiatric conditions.
- To be enrolled, patients must have:
- a score of 20 or greater on the University of California, Los Angeles Hoarding Severity Scale (UHSS)
- 40 or greater on the Savings Inventory-Revised (SI-R)
- severity rating of 4 or higher on the Anxiety Disorders Interview Schedule (ADIS-IV) rating scales for clutter and difficulty discarding
- and diagnosis confirmed at a consensus conference including at least two licensed professionals with expertise in CH (myself and at least one mentor).
Who cannot join
- Individuals with moderate to severe cognitive deficits (scores below 23 on the MMSE) will be excluded.
- Prospective participants must not have active substance abuse problems.
- Participants will also be excluded if they are currently in other forms of psychotherapy.
- Participants must have no change in any psychotropic medications for at least three months prior to the initial assessment.
- Patients with current psychosis or mania will be excluded.
- Mood and anxiety disorders are permitted as long as compulsive hoarding is the primary diagnosis.
- Participants will are not eligible if they have active suicidal ideation, those participants will be given immediate medical or mental health attention.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Treatment of Late Life Compulsive Hoarding
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.
Read the detailed description
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.
- Conditions
- Compulsive Hoarding
- Being tested
- Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding, Case Management
- Keywords
- exposure therapy, case management, older adults, cognitive rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Rehabilitation and Exposure Therapy for Compulsive HoardingBehavioural
The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
Case ManagementBehavioural
Case management
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Cognitive Rehabilitation | Experimental | Cognitive rehabilitation and exposure therapy for hoarding Receives: Behavioral: Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding |
| Arm 2: Case Management | Active comparator | Case management Receives: Behavioral: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compulsive HoardingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Catherine R Ayers, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227057
- Sponsor's protocol ID
- CSRD-068-10S
- Status last verified
- Jun 2018
- First submitted
- 20 Oct 2010
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28541646
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Late Life Compulsive Hoarding
- ClinicalTrials.gov ID
- NCT01227057
- Acronym / sponsor ID
- CSRD-068-10S
- Conditions
- Compulsive Hoarding
- Keywords
- exposure therapy, case management, older adults, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Posted 3 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Cognitive Rehabilitation | Experimental | Behavioral: Cognitive Rehabilitation and Exposure Therapy for Compulsive HoardingCognitive rehabilitation and exposure therapy for hoarding |
| Arm 2: Case Management | Active comparator | Behavioral: Case ManagementCase management |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- significant amount of clutter in active living spaces
- the urge to collect, buy, or acquire things
- an extreme reluctance to part with items
- clutter accumulation that causes distress or interferes with functioning
Key exclusion criteria (7 listed)
- Individuals with moderate to severe cognitive deficits (scores below 23 on the MMSE) will be excluded.
- Prospective participants must not have active substance abuse problems.
- Participants will also be excluded if they are currently in other forms of psychotherapy.
- Participants must have no change in any psychotropic medications for at least three months prior to the initial assessment.
- Patients with current psychosis or mania will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Rehabilitation and Exposure Therapy for Compulsive HoardingThe intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring. | Behavioural | Arm 1: Cognitive Rehabilitation |
| Case ManagementCase management | Behavioural | Arm 2: Case Management |
Primary outcome
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months
Time frame: 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.
2 secondary outcomes
The Activities of Daily Living in Hoarding (ADL-H)
Time frame: 6 months
Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28541646Ayers 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.
- Click here for more information about this study: Treatment of Late Life Compulsive HoardingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine R Ayers, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding and Case Management in people with Compulsive Hoarding, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.