Cognitive Rehabilitation for Hoarding Disorder

(CREST Trial)

Overseen By Catherine R Ayers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychosis, Mania, Neurodegenerative disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 27

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with Hoarding Disorder (HD), a condition that can complicate daily life and diminish quality of life. It compares two treatments: Personalized-CREST, which employs cognitive strategies and exposure therapy to manage clutter and reduce stress, and standard case management, which supports daily living challenges. The trial includes Veterans diagnosed with Hoarding Disorder who have maintained stable medication use for at least six weeks. Participants will receive treatment at home through telemedicine and home visits. As an unphased trial, this study provides Veterans the chance to access innovative treatments and contribute to research that may enhance care for Hoarding Disorder.

Will I have to stop taking my current medications?

The trial requires that participants be stable on their medications for at least 6 weeks, so you will not need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) is effective and well-received by older adults with Hoarding Disorder (HD). Studies have found that participants who tried CREST found it helpful. Although the data does not indicate any specific safety issues, positive feedback from participants suggests it is manageable. The treatment involves learning skills to manage cognitive challenges and reduce stress related to discarding items. It appears to be a promising and safe option for those dealing with HD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized-CREST for hoarding disorder because it offers a fresh approach compared to traditional case management. Unlike the standard care, which mainly focuses on managing the functional, housing, and legal issues associated with hoarding, CREST directly tackles the cognitive challenges faced by individuals with this condition. It introduces compensatory cognitive strategies to address executive dysfunction and uses exposure therapy to ease the emotional distress linked to discarding items. This dual approach not only aims to improve cognitive function but also helps patients cope with the emotional difficulties of letting go of possessions, offering a more comprehensive solution.

What evidence suggests that this trial's treatments could be effective for Hoarding Disorder?

Research shows that Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) holds promise for treating hoarding disorder (HD). In this trial, some participants will receive CREST, which studies have found can effectively reduce HD symptoms and improve thinking skills, particularly in decision-making and organizing. One study found that people using CREST improved more in tasks requiring focus shifts compared to those receiving standard support. CREST also offers strategies to manage the stress of letting go of items, a major challenge for those with HD. Overall, CREST provides significant benefits in managing HD symptoms and improving daily life. Meanwhile, other participants in this trial will receive Case Management, the standard of care, which involves managing the functional, housing, and legal ramifications of HD. ^{1 2 5 6 7}

Who Is on the Research Team?

Catherine R Ayers, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for adult Veterans diagnosed with Hoarding Disorder (HD) as their primary condition. Participants must be stable on medications for at least six weeks, voluntarily consent to join, and not have any neurodegenerative diseases or current psychosis. They should also not be undergoing any exposure-based psychotherapy.

Inclusion Criteria

DSM-5 diagnosis of HD as measured by the Structured Interview for Hoarding Disorder

My primary diagnosis is Huntington's disease and I've been stable on my medications for at least 6 weeks.

I have agreed to participate in this study willingly.

Exclusion Criteria

current psychosis or mania as measured by the Mini-International Neuropsychiatric Interview

suicide ideation will be monitored by the clinicians during sessions and VA standard suicide measure will be completed at all assessment points

You are currently undergoing any type of exposure-based psychotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Personalized-CREST or case management for 12 weeks, with 24 sessions delivered twice a week in the home

12 weeks

24 visits (12 in-person, 12 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Case Management
• Personalized-CREST

Trial Overview The study tests a personalized Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), delivered via telemedicine and home visits over 24 sessions, against standard case management. The aim is to improve function and quality of life in Veterans with HD.

How Is the Trial Designed?

Group I: CREST Experimental Treatment 1 Intervention

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.

Group II: Case Management Active Control 1 Intervention

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.

Personalized-CREST is already approved in United States for the following indications:

Approved in United States as Personalized-CREST for:

• Hoarding Disorder

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

San Diego Veterans Healthcare System

Collaborator

Trials

38

Recruited

5,500+

Published Research Related to This Trial

In a pilot study involving 16 participants with hoarding disorder, group cognitive-behavioral therapy (G-CBT) demonstrated very large to large effect sizes in reducing hoarding severity immediately after treatment and maintained improvements at a 6-month follow-up.

The inclusion of targeted reasoning and self-identity components in G-CBT further enhanced its efficacy, indicating that these elements may be beneficial in treating hoarding disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive-behavioural treatment with long-term follow-up and targeting self-identity for hoarding disorder: An open trial. O'Connor, K., Bodryzlova, Y., Audet, JS., et al.[2019]

Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) was found to be more effective than geriatric case management (CM) in reducing hoarding symptoms among older adults, with a 38% decrease in symptoms for CREST participants compared to a 25% decrease for CM participants.

Both treatments showed lasting benefits, as improvements were maintained at a 6-month follow-up, indicating that while CREST is more efficacious, CM also provides meaningful support for individuals with hoarding disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) for Hoarding Disorder in Older Adults: A Randomized Clinical Trial. Ayers, CR., Dozier, ME., Twamley, EW., et al.[2021]

A non-inferiority trial is being conducted to compare the effectiveness of group cognitive-behavioral therapy (CBT) and a structured support group called Buried in Treasures (BiT) for treating hoarding disorder, involving 300 participants over 16 weeks.

The primary goal of the study is to assess whether BiT can effectively reduce hoarding symptoms to a level comparable to that of traditional CBT, potentially increasing treatment accessibility for individuals with hoarding disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a peer facilitated support group to cognitive behavior therapy: Study protocol for a randomized controlled trial for hoarding disorder. Uhm, SY., Tsoh, JY., Mackin, RS., et al.[2022]

The community-based intervention using Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) showed significant improvements in hoarding severity and clutter volume among older adults with hoarding disorder, with 15 out of 37 participants completing the treatment in the first two years.

The successful implementation of the CREST intervention in clients' homes and community settings led to funding for program expansion, indicating its effectiveness and potential for broader application in San Diego County.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a community-based treatment for late-life hoarding. Pittman, JOE., Davidson, EJ., Dozier, ME., et al.[2022]

Hoarding disorder (HD) patients demonstrated significant difficulties in sustaining attention and using adaptive memory strategies compared to healthy controls, indicating neurocognitive challenges associated with the disorder.

While HD and obsessive-compulsive disorder (OCD) patients did not show significant differences in neuropsychological performance, a higher percentage of HD patients (67%) scored in the impaired range on at least one test, suggesting a distinct cognitive profile for HD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological functioning in hoarding disorder. Tolin, DF., Villavicencio, A., Umbach, A., et al.[2021]

A randomized controlled trial showed that Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) effectively reduced hoarding symptoms in older adults with hoarding disorder (HD).

Participants receiving CREST also demonstrated significant improvements in cognitive flexibility and inhibition, suggesting that this therapy may enhance executive functioning in addition to alleviating hoarding symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Rehabilitation and Exposure/Sorting Therapy for Late-Life Hoarding: Effects on Neuropsychological Performance. Ayers, CR., Davidson, EJ., Dozier, ME., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7295125/

Cognitive Rehabilitation and Exposure/Sorting Therapy ... To compare the efficacy of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) with geriatric case management (CM) in a sample of older adults ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28541646/

Cognitive Rehabilitation and Exposure/Sorting Therapy ... CREST appears to be an efficacious treatment compared to CM for older adults, but CM also showed meaningful benefits.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05254015

Cognitive Rehabilitation and Exposure Therapy for ... Data collected from this project includes self-report, observational, paradigm and physiology de-identified data from participants with hoarding disorder.

4. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(24)00259-2/fulltext

Outcomes of Exposure Based Treatment for Hoarding ... Neuropsychological tests scores improved for both groups, but with CREST demonstrated greater improvement in visual task-switching at baseline (b=0.803, p=0.036) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S106474812400143X

Outcomes of Exposure Based Treatment for Hoarding ... Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) for HD is effective in reducing HD symptoms and improving executive functioning (cognitive ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364921000026

Self-reported helpfulness of Cognitive Rehabilitation and ... Our results suggest that in addition to being efficacious, CREST is perceived to be a highly useful treatment by older adults with HD. Introduction. Hoarding ...

7. cochranelibrary.com cochranelibrary.com/central/doi/10.1002/central/CN-01952503/

Cognitive Rehabilitation and Exposure/Sorting Therapy ... Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) for Hoarding Disorder in Older Adults: a Randomized Clinical Trial. Ayers CR, Dozier ME ...