Hoarding DisorderCRESTNCT02402647
Cognitive Rehab and Exposure Treatment for Hoarding
A study testing Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) and Exposure Therapy (ET) in people with Hoarding Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hoarding Disorder
- What is being tested?
- Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) and Exposure Therapy (ET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 1 Feb 2023
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans age 18-85
- Hoarding Disorder diagnosis outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)6 as measured by the Structured Interview for Hoarding Disorder (SIHD)67
- HD as a primary diagnosis
- Stable on medications for at least 12 weeks, with no pharmacologic changes expected or made during the 12-month study
- Voluntary consent to participate
Who cannot join
- Diagnosis of:
- psychotic disorder
- substance abuse disorder as measured by the Mini-International Neuropsychiatric Interview (M.I.N.I.)68
- Current or history of any neurodegenerative disease
- Active suicidal ideation
- Concurrent participation in psychotherapy or ET for HD, or prior history of CREST for HD
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: Cognitive Rehabilitation and Exposure Therapy for Veterans With Hoarding Disorder
This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Further, the investigators hope to increase understanding of functional and long term outcomes in response to hoarding treatment.
Read the detailed description
Objective: The investigators propose to conduct a randomized controlled trial comparing six months (26 sessions) of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) treatment to a robust comparator, six months of Exposure Therapy alone, in 136 participants with HD.
Research Design: Assessments will be administered at baseline, during treatment (sessions 7, 13, 21), post-treatment, and 3- and 6-month follow-up, thus, all participants will be enrolled for one year.
Methodology: The primary objective is to evaluate whether CREST significantly reduces hoarding symptoms and improves functional capacity and quality of life when compared to exposure therapy alone. The investigators will also examine the impact of treatment mediators; treatment adherence, changes in executive functioning, avoidance, symptom severity on outcomes. Age and executive functioning will also be explored as potential moderators. Finally, by repeatedly measuring treatment targets, the investigators will examine time to maximum treatment effect in an effort to understand mechanisms of change.
Clinical Relationships: By providing a treatment for many Veterans with HD, the investigators can alter the course of their symptom trajectory and negative consequences, resulting in both healthcare costs savings and improved quality of life for Veterans.
- Conditions
- Hoarding Disorder
- Being tested
- Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST), Exposure Therapy (ET)
- Keywords
- Hoarding, Compulsive Hoarding
- Medical subject headings
- Hoarding Disorder, Hoarding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)Behavioural
Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility.
Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET.
Exposure Therapy (ET)Behavioural
The investigators propose to use a robust control condition, ET, with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) | Experimental | Compensatory Cognitive Training (CCT) is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility.
Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET. Receives: Behavioral: Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) |
| Exposure Therapy (ET) | Active comparator | The investigators propose to use a robust control condition, exposure therapy (ET), with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist. Receives: Behavioral: Exposure Therapy (ET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saving Inventory Revised
Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, a 23-item self-report measure used to assess common hoarding symptoms. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater than 13 indicate clinical significance (Max score=36), Difficulty Discarding/Saving Subscale (7 items): scores greater than 13 indicate clinical significance, Acquisition Subscale (7 items): scores greater than 15 indicate clinical significance (Max Score= 28). Total Max score = 92. A Total score greater than 40 is a typical score for people experiencing challenges with hoarding behaviors.
Measured: Baseline to 6 month-follow-up (12 months total)
Secondary outcomes (3)
UCSD Performance-Based Skills Assessment (UPSA)
The University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)76 is an assessment of everyday functioning skills including household skills (e.g., writing a shopping list based on a recipe, range 0 to 4), communication (e.g., rescheduling appointments, range 0 to 12), finance (e.g., paying a utility bill, range 0 to 11), comprehension and planning (e.g., planning outings, range 0 to 14), and transportation (e.g., comprehension of a bus schedule, range 0 to 9). The subscales are scored, converted to a percentage, and weighed equally toward the total score of 100; higher score equals better performance for all subscales and total. The UPSA has demonstrated high inter-rater reliability (0.91) and convergent validity with other performance-based measures. The total UPSA summary score will be used for analyses. *Nearly half of each timepoint was out of 60 due to adjustments for COVID-19, a total of 60 was used with financial, communication, and planning subscales.
Measured: Baseline to 6 months post-treatment (on average 1 year)
UCSD SORT Test
The UCSD SORT Test (U-SORT) is a cognitive test that will be used to measure Veteran participants' organizational skills as they relate to functional capacity. During the administration of the U-SORT, participants are instructed to sort 42 household objects (e.g., bent and unbent paper clips, used and unused condiment packets) from a hypothetical "junk drawer" into either "keep" or "trash" piles. Each item has a correct response and participants are given two minutes to complete the task and one point is awarded for each correctly sorted item, for a total of 42 points (range of 0 to 42). A higher total score indicates a higher level of organizational skills. The U-SORT has high internal consistency (? = .86) and adequate convergent validity. The total U-SORT score will be used in analyses.
Measured: Baseline to 6 months post-treatment
Specific Levels of Functioning Test (SLOF)
Self-reported functioning (secondary outcome) will be assessed with the Specific Levels of Functioning test (SLOF)78, a 43-item Likert scale questionnaire with higher scores indicating higher levels of functioning. Subscales include interpersonal relationships (score range of 7 to 35), social acceptability (score range of 6 to 30), participation in activities (score range of 11 to 55), and work skills (score range of 6 to 30). Total of 30 items across four categories and each item ranges from the scale of 1-5 (higher values= better outcomes). Category A. Interpersonal Relationships (items 1-7): 5= Highly Typical, 1= Highly Untypical. Category B. Social Acceptability (items 8-13): 5= Never, 1= Always. Category C. Activities (items 14-24): 5= Totally Self Sufficient, 1= No Opportunity to perform. Category D. Work Skills (items 25-30): 5= Highly Typical, 1= Highly Untypical. Total Max Score Range= 30-150).The SLOF has demonstrated excellent reliability and internal consistency.
Measured: Baseline to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 Dec 2021
- Study completion1 Feb 2023
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 Hoarding DisorderStudies 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
- Model description
- Cognitive rehabilitation and exposure/sorting therapy (CREST) versus Exposure therapy only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 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
- NCT02402647
- Sponsor's protocol ID
- CLNA-005-14S
- Acronym
- CREST
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2015
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayers CR, Zakrzewski JJ, Dozier ME, Mayes T, Thomas M, Twamley EW, Carty-Campbell A, Pittman J. Cognitive rehabilitation and exposure/sorting therapy for hoarding disorder: A randomized controlled trial. J Consult Clin Psychol. 2026 Aug;94(8):470-481. doi: 10.1037/ccp0001022.
PubMed 42658588
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation and Exposure Therapy for Veterans With Hoarding Disorder
- ClinicalTrials.gov ID
- NCT02402647
- Acronym / sponsor ID
- CREST / CLNA-005-14S
- Conditions
- Hoarding Disorder
- Keywords
- Hoarding, Compulsive Hoarding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Further, the investigators hope to increase understanding of functional and long term outcomes in response to hoarding treatment.
Detailed description
Objective: The investigators propose to conduct a randomized controlled trial comparing six months (26 sessions) of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) treatment to a robust comparator, six months of Exposure Therapy alone, in 136 participants with HD.
Research Design: Assessments will be administered at baseline, during treatment (sessions 7, 13, 21), post-treatment, and 3- and 6-month follow-up, thus, all participants will be enrolled for one year.
Methodology: The primary objective is to evaluate whether CREST significantly reduces hoarding symptoms and improves functional capacity and quality of life when compared to exposure therapy alone. The investigators will also examine the impact of treatment mediators; treatment adherence, changes in executive functioning, avoidance, symptom severity on outcomes. Age and executive functioning will also be explored as potential moderators. Finally, by repeatedly measuring treatment targets, the investigators will examine time to maximum treatment effect in an effort to understand mechanisms of change.
Clinical Relationships: By providing a treatment for many Veterans with HD, the investigators can alter the course of their symptom trajectory and negative consequences, resulting in both healthcare costs savings and improved quality of life for Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cognitive rehabilitation and exposure/sorting therapy (CREST) versus Exposure therapy only
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) | Experimental | Behavioral: Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)Compensatory Cognitive Training (CCT) is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility. Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET. |
| Exposure Therapy (ET) | Active comparator | Behavioral: Exposure Therapy (ET)The investigators propose to use a robust control condition, exposure therapy (ET), with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans age 18-85
- Hoarding Disorder diagnosis outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)6 as measured by the Structured Interview for Hoarding Disorder (SIHD)67
- HD as a primary diagnosis
- Stable on medications for at least 12 weeks, with no pharmacologic changes expected or made during the 12-month study
- Voluntary consent to participate
Key exclusion criteria (6 listed)
- Diagnosis of:
- Current or history of any neurodegenerative disease
- Active suicidal ideation
- Concurrent participation in psychotherapy or ET for HD, or prior history of CREST for HD
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/Sorting Treatment (CREST)Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility. Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET. | Behavioural | Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) |
| Exposure Therapy (ET)The investigators propose to use a robust control condition, ET, with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist. | Behavioural | Exposure Therapy (ET) |
Primary outcome
Saving Inventory Revised
Time frame: Baseline to 6 month-follow-up (12 months total)
Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, a 23-item self-report measure used to assess common hoarding symptoms. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater than 13 indicate clinical significance (Max score=36), Difficulty Discarding/Saving Subscale (7 items): scores greater than 13 indicate clinical significance, Acquisition Subscale (7 items): scores greater than 15 indicate clinical significance (Max Score= 28). Total Max score = 92. A Total score greater than 40 is a typical score for people experiencing challenges with hoarding behaviors.
3 secondary outcomes
UCSD Performance-Based Skills Assessment (UPSA)
Time frame: Baseline to 6 months post-treatment (on average 1 year)
UCSD SORT Test
Time frame: Baseline to 6 months post-treatment
Specific Levels of Functioning Test (SLOF)
Time frame: Baseline to 6 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42658588Ayers CR, Zakrzewski JJ, Dozier ME, Mayes T, Thomas M, Twamley EW, Carty-Campbell A, Pittman J. Cognitive rehabilitation and exposure/sorting therapy for hoarding disorder: A randomized controlled trial. J Consult Clin Psychol. 2026 Aug;94(8):470-481. doi: 10.1037/ccp0001022.
- Individual participant dataSharing planned: No
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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/Sorting Treatment (CREST) and Exposure Therapy (ET) in people with Hoarding Disorder, 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 5 inclusion and 6 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 19 Sep 2024. 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 19 Sep 2024). 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?
Saving Inventory Revised (time frame: Baseline to 6 month-follow-up (12 months total)). 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 NCT02402647, 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 19 Sep 2024.