Hoarding DisorderCRESTNCT05254015
Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding
A study testing Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) and Case Management in people with Hoarding Disorder and Obsessive-Compulsive Disorder, run by University of California, San Diego at 1 site in United States.
Trial summary
Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and public consequences, particularly for older adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hoarding Disorder, Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) and Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults age 50 and older
- voluntary informed consent for participation
- DSM-5 diagnosis of HD
- HD as a primary, most severe diagnosis
- stable on medications for at least 8 weeks
Who cannot join
- current psychosis or mania as measured by the Mini-International
- current or history of any neurodegenerative disease
- substance use disorder
- current use of benzodiazepine medication
- suicidality
- current participation in exposure-based therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and public consequences, particularly for older adults. This confirmatory efficacy trial will advance our knowledge of the mechanisms of action in the treatment of HD as well as reduce symptom severity, disability, and community consequences.
Read the detailed description
Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and community consequences, particularly for older adults. HD is defined by persistent difficulty discarding or parting with possessions due to distress associated with discarding, urges to save, and/or difficulty making decisions about what to keep and what to discard. As a result, clutter accumulates and fills active living areas, preventing the normal use of space and resulting in distress and disability. Community epidemiological reports estimate the prevalence of clinically significant hoarding symptoms at 7% in individuals over age 60 and even higher rates in those over age 70. HD is the only neuropsychiatric condition that progresses in severity and population prevalence with age apart from dementia.
Inhibition and cognitive switching have been identified as key deficits in older adults with HD. These executive functioning areas are consistent with the RDoC cognitive control domain and particularly the goal selection, updating, representation, and maintenance subconstruct. Findings suggest that these deficits may contribute to the symptomatic expression of HD, degree of functional impairment, and modest responses to HD treatment. Furthermore, anticipatory and experiential fear and anxiety, consistent with the RDoC constructs of acute and potential threat, lead to sustained problems with discarding items and clutter accumulation. When these constructs are targeted, our group has produced clinically and statistically significant outcomes.
Consistent with NIMH strategic goal 3.1, to arrive at effective treatment approaches for unmet therapeutic domains in behavioral science, this project seeks to conduct the first confirmatory efficacy trial for older adults with HD. We propose a RCT comparing CREST to a case management control condition for 150 adults age 50 and older with HD. We are examining age as a moderator and will therefore include both midlife and late life participants. An evaluation of treatment outcome, including hoarding severity and functional outcomes, will be conducted at baseline (0 months), mid-treatment (3 months), end of treatment (6 months), 3-month (9 months) and 6-month follow-up (12 months). Participants will receive 26 weekly 60-minute individual sessions over the course of 32 weeks maximum (6-7.5 months). They will receive 50% in home and 50% office visits. We will examine factors that mediate improvement in CREST (improved inhibition/cognitive switching and reduction in fear/anxiety of discarding items) through physiological, behavioral, self-report, and paradigm assessments. Individual factors (e.g., age and other demographic factors, baseline cognitive control, baseline hoarding severity) and treatment factors (e.g., session attendance) will be evaluated as moderators. The specific aims include determining confirmatory efficacy of CREST, mechanisms of CREST effects, and moderators of CREST. If successful, this project would lead to an effectiveness trial in a real world setting.
- Conditions
- Hoarding Disorder, Obsessive-Compulsive Disorder
- Being tested
- Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), Case Management
- Keywords
- older adult, executive dysfunction, hoarding, OCD, exposure therapy, cognitive rehabilitation
- Medical subject headings
- Hoarding Disorder, Obsessive-Compulsive 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 Therapy (CREST)Behavioural
Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) includes cognitive rehabilitation of executive functioning and exposure therapy for discarding/not acquiring.
Case ManagementBehavioural
Case management includes linking to resources, monitoring health, and safety hazards.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) | Experimental | Compensatory Cognitive Training (CCT) Modules (7 sessions). Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illnesses. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive impairments and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility.
Exposure to Discarding and Acquiring Modules (19 sessions). Symptoms of acquiring and saving are themselves avoidance behaviors to avoid internal distress related to negative thoughts and emotions. ET utilizes in vivo exposure exercises taking place in the home to enhance generalization of their new skills. Fear hierarchies typically start with a space that has low clutter volume or there is less of an urge to save a particular type of item in that environment. Receives: Behavioral: Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) |
| Case Management (CM) | Active comparator | Case Management (CM). CM consists of a set of well-established strategies commonly used in community service settings to address serious and complex problems in particularly vulnerable and often marginalized populations such as those with HD. Receives: Behavioral: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Saving Inventory-Revised (SI-R)
Hoarding symptom severity will be measured using the Saving Inventory-Revised (SI-R), a 23-item self-report measure used to assess common HD symptoms. Subscales include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, concurrent validity, divergent validity, and test-retest reliability in clinical samples with HD. The total score will be used for analyses.
Measured: through study completion, an average of 1 year
Change in Self-report Clutter Image Rating (CIR)
The Clutter Image Rating Scale (CIR) is a measure using a series of 9 photographs each of a kitchen, living room, and bedroom with varying levels of clutter. Participants and the rater independently select the photograph that most closely resembles each of the three rooms in the home. Internal consistency, test-retest reliability, inter-rater reliability, and correlations with validated HD measures for the CIR were high.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
PROMIS-43 Profile v2.
Functioning will be assessed with the PROMIS-43 Profile v2., which 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, 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.
Measured: through study completion, an average of 1 year
UCSD Performance-Based Skills Assessment (UPSA-2)
The UCSD Performance-Based Skills Assessment (UPSA-2) is an assessment of everyday functioning skills involved in household management (e.g., writing a shopping list based on a provided recipe), communication (e.g., rescheduling a doctor's appointment), finance (e.g., paying a utility bill), comprehension/planning (e.g., planning an outing), medication management (taking medications as planned), and transportation (e.g., reading comprehension of a bus schedule). The UPSA-2 has demonstrated high inter-rater reliability (0.91) and convergent validity with other performance-based measures. The total UPSA-2 summary score will be used for analyses.
Measured: through study completion, an average of 1 year
UCSD SORT Test (U-SORT)
The UCSD SORT Test (U-SORT) will be used to measure 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. 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. The U-SORT has high internal consistency (alpha = .86) and adequate convergent validity. The total U-SORT score will be used in analyses.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start21 Nov 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Ayers, University of California, San Diego
- Investigators
- Catherine Ayers, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254015
- Sponsor's protocol ID
- 1R01MH127056-01A1
- Acronym
- CREST
- Status last verified
- Apr 2023
- First submitted
- 9 Feb 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from this project includes self-report, observational, paradigm and physiology de-identified data from participants with hoarding disorder. During consent, participants will be provided with information about how their data will be shared. All de-identified data from this project will be shared in accordance with NIMH guidance via the NIMH Data Archive (NDA). Data will be individualized data of 150 participants. There will be no specialized tools or software that is required for access. Supporting documentation such as data collection instruments, protocols, data dictionaries and definitions will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding
- ClinicalTrials.gov ID
- NCT05254015
- Acronym / sponsor ID
- CREST / 1R01MH127056-01A1
- Conditions
- Hoarding Disorder, Obsessive-Compulsive Disorder
- Keywords
- older adult, executive dysfunction, hoarding, OCD, exposure therapy, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and public consequences, particularly for older adults. This confirmatory efficacy trial will advance our knowledge of the mechanisms of action in the treatment of HD as well as reduce symptom severity, disability, and community consequences.
Detailed description
Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and community consequences, particularly for older adults. HD is defined by persistent difficulty discarding or parting with possessions due to distress associated with discarding, urges to save, and/or difficulty making decisions about what to keep and what to discard. As a result, clutter accumulates and fills active living areas, preventing the normal use of space and resulting in distress and disability. Community epidemiological reports estimate the prevalence of clinically significant hoarding symptoms at 7% in individuals over age 60 and even higher rates in those over age 70. HD is the only neuropsychiatric condition that progresses in severity and population prevalence with age apart from dementia.
Inhibition and cognitive switching have been identified as key deficits in older adults with HD. These executive functioning areas are consistent with the RDoC cognitive control domain and particularly the goal selection, updating, representation, and maintenance subconstruct. Findings suggest that these deficits may contribute to the symptomatic expression of HD, degree of functional impairment, and modest responses to HD treatment. Furthermore, anticipatory and experiential fear and anxiety, consistent with the RDoC constructs of acute and potential threat, lead to sustained problems with discarding items and clutter accumulation. When these constructs are targeted, our group has produced clinically and statistically significant outcomes.
Consistent with NIMH strategic goal 3.1, to arrive at effective treatment approaches for unmet therapeutic domains in behavioral science, this project seeks to conduct the first confirmatory efficacy trial for older adults with HD. We propose a RCT comparing CREST to a case management control condition for 150 adults age 50 and older with HD. We are examining age as a moderator and will therefore include both midlife and late life participants. An evaluation of treatment outcome, including hoarding severity and functional outcomes, will be conducted at baseline (0 months), mid-treatment (3 months), end of treatment (6 months), 3-month (9 months) and 6-month follow-up (12 months). Participants will receive 26 weekly 60-minute individual sessions over the course of 32 weeks maximum (6-7.5 months). They will receive 50% in home and 50% office visits. We will examine factors that mediate improvement in CREST (improved inhibition/cognitive switching and reduction in fear/anxiety of discarding items) through physiological, behavioral, self-report, and paradigm assessments. Individual factors (e.g., age and other demographic factors, baseline cognitive control, baseline hoarding severity) and treatment factors (e.g., session attendance) will be evaluated as moderators. The specific aims include determining confirmatory efficacy of CREST, mechanisms of CREST effects, and moderators of CREST. If successful, this project would lead to an effectiveness trial in a real world setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) | Experimental | Behavioral: Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST)Compensatory Cognitive Training (CCT) Modules (7 sessions). Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illnesses. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive impairments and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility. Exposure to Discarding and Acquiring Modules (19 sessions). Symptoms of acquiring and saving are themselves avoidance behaviors to avoid internal distress related to negative thoughts and emotions. ET utilizes in vivo exposure exercises taking place in the home to enhance generalization of their new skills. Fear hierarchies typically start with a space that has low clutter volume or there is less of an urge to save a particular type of item in that environment. |
| Case Management (CM) | Active comparator | Behavioral: Case ManagementCase Management (CM). CM consists of a set of well-established strategies commonly used in community service settings to address serious and complex problems in particularly vulnerable and often marginalized populations such as those with HD. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults age 50 and older
- voluntary informed consent for participation
- DSM-5 diagnosis of HD
- HD as a primary, most severe diagnosis
- stable on medications for at least 8 weeks
Key exclusion criteria (6 listed)
- current psychosis or mania as measured by the Mini-International
- current or history of any neurodegenerative disease
- substance use disorder
- current use of benzodiazepine medication
- suicidality
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 Therapy (CREST)Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) includes cognitive rehabilitation of executive functioning and exposure therapy for discarding/not acquiring. | Behavioural | Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) |
| Case ManagementCase management includes linking to resources, monitoring health, and safety hazards. | Behavioural | Case Management (CM) |
Primary outcome
Change in Saving Inventory-Revised (SI-R)
Time frame: through study completion, an average of 1 year
Hoarding symptom severity will be measured using the Saving Inventory-Revised (SI-R), a 23-item self-report measure used to assess common HD symptoms. Subscales include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, concurrent validity, divergent validity, and test-retest reliability in clinical samples with HD. The total score will be used for analyses.
Change in Self-report Clutter Image Rating (CIR)
Time frame: through study completion, an average of 1 year
The Clutter Image Rating Scale (CIR) is a measure using a series of 9 photographs each of a kitchen, living room, and bedroom with varying levels of clutter. Participants and the rater independently select the photograph that most closely resembles each of the three rooms in the home. Internal consistency, test-retest reliability, inter-rater reliability, and correlations with validated HD measures for the CIR were high.
3 secondary outcomes
PROMIS-43 Profile v2.
Time frame: through study completion, an average of 1 year
UCSD Performance-Based Skills Assessment (UPSA-2)
Time frame: through study completion, an average of 1 year
UCSD SORT Test (U-SORT)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Yes. Data collected from this project includes self-report, observational, paradigm and physiology de-identified data from participants with hoarding disorder. During consent, participants will be provided with information about how their data will be shared. All de-identified data from this project will be shared in accordance with NIMH guidance via the NIMH Data Archive (NDA). Data will be individualized data of 150 participants. There will be no specialized tools or software that is required for access. Supporting documentation such as data collection instruments, protocols, data dictionaries and definitions will be made available.
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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.
Catherine Ayers, PhD principal investigator
University of California, San Diego
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 Therapy (CREST) and Case Management in people with Hoarding Disorder and Obsessive-Compulsive Disorder, run by University of California, San Diego 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Saving Inventory-Revised (SI-R) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.