An interventional study of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) and Case Management in Hoarding Disorder and Obsessive-Compulsive Disorder, sponsored by University of California, San Diego. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.
This study's planned enrollment of 150 is above the median of 37 across 28 interventional studies indexed under Hoarding Disorder.
Browse Hoarding Disorder studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST)
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.
Behavioral: Case Management
Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) includes cognitive rehabilitation of executive functioning and exposure therapy for discarding/not acquiring.
Case management includes linking to resources, monitoring health, and safety hazards.
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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
DKEFS
Cognitive Control (inhibition and cognitive switching) will be assessed using the Delis-Kaplan Executive Function System (D-KEFS), which was specifically designed to detect deficits in high-level cognitive functions and has demonstrated strong reliability and validity in various clinical populations. We will administer five tests from the D-KEFS that examine components of executive functioning, including inhibition (the Color-Word Interference Test), cognitive switching (Verbal Fluency, Trails, Design Fluency), and Planning (Tower).
Time frame: through study completion, an average of 1 year
Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)
The Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) is a validated measure that captures views of an adult's executive functions or self-regulation their everyday environment. This will be used to assess nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization.
Time frame: through study completion, an average of 1 year
Behavioral Avoidance Task (BAT)
Threat: Fear/Anxiety will be assessed via a Behavioral Avoidance Task (BAT), utilized for assessing avoidance to sorting and discarding possessions. The BAT has been validated for measuring avoidance in OCD samples, and will be adjusted for use in HD samples.
Time frame: through study completion, an average of 1 year
Heart Rate (HR)
Threat response to discarding in beats per minute during BAT.
Time frame: through study completion, an average of 1 year
Skin Conductance Response (SCR)
Threat response to discarding in changes in temperature.
Time frame: through study completion, an average of 1 year
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be shared as soon as possible, and no later than time of an associated publication or end of a performance period. We will make data available for as long as we believe it could be useful to the scientific community.
Access criteria: We will be using NDA and following the policies and procedures for access consistent with NIMH data policies. Access to databases generated under the project will be available for educational, research and non-profit purposes for non-commercial use. Such access will be provided using web-based applications and in a commonly used format.
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Feb 2027, 51 months after the start.
Of 20 interventional studies with no phase under Hoarding Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 48. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
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