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Enrolling by invitation NCT05254015

Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding

No phase Interventional Hoarding Disorder Obsessive-Compulsive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST), Case Management.
Who it may be relevant to
Registry conditions: Hoarding Disorder, Obsessive-Compulsive Disorder. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral Case Management
    Case management includes linking to resources, monitoring health, and safety hazards.

Primary outcome measures

  • Change in Saving Inventory-Revised (SI-R) [Time frame: through study completion, an average of 1 year]
  • Change in Self-report Clutter Image Rating (CIR) [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Guava Hall — San Diego

Identifiers

NCT: NCT05254015 · 1R01MH127056-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗