Clinical trial NCT05254015: Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding
Official title: Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hoarding Disorder
Obsessive-Compulsive Disorder
Keywords: older adult
executive dysfunction
hoarding
OCD
exposure therapy
cognitive rehabilitation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in Saving Inventory-Revised (SI-R)
timeFrame: through study completion, an average of 1 year
measure: Change in Self-report Clutter Image Rating (CIR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: PROMIS-43 Profile v2.
timeFrame: through study completion, an average of 1 year
measure: UCSD Performance-Based Skills Assessment (UPSA-2)
timeFrame: through study completion, an average of 1 year
measure: UCSD SORT Test (U-SORT)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: DKEFS
timeFrame: through study completion, an average of 1 year
measure: Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)
timeFrame: through study completion, an average of 1 year
measure: Behavioral Avoidance Task (BAT)
timeFrame: through study completion, an average of 1 year
measure: Heart Rate (HR)
timeFrame: through study completion, an average of 1 year
measure: Skin Conductance Response (SCR)
timeFrame: through study completion, an average of 1 year
Locations:
city: San Diego
country: United States
facility: Guava Hall
state: California
Study officials:
affiliation: University of California, San Diego
name: Catherine Ayers, PhD
role: PRINCIPAL_INVESTIGATOR
References: