Clinical trial NCT04697849: Functional and Cognitive Rehabilitation of Hoarding Disorder
Official title: Functional and Cognitive Rehabilitation of Hoarding Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hoarding Disorder
Keywords: hoarding
OCD
cognitive rehabilitation
exposure therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: San Diego Veterans Healthcare System
First posted: 2021-01-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) intervention provides compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, and then uses exposure therapy to reduce the distress associated with discarding items. CREST will be compared to case management for hoarding symptoms.
Primary purpose: TREATMENT

Brief summary: Hoarding Disorder (HD) is serious and disabling in Veterans. Present in up to 7% of Veterans and even higher symptom rates in older Veterans; HD contributes to functional impairment and poor quality of life. Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) has shown promising functional improvement and symptom reduction. To reduce burdens and barriers to implementation of CREST, the proposed project will individualize CREST based on cognitive testing and participant preferences, provide all care in the participant's home through telemedicine and home visits, and shorten the timeframe of treatment. A randomized controlled trial comparing 24 sessions of Personalized-CREST to case management for 130 adult Veterans with HD is proposed. Multifaceted functional and recovery outcomes including quality of life, HD severity, and sustained recovery outcomes will be examined throughout treatment and follow-up. By advancing the knowledge of the rehabilitative care of HD, we can interrupt the trajectory of this chronic and debilitating condition.

Detailed description: Hoarding Disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and public health consequences. 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. Subsequent accumulation of clutter can become so dangerous that it puts individuals at risk of falls, fires, infestations, food contamination, medication mismanagement, social isolation, nutritional deprivation, and eviction. Medical problems, activities of daily living (ADL) impairment, decreased quality of life, and functional disability are associated with HD symptom severity. HD starts early in life, does not remit if left untreated, and increases in severity with age. The highest rates of HD are seen in older adults, with up to 25% experiencing HD symptoms. The population of older Veterans is substantial, with 41% expected to be over the age of 65 by 2030. Recent research has found that Veterans with HD experience more medical and psychiatric comorbidities; thus, Veterans represent a group with high needs for effective HD treatment to reduce disability and improve multiple aspects of functioning.

Dr. Ayers' group has developed and evaluated Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) in randomized controlled trials. The CREST intervention provides compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, and then uses exposure therapy to reduce the distress associated with discarding items. CREST improves HD symptoms and functioning in Veterans with HD, but the intensive nature of the program (6-8 months) burdens mental health clinics and slows progress. Given that the home is the primary site of clutter and the need for sorting of a large volume of items during treatment, a home-based treatment approach is needed. To reduce the burdens and barriers to implementation of CREST, the investigators will use a novel approach, referred to as Personalized-CREST, designed to reflect a precision medicine approach to evidence-based treatment for HD. Personalized-CREST will be more individualized (matching cognitive strategies to Veteran needs and priorities), more efficient (shorter timeframe over 12 weeks), and easier to access (in-home sessions and home-based video telemedicine \[HBVT\] sessions). Recent pilot data suggest that HBVT for HD is feasible, efficacious, requires minimal adaptation, and is a preferred. Based on 73 non-Veteran community Personalized-CREST completers, results indicated statistically significant decreases in functional impairment, disability, and of HD symptom severity.

The proposed randomized controlled trial will compare Personalized-CREST to a case management (CM) control condition for 130 adult Veterans with HD. Personalized-CREST will be delivered twice a week in the home (one face-to-face and one HBVT session) for 60 minutes per session. A total of 24 sessions will be provided over 3 months. Per the standard of care for CM, a social worker will visit the Veteran once a week in their home. A thorough evaluation of treatment outcomes, including multifaceted functional and rehabilitative outcomes, including quality of life and hoarding severity will be conducted at baseline (0 months), mid-treatment, end of treatment (3 months), and 6-month follow-up. The investigators will also examine factors that mediate improvement in Personalized-CREST (improved executive functioning and reduction in avoidance of discarding items). Individual factors (e.g., age, baseline executive functioning, baseline HD severity, gender and economic factors) and treatment factors (e.g., attendance) will be explored as moderators. The proposed study will generate knowledge to advance the rehabilitative care of Veterans with HD.

Eligibility criteria: Inclusion Criteria:

* Veterans age 18 and older
* voluntary informed consent for participation
* DSM-5 diagnosis of HD as measured by the Structured Interview for Hoarding Disorder
* HD as a primary diagnosis, and 5) stable on medications for at least 6 weeks

Exclusion Criteria:

* current psychosis or mania as measured by the Mini-International Neuropsychiatric Interview
* current or history of any neurodegenerative disease
* concurrent participation in any form of exposure-based psychotherapy

  * suicide ideation will be monitored by the clinicians during sessions and VA standard suicide measure will be completed at all assessment points

Primary outcomes:
measure: World Health Organization Disability Assessment Schedule (WHODAS 2.0) Change
timeFrame: Baseline, 1.5 months, 3 months, and 9 months
measure: Activities of Daily Living in Hoarding Scale Change
timeFrame: Baseline, 1.5 months, 3 months, and 9 months
measure: PROMIS-43 Profile v2.1 Change
timeFrame: Baseline, 1.5 months, 3 months, and 9 months
measure: Quality of Life in Neurological Disorders (Neuro-QoL) Positive Affect and Well-Being Short form Change
timeFrame: Baseline, 1.5 months, 3 months, and 9 months
Secondary outcomes:
measure: Savings Inventory-Revised (SI-R) Change
timeFrame: Baseline, 1.5 months, 3 months, and 9 months
measure: Clutter Image Rating Scale (CIR) Change
timeFrame: Baseline, 1.5 months, 3 months, and 9 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Catherine R Ayers, PhD
role: PRINCIPAL_INVESTIGATOR
References: