Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding

NCT05254015 | Enrolling By Invitation DMC

• 1 other identifier: 1R01MH127056-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hoarding Disorder; Obsessive-Compulsive Disorder

Keywords

older adult; executive dysfunction; hoarding; OCD; exposure therapy; cognitive rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• PROMIS-43 Profile v2.

  through study completion, an average of 1 year

• UCSD Performance-Based Skills Assessment (UPSA-2)

  through study completion, an average of 1 year

• UCSD SORT Test (U-SORT)

  through study completion, an average of 1 year

Other Outcomes (5)

• DKEFS

  through study completion, an average of 1 year

• Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)

  through study completion, an average of 1 year

• Behavioral Avoidance Task (BAT)

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Behavioral: Case Management

Interventions

Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) BEHAVIORAL

Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) includes cognitive rehabilitation of executive functioning and exposure therapy for discarding/not acquiring.

Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST)

Case Management BEHAVIORAL

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

Case Management (CM)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Guava Hall

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Hoarding Disorder; Obsessive-Compulsive Disorder; Hoarding

Interventions

Cognitive Training; Case Management

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Catherine Ayers, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 24, 2022
• Study Start: November 21, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)