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NCT02402647: CREST

Cognitive Rehab and Exposure Treatment for Hoarding

Completed NA Results posted Last updated 19 September 2024
What this trial tests

NA trial testing Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) in Hoarding Disorder in 115 participants. Completed in 1 February 2023.

Timeline
1 October 2015
Primary endpoint
31 December 2021
1 February 2023

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment115
Start date1 October 2015
Primary completion31 December 2021
Estimated completion1 February 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 85, any sex, with Hoarding Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Saving Inventory Revised Primary · Baseline to 6 month-follow-up (12 months total)

Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, a 23-item self-report measure used to assess common hoarding symptoms. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater

Baseline SI-R:
GroupValue95% CI
CREST59.9± 15.8
Exposure Therapy55.3± 14.8
Baseline SI-R: Clutter Subcategory
GroupValue95% CI
CREST25.2± 7.7
Exposure Therapy23.0± 8.2
Baseline SI-R: Acquisition Subcategory
GroupValue95% CI
CREST16.6± 5.5
Exposure Therapy14.4± 5.4
Baseline SI-R: Discarding Subcategory
GroupValue95% CI
CREST18.1± 5.5
Exposure Therapy17.9± 5.1
Timepoint 1 (S7) SI-R
GroupValue95% CI
CREST51.6± 16.8
Exposure Therapy50.5± 16.4
Timepoint 1 (S7) SI-R: Clutter Subcategory
GroupValue95% CI
CREST22.6± 8.4
Exposure Therapy21.7± 8.0
Timepoint 1 (S7) SI-R: Acquisition Subcategory
GroupValue95% CI
CREST14.1± 5.8
Exposure Therapy12.9± 6.1
Timepoint 1 (S7) SI-R: Discarding Subcategory
GroupValue95% CI
CREST14.9± 5.2
Exposure Therapy15.9± 5.0
UCSD Performance-Based Skills Assessment (UPSA) Secondary · Baseline to 6 months post-treatment (on average 1 year)

The University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA)76 is an assessment of everyday functioning skills including household skills (e.g., writing a shopping list based on a recipe, range 0 to 4), communication (e.g., rescheduling appointments, range 0 to 12), finance (e.g., paying a utility bill, range 0 to 11), comprehension and planning (e.g., planning outings, range 0 to 14), and transportation (e.g., comprehension of a bus schedule, range 0 to 9). The subscales are scored, converted to a percentage, and weighed equally toward the total score of 100; highe

Baseline UPSA
GroupValue95% CI
CREST49.0± 7.4
Exposure Therapy49.1± 6.8
Baseline UPSA: Financial Subcategory
GroupValue95% CI
CREST18.3± 2.5
Exposure Therapy18.0± 2.2
Baseline UPSA: Communication Subcategory
GroupValue95% CI
CREST16.2± 2.6
Exposure Therapy15.3± 3.1
Baseline UPSA: Comprehension/Planning Subcategory
GroupValue95% CI
CREST14.5± 5.2
Exposure Therapy15.8± 4.2
Baseline UPSA: Transportation Subcategory
GroupValue95% CI
CREST16.2± 2.8
Exposure Therapy15.9± 3.8
Baseline UPSA: Household Skills Subcategory
GroupValue95% CI
CREST17.6± 3.7
Exposure Therapy18.5± 2.3
Timepoint 1 (S7) UPSA
GroupValue95% CI
CREST50.3± 8.3
Exposure Therapy50.9± 6.4
Timepoint 1 (S7) UPSA: Financial Subcategory
GroupValue95% CI
CREST18.8± 1.5
Exposure Therapy18.3± 2.3
UCSD SORT Test Secondary · Baseline to 6 months post-treatment

The UCSD SORT Test (U-SORT) is a cognitive test that will be used to measure Veteran 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. Each item has a correct response and 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 (range of 0 to 42). A hig

Baseline USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy33.1± 3.9
Exposure Therapy31.2± 4.7
Timepoint 1 (S7) USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy32.5± 5.0
Exposure Therapy32.7± 5.3
Timepoint 2 (S13) USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy34.2± 4.1
Exposure Therapy34.2± 4.2
Timepoint 3 (S21) USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy33.2± 6.1
Exposure Therapy32.9± 4.4
Post-Treatment USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy34.5± 3.4
Exposure Therapy32.3± 5.2
3 month Post-Treatment USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy36.1± 4.0
Exposure Therapy31.4± 6.9
6 month Post-Treatment USORT
GroupValue95% CI
Cognitive Rehabilitation and Exposure/Sorting Therapy35.9± 2.9
Exposure Therapy34.0± 5.2
Specific Levels of Functioning Test (SLOF) Secondary · Baseline to 6 months post-treatment

Self-reported functioning (secondary outcome) will be assessed with the Specific Levels of Functioning test (SLOF)78, a 43-item Likert scale questionnaire with higher scores indicating higher levels of functioning. Subscales include interpersonal relationships (score range of 7 to 35), social acceptability (score range of 6 to 30), participation in activities (score range of 11 to 55), and work skills (score range of 6 to 30). Total of 30 items across four categories and each item ranges from the scale of 1-5 (higher values= better outcomes). Category A. Interpersonal Relationships (items 1-7)

Baseline SLOF Overall
GroupValue95% CI
CREST123.9± 12.9
Exposure Therapy128.0± 15.0
Baseline Interpersonal Relationships Subscale
GroupValue95% CI
CREST25.6± 6.2
Exposure Therapy24.7± 7.0
Baseline Social Acceptability Subscale
GroupValue95% CI
CREST26.6± 2.5
Exposure Therapy26.7± 2.5
Baseline Activities Subscale
GroupValue95% CI
CREST50.7± 4.8
Exposure Therapy51.8± 5.7
Baseline Work Skills Subscale
GroupValue95% CI
CREST24.5± 4.9
Exposure Therapy25.2± 4.9
Timepoint 1 (S7) SLOF Overall
GroupValue95% CI
CREST127.0± 15.2
Exposure Therapy128.1± 13.9
Timepoint 1 (S7) Interpersonal Relationships Subscale
GroupValue95% CI
CREST23.1± 6.7
Exposure Therapy24.4± 7.0
Timepoint 1 (S7) Social Acceptability Subscale
GroupValue95% CI
CREST26.8± 2.7
Exposure Therapy27.4± 2.0

Sponsor's own description

This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Further, the investigators hope to increase understanding of functional and long term outcomes in response to hoarding treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02402647.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing