Trial Outcomes & Findings for Hoarding Older Adults (NCT NCT01227057)

NCT ID: NCT01227057

Last Updated: 2018-07-24

Results Overview

Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

6 months

Results posted on

2018-07-24

Participant Flow

Participant milestones

Participant milestones
Measure
Arm 1: Cognitive Rehabilitation
Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
Arm 2: Case Management
Case Management: Case management
Overall Study
STARTED
31
27
Overall Study
COMPLETED
25
19
Overall Study
NOT COMPLETED
6
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hoarding Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1: Cognitive Rehabilitation
n=31 Participants
Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
Arm 2: Case Management
n=27 Participants
Case Management: Case management
Total
n=58 Participants
Total of all reporting groups
Age, Continuous
69.35 years
STANDARD_DEVIATION 6.49 • n=5 Participants
64.19 years
STANDARD_DEVIATION 5.35 • n=7 Participants
66.95 years
STANDARD_DEVIATION 6.48 • n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
17 Participants
n=7 Participants
41 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
10 Participants
n=7 Participants
17 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
27 Participants
n=5 Participants
24 Participants
n=7 Participants
51 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
31 participants
n=5 Participants
27 participants
n=7 Participants
58 participants
n=5 Participants
Saving Inventory Revised
57.35 units on a scale
STANDARD_DEVIATION 10.23 • n=5 Participants
59.48 units on a scale
STANDARD_DEVIATION 14.01 • n=7 Participants
58.34 units on a scale
STANDARD_DEVIATION 12.08 • n=5 Participants
Clutter Image Rating
4.15 units on a scale
STANDARD_DEVIATION 1.71 • n=5 Participants
4.33 units on a scale
STANDARD_DEVIATION 2.11 • n=7 Participants
4.24 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
University of California, Los Angeles Hoarding Severity Scale
26.35 units on a scale
STANDARD_DEVIATION 5.31 • n=5 Participants
28.85 units on a scale
STANDARD_DEVIATION 5.82 • n=7 Participants
27.52 units on a scale
STANDARD_DEVIATION 5.65 • n=5 Participants
Activities of Daily Living - Hoarding
30.85 units on a scale
STANDARD_DEVIATION 9.3 • n=5 Participants
31.90 units on a scale
STANDARD_DEVIATION 13.53 • n=7 Participants
31.31 units on a scale
STANDARD_DEVIATION 11.23 • n=5 Participants
Hospital Anxiety and Depression
Hospital Anxiety and Depression - Anxiety
9.06 units on a scale
STANDARD_DEVIATION 4.39 • n=5 Participants
10.15 units on a scale
STANDARD_DEVIATION 3.41 • n=7 Participants
9.56 units on a scale
STANDARD_DEVIATION 3.98 • n=5 Participants
Hospital Anxiety and Depression
Hospital Anxiety and Depression - Depression
7.13 units on a scale
STANDARD_DEVIATION 3.23 • n=5 Participants
8.56 units on a scale
STANDARD_DEVIATION 4.97 • n=7 Participants
7.79 units on a scale
STANDARD_DEVIATION 4.16 • n=5 Participants
Clinician Global Improvement - Severity scale
3.67 units on a scale
STANDARD_DEVIATION .92 • n=5 Participants
3.96 units on a scale
STANDARD_DEVIATION 1.19 • n=7 Participants
3.81 units on a scale
STANDARD_DEVIATION 1.06 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.

Outcome measures

Outcome measures
Measure
Arm 1: Cognitive Rehabilitation
n=25 Participants
Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
Arm 2: Case Management
n=19 Participants
Case Management: Case management
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months
35.44 units on a scale
Standard Deviation 15.48
44.68 units on a scale
Standard Deviation 13.29

SECONDARY outcome

Timeframe: 6 months

The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment. Higher scores represent increased impairment. Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.

Outcome measures

Outcome measures
Measure
Arm 1: Cognitive Rehabilitation
n=25 Participants
Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
Arm 2: Case Management
n=19 Participants
Case Management: Case management
The Activities of Daily Living in Hoarding (ADL-H)
21.09 units on a scale
Standard Deviation 6.67
27.81 units on a scale
Standard Deviation 14.29

SECONDARY outcome

Timeframe: 6 months

The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.

Outcome measures

Outcome measures
Measure
Arm 1: Cognitive Rehabilitation
n=25 Participants
Cognitive rehabilitation and exposure therapy for hoarding Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
Arm 2: Case Management
n=19 Participants
Case Management: Case management
Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months
10.8 units on a scale
Standard Deviation 3.67
10.8 units on a scale
Standard Deviation 3.11

Adverse Events

Arm 1: Cognitive Rehabilitation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 2: Case Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Ayers

VASDHS

Phone: 8585528585

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place