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.
COMPLETED
NA
58 participants
6 months
2018-07-24
Participant Flow
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
| 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 monthsHoarding 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
| 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 monthsThe 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
| 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 monthsThe 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
| 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
Arm 2: Case Management
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place