Trial Outcomes & Findings for Hoarding Disorder Treatment With Virtual Reality (NCT NCT03828461)

Last Updated: 2024-04-01

Results Overview

The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition. The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter. For the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition. For the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding. For the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Change from baseline to 16 weeks after treatment

Results posted on

2024-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	BITS + VR Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	BITS + VR Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Hoarding Disorder Treatment With Virtual Reality

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BITS + VR n=9 Participants Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice
Age, Continuous	64 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 16 weeks after treatment

Outcome measures

Outcome measures
Measure	BITS + VR n=9 Participants Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice
Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)	14.2 score on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: Change from baseline to 16 weeks after treatment

Clutter Imaging Rating (CIR) Scale consists of three sets of photographs of a room, each containing nine photos with varying levels of clutter. This scale assesses the clutter levels in the bedroom, living room and kitchen. Patients were asked to select the picture "that most accurately reflects the amount of clutter in your room". Scores on range from 1 (least cluttered) to 9 (most cluttered). A mean composite score ranging from 1 to 9 was calculated across the three rooms for each individual. A cut-off score of 4 or higher indicate significant clutter.

Outcome measures

Outcome measures
Measure	BITS + VR n=9 Participants Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice
Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale	0.77 score on a scale Standard Deviation 0.58

Adverse Events

BITS + VR

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BITS + VR n=9 participants at risk Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice
Nervous system disorders dizziness	33.3% 3/9 • Number of events 3 • up to 16 weeks
Nervous system disorders general discomfort	77.8% 7/9 • Number of events 7 • up to 16 weeks
Nervous system disorders fatigue	33.3% 3/9 • Number of events 3 • up to 16 weeks
Nervous system disorders headache	33.3% 3/9 • Number of events 3 • up to 16 weeks
Eye disorders eye strain	55.6% 5/9 • Number of events 5 • up to 16 weeks
Eye disorders difficulty focusing	55.6% 5/9 • Number of events 5 • up to 16 weeks
Gastrointestinal disorders salivation increasing	11.1% 1/9 • Number of events 1 • up to 16 weeks
Skin and subcutaneous tissue disorders sweating	11.1% 1/9 • Number of events 1 • up to 16 weeks
Gastrointestinal disorders nausea	44.4% 4/9 • Number of events 4 • up to 16 weeks
Nervous system disorders difficulty concentrating	22.2% 2/9 • Number of events 2 • up to 16 weeks
Nervous system disorders fullness of head	33.3% 3/9 • Number of events 3 • up to 16 weeks
Eye disorders blurred vision	44.4% 4/9 • Number of events 4 • up to 16 weeks
Nervous system disorders veritgo	33.3% 3/9 • Number of events 3 • up to 16 weeks
Gastrointestinal disorders stomach awareness	33.3% 3/9 • Number of events 3 • up to 16 weeks

Additional Information

Carolyn Rodriguez, MD, PhD

Stanford University

Phone: 650-723-4095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place