- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828461
Hoarding Disorder Treatment With Virtual Reality (HDVR)
Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford Psychiatry Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age greater than 55
- Either gender and all ethno-racial groups
- Physically healthy male or non-pregnant female.
- Hoarding Disorder primary condition
- Willing and able to understand and complete consent and study procedures
- English speaking
- Participant should have the technology to host Zoom calls
Exclusion Criteria:
- Current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year.
- Clinically at risk of suicide with Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Subscale of 4 or higher (i.e. suicidal intent without specific plan)
- Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
- Unable or unwilling to allow study staff into home for home assessment
- Currently at high risk for eviction
- Animal hoarding or squalor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BITS + VR
Facilitated group therapy with behavioral practice; 16 weeks
|
Facilitated group therapy for hoarding disorder with behavioral practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R)
Time Frame: Change from baseline to 16 weeks after treatment
|
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. |
Change from baseline to 16 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale
Time Frame: 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.
|
Change from baseline to 16 weeks after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn I Rodriguez, MD, PhD, Stanford University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41899
- 1P30AG059307 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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