Hoarding Disorder Treatment With Virtual Reality (HDVR)
Primary Purpose
Hoarding Disorder, Hoarding, Clutter
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facilitated group therapy with behavioral practice; 16 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hoarding Disorder focused on measuring hoarding disorder, hoarding, clutter
Eligibility Criteria
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
Sites / Locations
- Stanford Psychiatry Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BITS + VR
Arm Description
Facilitated group therapy with behavioral practice; 16 weeks
Outcomes
Primary Outcome Measures
Saving Inventory-Revised (SI-R)
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.
Secondary Outcome Measures
Clutter Image Rating Scale
Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home.
This scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life.
Full Information
NCT ID
NCT03828461
First Posted
January 31, 2019
Last Updated
March 28, 2023
Sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03828461
Brief Title
Hoarding Disorder Treatment With Virtual Reality
Acronym
HDVR
Official Title
Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study explores whether a facilitated peer support group called Buried in Treasures (BIT) and a virtual reality decluttering practice can help individuals with clutter challenges.
Detailed Description
Individuals with clutter challenges participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. The investigators hypothesize that adding virtual reality decluttering practice to the BIT workshop will decrease hoarding symptoms and level of clutter over time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder, Hoarding, Clutter
Keywords
hoarding disorder, hoarding, clutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BITS + VR
Arm Type
Experimental
Arm Description
Facilitated group therapy with behavioral practice; 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Facilitated group therapy with behavioral practice; 16 weeks
Intervention Description
Facilitated group therapy for hoarding disorder with behavioral practice
Primary Outcome Measure Information:
Title
Saving Inventory-Revised (SI-R)
Description
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.
Time Frame
Change from baseline at 8 weeks and 16 weeks after treatment
Secondary Outcome Measure Information:
Title
Clutter Image Rating Scale
Description
Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home.
This scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life.
Time Frame
Change from baseline at 8 weeks and 16 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn I Rodriguez, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Psychiatry Department
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Links:
URL
http://med.stanford.edu/rodriguezlab.html
Description
Rodriguez Lab Website
URL
https://med.stanford.edu/profiles/carolyn-rodriguez?tab=bio
Description
Dr. Carolyn Rodriguez Faculty Page
Learn more about this trial
Hoarding Disorder Treatment With Virtual Reality
We'll reach out to this number within 24 hrs