Hoarding DisorderHDVRNCT03828461
Hoarding Disorder Treatment With Virtual Reality
A study testing Facilitated group therapy with behavioral practice; 16 weeks in people with Hoarding Disorder and Hoarding, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Hoarding Disorder, Hoarding, Clutter
- What is being tested?
- Facilitated group therapy with behavioral practice; 16 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Psychiatry Department
Stanford, California, 94305
About this study
Official title: Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality
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.
Read the 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.
- Conditions
- Hoarding Disorder, Hoarding, Clutter
- Being tested
- Facilitated group therapy with behavioral practice; 16 weeks
- Keywords
- hoarding disorder, hoarding, clutter
- Medical subject headings
- Hoarding Disorder, Hoarding, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated group therapy with behavioral practice; 16 weeksBehavioural
Facilitated group therapy for hoarding disorder with behavioral practice
| Study group | Role | What they receive |
|---|---|---|
| BITS + VR | Experimental | Facilitated group therapy with behavioral practice; 16 weeks Receives: Behavioral: Facilitated group therapy with behavioral practice; 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hoarding Symptom Severity as Measured by 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.
Measured: Change from baseline to 16 weeks after treatment
Secondary outcomes (1)
Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale
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.
Measured: Change from baseline to 16 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Jul 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Carolyn Rodriguez, Stanford University
- Investigators
- Carolyn I Rodriguez, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828461
- Sponsor's protocol ID
- 41899
- Other IDs
- 1P30AG059307
- Acronym
- HDVR
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2019
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raila H, Avanesyan T, Valentine KE, Koo B, Huang C, Tsutsumi Y, Andreeff E, Qiu T, Munoz Rodriguez PA, Varias A, Filippou-Frye M, van Roessel P, Bullock K, Periyakoil VS, Rodriguez CI. Augmenting group hoarding disorder treatment with virtual reality discarding: A pilot study in older adults. J Psychiatr Res. 2023 Oct;166:25-31. doi: 10.1016/j.jpsychires.2023.08.002. Epub 2023 Aug 9.
PubMed 37716272
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality
- ClinicalTrials.gov ID
- NCT03828461
- Acronym / sponsor ID
- HDVR / 41899
- Conditions
- Hoarding Disorder, Hoarding, Clutter
- Keywords
- hoarding disorder, hoarding, clutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BITS + VR | Experimental | Behavioral: Facilitated group therapy with behavioral practice; 16 weeksFacilitated group therapy with behavioral practice; 16 weeks |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated group therapy with behavioral practice; 16 weeksFacilitated group therapy for hoarding disorder with behavioral practice | Behavioural | BITS + VR |
Primary outcome
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.
1 secondary outcome
Change in the Severity of Clutter Level as Measured by Clutter Image Rating Scale
Time frame: Change from baseline to 16 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37716272Raila H, Avanesyan T, Valentine KE, Koo B, Huang C, Tsutsumi Y, Andreeff E, Qiu T, Munoz Rodriguez PA, Varias A, Filippou-Frye M, van Roessel P, Bullock K, Periyakoil VS, Rodriguez CI. Augmenting group hoarding disorder treatment with virtual reality discarding: A pilot study in older adults. J Psychiatr Res. 2023 Oct;166:25-31. doi: 10.1016/j.jpsychires.2023.08.002. Epub 2023 Aug 9.
- Rodriguez Lab WebsiteLink provided by the sponsor.
- Dr. Carolyn Rodriguez Faculty PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn I Rodriguez, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated group therapy with behavioral practice; 16 weeks in people with Hoarding Disorder and Hoarding, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hoarding Symptom Severity as Measured by Saving Inventory-Revised (SI-R) (time frame: Change from baseline to 16 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.