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Trial record 7 of 10 for:    Carolyn Rodriguez

Hoarding Disorder Treatment With Virtual Reality (HDVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828461
Recruitment Status : Enrolling by invitation
First Posted : February 4, 2019
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

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.

Condition or disease Intervention/treatment Phase
Hoarding Disorder Hoarding Clutter Behavioral: Facilitated group therapy with behavioral practice; 16 weeks Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Experimental: BITS + VR
Facilitated group therapy with behavioral practice; 16 weeks
Behavioral: Facilitated group therapy with behavioral practice; 16 weeks
Facilitated group therapy for hoarding disorder with behavioral practice




Primary Outcome Measures :
  1. Saving Inventory-Revised (SI-R) [ Time Frame: Change from baseline at 8 weeks and 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.



Secondary Outcome Measures :
  1. Clutter Image Rating Scale [ Time Frame: Change from baseline at 8 weeks and 16 weeks after treatment ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 55
  2. Either gender and all ethno-racial groups
  3. Physically healthy male or non-pregnant female.
  4. Hoarding Disorder primary condition
  5. Willing and able to understand and complete consent and study procedures
  6. English speaking
  7. Participant should have the technology to host Zoom calls

Exclusion Criteria:

  1. Current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year.
  2. 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)
  3. Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
  4. Unable or unwilling to allow study staff into home for home assessment
  5. Currently at high risk for eviction
  6. Animal hoarding or squalor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828461


Locations
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United States, California
Stanford Psychiatry Department
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Carolyn I Rodriguez, MD, PhD Stanford University
Additional Information:
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Responsible Party: Carolyn Rodriguez, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03828461    
Other Study ID Numbers: 41899
1P30AG059307 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn Rodriguez, Stanford University:
hoarding disorder
hoarding
clutter
Additional relevant MeSH terms:
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Disease
Hoarding Disorder
Pathologic Processes
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders