<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03828461</url>
  </required_header>
  <id_info>
    <org_study_id>41899</org_study_id>
    <secondary_id>1P30AG059307</secondary_id>
    <nct_id>NCT03828461</nct_id>
  </id_info>
  <brief_title>Hoarding Disorder Treatment With Virtual Reality</brief_title>
  <acronym>HDVR</acronym>
  <official_title>Enhancing Evidence-Based Treatment of Hoarding Disorder With Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study explores whether a facilitated peer support group called Buried in Treasures (BIT)&#xD;
      and a virtual reality decluttering practice can help individuals with clutter challenges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with clutter challenges participate in Buried in Treasures Workshop (BIT) that&#xD;
      has been shown to improve symptoms of hoarding disorder. The investigators hypothesize that&#xD;
      adding virtual reality decluttering practice to the BIT workshop will decrease hoarding&#xD;
      symptoms and level of clutter over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 6, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Saving Inventory-Revised (SI-R)</measure>
    <time_frame>Change from baseline at 8 weeks and 16 weeks after treatment</time_frame>
    <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.&#xD;
The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.&#xD;
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.&#xD;
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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clutter Image Rating Scale</measure>
    <time_frame>Change from baseline at 8 weeks and 16 weeks after treatment</time_frame>
    <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.&#xD;
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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hoarding Disorder</condition>
  <condition>Hoarding</condition>
  <condition>Clutter</condition>
  <arm_group>
    <arm_group_label>BITS + VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facilitated group therapy with behavioral practice; 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Facilitated group therapy with behavioral practice; 16 weeks</intervention_name>
    <description>Facilitated group therapy for hoarding disorder with behavioral practice</description>
    <arm_group_label>BITS + VR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater than 55&#xD;
&#xD;
          2. Either gender and all ethno-racial groups&#xD;
&#xD;
          3. Physically healthy male or non-pregnant female.&#xD;
&#xD;
          4. Hoarding Disorder primary condition&#xD;
&#xD;
          5. Willing and able to understand and complete consent and study procedures&#xD;
&#xD;
          6. English speaking&#xD;
&#xD;
          7. Participant should have the technology to host Zoom calls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or past history of bipolar, psychotic or eating disorders, substance&#xD;
             dependence, or substance abuse in the last year.&#xD;
&#xD;
          2. Clinically at risk of suicide with Columbia Suicide Severity Rating Scale (C-SSRS)&#xD;
             Suicidal Ideation Subscale of 4 or higher (i.e. suicidal intent without specific plan)&#xD;
&#xD;
          3. Major medical or neurological conditions that increase the risk of participation or&#xD;
             that would prevent completing assigned behavioral practice tasks.&#xD;
&#xD;
          4. Unable or unwilling to allow study staff into home for home assessment&#xD;
&#xD;
          5. Currently at high risk for eviction&#xD;
&#xD;
          6. Animal hoarding or squalor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>56 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolyn I Rodriguez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Psychiatry Department</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://med.stanford.edu/rodriguezlab.html</url>
    <description>Rodriguez Lab Website</description>
  </link>
  <link>
    <url>https://med.stanford.edu/profiles/carolyn-rodriguez?tab=bio</url>
    <description>Dr. Carolyn Rodriguez Faculty Page</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Carolyn Rodriguez</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>hoarding disorder</keyword>
  <keyword>hoarding</keyword>
  <keyword>clutter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hoarding Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03828461
org study id: 41899
secondary id: 1P30AG059307
nct id: NCT03828461
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Saving Inventory-Revised (SI-R)
time frame: Change from baseline at 8 weeks and 16 weeks after treatment
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.
measure: Clutter Image Rating Scale
time frame: Change from baseline at 8 weeks and 16 weeks after treatment
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.
arm group label: BITS + VR
arm group type: Experimental
description: Facilitated group therapy with behavioral practice; 16 weeks
intervention type: Behavioral
intervention name: Facilitated group therapy with behavioral practice; 16 weeks
description: Facilitated group therapy for hoarding disorder with behavioral practice
arm group label: BITS + VR
criteria: 
gender: All
minimum age: 56 Years
maximum age: N/A
healthy volunteers: No
last name: Carolyn I Rodriguez, MD, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
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
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Carolyn Rodriguez
investigator title: Assistant Professor
mesh term: Hoarding Disorder