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Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice (BITS)

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ClinicalTrials.gov Identifier: NCT02843308
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

Brief Summary:
The proposed study aims to investigate the efficacy of adding in-home decluttering practice to Buried in Treasures Workshop (BIT) facilitated group treatment for hoarding disorder.

Condition or disease Intervention/treatment Phase
Hoarding Disorder Hoarding Clutter Behavioral: Facilitated group therapy with behavioral practice; 18 weeks Not Applicable

Detailed Description:
Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. The investigators hypothesize that adding in-home 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 : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Building Community-Academic Partnerships for the Evidence-Based Treatment of Hoarding Disorder
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Immediate Treatment
Facilitated group therapy with behavioral practice; 18 weeks
Behavioral: Facilitated group therapy with behavioral practice; 18 weeks
Facilitated group therapy for hoarding disorder with behavioral practice

Experimental: Delayed Treatment
Facilitated group therapy with behavioral practice; 18 weeks (after a 18-20 week delay)
Behavioral: Facilitated group therapy with behavioral practice; 18 weeks
Facilitated group therapy for hoarding disorder with behavioral practice

No Intervention: Healthy Control
This group is matched to the immediate treatment group on age and gender. They do not receive an active treatment.



Primary Outcome Measures :
  1. Saving Inventory-Revised (SI-R) [ Time Frame: Change from baseline at 8 weeks and 16 weeks after treatment ]
    The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition


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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Individuals with Hoarding Disorder:

  1. Age 18 to 65 years
  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

Exclusion Criteria for Individuals with Hoarding Disorder:

  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

Inclusion Criteria for Healthy Controls:

  1. Age 18 to 65 years
  2. Either gender and all ethno-racial groups
  3. Physically healthy male or non-pregnant female.
  4. Willing and able to understand and complete consent and study procedures
  5. English speaking

Exclusion Criteria for Healthy Controls:

  1. any current or lifetime psychiatric diagnosis
  2. current or past use of psychotropic medication
  3. major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma)
  4. Metal in body or any other contraindication for MRI

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): NCT02843308


Contacts
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Contact: Andrea Varias, MSHS 650-724-8912 clutterhelp@stanford.edu
Contact: Maria Filippou-Frye, M.D., MBS 650-724-8912 clutterhelp@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Andrea Varias, MSHS    650-724-8912    clutterhelp@stanford.edu   
Contact: Maria Filippou-Frye, MD, MBS    650-724-8912    clutterhelp@stanford.edu   
Principal Investigator: Carolyn Rodriguez, MD, PhD         
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Carolyn Rodriguez, M.D., Ph.D. Stanford University

Additional Information:
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Responsible Party: Carolyn Rodriguez, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02843308     History of Changes
Other Study ID Numbers: 36788
K23MH092434 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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