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

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: NCT02843308
Recruitment Status : Active, not recruiting
First Posted : July 25, 2016
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Carolyn Rodriguez, Stanford University

Tracking Information
First Submitted Date  ICMJE July 20, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date June 29, 2020
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice
Official Title  ICMJE Building Community-Academic Partnerships for the Evidence-Based Treatment of Hoarding Disorder
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hoarding Disorder
  • Hoarding
  • Clutter
Intervention  ICMJE Behavioral: Facilitated group therapy with behavioral practice; 18 weeks
Facilitated group therapy for hoarding disorder with behavioral practice
Study Arms  ICMJE
  • Experimental: Immediate Treatment
    Facilitated group therapy with behavioral practice; 18 weeks
    Intervention: Behavioral: Facilitated group therapy with behavioral practice; 18 weeks
  • Experimental: Delayed Treatment
    Facilitated group therapy with behavioral practice; 18 weeks (after a 18-20 week delay)
    Intervention: Behavioral: Facilitated group therapy with behavioral practice; 18 weeks
  • No Intervention: Healthy Control
    This group is matched to the immediate treatment group on age and gender. They do not receive an active treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Individuals with Hoarding Disorder:

  1. Age 18 to 70 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 70 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843308
Other Study ID Numbers  ICMJE 36788
K23MH092434 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carolyn Rodriguez, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Carolyn Rodriguez, M.D., Ph.D. Stanford University
PRS Account Stanford University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP