Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice (BITS)
Primary Purpose
Hoarding Disorder, Hoarding, Clutter
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facilitated group therapy with behavioral practice; 18 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hoarding Disorder focused on measuring hoarding disorder, hoarding, clutter
Eligibility Criteria
Inclusion Criteria for Individuals with Hoarding Disorder:
- Age 18 to 70 years
- 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
Exclusion Criteria for Individuals with Hoarding Disorder:
- 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
Inclusion Criteria for Healthy Controls:
- Age 18 to 70 years
- Either gender and all ethno-racial groups
- Physically healthy male or non-pregnant female.
- Willing and able to understand and complete consent and study procedures
- English speaking
Exclusion Criteria for Healthy Controls:
- any current or lifetime psychiatric diagnosis
- current or past use of psychotropic medication
- major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma)
- Metal in body or any other contraindication for MRI
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Immediate Treatment
Delayed Treatment
Healthy Control
Arm Description
Facilitated group therapy with behavioral practice; 18 weeks
Facilitated group therapy with behavioral practice; 18 weeks (after a 18-20 week delay)
This group is matched to the immediate treatment group on age and gender. They do not receive an active treatment.
Outcomes
Primary Outcome Measures
Saving Inventory-Revised (SI-R)
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
Clutter Image Rating Scale
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.
Full Information
NCT ID
NCT02843308
First Posted
July 20, 2016
Last Updated
April 10, 2023
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02843308
Brief Title
Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice
Acronym
BITS
Official Title
Building Community-Academic Partnerships for the Evidence-Based Treatment of Hoarding Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder, Hoarding, Clutter
Keywords
hoarding disorder, hoarding, clutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Facilitated group therapy with behavioral practice; 18 weeks
Arm Title
Delayed Treatment
Arm Type
Experimental
Arm Description
Facilitated group therapy with behavioral practice; 18 weeks (after a 18-20 week delay)
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
This group is matched to the immediate treatment group on age and gender. They do not receive an active treatment.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated group therapy with behavioral practice; 18 weeks
Intervention Description
Facilitated group therapy for hoarding disorder with behavioral practice
Primary Outcome Measure Information:
Title
Saving Inventory-Revised (SI-R)
Description
The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition
Time Frame
Change from baseline at 8 weeks and 16 weeks after treatment
Secondary Outcome Measure Information:
Title
Clutter Image Rating Scale
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.
Time Frame
Change from baseline at 8 weeks and 16 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Individuals with Hoarding Disorder:
Age 18 to 70 years
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
Exclusion Criteria for Individuals with Hoarding Disorder:
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
Inclusion Criteria for Healthy Controls:
Age 18 to 70 years
Either gender and all ethno-racial groups
Physically healthy male or non-pregnant female.
Willing and able to understand and complete consent and study procedures
English speaking
Exclusion Criteria for Healthy Controls:
any current or lifetime psychiatric diagnosis
current or past use of psychotropic medication
major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma)
Metal in body or any other contraindication for MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Rodriguez, M.D., Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
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
Learn more about this trial
Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice
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