- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02843308
Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice (BITS)
April 10, 2024 updated by: Carolyn Rodriguez, Stanford University
Building Community-Academic Partnerships for the Evidence-Based Treatment of Hoarding Disorder
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Treatment
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)
|
Facilitated group therapy for hoarding disorder with behavioral practice
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No Intervention: Healthy Control
This group is matched to the immediate treatment group on age and gender.
They do not receive an active treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline at 8 weeks and 16 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline at 8 weeks and 16 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn Rodriguez, M.D., Ph.D., Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
July 20, 2016
First Submitted That Met QC Criteria
July 20, 2016
First Posted (Estimated)
July 25, 2016
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
April 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36788
- K23MH092434 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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