- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02843308
Enhancing Treatment of Hoarding Disorder With Personalized In-Home Sorting and Decluttering Practice (BITS)
Building Community-Academic Partnerships for the Evidence-Based Treatment of Hoarding Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Study Plan
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients Who Met and Exceeded Response Criteria of the Saving Inventory-Revised (SI-R)
Time Frame: Change from baseline (pre-treatment) to week 18 (post-treatment) the Immediate Treatment Arm/Group and change from baseline (pre-treatment at 18 weeks) to 36 weeks (post-treatment) for the Delayed Treatment Arm/Group
|
The SI-R is a 23-item questionnaire with 3 sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition. The total score ranges from 0 to 92. The greater the score, the more severe the hoarding symptoms. Total score higher than 41 shows significant difficulty with clutter. For the acquisition subscale, items 2 (reverse score), 9, 11, 14, 16, 18 and 21 are summed together. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition. For the difficulty discarding subscale, items 4(reverse score), 6, 7, 13, 17, 19, 23 are summed together. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding. For the clutter subscale, items 1, 3, 5, 8, 10, 12, 15, 20, 22 are summed together. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter. Response was defined as at least a 14 point change (pre-post) in the total score. |
Change from baseline (pre-treatment) to week 18 (post-treatment) the Immediate Treatment Arm/Group and change from baseline (pre-treatment at 18 weeks) to 36 weeks (post-treatment) for the Delayed Treatment Arm/Group
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn Rodriguez, M.D., Ph.D., Stanford University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Anxiety Disorders
- Obsessive-Compulsive Disorder
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Hoarding Disorder
- Speech Disorders
- Hoarding
Other Study ID Numbers
- 36788
- K23MH092434 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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