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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

About this trial

This is an interventional treatment trial for Hoarding Disorder focused on measuring hoarding disorder, hoarding, clutter

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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

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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