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Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

Primary Purpose

Hoarding Disorder

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

About this trial

This is an interventional treatment trial for Hoarding Disorder focused on measuring Hoarding

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Include:
- Individuals who exhibit subclinical and clinical levels of hoarding disorder, as determined by the SCID interview conducted at the screening assessment, will be eligible to participate in the study. Individuals may also display clinically relevant symptoms of hoarding as indicated by scores on the Hoarding Rating Scale Interview (HRS-I) and/or on the Saving Inventory-Revised (SIR).
- Comorbid mood and anxiety disorders are permitted.
- English-speaking
- Pregnant women

Exclusion Criteria:

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Individuals who are over the age of 85
Individuals with cognitive or physical impairments that would interfere with their participation (e.g., Dementia, uncorrected hearing)
Participants who have current or past psychotic symptoms or current or past alcohol/substance abuse/dependence may also be excluded.
Participants may also be excluded if they are currently in other forms of psychotherapy.
Participants may be excluded if they have had a change in psychotropic medications within three months of the baseline assessment/first class.
Participants may be excluded if hoarding is not their primary diagnosis.
Prisoners

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Rehabilitation and Exposure-based Class for Compulsi

Arm Description

Cognitive training is to improve thinking by learning new skills and strategies. The class begins with cognitive training to increase ability to carry out the skills learned later in treatment. Exposure therapy for discarding and acquiring helps to improve ability to make choices about possessions and learn to tolerate anxiety. Participants will face making difficult choices about items and potentially letting them go. Through repeated exposure to decisions about discarding and acquiring, distress about letting go or making choices about items will decrease over time.

Outcomes

Primary Outcome Measures

Hoarding Rating Scale Interview

The Hoarding Rating scale has a total score ranging from 0 -40 with the higher score indicating higher symptoms of hoarding. This will be used to assess whether hoarding symptoms decrease as a result of treatment.

Clinician's Global Impression Improvement and Severity ratings

The CGI has a score range of 0-7 with the higher score indicating more severe symptoms.This will be used to assess whether hoarding symptoms decrease as a result of treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT02306174

First Posted

December 1, 2014

Last Updated

September 28, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT02306174

Brief Title

Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

Official Title

Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this protocol is to investigate the effectiveness of a manualized, 20-week group cognitive rehabilitation (CR) and exposure therapy (ET) course for compulsive hoarding. The overarching aim is to understand whether this course will decrease the core symptoms of hoarding and associated features.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hoarding Disorder

Keywords

Hoarding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Rehabilitation and Exposure-based Class for Compulsi

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

Intervention Description

The group sessions consists of 20 classes, each lasting approximately 90 minutes and may consist of some or all of the following: A group agreement and a confidentiality contract Homework assignments Viewing informational videos about hoarding Behavioral experiments including sorting and discarding exercises Non-acquisition exposures This course is based on the Manual Cognitive Rehabilitation and Exposure/Sorting Therapy for Compulsive Hoarding (Ayers et al., 2014).

Primary Outcome Measure Information:

Title

Hoarding Rating Scale Interview

Description

Time Frame

22 weeks

Title

Clinician's Global Impression Improvement and Severity ratings

Description

The CGI has a score range of 0-7 with the higher score indicating more severe symptoms.This will be used to assess whether hoarding symptoms decrease as a result of treatment.

Time Frame

22 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Include: Individuals who exhibit subclinical and clinical levels of hoarding disorder, as determined by the SCID interview conducted at the screening assessment, will be eligible to participate in the study. Individuals may also display clinically relevant symptoms of hoarding as indicated by scores on the Hoarding Rating Scale Interview (HRS-I) and/or on the Saving Inventory-Revised (SIR). Comorbid mood and anxiety disorders are permitted. English-speaking Pregnant women Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Individuals who are over the age of 85 Individuals with cognitive or physical impairments that would interfere with their participation (e.g., Dementia, uncorrected hearing) Participants who have current or past psychotic symptoms or current or past alcohol/substance abuse/dependence may also be excluded. Participants may also be excluded if they are currently in other forms of psychotherapy. Participants may be excluded if they have had a change in psychotropic medications within three months of the baseline assessment/first class. Participants may be excluded if hoarding is not their primary diagnosis. Prisoners

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kiara Timpano, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33146

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

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