- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01227057
Hoarding Older Adults
June 26, 2018 updated by: VA Office of Research and Development
Treatment of Late Life Compulsive Hoarding
The purpose of this investigation is to examine treatment outcome of a new intervention for hoarding in older adults compared to standard case management for hoarding.
The new intervention combines exposure therapy and cognitive remediation.
Study Overview
Status
Completed
Conditions
Detailed Description
Research has shown that hoarding disorder (HD) is debilitating chronic and progressive condition that has significant public health implications.
Older adults represent the largest group of HD suffers due to increasing severity with age.
Often, Veterans with HD are seen in the VA system and the status of their hoarding is never assessed.
Providers are treating patients for other health and social service issues yet missing an important source of disability and distress.
This insidious, often undetected condition leads to greater medical and social disability and is costly to the VA system as patients continue to decompensate.
When HD is even detected, patients in the VA receive indefinite case management and inadequate treatment.
The cases the investigators know about have caused significant financial burden to the investigators' system.
Most importantly, HD causes significant impairment and poor quality of life for the Veterans, particularly older Veterans.
Unfortunately, the investigators know nothing about how to treat late life HD.
Nor do the investigators know how neurocognitive features impact treatment response, which the investigators strongly suspect influence treatment outcome.
HD is a potentially treatable source of disability in the VA system - one that the VA must research and treat.
This study represents the first randomized controlled trial of a novel intervention for the treatment of HD in older Veterans.
The main objective of this proposal is to further refine and test a new treatment for hoarding in older Veterans (age 60-85) which will be accomplished through a series of treatment development phases (case series, open labeled trial) and a randomized controlled trial.
The new treatment (Cognitive Remediation and Exposure Therapy for hoarding; CogRET) is hypothesis driven and based on late life anxiety literature, consultation with mentors, results of the pilot study using a standard cognitive-behavioral intervention, and several case series that will be completed prior to the start of the Career Development Award (CDA).
The first draft of CogRET is complete and is currently being used with several case studies.
The research and training plan is divided into 5 phases; 1) training and preparation 2) training, further case studies using CogRET, further modification of CogRET 3)training, open label trial of CogRET, further modification of CogRET 4) randomized controlled trial and 5) presenting, publishing, dissemination of results and submission of a VA Merit grant.
Primary hypotheses include 1) when randomized to CogRET, older Veterans with HD will show significant decreases in acquisition, difficulty discarding, and excessive clutter compared to those randomized to case management and 2) executive functioning (EF) is a significant moderator of treatment response.
Other mediators and moderates of treatment response (psychiatric, medical, demographic, etc.) will be explored.
Study Type
Interventional
Enrollment (Actual)
58
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
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System, San Diego, CA
-
-
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
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Participants must be between the ages of 60 - 85 years old and meet clinical criteria for Compulsive Hoarding (CH) developed by the Steketee and Frost (2000) research group. These criteria include:
- significant amount of clutter in active living spaces
- the urge to collect, buy, or acquire things
- an extreme reluctance to part with items
- clutter accumulation that causes distress or interferes with functioning
- symptom duration of at least 6 months
- the reluctance to part with items is not accounted for by other psychiatric conditions.
To be enrolled, patients must have:
- a score of 20 or greater on the University of California, Los Angeles Hoarding Severity Scale (UHSS)
- 40 or greater on the Savings Inventory-Revised (SI-R)
- severity rating of 4 or higher on the Anxiety Disorders Interview Schedule (ADIS-IV) rating scales for clutter and difficulty discarding
- and diagnosis confirmed at a consensus conference including at least two licensed professionals with expertise in CH (myself and at least one mentor).
Exclusion Criteria:
- Individuals with moderate to severe cognitive deficits (scores below 23 on the MMSE) will be excluded.
- Prospective participants must not have active substance abuse problems.
- Participants will also be excluded if they are currently in other forms of psychotherapy.
- Participants must have no change in any psychotropic medications for at least three months prior to the initial assessment.
- Patients with current psychosis or mania will be excluded.
- Mood and anxiety disorders are permitted as long as compulsive hoarding is the primary diagnosis.
- Participants will are not eligible if they have active suicidal ideation, those participants will be given immediate medical or mental health attention.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Cognitive Rehabilitation
Cognitive rehabilitation and exposure therapy for hoarding
|
The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
|
|
Active Comparator: Arm 2: Case Management
Case management
|
Case management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months
Time Frame: 6 months
|
Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms.
Subtests include excessive clutter, compulsive acquisition, and difficulty discarding.
The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding.
The total score will be used for analyses.
The range of the total score is 0-92, with higher scores indicating worse hoarding severity.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Activities of Daily Living in Hoarding (ADL-H)
Time Frame: 6 months
|
The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment.
Higher scores represent increased impairment.
Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.
|
6 months
|
|
Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months
Time Frame: 6 months
|
The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning.
Scaled scores range from 1-19.
Higher scores represent less impairment.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Catherine R Ayers, PhD, VA San Diego Healthcare System, San Diego, CA
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.
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
November 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 20, 2010
First Submitted That Met QC Criteria
October 20, 2010
First Posted (Estimate)
October 22, 2010
Study Record Updates
Last Update Posted (Actual)
July 24, 2018
Last Update Submitted That Met QC Criteria
June 26, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CSRD-068-10S
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.
Clinical Trials on Compulsive Hoarding
-
Hartford HospitalNeuroneticsCompleted
-
VA Office of Research and DevelopmentSan Diego Veterans Healthcare SystemCompletedHoarding DisorderUnited States
-
Stanford UniversityNational Institute on Aging (NIA)CompletedHoarding Disorder | Hoarding | ClutterUnited States
-
Hartford HospitalNational Institute of Mental Health (NIMH)Completed
-
University of California, San DiegoCompletedDepression | Hoarding Disorder | HoardingUnited States
-
Mississippi State UniversityNational Institute of Mental Health (NIMH)RecruitingHoarding DisorderUnited States
-
Florida State UniversityCompleted
-
New York State Psychiatric InstituteHartford HospitalCompleted
-
New York State Psychiatric InstituteCompleted
-
Karolinska InstitutetCompletedHoarding DisorderSweden
Clinical Trials on Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding
-
University of MiamiCompletedHoarding DisorderUnited States
-
University of ZurichUnknownUnipolar DepressionSwitzerland
-
University of California, San DiegoEnrolling by invitationObsessive-Compulsive Disorder | Hoarding DisorderUnited States
-
University of North Carolina, Chapel HillSociety for a Science of Clinical Psychology; Association for Behavioral and...CompletedSpecific PhobiaUnited States
-
Palo Alto Veterans Institute for ResearchBoston University; The University of Texas Health Science Center at San Antonio and other collaboratorsCompletedInsomnia | Posttraumatic Stress Disorder | NightmareUnited States
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH); National Alliance for Research... and other collaboratorsCompletedAnorexia NervosaUnited States
-
VA Eastern KansasTerminated
-
Palo Alto Veterans Institute for ResearchThe University of Texas Health Science Center at San Antonio; University of... and other collaboratorsRecruitingInsomnia | Nightmares | PTSD - Post Traumatic Stress DisorderUnited States
-
University of TulsaCompletedInsomnia | Trauma | NightmareUnited States
-
University of KonstanzVivo international e.V.; Psychologues sans Frontières Burundi; Université Lumière...CompletedPosttraumatic Stress Disorder | Aggressive BehaviorBurundi