Hoarding Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01227057
First received: October 20, 2010
Last updated: April 27, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Compulsive Hoarding
Behavioral: Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding
Behavioral: Case Management
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Late Life Compulsive Hoarding

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Functional Impairment as Measured by the Activities of Daily Living, Functional Disability Index, Clutter Image Rating Scale [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: November 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Cognitive Rehabilitation
Cognitive rehabilitation and exposure therapy for hoarding
Behavioral: Cognitive Rehabilitation and Exposure Therapy for Compulsive 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
Behavioral: Case Management
Case management

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.
  Eligibility

Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227057

Locations
United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Catherine R Ayers, PhD VA San Diego Healthcare System, San Diego, CA
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01227057     History of Changes
Other Study ID Numbers: CSRD-068-10S 
Study First Received: October 20, 2010
Results First Received: March 11, 2016
Last Updated: April 27, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
exposure therapy
case management
older adults
cognitive rehabilitation

Additional relevant MeSH terms:
Obsessive Hoarding
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 22, 2016