Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Rehab and Exposure Treatment for Hoarding (CREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02402647
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 25, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE October 1, 2015
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
Saving Inventory Revised [ Time Frame: 6 months ]
Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
  • UCSD Performance-Based Skills Assessment (UPSA) [ Time Frame: 6 months ]
    The University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)76 is an assessment of everyday functioning skills involved in household chores (e.g., writing a shopping list based on a provided recipe), communication (e.g., rescheduling a doctor's appointment), finance (e.g., paying a utility bill), recreation planning (e.g., planning an outing to the beach or zoo), and transportation (e.g., reading comprehension of a bus schedule). The UPSA has demonstrated high inter-rater reliability (0.91) and convergent validity with other performance-based measures. The total UPSA summary score will be used for analyses.
  • UCSD SORT Test [ Time Frame: 6 months ]
    The UCSD SORT Test (U-SORT)77 will be used to measure Veteran participants' organizational skills as they relate to functional capacity. During the administration of the U-SORT, participants are instructed to sort 42 household objects (e.g., bent and unbent paper clips, used and unused condiment packets) from a hypothetical "junk drawer" into either "keep" or "trash" piles. Participants are given two minutes to complete the task and one point is awarded for each correctly sorted item, for a total of 42 points. The U-SORT has high internal consistency (? = .86) and adequate convergent validity. The total U-SORT score will be used in analyses.
  • Specific Levels of Functioning test (SLOF) [ Time Frame: 6 months ]
    Self-reported functioning (secondary outcome) will be assessed with the Specific Levels of Functioning test (SLOF)78, a 43-item questionnaire regarding areas such as interpersonal relationships, participation in community activities, and work skills. The SLOF has demonstrated excellent reliability and internal consistency.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
  • UCSD Performance-Based Skills Assessment (UPSA) [ Time Frame: 6 months ]
    he UCSD Performance-Based Skills Assessment (UPSA)76 is an assessment of everyday functioning skills involved in household chores (e.g., writing a shopping list based on a provided recipe), communication (e.g., rescheduling a doctor�s appointment), finance (e.g., paying a utility bill), recreation planning (e.g., planning an outing to the beach or zoo), and transportation (e.g., reading comprehension of a bus schedule). The UPSA has demonstrated high inter-rater reliability (0.91) and convergent validity with other performance-based measures. The total UPSA summary score will be used for analyses.
  • UCSD SORT Test [ Time Frame: 6 months ]
    The UCSD SORT Test (U-SORT)77 will be used to measure Veteran participants� organizational skills as they relate to functional capacity. During the administration of the U-SORT, participants are instructed to sort 42 household objects (e.g., bent and unbent paper clips, used and unused condiment packets) from a hypothetical �junk drawer� into either �keep� or �trash� piles. Participants are given two minutes to complete the task and one point is awarded for each correctly sorted item, for a total of 42 points. The U-SORT has high internal consistency (? = .86) and adequate convergent validity. The total U-SORT score will be used in analyses.
  • Specific Levels of Functioning test (SLOF) [ Time Frame: 6 months ]
    Self-reported functioning (secondary outcome) will be assessed with the Specific Levels of Functioning test (SLOF)78, a 43-item questionnaire regarding areas such as interpersonal relationships, participation in community activities, and work skills. The SLOF has demonstrated excellent reliability and internal consistency.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Rehab and Exposure Treatment for Hoarding
Official Title  ICMJE Cognitive RehabiMeeting Service Needs of Veterans Experiencing Homelessness: A Process Improvement Initiative Employing Unannounced Standardized Veterans Posure Therapy for Veterans With Hoarding Disorder
Brief Summary This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Further, the investigators hope to increase understanding of functional and long term outcomes in response to hoarding treatment.
Detailed Description

Objective: The investigators propose to conduct a randomized controlled trial comparing six months (26 sessions) of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) treatment to a robust comparator, six months of Exposure Therapy alone, in 136 participants with HD.

Research Design: Assessments will be administered at baseline, during treatment (sessions 7, 13, 21), post-treatment, and 3- and 6-month follow-up, thus, all participants will be enrolled for one year.

Methodology: The primary objective is to evaluate whether CREST significantly reduces hoarding symptoms and improves functional capacity and quality of life when compared to exposure therapy alone. The investigators will also examine the impact of treatment mediators; treatment adherence, changes in executive functioning, avoidance, symptom severity on outcomes. Age and executive functioning will also be explored as potential moderators. Finally, by repeatedly measuring treatment targets, the investigators will examine time to maximum treatment effect in an effort to understand mechanisms of change.

Clinical Relationships: By providing a treatment for many Veterans with HD, the investigators can alter the course of their symptom trajectory and negative consequences, resulting in both healthcare costs savings and improved quality of life for Veterans.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cognitive rehabilitation and exposure/sorting therapy (CREST) versus Exposure therapy only
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hoarding Disorder
Intervention  ICMJE
  • Behavioral: CREST

    Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility.

    Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET.

  • Behavioral: ET
    The investigators propose to use a robust control condition, ET, with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist.
Study Arms  ICMJE
  • Experimental: CREST

    Compensatory Cognitive Training (CCT) is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility.

    Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET.

    Intervention: Behavioral: CREST
  • Active Comparator: ET
    The investigators propose to use a robust control condition, ET, with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist.
    Intervention: Behavioral: ET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2015)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Veterans age 18-85
  • Hoarding Disorder diagnosis outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)6 as measured by the Structured Interview for Hoarding Disorder (SIHD)67
  • HD as a primary diagnosis
  • Stable on medications for at least 12 weeks, with no pharmacologic changes expected or made during the 12-month study
  • Voluntary consent to participate

Exclusion Criteria:

  • Diagnosis of:

    • psychotic disorder
    • substance abuse disorder as measured by the Mini-International Neuropsychiatric Interview (M.I.N.I.)68
  • Current or history of any neurodegenerative disease
  • Active suicidal ideation
  • Concurrent participation in psychotherapy or ET for HD, or prior history of CREST for HD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eliza Davidson Eliza.Davidson@va.gov
Contact: Lauren J Schwarz, MA (858) 552-8585 Lauren.Schwarz@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02402647
Other Study ID Numbers  ICMJE CLNA-005-14S
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine R Ayers, PhD VA San Diego Healthcare System, San Diego, CA
PRS Account VA Office of Research and Development
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP