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Cognitive Rehab and Exposure Treatment for Hoarding (CREST)

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ClinicalTrials.gov Identifier: NCT02402647
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Hoarding Disorder Behavioral: CREST Behavioral: ET Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
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
Official Title: Cognitive Rehabilitation and Exposure Therapy for Veterans With Hoarding Disorder
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : October 1, 2020

Arm Intervention/treatment
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.

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.


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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402647


Contacts
Contact: Catherine R Ayers, PhD (858) 642-2976 Catherine.Ayers1@va.gov
Contact: Mary E Dozier, MS (858) 642-1251 mary.dozier2@va.gov

Locations
United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Catherine R Ayers, PhD    858-642-2976    Catherine.Ayers1@va.gov   
Contact: Patricia A Franklin, AA BS    (858) 552-8585 ext 7441    patricia.franklin2@va.gov   
Principal Investigator: Catherine R Ayers, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Catherine R Ayers, PhD VA San Diego Healthcare System, San Diego, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02402647     History of Changes
Other Study ID Numbers: CLNA-005-14S
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by VA Office of Research and Development:
Hoarding
Compulsive Hoarding

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