Cognitive Rehab and Exposure Treatment for Hoarding

Hoarding Disorder Clinical Trial

— CREST  

Official title:

Cognitive Rehabilitation and Exposure Therapy for Veterans With Hoarding Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02402647
• Other study ID #: CLNA-005-14S
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: February 1, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hoarding Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saving Inventory Revised	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.	6 months
Secondary	UCSD Performance-Based Skills Assessment (UPSA)	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.	6 months
Secondary	UCSD SORT Test	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.	6 months
Secondary	Specific Levels of Functioning test (SLOF)	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.	6 months