Cognitive Rehab and Exposure Treatment for Hoarding

NCT02402647 | Completed Results

• 1 other identifier: CLNA-005-14S
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Hoarding Disorder

Keywords

Hoarding; Compulsive Hoarding

Outcome Measures

Primary Outcomes (1)

• 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. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater than 13 indicate clinical significance (Max score=36), Difficulty Discarding/Saving Subscale (7 items): scores greater than 13 indicate clinical significance, Acquisition Subscale (7 items): scores greater than 15 indicate clinical significance (Max Score= 28). Total Max score = 92. A Total score greater than 40 is a typical score for people experiencing challenges with hoarding behaviors.

  Baseline to 6 month-follow-up (12 months total)

Secondary Outcomes (3)

• UCSD Performance-Based Skills Assessment (UPSA)

  Baseline to 6 months post-treatment (on average 1 year)

• UCSD SORT Test

  Baseline to 6 months post-treatment

• Specific Levels of Functioning Test (SLOF)

  Baseline to 6 months post-treatment

Study Arms (2)

Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)

EXPERIMENTAL

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: Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)

Exposure Therapy (ET)

ACTIVE COMPARATOR

The investigators propose to use a robust control condition, exposure therapy (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: Exposure Therapy (ET)

Interventions

Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST) BEHAVIORAL

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.

Cognitive Rehabilitation and Exposure/Sorting Treatment (CREST)

Exposure Therapy (ET) BEHAVIORAL

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.

Exposure Therapy (ET)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Hoarding Disorder; Hoarding

Interventions

Cognitive Training; Implosive Therapy

Condition Hierarchy (Ancestors)

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The addition of motivational interviewing techniques prior to study initiation greatly reduced drop outs. Further, the last half of the study employed licensed clinicians. Finally, due to COVID-19, the study was shut down for several months while we transitioned to all virtual care. During that time, we lost participants to follow-up and those who preferred in person care only.

Results Point of Contact

• Title: Catherine Ayers
• Organization: VA San Diego

catherine.ayers1@va.gov

858-220-4041

Study Officials

• Catherine R Ayers, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Cognitive rehabilitation and exposure/sorting therapy (CREST) versus Exposure therapy only

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2021
• Study Completion: February 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)