Clinical trial NCT02402647: Cognitive Rehab and Exposure Treatment for Hoarding
Official title: Cognitive Rehabilitation and Exposure Therapy for Veterans With Hoarding Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hoarding Disorder
Keywords: Hoarding
Compulsive Hoarding
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-30
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cognitive rehabilitation and exposure/sorting therapy (CREST) versus Exposure therapy only
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Saving Inventory Revised
timeFrame: Baseline to 6 month-follow-up (12 months total)
Secondary outcomes:
measure: UCSD Performance-Based Skills Assessment (UPSA)
timeFrame: Baseline to 6 months post-treatment (on average 1 year)
measure: UCSD SORT Test
timeFrame: Baseline to 6 months post-treatment
measure: Specific Levels of Functioning Test (SLOF)
timeFrame: Baseline to 6 months post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Catherine R Ayers, PhD
role: PRINCIPAL_INVESTIGATOR
References: