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Comparison of Treatment for Hoarding Disorder

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ClinicalTrials.gov Identifier: NCT02040805
Recruitment Status : Unknown
Verified August 2016 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2014
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study proposes to compare two forms of treatment for Hoarding Disorder (HD), a common and impairing neuropsychiatric syndrome that has a profound impact on the lives and functioning of individuals, families, and society. Specifically, we will compare a novel community-based group treatment led by individuals from the community who are not mental health professionals to the current standard of care treatment for Hoarding Disorder, cognitive behavioral therapy, conducted by psychologists in a group setting. We hypothesized that both treatment types will be similarly effective in reducing hoarding severity.

Condition or disease Intervention/treatment Phase
Hoarding Disorder Behavioral: Group Cognitive Behavioral Therapy Behavioral: Peer Facilitated Manualized Support Group Not Applicable

Detailed Description:
The study design for this proposal is a stratified, randomized, single-blind, non- inferiority trial comparing the current standard of care for treatment of Hoarding Disorder (HD), Group Cognitive Behavioral Therapy (G-CBT), to an innovative and promising community-based treatment, Group Buried in Treasures (G-BiT). Participants will be stratified by gender, psychiatric status (high vs. low burden of psychiatric symptoms) and insurance status (insured vs. under- or un-insured) so that equal numbers of individuals with each of these characteristics are randomized to each treatment arm. They will then be randomly assigned (randomized) to either G-CBT or G-BiT. Participants will know which treatment group they are assigned to, but those members of the research team who are conducting clinical or neuropsychological assessments or analyzing the data will not; they will be blinded to participant group assignment, and group leaders will be blinded to the psychiatric status, neurocognitive status, insurance status, etc, of participants. The study is a non-inferiority trial, that is, the hypothesis to be tested is that G-BiT is as effective, or no less effective, than G-CBT. We chose a non-inferiority design because we have no reason to believe G-BiT is better than G-CBT and our preliminary data, as well as outcomes previously reported for G- CBT and G-BiT, suggest that these treatments may have similar efficacies.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder
Study Start Date : February 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Group Cognitive-Behavioral Thearapy
Sixteen sessions of group therapy facilitated by a psychologist.
Behavioral: Group Cognitive Behavioral Therapy
Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF.

Experimental: Peer Facilitated Manualized Support Group
Sixteen sessions of peer-facilitated group support.
Behavioral: Peer Facilitated Manualized Support Group
Sixteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.




Primary Outcome Measures :
  1. Saving Inventory-Revised (SI-R) [ Time Frame: Administered at screening before start of treatment groups and after last treatment group (20 weeks later). ]
    This is a 26-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference.


Secondary Outcome Measures :
  1. Neuropsychological Test Battery [ Time Frame: Administered at screening before start of treatment groups and after last treatment group (20 weeks later). ]
    The primary purpose of the neuropsychological evaluation is to characterize aspects of executive function (visual and verbal learning and memory, categorization, information processing speed, visual spatial perception, abstract reasoning abilities, attention).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Hoarding Disorder

Exclusion Criteria:

  • Individuals with active psychosis, schizophrenia, intellectual disability, or known dementia will be excluded
  • Individuals who have participated in either cognitive-behavioral therapy for hoarding (group or individual) or in group Buried in Treasures in the past year

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): NCT02040805


Locations
United States, California
Mental Health Association San Francisco
San Francisco, California, United States, 94102
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Carol A Mathews, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02040805     History of Changes
Other Study ID Numbers: CE-1304-6000
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Keywords provided by University of California, San Francisco:
compulsive hoarding
clutter
hoarding disorder

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