Comparison of Treatment for Hoarding Disorder

Hoarding Disorder Clinical Trial

Official title:

Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040805
• Other study ID #: CE-1304-6000
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Hoarding Disorder

Intervention

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.
• Peer Facilitated Support Group
Fifteen 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.

Locations

Country	Name	City	State
United States	Mental Health Association	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saving Inventory-Revised (SI-R)	This is a 23-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. The SI-R is scored on a scale of 0-92. Higher scores indicate more severe hoarding, and scores of 42 and over are considered clinically significant hoarding. Although subscale scores can be calculated, this study uses total scores as the primary outcome.	Administered at screening before start of treatment groups and after last treatment group (20 weeks later).
Secondary	Activities of Daily Living Scale, Hoarding (ADL-H)	The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. For this study, the score on each ADL-H item was summed to create a total score ranging from 0 to 75. Higher scores indicate more severe functional impairment due to hoarding.	Administered at baseline and after last treatment group (20 weeks later).