Clinical trial NCT02040805: Comparison of Treatment for Hoarding Disorder
Official title: Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hoarding Disorder
Keywords: compulsive hoarding
clutter
hoarding disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-01-20
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel clinical trial with assessments pre- and post-treatment.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Saving Inventory-Revised (SI-R)
timeFrame: Administered at screening before start of treatment groups and after last treatment group (20 weeks later).
Secondary outcomes:
measure: Activities of Daily Living Scale, Hoarding (ADL-H)
timeFrame: Administered at baseline and after last treatment group (20 weeks later).
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Mental Health Association
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of Florida
name: Carol A. Mathews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kevin L. Delucchi, PhD
role: PRINCIPAL_INVESTIGATOR
References: