Hoarding DisorderNCT02040805
Comparison of Treatment for Hoarding Disorder
A study testing Group Cognitive Behavioral Therapy and Peer Facilitated Support Group in people with Hoarding Disorder, run by University of California, San Francisco at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hoarding Disorder
- What is being tested?
- Group Cognitive Behavioral Therapy and Peer Facilitated Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Hoarding Disorder
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mental Health Association
San Francisco, California, 94102
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder
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.
Read the 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.
- Conditions
- Hoarding Disorder
- Being tested
- Group Cognitive Behavioral Therapy, Peer Facilitated Support Group
- Keywords
- compulsive hoarding, clutter, hoarding disorder
- Medical subject headings
- Hoarding Disorder, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioral TherapyBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive-Behavioral Therapy | Experimental | Sixteen sessions of group therapy facilitated by a psychologist. Receives: Behavioral: Group Cognitive Behavioral Therapy |
| Peer Facilitated Support Group | Experimental | Fifteen sessions of peer-facilitated group support. Receives: Behavioral: Peer Facilitated Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Administered at screening before start of treatment groups and after last treatment group (20 weeks later).
Secondary outcomes (1)
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.
Measured: Administered at baseline and after last treatment group (20 weeks later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel clinical trial with assessments pre- and post-treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Carol A. Mathews, MD, Principal investigator, University of FloridaKevin L. Delucchi, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040805
- Sponsor's protocol ID
- CE-1304-6000
- Status last verified
- Feb 2020
- First submitted
- 16 Jan 2014
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peer Facilitated Support Group and Cognitive Behavioral Therapy for Hoarding Disorder
- ClinicalTrials.gov ID
- NCT02040805
- Acronym / sponsor ID
- CE-1304-6000
- Conditions
- Hoarding Disorder
- Keywords
- compulsive hoarding, clutter, hoarding disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Feb 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel clinical trial with assessments pre- and post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive-Behavioral Therapy | Experimental | Behavioral: Group Cognitive Behavioral TherapySixteen sessions of group therapy facilitated by a psychologist. |
| Peer Facilitated Support Group | Experimental | Behavioral: Peer Facilitated Support GroupFifteen sessions of peer-facilitated group support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Hoarding Disorder
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Cognitive Behavioral TherapyGroup 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. | Behavioural | Group Cognitive-Behavioral Therapy |
| Peer Facilitated Support GroupFifteen 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. | Behavioural | Peer Facilitated Support Group |
Primary outcome
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 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.
1 secondary outcome
Activities of Daily Living Scale, Hoarding (ADL-H)
Time frame: Administered at baseline and after last treatment group (20 weeks later).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Hoarding Disorder
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Neural Mechanisms of Decision Making in Hoarding Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol A. Mathews, MD principal investigator
University of Florida
Kevin L. Delucchi, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behavioral Therapy and Peer Facilitated Support Group in people with Hoarding Disorder, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saving Inventory-Revised (SI-R) (time frame: Administered at screening before start of treatment groups and after last treatment group (20 weeks later).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.