Hoarding DisorderNCT02377986
Augmenting Buried in Treasures Workshop (BIT) With In-home Decluttering Practice for Individuals With Hoarding Disorder
A study testing BIT+in-home decluterring and In-Home Decluttering in people with Hoarding Disorder, run by New York State Psychiatric Institute.
Trial summary
Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an intervention to add in-home decluttering practice to the BIT workshop. 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?
- BIT+in-home decluterring and In-Home Decluttering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2015
- 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
- 18 years or older at consent
- Primary hoarding disorder, Saving Inventory Revised greater than or equal to 40.
- Clutter Image Rating Scale greater than or equal to 3 and less than or equal to 7.
- Low risk for eviction
- English speaking
- Will and able to understand and complete consent procedures
Who cannot join
- Hoarding disorder not primary
- Severely depressed individuals; Hamilton Depressions Rating Scale greater than 30 or judged clinically to be at risk of suicide with Columbia Suicide Severity Scale
- Unable or unwilling to allow study staff into home for home assessment OR a Clutter Image Rating Score of less than 2 or greater than 7.
- At risk for eviction
- Animal Hoarding or squalor of any kind
About this study
Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an intervention to add in-home decluttering practice to the BIT workshop.
- Conditions
- Hoarding Disorder
- Being tested
- BIT+in-home decluterring, In-Home Decluttering
- Medical subject headings
- Hoarding Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIT+in-home decluterringBehavioural
BIT Workshop + In-home decluttering practice
In-Home DeclutteringBehavioural
In-home decluttering practice
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BIT+In-home Decluttering | Experimental | Patients who have not received the BIT workshop through our previous study (IRB 6681) will receive BIT+in-home decluttering practice. Receives: Behavioral: BIT+in-home decluterring; Behavioral: In-Home Decluttering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Savings Inventory Revised
The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.
The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.
For the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition.
For the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding.
For the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter.
Measured: Change from baseline at 0, 12 weeks and 18 weeks after treatment start
Clutter Image Rating Scale
Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home.
This scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life.
Measured: Change from baseline at 0, 12 weeks and 18 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hoarding DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn I. Rodriguez, Stanford University
- Investigators
- H Blair Simpson, MD, PhD, Principal investigator, Columbia-NYSPI-RFMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377986
- Sponsor's protocol ID
- 7073
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2015
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Linkovski O, Zwerling J, Cordell E, Sonnenfeld D, Willis H, La Lima CN, Baker C, Ghazzaoui R, Girson R, Sanchez C, Wright B, Alford M, Varias A, Filippou-Frye M, Shen H, Jo B, Shuer L, Frost RO, Rodriguez CI. Augmenting Buried in Treasures with in-home uncluttering practice: Pilot study in hoarding disorder. J Psychiatr Res. 2018 Dec;107:145-150. doi: 10.1016/j.jpsychires.2018.10.001. Epub 2018 Oct 5.
PubMed 30419524
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
- Augmenting Buried in Treasures Workshop (BIT) With In-home Decluttering Practice for Individuals With Hoarding Disorder
- ClinicalTrials.gov ID
- NCT02377986
- Acronym / sponsor ID
- 7073
- Conditions
- Hoarding Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Mar 2015 (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.
Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an intervention to add in-home decluttering practice to the BIT workshop.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: BIT+In-home Decluttering | Experimental | Behavioral: BIT+in-home decluterring, Behavioral: In-Home DeclutteringPatients who have not received the BIT workshop through our previous study (IRB 6681) will receive BIT+in-home decluttering practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older at consent
- Primary hoarding disorder, Saving Inventory Revised greater than or equal to 40.
- Clutter Image Rating Scale greater than or equal to 3 and less than or equal to 7.
- Low risk for eviction
- English speaking
Key exclusion criteria (5 listed)
- Hoarding disorder not primary
- Severely depressed individuals; Hamilton Depressions Rating Scale greater than 30 or judged clinically to be at risk of suicide with Columbia Suicide Severity Scale
- Unable or unwilling to allow study staff into home for home assessment OR a Clutter Image Rating Score of less than 2 or greater than 7.
- At risk for eviction
- Animal Hoarding or squalor of any kind
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 |
|---|---|---|
| BIT+in-home decluterringBIT Workshop + In-home decluttering practice | Behavioural | Experimental: BIT+In-home Decluttering |
| In-Home DeclutteringIn-home decluttering practice | Behavioural | Experimental: BIT+In-home Decluttering |
Primary outcome
Savings Inventory Revised
Time frame: Change from baseline at 0, 12 weeks and 18 weeks after treatment start
The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition. The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter. For the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition. For the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding. For the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter.
Clutter Image Rating Scale
Time frame: Change from baseline at 0, 12 weeks and 18 weeks after treatment start
Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home. This scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life.
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.
- Results publication: PubMed 30419524Linkovski O, Zwerling J, Cordell E, Sonnenfeld D, Willis H, La Lima CN, Baker C, Ghazzaoui R, Girson R, Sanchez C, Wright B, Alford M, Varias A, Filippou-Frye M, Shen H, Jo B, Shuer L, Frost RO, Rodriguez CI. Augmenting Buried in Treasures with in-home uncluttering practice: Pilot study in hoarding disorder. J Psychiatr Res. 2018 Dec;107:145-150. doi: 10.1016/j.jpsychires.2018.10.001. Epub 2018 Oct 5.
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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.
H Blair Simpson, MD, PhD principal investigator
Columbia-NYSPI-RFMH
Questions about this trial
What is this clinical trial studying?
A study testing BIT+in-home decluterring and In-Home Decluttering in people with Hoarding Disorder, run by New York State Psychiatric Institute.
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 6 inclusion and 5 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.
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?
Savings Inventory Revised (time frame: Change from baseline at 0, 12 weeks and 18 weeks after treatment start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377986, which also lists 1 linked publication.
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.