- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712474
In-home Decluttering Augmentation of Group CBT for HD
June 27, 2023 updated by: Volen Ivanov, Karolinska Institutet
In-home Decluttering Augmentation of Group Cognitive-behavior Therapy for Hoarding Disorder: The Joining Forces Randomized Controlled Trial
The primary aim of trial is to determine the clinical efficacy of in-home decluttering augmentation of group CBT for reducing hoarding severity in adults with HD.
The trial takes place in Sweden.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Cognitive behavioral therapy (CBT) is the current evidence-based treatment for HD but the majority of sufferers remain symptomatic after CBT with impairing levels of clutter in their homes.
Home visits, with a focus on in-home decluttering, have in previous research been shown to be a promising intervention when combined with CBT.
However, augmenting CBT with subsequent home visits has not yet been tested in a randomized controlled trial (RCT).
In response to this, in this trial, we aim to investigate the efficacy of a coordinated intervention, consisting of CBT and in-home decluttering for HD, in an RCT.
In this trial, 90 participants with HD will initially receive 12 sessions of CBT through a psychiatric outpatient service.
After CBT, participants will be randomized to receive either 10 home visits in 10 weeks, or to a wait list condition.
Our hypothesis is that augmenting CBT with home visits will lead to a reduction in hoarding symptoms and clutter and improved daily functioning compared to wait list.
We will also investigate the cost-economical aspects of the intervention.
Results from this trial have the potential to reveal whether in-home decluttering should be added to CBT in order to reduce symptoms of hoarding and improve function in indviduals with HD.
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sofia Jägholm, MSc
- Phone Number: +46725190673
- Email: sofia.jagholm@ki.se
Study Contact Backup
- Name: Volen Ivanov, PhD
- Phone Number: +46725190673
- Email: volen.ivanov@ki.se
Study Locations
-
-
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Stockholm, Sweden, 141 86
- Recruiting
- M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86
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Contact:
- Volen Ivanov, PhD
- Email: volen.ivanov@ki.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older.
- Hoarding disorder as primary psychiatric condition.
- Willing and able to understand and complete consent and study procedures.
- Living in the Stockholm county (Sweden) and within a 1-hour commute by public transport from the social services office.
Exclusion Criteria:
- Concurrent CBT or having received CBT for HD during the last two years, for a minimum of 8 sessions including active strategies for reducing acquisition and practice of discarding with a qualified therapist or 8 previous in-home decluttering sessions with a qualified social worker.
- Unable or unwilling to allow study staff into home for home assessment.
- Animal hoarding or squalid (i.e. extremely unhygienic) home conditions that are deemed to put the personnel at risk during the in-home decluttering.
- A diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder without stable medication or with symptoms within the last 6 months, anorexia nervosa or alcohol/substance dependence or abuse.
- Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
- Immediate risk to self or others, requiring urgent medical attention, such as high suicidality risk.
- Participant not able to read and communicate in Swedish.
- Currently at high risk for eviction (for instance having received a "rättelseanmaning" by the housing company or Swedish court).
- Potential participant lives in the same household as an already included participant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: In-home decluttering
Study participants receive weekly sessions of in-home decluttering for 10 weeks.
|
The in-home decluttering intervention comprises 10, 1.5-hour home-visits over the course of 10 weeks. These home visits are personalized, goal-oriented and focused on decluttering. They include 1) a brief check-in, 2) guided unclutter time 3) a reflective period during which participants share their thoughts and objectives for the coming week, and 4) homework assignments. |
No Intervention: Delayed treatment
Study participants receive weekly session of in-home decluttering after a 10 week delay.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saving Inventory-Revised (SI-R)
Time Frame: Change from baseline (week 0) to post-treatment (week 10),
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The SI-R is a 23-item questionnaire with 3 sub-scales: 1) difficulty discarding, 2) excessive clutter, and 3) excessive acquisition.
|
Change from baseline (week 0) to post-treatment (week 10),
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Clutter Image Rating Scale (CIR)
Time Frame: Change from baseline (week 0) to post-treatment (week 10).
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Three sets of photographs, each comprising 9 photos of a room with varying levels of clutter.
A selection is made as to which photograph best resembles the room of the participant.
|
Change from baseline (week 0) to post-treatment (week 10).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Volen Ivanov, PhD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2021
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
January 15, 2025
Study Registration Dates
First Submitted
January 13, 2021
First Submitted That Met QC Criteria
January 13, 2021
First Posted (Actual)
January 15, 2021
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-05798
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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