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In-home Decluttering Augmentation of Group CBT for HD

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ClinicalTrials.gov Identifier: NCT04712474
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
Stockholm County Council, Sweden
City of Stockholm
Swedish research council for health, working life and welfare
Information provided by (Responsible Party):
Volen Ivanov, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hoarding Disorder Behavioral: In-home decluttering practice Not Applicable

Detailed Description:

Primary objective: To determine the clinical efficacy of in-home decluttering augmentation of group CBT for reducing hoarding severity in adults with HD.

Secondary objectives: To assess the cost-effectiveness of in-home decluttering, from a social services provider perspective. Type of trial: Single-blind parallel-group randomized controlled superiority trial.

Methods:

Participants who are eligible and have consented to participate in the trial will receive protocol-driven group CBT for HD for 12 weeks. After group CBT, participants are immediately randomized to one of two trial arms. In the experimental arm, participants receive 10 weeks of in-home decluttering. In the waitlist arm, participants receive no intervention but fill out questionnaires with identical procedures as in the intervention group.

Participants will complete outcome measures at pre-CBT, mid-CBT (week 6), baseline (i.e. immediately after receiving CBT and before inhome decluttering), twice during in-home decluttering (week 4 and 7), post-treatment (week 10 of in-home decluttering), and 3-, 6-, and 12- months post-treatment. Two primary outcome variables will be used in this study; the total score on the Saving Inventory- Revised (SI-R) and the total score on the clinician-reported Clutter Image Rating (CIR). The primary endpoint is post-treatment (i.e. week 10 of in-home decluttering or waitlist).

Secondary outcomes include participants' cognitions about discarding (SCI), relationship between self and items (RSI), measures of clutter (CIR), squalor (HEI), impairment of daily functioning (ADL-H), severity and improvement (CGI), adverse events, and treatment satisfaction (CSQ8). Relatives of trial participants will rate levels burden and accommodation with the Family Impact Scale for Hoarding Disorder (FISH) and the Caregiver Burden Inventory (CBI), respectively. The Trimbos Questionnaire for Costs associated with Psychiatric Illness will be used to assess healthcare and societal resource use. Follow-up assessments will be conducted at the clinic or via videoconferencing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In-home Decluttering Augmentation of Group Cognitive-behavior Therapy for Hoarding Disorder: The Joining Forces Randomized Controlled Trial
Estimated Study Start Date : January 13, 2021
Estimated Primary Completion Date : January 15, 2024
Estimated Study Completion Date : January 15, 2025

Arm Intervention/treatment
Experimental: In-home decluttering
Study participants receive weekly sessions of in-home decluttering for 10 weeks.
Behavioral: In-home decluttering practice

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.



Primary Outcome Measures :
  1. Saving Inventory-Revised (SI-R) [ Time Frame: Change from baseline (week 0) to post-treatment (week 10), ]
    The SI-R is a 23-item questionnaire with 3 sub-scales: 1) difficulty discarding, 2) excessive clutter, and 3) excessive acquisition.

  2. Clutter Image Rating Scale (CIR) [ Time Frame: Change from baseline (week 0) to post-treatment (week 10). ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older.
  2. Hoarding disorder as primary psychiatric condition.
  3. Willing and able to understand and complete consent and study procedures.
  4. Living in the Stockholm county (Sweden) and within a 1-hour commute by public transport from the social services office.

Exclusion Criteria:

  1. 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.
  2. Unable or unwilling to allow study staff into home for home assessment.
  3. Animal hoarding or squalid (i.e. extremely unhygienic) home conditions that are deemed to put the personnel at risk during the in-home decluttering.
  4. 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.
  5. Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
  6. Immediate risk to self or others, requiring urgent medical attention, such as high suicidality risk.
  7. Participant not able to read and communicate in Swedish.
  8. Currently at high risk for eviction (for instance having received a "rättelseanmaning" by the housing company or Swedish court).
  9. Potential participant lives in the same household as an already included participant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712474


Contacts
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Contact: Sofia Jägholm, MSc +46725190673 sofia.jagholm@ki.se
Contact: Volen Ivanov, PhD +46725190673 volen.ivanov@ki.se

Locations
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Sweden
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86 Recruiting
Stockholm, Sweden, 141 86
Contact: Volen Ivanov, PhD       volen.ivanov@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
City of Stockholm
Swedish research council for health, working life and welfare
Investigators
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Principal Investigator: Volen Ivanov, PhD Karolinska Institutet
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Responsible Party: Volen Ivanov, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04712474    
Other Study ID Numbers: 2020-05798
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Volen Ivanov, Karolinska Institutet:
hoarding
clutter
Additional relevant MeSH terms:
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Hoarding Disorder
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders