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In-home Decluttering Augmentation of Group CBT for HD

Primary Purpose

Hoarding Disorder

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

In-home decluttering practice

About this trial

This is an interventional treatment trial for Hoarding Disorder focused on measuring hoarding, clutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

In-home decluttering

Delayed treatment

Arm Description

Study participants receive weekly sessions of in-home decluttering for 10 weeks.

Study participants receive weekly session of in-home decluttering after a 10 week delay.

Outcomes

Primary Outcome Measures

Saving Inventory-Revised (SI-R)

The SI-R is a 23-item questionnaire with 3 sub-scales: 1) difficulty discarding, 2) excessive clutter, and 3) excessive acquisition.

Clutter Image Rating Scale (CIR)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04712474

First Posted

January 13, 2021

Last Updated

June 27, 2023

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm, City of Stockholm, Swedish Council for Working Life and Social Research

1. Study Identification

Unique Protocol Identification Number

NCT04712474

Brief Title

In-home Decluttering Augmentation of Group CBT for HD

Official Title

In-home Decluttering Augmentation of Group Cognitive-behavior Therapy for Hoarding Disorder: The Joining Forces Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 29, 2021 (Actual)

Primary Completion Date

August 31, 2024 (Anticipated)

Study Completion Date

January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

Collaborators

Region Stockholm, City of Stockholm, Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hoarding Disorder

Keywords

hoarding, clutter

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

In-home decluttering

Arm Type

Experimental

Arm Description

Study participants receive weekly sessions of in-home decluttering for 10 weeks.

Arm Title

Delayed treatment

Arm Type

No Intervention

Arm Description

Study participants receive weekly session of in-home decluttering after a 10 week delay.

Intervention Type

Behavioral

Intervention Name(s)

In-home decluttering practice

Intervention Description

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.

Primary Outcome Measure Information:

Title

Saving Inventory-Revised (SI-R)

Description

The SI-R is a 23-item questionnaire with 3 sub-scales: 1) difficulty discarding, 2) excessive clutter, and 3) excessive acquisition.

Time Frame

Change from baseline (week 0) to post-treatment (week 10),

Title

Clutter Image Rating Scale (CIR)

Description

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.

Time Frame

Change from baseline (week 0) to post-treatment (week 10).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sofia Jägholm, MSc

Phone

+46725190673

sofia.jagholm@ki.se

First Name & Middle Initial & Last Name or Official Title & Degree

Volen Ivanov, PhD

Phone

+46725190673

volen.ivanov@ki.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Volen Ivanov, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Volen Ivanov, PhD

volen.ivanov@ki.se

12. IPD Sharing Statement

Learn more about this trial

In-home Decluttering Augmentation of Group CBT for HD

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