Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001267347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/10/2026
Date registered
Help: Date registered
22/10/2026
Date last updated
Help: Date last updated
22/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
22/10/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot feasibility study of an evidence-based group intervention for family members of individuals with hoarding disorder.
Scientific title
Pilot feasibility study of an evidence-based group intervention 'Making sense of the Clutter' for family members of individuals with hoarding disorder.
Additional trial identifiers [1] 318597 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Hoarding Disorder 343798 0
Condition category
Condition code
Mental Health 339935 339935 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The novel group intervention is a 6 week group for family members of people with hoarding disorder. The sessions are administered weekly and are 2 hours long. The 6 week program is informed by principles of cognitive behaviour therapy, distress tolerance and mindfulness. Topics covered across the group include psychoeducation about hoarding disorder and the impact on family members, psychoeducation about relationship building and three mindfulness strategies.

Delivered by two clinicians either (Clinical Psychologist + Clinical Psychology Registrar or a Clinical psychology registrar and provisional psychologist who are supervised by a Clinical Psychologist). Delivered in person across two clinic locations. Email reminders sent weekly to support adherence. Groups run with 4-5 participants in each.

An additional one on one coaching session is conducted with participants between weeks 2-5 of the group. During this session participants are able to apply one of the skills learnt during the group to their day to day life and explore any difficulties or questions raised by the group.

During the 1 hour follow up session participants review a ‘wellness plan’ that is created during week 5 of the group intervention. This plan details their strengths and current ways of coping and managing the relationship with their family member with hoarding disorder. During this session participants complete a series of questionnaires which are also administered at pre and post intervention.
Intervention code [1] 335504 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 347101 0
General psychological distress
Timepoint [1] 347101 0
Baseline (week 1 of intervention), weekly for 5 weeks, and 3 month post-intervention completion follow up.
Primary outcome [2] 347104 0
Self Efficacy
Timepoint [2] 347104 0
Baseline (week 1 of intervention), weekly for 5 weeks, and 3 month post-intervention completion follow up.
Secondary outcome [1] 468937 0
Family Member Impact
Timepoint [1] 468937 0
Baseline (week 1 of intervention), post treatment completion (week 6 of intervention) and 3 month post-intervention completion follow up.
Secondary outcome [2] 468938 0
Knowledge
Timepoint [2] 468938 0
Baseline (week 1 of intervention), post treatment completion (week 6 of intervention) and 3 month post-intervention completion follow up.
Secondary outcome [3] 468939 0
Distress
Timepoint [3] 468939 0
Baseline (week 1 of intervention), post treatment completion (week 6 of intervention) and 3 month post-intervention completion follow up.
Secondary outcome [4] 468940 0
Life Impact
Timepoint [4] 468940 0
Baseline (week 1 of intervention), post treatment completion (week 6 of intervention) and 3 month post-intervention completion follow up.

Eligibility
Key inclusion criteria
- Has a family member with features or a formal diagnosis of hoarding disorder
- Able to read, write, and comprehend English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Mentally too unwell to participate

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a pilot feasibility trial. Twenty participants were needed to detect a small to moderate effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/09/2024
Date of last participant enrolment
Anticipated
Actual
14/01/2026
Date of last data collection
Anticipated
Actual
20/05/2026
Sample size
Target
20
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 323171 0
University
Name [1] 323171 0
Research Training Program - The University of Sydney
Country [1] 323171 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 326136 0
Government body
Name [1] 326136 0
NSW Health - Nepean Blue Mountains Local Health District
Address [1] 326136 0
Country [1] 326136 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321577 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 321577 0
Ethics committee country [1] 321577 0
Australia
Date submitted for ethics approval [1] 321577 0
30/05/2017
Approval date [1] 321577 0
20/03/2019
Ethics approval number [1] 321577 0
2019/ETH01449

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154134 0
Miss Emily Dewar
Address 154134 0
The University of Sydney, Camperdown, NSW, 2050
Country 154134 0
Australia
Phone 154134 0
+61414135832
Fax 154134 0
Email 154134 0
[email protected]
Contact person for public queries
Name 154135 0
Ilona Juraskova
Address 154135 0
The University of Sydney, Camperdown, NSW, 2050
Country 154135 0
Australia
Phone 154135 0
+610293516811
Fax 154135 0
Email 154135 0
[email protected]
Contact person for scientific queries
Name 154136 0
Ilona Juraskova
Address 154136 0
The University of Sydney, Camperdown, NSW, 2050
Country 154136 0
Australia
Phone 154136 0
+610293516811
Fax 154136 0
Email 154136 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.