Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000622404
Ethics application status
Approved
Date submitted
28/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Imagery rescripting to manage hoarding disorder
Scientific title
A randomised multiple baseline case series evaluating the effects of imagery rescripting on symptoms of hoarding disorder
Secondary ID [1] 314549 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hoarding Disorder 337650 0
Condition category
Condition code
Mental Health 333981 333981 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a 60-90 minute assessment session, and will then be randomised to a baseline monitoring period lasting between 1 and 3 weeks.

Participants will then attend 12x 60 minute intervention sessions occurring approximately twice weekly over a period of 6 weeks. These will occur either online (via Zoom) or in-person, depending on participant preference. In these sessions, participants will engage in an Imagery Rescripting Intervention with a registered psychologist (i.e., Clinical Psychology Registrar or Clinical Psychologist).

The imagery rescripting procedure is based on Arntz's (2012) Three Stage Protocol, with adaptations to address hoarding. Sessions will involve identifying an object that the participant is having difficulty parting with, generating an mental image where participants' will imagine parting with that object, the therapist attuning to the resultant distress and identifying an affectively-linked memory, engaging in rescripting of this memory (therapist led, and later participant-led), followed by an exploration of whether the participant is able to think or feel differently about parting with their initial chosen object. Each session will involve 1 imagery rescripting exercise.

Adherence to the intervention will be monitored by a board approved supervisor in clinical psychology and a accredited schema therapy supervisor and trainer, who will review a random selection of recordings of the intervention session, and provide feedback regarding fidelity to the study protocol and therapist competence. Therapists will be rated using the relevant subsections of the Schema Therapy Competence Rating Scale (STCS-I-1).

Participants will be asked to complete a range of questionnaires throughout the study, and at 1-month follow up.
Intervention code [1] 331177 0
Treatment: Other
Comparator / control treatment
Participants will first be randomised into a baseline monitoring period lasting between 1 and 3 weeks. The baseline lengths will be 7 days, 14 days, and 21 days and four participants will be assigned to each length. Participants will complete the battery of standardised questionnaires at the beginning of the baseline monitoring period (i.e., day 1; 'pre-baseline measures') and again at the end of the baseline monitoring period (i.e., day 7, 14, or 21; 'post-baseline measures').
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341643 0
Hoarding disorder symptom severity
Timepoint [1] 341643 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (after 6th intervention session), post-treatment (after 12th intervention session), follow up (1 month after final intervention session).
Primary outcome [2] 341644 0
Maladaptive cognitions associated with hoarding
Timepoint [2] 341644 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (after 6th intervention session), post-treatment (after 12th intervention session), follow up (1 month after final intervention session).
Primary outcome [3] 341645 0
Negative intrusive imagery
Timepoint [3] 341645 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (after 6th intervention session), post-treatment (after 12th intervention session), follow up (1 month after final intervention session).
Secondary outcome [1] 448188 0
Depression Score
Timepoint [1] 448188 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (after 6th intervention session), post-treatment (after 12th intervention session), follow up (1 month after final intervention session)
Secondary outcome [2] 448189 0
Anxiety score
Timepoint [2] 448189 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (after 6th intervention session), post-treatment (after 12th intervention session), follow up (1 month after final intervention session)
Secondary outcome [3] 448190 0
Obsessive compulsive disorder score
Timepoint [3] 448190 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (after 6th intervention session), post-treatment (After 12th intervention session), follow up (1 month after final intervention session).
Secondary outcome [4] 448192 0
Attachment score
Timepoint [4] 448192 0
Pre-Baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (After 6th intervention session), post-treatment (after 12th intervention session), follow up (1 month after final intervention session).
Secondary outcome [5] 448193 0
Clutter score
Timepoint [5] 448193 0
Pre-baseline monitoring period, post-baseline monitoring period (within 48 hours of completion of the baseline monitoring period), mid-treatment (After 6th intervention session), post-treatment (After 12th intervention session), follow-up (1 month after final intervention session)
Secondary outcome [6] 448194 0
Client satisfaction
Timepoint [6] 448194 0
Post-treatment (after 12th intervention session)
Secondary outcome [7] 448197 0
Client perceptions of intervention credibility
Timepoint [7] 448197 0
After the first intervention session
Secondary outcome [8] 448492 0
Client perceptions of intervention benefits and adverse events
Timepoint [8] 448492 0
After the final intervention session
Secondary outcome [9] 448493 0
Recruitment rates
Timepoint [9] 448493 0
Over the course of the intervention
Secondary outcome [10] 448719 0
Retention Rates
Timepoint [10] 448719 0
Over the course of the intervention

Eligibility
Key inclusion criteria
- Age 18 or older
- Primary or co-primary diagnosis of hoarding disorder (i.e., persistent difficulties discarding objects, resulting in distress and impairment)
- Willing and able to attend an assessment interview and twelve 60-minute intervention sessions delivered twice weekly (1-hour each) with a psychologist at no cost to the participant, and to complete regular questionnaires (ranging between 2 and 30 minutes)
- Willing to discuss memories of potentially upsetting past experiences
- Understand spoken English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to experience mental images
- Experience active and not adequately managed suicidal intent or planning, symptoms of psychosis, bipolar disorder, substance use, or have a tendency to dissociate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator to allocate participants to baseline monitoring periods of different lengths; 7 days, 14 days or 21 days.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A non-concurrent, randomised multiple baseline (A1-B-A2) case series design will be employed. A1 is the multiple baseline phase, where participants will be randomly
allocated to either a 7 day, 14 day, or 21 day baseline monitoring phase. B is
the intervention phase (12 sessions of ImRs, conducted biweekly over a period of 6 weeks), and A2 is the 1 month follow up period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2025
Actual
Date of last participant enrolment
Anticipated
22/10/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319099 0
University
Name [1] 319099 0
The University of New South Wales
Country [1] 319099 0
Australia
Primary sponsor type
University
Name
UNSW, Sydney
Address
Country
Australia
Secondary sponsor category [1] 321562 0
None
Name [1] 321562 0
Address [1] 321562 0
Country [1] 321562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317698 0
The University of New South Wales Human Research Ethics Committee C
Ethics committee address [1] 317698 0
Ethics committee country [1] 317698 0
Australia
Date submitted for ethics approval [1] 317698 0
03/03/2025
Approval date [1] 317698 0
01/05/2025
Ethics approval number [1] 317698 0
iRECS8438

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

Contacts
Principal investigator
Name 141846 0
Prof Jessica R. Grisham
Address 141846 0
School of Psychology, UNSW Sydney, NSW Kensington 2052
Country 141846 0
Australia
Phone 141846 0
+61 02 9065 9982
Fax 141846 0
Email 141846 0
[email protected]
Contact person for public queries
Name 141847 0
Isaac Sabel
Address 141847 0
School of Psychology, UNSW Sydney, NSW Kensington, 2052
Country 141847 0
Australia
Phone 141847 0
+61 02 9065 9982
Fax 141847 0
Email 141847 0
[email protected]
Contact person for scientific queries
Name 141848 0
Isaac Sabel
Address 141848 0
School of Psychology, UNSW Sydney, NSW Kensington, 2052
Country 141848 0
Australia
Phone 141848 0
+61 02 9065 9982
Fax 141848 0
Email 141848 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Access provided by principal investigator, who can be contacted via email at [email protected]

Are there extra considerations when requesting access to 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.