Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001388505p
Ethics application status
Submitted, not yet approved
Date submitted
1/11/2024
Date registered
22/11/2024
Date last updated
22/11/2024
Date data sharing statement initially provided
22/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing online imagery rescripting and psychoeducation on self-compassion among young people who are at risk of developing an eating disorder
Scientific title
A randomised controlled trial comparing online imagery rescripting and psychoeducation on self-compassion among young people who are at risk of developing an eating disorder
Secondary ID [1] 313289 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered eating 335627 0
Condition category
Condition code
Mental Health 332185 332185 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Body imagery rescripting:

Body imagery rescripting is a therapeutic technique where people rescript an unpleasant visual memory where they might have felt ashamed or embarrassed of their bodies or how their bodies look in a compassionate way. It involves three steps:

(1) Reliving (i.e., identify problematic memory; 5 minutes). A person visualize a recent event of an unpleasant body experience where they might have felt ashamed or embarrassed of their bodies or how their bodies look. An example could be peer teasing or negative comments with respect to appearance, or feeling uncomfortable when looking in the mirror. Then they are asked to hold on to or reflect on the feelings they have during this imagery, and identify the earliest event they could remember associated with those feelings. They then write down as much details as possible about this earlier event, in first person, as if it were happening to them “right now”. Immediately after induction, participants complete a brief questionnaire that contains only the state measures in order to assess the impact of the induction.

(2) Observing (5 minutes). Participants are asked to imagine and then write about the same memory (i.e., the earliest event) but from an observer's point of view (i.e., in third person), watching what happened to their younger self as it unfolds. Prompts are provided at the end of the writing task for participants to reflect upon what needs to happen in the memory in order for the younger self to feel better or if there’s anything the adult self would like to do to help the younger self in that situation.

(3) Rescripting (5 minutes). Participants will then asked to re-imagine the same event in first person, but this time the wiser and more compassionate adult self is with them who can intervene the situation if they want her to. Participants are asked to write about what happened this time with the adult compassionate self presence in as much details as possible.

All questionnaires, study instruction and interventions will be delivered online. Participants will receive instructions on body imagery rescripting on a computer screen. And they will be asked to type their responses (e.g., their rescripted memory) in a text box. A quality rating scale has been previously developed to assess intervention fidelity on all three steps of imagery rescripting intervention and will be used to rate fidelity based on participants' typed responses for imagery rescripting. The intervention will be delivered once at baseline (i.e., a single session intervention), and participants will be instructed to do homework (i.e., practice the rescripting step of the imagery rescripting once per day).

The duration of the single session intervention will take around 30 minutes. The overall duration of the homework component (i.e., the rescripting step of the imagery rescripting) will be 20 minutes (4 X 5 minutes).
Intervention code [1] 329866 0
Behaviour
Comparator / control treatment

Psychoeducation:
After undergoing the first step of the body imagery rescripting, participants in the psychoeducational condition will receive and read Module 1 from the Building Self-Compassion Workbook developed by the Centre of Clinical Intervention (retrieved from: https://www.cci.health.wa.gov.au/~/media/CCI/Consumer-Modules/Building-Self-Compassion/Building-Self-Compassion---01---Understanding-Self-Compassion.pdf). This module discusses what self-compassion is, why it is important, self-criticism, barriers to be self-compassionate, and its relevance to the reader.

The psychoeducational intervention will also be delivered online. Participants will receive a PDF of the Self-compassion module. The fidelity of the psychoeducational group was assessed using a quiz containing simple reading comprehension questions of the materials immediately after the intervention, and an open-ended question "Did reading about the materials provided a week (or 2/3/4 weeks) ago change your thinking/behaviours in any way during the past week?" at follow-up timepoints.
Control group
Active

Outcomes
Primary outcome [1] 339772 0
Disordered eating
Timepoint [1] 339772 0
Baseline and at one-, two-, three-, and four-week follow-ups (primary timepoint).
Primary outcome [2] 339770 0
Self-compassion
Timepoint [2] 339770 0
Baseline and at one-, two-, three-, and four-week follow-ups (primary timepoint).
Secondary outcome [1] 441812 0
Depression anxiety and stress
Timepoint [1] 441812 0
Baseline and at one-, two-, three-, and four-week follow-ups.
Secondary outcome [2] 441262 0
Shame
Timepoint [2] 441262 0
Baseline and at one-, two-, three-, and four-week follow-ups.
Secondary outcome [3] 441255 0
Self criticism
Timepoint [3] 441255 0
Baseline and at one-, two-, three-, and four-week follow-ups.

Eligibility
Key inclusion criteria
Anyone aged 18 -25 years, who were at risk of developing an eating disorder, as indicated by a score on the Weight Concern Scale (WCS; Killen et al., 1994) >= 47, considered a cut-off with good predictive validity for eating disorder cases (Jacobi, Abascal, & Taylor, 2004; Killen et al., 1994; 1996), will be included in the study.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently engaged with treatment of an eating disorder or eating disorder concerns

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26664 0
United States of America
State/province [1] 26664 0
Country [2] 26665 0
Canada
State/province [2] 26665 0

Funding & Sponsors
Funding source category [1] 317739 0
University
Name [1] 317739 0
Flinders University, University’s strategic fund (USF)
Country [1] 317739 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320057 0
None
Name [1] 320057 0
Address [1] 320057 0
Country [1] 320057 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316427 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 316427 0
Ethics committee country [1] 316427 0
Australia
Date submitted for ethics approval [1] 316427 0
11/11/2024
Approval date [1] 316427 0
Ethics approval number [1] 316427 0

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

Contacts
Principal investigator
Name 137858 0
Dr Yuan Zhou
Address 137858 0
Flinders University Institute for Mental Health and Wellbeing; Sturt Rd, Bedford Park SA 5042
Country 137858 0
Australia
Phone 137858 0
+61 8 8201 7587
Fax 137858 0
Email 137858 0
[email protected]
Contact person for public queries
Name 137859 0
Yuan Zhou
Address 137859 0
Flinders University Institute for Mental Health and Wellbeing; Sturt Rd, Bedford Park SA 5042
Country 137859 0
Australia
Phone 137859 0
+61 8 8201 7587
Fax 137859 0
Email 137859 0
[email protected]
Contact person for scientific queries
Name 137860 0
Yuan Zhou
Address 137860 0
Flinders University Institute for Mental Health and Wellbeing; Sturt Rd, Bedford Park SA 5042
Country 137860 0
Australia
Phone 137860 0
+61 8 8201 7587
Fax 137860 0
Email 137860 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:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Participants' de-identified summary scores will be made available upon request

What types of analyses could be done with individual participant data?
• Analyses for achieving similar aims in the approved proposal, and for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting the principal investigator via [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.