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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
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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
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Secondary ID [1]
313289
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Disordered eating
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Condition category
Condition code
Mental Health
332185
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0
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Eating disorders
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
329866
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Disordered eating
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Assessment method [1]
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Eating Disordered Examination Questionnaire 7 (EDE-Q7; Jenkins & Davey, 2020)
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Timepoint [1]
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Baseline and at one-, two-, three-, and four-week follow-ups (primary timepoint).
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Primary outcome [2]
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Self-compassion
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Assessment method [2]
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Self-Compassion Scale Short Form (Raes et al., 2010)
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Timepoint [2]
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Baseline and at one-, two-, three-, and four-week follow-ups (primary timepoint).
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Secondary outcome [1]
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Depression anxiety and stress
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Assessment method [1]
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Depression, Anxiety and Stress Scale (DASS21; Lovibond & Lovibond; 1995)
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Timepoint [1]
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Baseline and at one-, two-, three-, and four-week follow-ups.
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Secondary outcome [2]
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Shame
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Assessment method [2]
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External and Internal Shame Scale (EISS; Ferreira et al., 2020)
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Timepoint [2]
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Baseline and at one-, two-, three-, and four-week follow-ups.
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Secondary outcome [3]
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Self criticism
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Assessment method [3]
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Self-Critical Rumination Scale (SCRS, Smart, Peters, & Baer, 2016)
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Timepoint [3]
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Baseline and at one-, two-, three-, and four-week follow-ups.
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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.
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Minimum age
18
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Currently engaged with treatment of an eating disorder or eating disorder concerns
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/11/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Country [2]
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Canada
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State/province [2]
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Flinders University, University’s strategic fund (USF)
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Flinders University Human Research Ethics Committee
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Ethics committee address [1]
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https://staff-projects.flinders.edu.au/research-support/integrity/human-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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11/11/2024
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Approval date [1]
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Ethics approval number [1]
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Summary
Brief summary
This study aims to examine (1) the efficacy of using body imagery rescripting to improve self-compassion compared to psychoeducation, and (2) the underlying mechanism of body image rescripting as a single-session intervention for self-compassion. Previous research has shown that body imagery rescripting increases self-compassion more than a psychoeducation task, while also reducing disordered eating, and improving body acceptance (Pennesi & Wade, 2018; Zhou et al., 2020). However, the mechanism behind these effects remains unclear. Understanding the mechanisms of such effective single-session intervention can shed light on specific targets to address in eating disorder early intervention and treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Yuan Zhou
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Address
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Flinders University Institute for Mental Health and Wellbeing; Sturt Rd, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 8 8201 7587
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Yuan Zhou
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Address
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Flinders University Institute for Mental Health and Wellbeing; Sturt Rd, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 8 8201 7587
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Yuan Zhou
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Address
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Flinders University Institute for Mental Health and Wellbeing; Sturt Rd, Bedford Park SA 5042
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Country
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Australia
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Phone
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+61 8 8201 7587
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Fax
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Email
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[email protected]
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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:
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only researchers who provide a methodologically sound proposal
Conditions for requesting access:
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-
What individual participant data might be shared?
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Participants' de-identified summary scores will be made available upon request
What types of analyses could be done with individual participant data?
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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:
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Where can requests to access individual participant data be made, or data be obtained directly?
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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.
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