Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001641189
Ethics application status
Approved
Date submitted
6/11/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Imagery rescripting among young women at risk of developing an eating disorder
Scientific title
Combating disordered eating and poor body image with the use of imagery rescripting among young women at risk of developing an eating disorder
Secondary ID [1] 299724 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
disordered eating 315071 0
Condition category
Condition code
Mental Health 313407 313407 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
When participants arrive at laboratory, they complete some questionnaires and are randomly assigned to one of the four conditions i.e., two imagery rescripting (IR) conditions – body versus general, psychoeducation and control. Both IR conditions consist of three steps: (1) Reliving (i.e., identify problematic memory); Participants complete a battery state measures immediately after this step, (2) Observing (i.e., relive memory from an observer perspective), and (3) Rescripting (i.e., rescript memory in a compassionate manner). The only difference between the general and specific IR conditions is the first step – whether they are prompted to recall a body-specific negative memory or a generic negative memory. Half of the participants in the control group are randomised to undergo step 1 in the body specific IR condition, and half undergo step 1 in the general IR condition. This is designed to standardize the effect of induction (i.e., step 1 in the IR conditions) across conditions. All the interventions are delivered on a computer.

Body IR (BIR, n = 35).
Reliving (5 minutes). Participants in this condition are asked to close their eyes and visualize a recent event of 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.
Observing (5 minutes). Participants are asked to imagine and then write about the same memory (i.e., the earliest event) but in an observer 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.
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.

General IR (GIR, n = 31).
All steps of IR will be identical to the previous condition except for Step 1 - (1) Reliving (5 minutes): participants are revisited a recent negative event (which is not body related) that has resulted in an intrusive aversive memory. An example could be a social rejection, or emotional neglect, which resulted in them feeling bad about themselves as a person. They will then be asked to trace back their memories to identify any previous events that are associated with that bad feelings about the self, and describe (write about) this early event in as much details as possible. Steps 2 and 3 are identical with respect to this memory as the Body Specific IR condition.


Psychoeducation (n=34).
After undergoing either step 1 from BIR or GIR, participants in the psychoeducation condition received a handout that contained four sections: “the role of genetics in eating disorders”, “the gene-environment interaction”, “how eating disorders affect the brain” and “what does all this mean for recovery?”. Participants were also then presented with a short quiz which consisted of 7 multiple-choice questions and one open-ended question that were designed to help them engage in the reading. Participants were asked to spend not less than 10 minutes on this task and can only proceed if they have answered the multiple-choice questions correctly based on the handout. This handout is available to download on the Clinical Centre of Intervention website (https://www.cci.health.wa.gov.au/Resources/For-Clinicians/Eating-Disorders).
Intervention code [1] 315988 0
Behaviour
Intervention code [2] 316182 0
Treatment: Other
Comparator / control treatment
Control. After undergoing either step 1 from BIR or GIR, participants in the control condition receive instruction to let their mind wander for 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 321885 0
Disordered eating measured by Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994).
Timepoint [1] 321885 0
Baseline and one-week follow up
Primary outcome [2] 321886 0
Body image acceptance measured by the Body Image Acceptance & Action Questionnaire (BI-AAQ; Sandoz, Wilson, Merwin, & Kate Kellum, 2013).
Timepoint [2] 321886 0
Baseline and one-week follow up
Secondary outcome [1] 376593 0
Self-compassion measured by Self-Compassion Scale – Short Form (SCS-SF; Raes et al., 2011).
Timepoint [1] 376593 0
Baseline and one-week follow up
Secondary outcome [2] 376594 0
Fear of self-compassion measured by Fear of Self-Compassion (FSC) Scale (Gilbert et al., 2011).
Timepoint [2] 376594 0
Baseline and one-week follow up
Secondary outcome [3] 376595 0
Negative core beliefs measured by Dysfunctional Attitude Scales Short Form1 (DAS-SF1; Beevers, Strong, Meyer, Pilkonis, & Miller, 2007).
Timepoint [3] 376595 0
Baseline and one-week follow-up
Secondary outcome [4] 376596 0
Confidence to change disordered eating behaviours measured by one item "“If you decided to work on improving the way you feel about your body, how confident are you that you would succeed?”"
Timepoint [4] 376596 0
Baseline and one-week follow up

Eligibility
Key inclusion criteria
Females Flinders University undergraduates aged 17 -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), were included in the study.
Minimum age
17 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

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
Completed
Date of first participant enrolment
Anticipated
Actual
9/08/2018
Date of last participant enrolment
Anticipated
Actual
19/06/2019
Date of last data collection
Anticipated
Actual
26/06/2019
Sample size
Target
144
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 304195 0
Charities/Societies/Foundations
Name [1] 304195 0
Breakthrough Mental Health Research Foundation
Country [1] 304195 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breakthrough Mental Health Research Foundation
Address
Breakthrough Mental Health Research Foundation
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 304427 0
None
Name [1] 304427 0
Address [1] 304427 0
Country [1] 304427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304664 0
Social and Behavioural Research Ethics Committee (SBREC)
Ethics committee address [1] 304664 0
Ethics committee country [1] 304664 0
Australia
Date submitted for ethics approval [1] 304664 0
Approval date [1] 304664 0
05/07/2018
Ethics approval number [1] 304664 0
8041

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

Contacts
Principal investigator
Name 97774 0
Miss Yuan Zhou
Address 97774 0
Flinders University
College of Education, Psychology and Social Work
Humanities Road, Bedford Park,
South Australia, 5042
Country 97774 0
Australia
Phone 97774 0
+61 8 8201 3736
Fax 97774 0
Email 97774 0
[email protected]
Contact person for public queries
Name 97775 0
Yuan Zhou
Address 97775 0
Flinders University
College of Education, Psychology and Social Work
Humanities Road, Bedford Park,
South Australia, 5042
Country 97775 0
Australia
Phone 97775 0
+61 8 8201 3736
Fax 97775 0
Email 97775 0
[email protected]
Contact person for scientific queries
Name 97776 0
Yuan Zhou
Address 97776 0
Flinders University
College of Education, Psychology and Social Work
Humanities Road, Bedford Park,
South Australia, 5042
Country 97776 0
Australia
Phone 97776 0
+61 8 8201 3736
Fax 97776 0
Email 97776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participants' line-by-line de-identified, scored data will be shared. (Participants' questionnaires were scored based on their respective scoring instructions. These data are shared as they might be more helpful for further analyses than specific questionnaire item response from every questionnaire).
When will data be available (start and end dates)?
Data will be available in Feb 15th, 2020. No end date determined.
Available to whom?
Data will be available to anyone on reasonable request.
Available for what types of analyses?
Data are available to achieve the aim of the current study and some meta-analyses.
How or where can data be obtained?
Data can be obtained by emailing Tracey Wade at Flinders University via [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Zhou, Y., Pennesi, J. L., & Wade, T. D. (2020). On... [More Details] 378679-(Uploaded-27-10-2020-12-33-51)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.