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Trial registered on ANZCTR


Registration number
ACTRN12619000646145
Ethics application status
Approved
Date submitted
24/04/2019
Date registered
30/04/2019
Date last updated
13/11/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of new methods to improve body image among people with eating disorders
Scientific title
Investigating the effect of Imagery rescripting on body image and disordered eating behaviours among people with eating disorders
Secondary ID [1] 298054 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 312542 0
Condition category
Condition code
Mental Health 311070 311070 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trained student therapists will deliver Imagery Rescripting (IR) in person in the first few days of admission to Treatment as usual over a one hour session. In the IR condition, participants will first be introduced to IR and provided with rationale to use this intervention. Then participants will be asked to identify a negative experience/image associated with the (negative) ways they feel about themselves. Participants will be doing other exercises such as identifying a kinder, older self to prepare themselves for the intervention. After this preparation stage, there will be three phases of the IR intervention itself: (1) Reliving as the younger self; (2) Rescripting as the older self, and (3) Rescripting as the younger self.

During the first phase – reliving as the younger self, participants will revisit the most significant negative event that they identified during the preparation stage. They will then be asked prompt questions such as “where are you? What are you doing? Who is there?” in order to relive the experience in as many details as possible from their own perspective.

During the second phase – rescripting as the older self, participants are asked to recall the same experience again but this time they will observe the event through the lens of their older selves. They will also be given the opportunity to intervene in the situation and help their younger selves. They will be asked questions such as “How do you feel offering this support? Where do you feel this in your body?” to help participants articulate their emotions.

During the third and final phase – rescripting as the younger self, participants are asked to recall the same experience but imagine they are the younger self again. This time, however, their older, kinder self is also present in the image. They will be reliving the “updated” version of their experience as their older kinder self intervenes in the situation. They will be asked prompting questions such as “what is happening? How are you feeling?”

Debriefing will be provided at the end of the IR session. In this debrief, patients will reflect on their experience with prompted questions asked by the student therapist, for instance, "what did you learn about the original event" and "what impact does this new perspective have on how you feel about the event". The student therapist will also check in with the patient in terms of their distress level and help patients utilise their own helpful coping strategies that were identified at the beginning of the IR session if needed.

Participants will practice IR exercise daily for a week after the initial meeting. Specifically, they will receive a link to write about the the content of the third phase of the IR that they did with the student therapist (i.e., rescripting as the younger self with adult self intervening) for 5 minutes everyday. A quality rating scheme was developed from a previous study that included such home practice (Pennesi & Wade, 2018) and will be used to assess intervention fidelity at home practice in this study. Patients and therapists will meet again at the end of the first week to review progress and modify the IR exercise as needed. Patients will practice IR for another week after the meeting.

The IR procedure is exactly the same for both inpatients and outpatients. The only procedure element that is different between inpatients and outpatients is the assessment timepoints. Specifically, inpatients will complete 3 assessments (at the beginning of their treatment program, after the IR session, and at completion of their treatment program); outpatients will complete 5 assessments (at the beginning of their treatment program, 2 and 4 weeks after treatment commences, at completion of their treatment program, and 3 months after completion of their treatment program).
Intervention code [1] 314288 0
Treatment: Other
Intervention code [2] 314325 0
Behaviour
Comparator / control treatment
Treatment as Usual (TAU).
TAU is either inpatient with purpose of medical and psychological stabalisation and weight gain if underweight, and the day program is a voluntary, group-based treatment program for individuals with a diagnosed eating disorder (anorexia nervosa, bulimia nervosa, or OSFED). The service runs 4 day per week. It is an open group program. Participants are required to be over 15 years, have a BMI over 15 (or corresponding percentile for children), and be medically stable (both at intake and throughout their treatment). Admission length is a minimum of 4 weeks. A participant’s treatment term is extended past the 4 weeks if treatment goals, as outlined in the participant’s treatment plan, are being met. There is a maximum of 8 participants in the program at any one time. Meals supported at the program include: morning tea, lunch, afternoon, and dinner. The day program is designed for people who may require intensive treatment and support without hospitalisation (e.g., not responding to outpatient care), or those who require transitional care following an inpatient stay (step-down). As well as providing nutritional support, there is a strong focus on helping participants to challenge disordered eating behaviours and thought patterns through group-based therapeutic interventions, predominantly using CBT or dialectical behaviour therapy.
Control group
Active

Outcomes
Primary outcome [1] 319850 0
Disordered eating behaviours. Disordered eating behaviours will be measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). The EDE-Q is a 22 item scale that measures disordered eating episode in the past 28 days. Behaviours that are assessed include fasting, self-induced vomiting, laxative or diuretic misuse and driven exercise. The global EDE-Q score is used to indicate disordered eating pathology.
Timepoint [1] 319850 0
For inpatients, there will be 3 assessment time points (at the beginning of their treatment, after IR session [primary timepoint] and at completion of their treatment),

For day patients, there will be 5 assessment time points (at the beginning of their treatment, 2 and 4 weeks after treatment commences [primary timepoint], at completion of their treatment program and 3 months after completion of their treatment program).

Please note that completion time of treatment varies for all patients depending on progress with eating related goals.
Primary outcome [2] 319851 0
Body dissatisfaction. Body dissatisfaction will be measured by the Body Image Acceptance & Action Questionnaire (BI-AAQ; Sandoz, Wilson, Merwin, & Kate Kellum, 2013). The BI-AAQ is a 12-item self-report questionnaire that measures body image flexibility, that is, flexible responding to body-related thoughts and feelings. Participants rate how true each statement such as “Worrying about my weight makes it difficult for me to live a life that I value”, “I care too much about my weight and body shape” describe them on a 7-point Likert Scale (1= never true; 7 = always true). Body image flexibility has been found to be correlated with lower body dissatisfaction, and disordered eating, higher psychological flexibility (Sandoz et al., 2013).
Timepoint [2] 319851 0
For inpatients, there will be 3 assessment time points (at the beginning of their treatment, after IR session [primary timepoint] and at completion of their treatment),

For day patients, there will be 5 assessment time points (at the beginning of their treatment, 2 and 4 weeks after treatment commences [primary timepoint], at completion of their treatment program and 3 months after completion of their treatment program).

Please note that completion time of treatment varies for all patients depending on progress with eating related goals.
Secondary outcome [1] 369700 0
Negative core beliefs. Negative core beliefs will be measured using the Dysfunctional Attitude Scales Short Form1 (DAS-SF1; Beevers, Strong, Meyer, Pilkonis, & Miller, 2007). DAS-SF1 is a 9-item scale, originated from the Dysfunctional Attitude Scale, form A (Weissman & Beck, 1979), which measures dysfunctional beliefs an individual possesses. Participants rate the extent to which they agree with each attitude statement such as “my value as a person depends greatly on what others think of me”, “I am nothing if a person I love doesn’t love me” on a 4-point Likert scale (1= totally agree; 4 = totally disagree). DAS-SF1 has found to be highly correlated with the original DAS-A scale (Beevers et al., 2007).
Timepoint [1] 369700 0
For inpatients, there will be 3 assessment time points (at the beginning of their treatment, after IR session and at completion of their treatment),

For day patients, there will be 5 assessment time points (at the beginning of their treatment, 2 and 4 weeks after treatment commences, at completion of their treatment program and 3 months after completion of their treatment program).

Please note that completion time of treatment varies for all patients depending on progress with eating related goals.
Secondary outcome [2] 369701 0
Perfectionism. Perfectionism will be measured using the Clinical Perfectionism Questionnaire (CPQ; Fairburn, Cooper, & Shafran, 2003). CPQ is a 12-item scale that measures the extent to which an individual strives to meet demanding standards despite negative consequences, and bases self-worth on achievement. Research suggests that clinical perfectionism is a maintaining risk factor in the transdiagnostic model of eating disorders (Fairburn, Cooper, & Shafran, 2003a).
Timepoint [2] 369701 0
For inpatients, there will be 3 assessment time points (at the beginning of their treatment, after IR session and at completion of their treatment),

For day patients, there will be 5 assessment time points (at the beginning of their treatment, 2 and 4 weeks after treatment commences, at completion of their treatment program and 3 months after completion of their treatment program).

Please note that completion time of treatment varies for all patients depending on progress with eating related goals.
Secondary outcome [3] 369702 0
Self-compassion. Self-compassion will be measured using the Self-Compassion Scale – Short Form (SCS-SF; Raes et al., 2011). The SCS – SF is a 12-item self-report measure that the extent to which an individual act in a self-compassionate manner in difficult times. Participant respond on a 5-point Likert Scale (1= almost never; 5= almost always). Self-compassion has been shown as a protective factor of eating disorder pathology, and those who have higher self-compassion respond better to eating disorders treatments (Ferreira, Pinto-Gouveia, & Duarte, 2013; Kelly, Carter, Zuroff, & Borairi, 2013).
Timepoint [3] 369702 0
For inpatients, there will be 3 assessment time points (at the beginning of their treatment, after IR session and at completion of their treatment),

For day patients, there will be 5 assessment time points (at the beginning of their treatment, 2 and 4 weeks after treatment commences, at completion of their treatment program and 3 months after completion of their treatment program).

Please note that completion time of treatment varies for all patients depending on progress with eating related goals.

Eligibility
Key inclusion criteria
All patients who are 18 years old or older, and received services at SEDS and consent to participate in research will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are under 18 years old and considered by treatment staff medically unstable to participate in research.

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
Recruiting
Date of first participant enrolment
Anticipated
17/06/2019
Actual
29/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 302582 0
Self funded/Unfunded
Name [1] 302582 0
This project is not funded at all.
Country [1] 302582 0
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
College of Education, Psychology and Social Work
Humanities Road
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 302494 0
Hospital
Name [1] 302494 0
Statewide Eating Disorders Services
Address [1] 302494 0
2A Jetty Rd, Brighton SA 5048
Country [1] 302494 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303223 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 303223 0
Ethics committee country [1] 303223 0
Australia
Date submitted for ethics approval [1] 303223 0
28/02/2019
Approval date [1] 303223 0
12/06/2019
Ethics approval number [1] 303223 0
HREC/19/SAC/54

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

Contacts
Principal investigator
Name 92910 0
Prof Tracey Wade
Address 92910 0
School of Psychology
Room 330, Social Sciences North
Flinders University
BEDFORD PARK SA 5042
Country 92910 0
Australia
Phone 92910 0
+61 8 8201 3736
Fax 92910 0
Email 92910 0
[email protected]
Contact person for public queries
Name 92911 0
Tracey Wade
Address 92911 0
School of Psychology
Room 330, Social Sciences North
Flinders University
BEDFORD PARK SA 5042
Country 92911 0
Australia
Phone 92911 0
+61 8 8201 3736
Fax 92911 0
Email 92911 0
[email protected]
Contact person for scientific queries
Name 92912 0
Tracey Wade
Address 92912 0
School of Psychology
Room 330, Social Sciences North
Flinders University
BEDFORD PARK SA 5042
Country 92912 0
Australia
Phone 92912 0
+61 8 8201 3736
Fax 92912 0
Email 92912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.