Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000763448p
Ethics application status
Not yet submitted
Date submitted
25/06/2025
Date registered
18/07/2025
Date last updated
18/07/2025
Date data sharing statement initially provided
18/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The EM-Body Trial: Treating body image dissatisfaction in women using Eye Movement and Desensitisation Reprocessing.
Scientific title
The EM-body Trial: Examining the neurobiology of body image dissatisfaction and its treatment using Eye Movement and Desensitisation Reprocessing in women.
Secondary ID [1] 314461 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body image dissatisfaction 337495 0
Condition category
Condition code
Mental Health 334432 334432 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitization and Reprocessing (EMDR) Therapy:
Description of the Intervention: This trial will use the Standard EMDR Protocol, an 8-phase structured treatment that incorporates bilateral stimulation, typically in the form of eye movements.

Procedure:
The treatment protocol is comprised of the following phases:

Phase 1 History Taking: Understanding participants’ backgrounds, current experiences associated with body image dissatisfaction and distress, as well as impact.

Phase 2 Preparation: Providing psychoeducational to clients regarding EMDR and supporting the client to develop resources and coping strategies for subsequent phases of treatment.

Phase 3 Assessment: Identifying appropriate body image-related target memories, identifying associated beliefs, emotions and physical sensations.

Phase 4 Desensitization: Using bilateral stimulation (commonly eye movements) to process distressing body image memories.

Phase 5 Installation: Positive beliefs and cognitions are installed using bilateral stimulation.

Phase 6 Body Scan: At the conclusion of installation, bodily sensations are identified and processed using bilateral stimulation.

Phase 7 Closure: Supporting clients to feel safe and grounded following processing.

Phase 8 Re-evaluation: Assessing progress, re-checking target memories and associated distress.

Intervention Delivery:

Providers: The intervention will be delivered by a clinical psychologist trained in EMDR, supervised by an EMDR consultant.

Mode of Delivery: The therapy will be provided individually and in-person. It will be delivered in a clinical setting at a University.

Fidelity: Fidelity to the intervention will be assessed by a EMDR consultant. Each session will be video recorded, and the consultant willl review 10% of sessions and assess according to the pre-established EMDR fidelity checklist.

Number of Sessions and Duration:
Session Schedule: The intervention will consist of 5 90-minute sessions.

Frequency: The sessions will be scheduled weekly.
Intervention code [1] 331085 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341589 0
Body image memory distress
Timepoint [1] 341589 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Primary outcome [2] 341491 0
Body image dissatisfaction
Timepoint [2] 341491 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Primary outcome [3] 341490 0
Body image dissatisfaction
Timepoint [3] 341490 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Secondary outcome [1] 447739 0
Weight Bias
Timepoint [1] 447739 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Secondary outcome [2] 447740 0
Quality of Life
Timepoint [2] 447740 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Secondary outcome [3] 449101 0
Post-Traumatic Stress Symptoms
Timepoint [3] 449101 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Secondary outcome [4] 447736 0
Self-compassion
Timepoint [4] 447736 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Secondary outcome [5] 447737 0
Body Image Avoidance
Timepoint [5] 447737 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.
Secondary outcome [6] 447738 0
Body Acceptance
Timepoint [6] 447738 0
Baseline, end of 5-week treatment program, 3 month and 6 month post treatment completion.

Eligibility
Key inclusion criteria
Participants must be right-handed women, aged 18 and 35 years old with English proficiency. To identify those with high BID, individuals must score >4 on both the body image subscales of the EDE-Q.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include a past or present diagnosis of a restrictive ED, be medically unstable due to an ED, a diagnosis of a neurodegenerative disorder, schizophrenia-spectrum or bipolar disorder, obsessive compulsive disorder, developmental disorder (e.g., ADHD or Autism), a present substance use disorder, ocular conditions, major depressive disorder, an anxiety disorder and acute suicidality. Participants exhibiting MRI contraindications (e.g., immoveable ferromagnetic objects in/on the body) will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
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
4/08/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318999 0
University
Name [1] 318999 0
Swinburne University of Technology
Country [1] 318999 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 321465 0
None
Name [1] 321465 0
Address [1] 321465 0
Country [1] 321465 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317612 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 317612 0
Ethics committee country [1] 317612 0
Australia
Date submitted for ethics approval [1] 317612 0
01/08/2025
Approval date [1] 317612 0
Ethics approval number [1] 317612 0

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

Contacts
Principal investigator
Name 141562 0
Dr Kathleen de Boer
Address 141562 0
Swinburne University of Technology, John Street, Hawthorn, Victoria 3122
Country 141562 0
Australia
Phone 141562 0
+61448553483
Fax 141562 0
Email 141562 0
[email protected]
Contact person for public queries
Name 141563 0
Kathleen de Boer
Address 141563 0
Swinburne University of Technology, John Street, Hawthorn, Victoria 3122
Country 141563 0
Australia
Phone 141563 0
+61448553483
Fax 141563 0
Email 141563 0
[email protected]
Contact person for scientific queries
Name 141564 0
Kathleen de Boer
Address 141564 0
Swinburne University of Technology, John Street, Hawthorn, Victoria 3122
Country 141564 0
Australia
Phone 141564 0
+61448553483
Fax 141564 0
Email 141564 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 review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
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)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
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?
• Data repository: Data will be stored on the Open Science Framework.

• Email of trial custodian, sponsor or committee: Individuals requesting to access the data can contact [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.