Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000365460
Ethics application status
Approved
Date submitted
28/03/2025
Date registered
24/04/2025
Date last updated
9/07/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
BFED: Investigating the Effects of Self-Help Eating Disorder Modules on a Community Sample
Scientific title
BFED: Investigating the Effects of Self-Help Eating Disorder Modules on Disorder Symptoms in an Adult Community Sample
Secondary ID [1] 314225 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 336800 0
Condition category
Condition code
Mental Health 333293 333293 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of 14 self-help cognitive behavioural therapy modules from the Centre for Clinical Interventions' (CCI) Break Free from ED manual (https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Disordered-Eating). The information within the modules is presented as written information with images. Each module will take approximately 60 minutes per week to complete.

Following recruitment and the pre-screener, participants will complete baseline symptom monitoring. Following the baseline phase, participants will receive their weekly measures survey and access to that week’s module. For the first 9 modules, they will be emailed out weekly to participants. The email will provide minimal guidance, encouraging participants to complete this week’s measures and homework. In week 10, participants will be sent their weekly measures survey and the remaining 5 modules to complete at their own pace over the following month. In the one month follow-up survey, participants will be complete the measures survey, and asked which modules they engaged with. Three months post intervention, participants will be asked to complete a final measures survey. Adherence to the modules will be self-reported in the weekly and follow-up surveys.

Module 1: What are Eating Disorders?
This module introduces you to eating disorders, their impact on physical, psychological and social functioning, and some of the factors that can lead to the development of an eating disorder.

Module 2: What Keeps Eating Disorders Going?
This module takes you through the key factors that keep eating disorders going and introduces you to the ways in which this workbook will address each of these factors.

Module 3: Understanding the Number on the Scale
This module discusses the many factors that influence the number on the scale, explores how much control people really have over their weight, and introduces Weekly Weighing.

Module 4: Self-monitoring
This module introduces self-monitoring, a key strategy that assists you to record your eating behaviours, thoughts, and feelings in real time, focusing on patterns occurring throughout each week.

Module 5: Food and Energy
This module discusses the relationship between what you eat and your energy levels, highlighting the impacts of low and high energy and guiding you through understanding how your own eating impacts your energy levels.

Module 6: Eating for Recovery - Part 1
This module introduces you to ‘Eating for Recovery’, focusing on establishing regular and adequate nutritional intake, and providing guidelines for change in these areas.

Module 7: Eating for Recovery - Part 2
This module focuses on another aspect of ‘Eating for Recovery’, the variety of your nutritional intake, highlighting the importance of tackling rigid food rules and experimenting with feared foods.

Module 8: Binge Eating
This module provides information about binge eating and introduces strategies for reducing and ceasing this behaviour.;

Module 9: Purging
This module provides information about purging and introduces strategies for reducing and ceasing this behaviour.

Module 10: Driven Exercise
This module provides information about driven exercise and introduces strategies for developing a more healthy and balanced relationship with moving your body.

Module 11: Body Image 1 - Body Checking
This module discusses body checking and uses experiments to examine whether body checking is as helpful as you think and how we can reduce it.

Module 12: Body Image 2 - Body Avoidance
This module discusses body avoidance and introduces exposure experiments to reduce body avoidance.

Module 13: Core Beliefs
This module introduces core beliefs, discussing the role these play in maintaining eating disorder behaviours and introducing strategies to challenge them.

Module 14: Maintaining Your Gains and Dealing with Setbacks
This final module summarises the key strategies from the workbook and guides you through developing a plan for maintaining your gains and dealing with setbacks.
Intervention code [1] 330630 0
Treatment: Other
Intervention code [2] 330836 0
Behaviour
Comparator / control treatment
Participants will be randomized into either a 3 or 5 week baseline. In the baseline phase, participants will complete a weekly survey to monitor their current eating disorder symptoms and any risk.
Control group
Active

Outcomes
Primary outcome [1] 340864 0
Eating Disorder Symptoms
Timepoint [1] 340864 0
Measured at baseline, week 10, 1 month follow up and three month follow up post-commencement of intervention.
Primary outcome [2] 340865 0
Eating Disorder Symptoms
Timepoint [2] 340865 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [1] 445293 0
Clinical Impairment
Timepoint [1] 445293 0
Measured at baseline, week 1, 5 and 10 post-commencement of intervention. Measured at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [2] 445294 0
Anxiety, depression & stress symptoms - measured as a composite secondary outcome.
Timepoint [2] 445294 0
Measured at baseline, week 10, 1 month follow up and three month follow up post-commencement of intervention.
Secondary outcome [3] 445295 0
Psychological Distress
Timepoint [3] 445295 0
Measured at week 1, week 5, week 10 and 1 month and 3 months follow up post-commencement of intervention.
Secondary outcome [4] 445297 0
Module Engagement
Timepoint [4] 445297 0
Measured weekly from week 2 to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [5] 445298 0
Overall Satisfaction
Timepoint [5] 445298 0
Measured at week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [6] 445299 0
Feasibility
Timepoint [6] 445299 0
Measured each week from baseline until 1 month follow up post-commencement of intervention.
Secondary outcome [7] 446407 0
Physical Risk - BMI
Timepoint [7] 446407 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [8] 446408 0
Physical Risk - Dizziness
Timepoint [8] 446408 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [9] 446410 0
Physical Risk - Fainting
Timepoint [9] 446410 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [10] 446411 0
Physical Risk - Blood in Vomit
Timepoint [10] 446411 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.
Secondary outcome [11] 446413 0
Physical Risk - Chest Pains
Timepoint [11] 446413 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention
Secondary outcome [12] 446415 0
Physical Risk - Heart Palpitations
Timepoint [12] 446415 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention
Secondary outcome [13] 446417 0
Psychiatric Risk - Suicide Risk
Timepoint [13] 446417 0
Measured weekly from baseline to week 10 post-commencement of intervention; then at 1 month and 3 month follow up post-commencement of intervention.

Eligibility
Key inclusion criteria
Participants must be (a) 18 years old or above, (b) have disordered eating symptoms above a clinical cut off in the EDE-Q (a cut of score equal to or greater than 2.3 will be used for females [Mond et al., 2006], and a cut of score equal to or greater than 1.68 will be used for males [Schaefer et al., 2018]), (c) currently being medically monitored by a general practitioner and are willing to provide the research team with their contact details, (d) currently seeking psychological treatment for their eating disorder, (e) access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they (a) have a body mass index <16, (b) are at imminent suicide risk, (c) are at imminent medical risk, (d) have a psychotic illness, (e) reside outside of Australia, (f) have a severe mental illness.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomised to a 3 or 5 baseline weekly measures. Participants will be randomly allocated to variable baselines using a random number generator in blocks of two. A priori randomisation will occur based on participant enrolment order. This is to minimise disengagement, rather than waiting for all participants to enrol before randomisation occurs.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2025
Actual
20/05/2025
Date of last participant enrolment
Anticipated
25/08/2025
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
5
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318557 0
University
Name [1] 318557 0
Curtin University
Country [1] 318557 0
Australia
Funding source category [2] 318561 0
Government body
Name [2] 318561 0
NMHS Mental Health
Country [2] 318561 0
Australia
Primary sponsor type
Government body
Name
NMHS Mental Health
Address
Country
Australia
Secondary sponsor category [1] 320955 0
University
Name [1] 320955 0
Curtin University
Address [1] 320955 0
Country [1] 320955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317157 0
North Metropolitan Area Mental Health Services Human Research Ethics Committee
Ethics committee address [1] 317157 0
Ethics committee country [1] 317157 0
Australia
Date submitted for ethics approval [1] 317157 0
17/02/2024
Approval date [1] 317157 0
13/05/2024
Ethics approval number [1] 317157 0
RGS0000006683
Ethics committee name [2] 317176 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 317176 0
Ethics committee country [2] 317176 0
Australia
Date submitted for ethics approval [2] 317176 0
20/05/2024
Approval date [2] 317176 0
29/05/2024
Ethics approval number [2] 317176 0
HRE2024-0264

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

Contacts
Principal investigator
Name 140194 0
Prof Peter McEvoy
Address 140194 0
Curtin University, Kent St, Bentley, WA, 6102
Country 140194 0
Australia
Phone 140194 0
+61892665110
Fax 140194 0
Email 140194 0
[email protected]
Contact person for public queries
Name 140195 0
Peter McEvoy
Address 140195 0
Curtin University, Kent St, Bentley, WA, 6102
Country 140195 0
Australia
Phone 140195 0
+61892665110
Fax 140195 0
Email 140195 0
[email protected]
Contact person for scientific queries
Name 140196 0
Peter McEvoy
Address 140196 0
Curtin University, Kent St, Bentley, WA, 6102
Country 140196 0
Australia
Phone 140196 0
+61892665110
Fax 140196 0
Email 140196 0
[email protected]

Data sharing statement
Will the study consider sharing 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.