Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000059460
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Piloting single session interventions for the early intervention of eating disorders
Scientific title
Piloting single session interventions of key transdiagnostic processes for the early intervention of eating disorders in youth: A randomised controlled trial
Secondary ID [1] 313596 0
NHMRC2025665
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 336289 0
depression 336290 0
eating disorder 336139 0
Condition category
Condition code
Mental Health 332827 332827 0 0
Anxiety
Mental Health 332828 332828 0 0
Depression
Mental Health 332688 332688 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 9 Single Session Interventions (SSIs) developed for this study were based on the top transdiagnostic targets deemed essential for the early intervention of eating disorder treatment by key stakeholders (people with lived experience N=38; significant others N=27; clinicians N=44; and researchers N=29) in a Delphi study (Pennesi et al., 2024). We also include an existing SSI by our team focused on behavioural activation to target low mood and motivation. Each of the 9 SSIs will be placed on a smartphone application, “NourishED Mind” and participants will only be given access to the one SSI they have been randomly assigned. Each SSI follows the B.E.S.T. elements of SSIs by Schleider et al. (2020). These are: “B: Brain science to normalize concepts in the program; E: Empower youths to a “helper” or “expert” role; S: Saying-is-believing exercises to solidify learning; T: Testimonials and evidence from valued others” (Schleider et al., 2020, p. 268). Each SSI will contain a ‘Learn’ section with psychoeducation and a ‘Do’ section containing interactive activities. All SSIs will include psychoeducation on functional nutrition and goals focused on increasing complex carbohydrate intake to support this. SSI content is evidence-based, drawing upon approaches such as Cognitive Behavioural Therapy (CBT: Beck, 1979), Acceptance and Commitment Therapy (ACT: Hayes et al., 2011), self-compassion (Neff, 2011), and Dialectical Behaviour Therapy (DBT: Linehan, 2015), and eating disorder specific approaches including CBT for eating disorders (CBT-E: Fairburn, 2008; Waller et al., 2007) and the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA: Schmidt et al., 2012). Each SSI is designed to be brief, between 20 to 40 minutes on one occasion, to sustain young peoples’ attention. The 9 SSIs cover the following topics: (1) Basing self-worth on just one or two limited areas; (2) Difficulty coping with developmental life transitions and change; (3) Distress tolerance and emotion regulation skills; (4) Low mood and motivation; (5) Low self-worth and self-acceptance; (6) Negative body image; (7) Persistent excessively high standards; (8) Self-criticism and low self-compassion; (9) Social media use. SSI adherence will be measured by assessing participants' time spent on the app NourishED Mind. Push notifications will be sent within the NourishED Mind app to promote completion of the SSIs and researchers will send email and text message reminders to aid participant retention and data collection.
Intervention code [1] 330193 0
Prevention
Comparator / control treatment
A waitlist control condition will be included to compare outcomes against the 9 SSI conditions. Participants will complete measures only at the same time points as intervention participants and receive the same reimbursement. The control group will receive access to the intervention after the 9-week period (following last assessment time point).
Control group
Active

Outcomes
Primary outcome [1] 340213 0
Global Eating Disorder Psychopathology
Timepoint [1] 340213 0
baseline, post-intervention, 1-month follow up.
Secondary outcome [1] 443322 0
Self-Injurious Thoughts and Behaviours
Timepoint [1] 443322 0
baseline, post-intervention, 1-month follow-up
Secondary outcome [2] 443320 0
Depression
Timepoint [2] 443320 0
baseline, post-intervention, 1-month follow up
Secondary outcome [3] 443319 0
Anxiety
Timepoint [3] 443319 0
baseline, post-intervention, 1-month follow up
Secondary outcome [4] 443321 0
Help-seeking Behaviour
Timepoint [4] 443321 0
baseline, post-intervention, 1 month follow-up

Eligibility
Key inclusion criteria
Eligibility criteria include: 1) being a young person aged 14 to 25 years, 2) having adequate literacy levels in English, 3) internet/computer/smartphone access, and 4) meeting a cut-off score of 47 or more using the Weight Concern Scale (Killen et al., 1996), demonstrating a participant is at risk of developing an eating disorder.
Minimum age
14 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised after first establishing eligibility. There will be no restriction on randomisation. As randomisation will occur via Qualtrics, allocation will be concealed from the research team until the intervention has been assigned. The research team will then send a text message to each participant with their assigned intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed using the inbuilt randomisation function on Qualtrics (i.e. sequence generation is random through this platform).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Continuous primary and secondary outcomes will be analysed using linear mixed-model analyses to retain all participants randomised to a condition. A 10 (condition) × 2 (time) fixed effect model (x3 time for state measures) will be created for each outcome variable. Between-group effect sizes and 95% confidence intervals will be calculated. Demographic information and categorical variables will be explored with descriptive statistics. To assess sample size required, we considered a moderate (0.50) effect size difference between the interventions and control condition for our primary outcome to be clinically significant. A power analysis using a power level of 0.80 and an alpha of .05 and expecting a 57% retention (Schleider et al., 2022) revealed that 64 participants were required with an expectation that 36 would complete all waves of data (Hedeker et al., 1999). Therefore, a total of 576 participants will be recruited.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
5/11/2025
Actual
Sample size
Target
576
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318065 0
Government body
Name [1] 318065 0
National Health and Medical Research Council
Country [1] 318065 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320420 0
University
Name [1] 320420 0
Flinders University Institute for Mental Health and Wellbeing
Address [1] 320420 0
Country [1] 320420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316716 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 316716 0
Ethics committee country [1] 316716 0
Australia
Date submitted for ethics approval [1] 316716 0
22/11/2024
Approval date [1] 316716 0
19/12/2024
Ethics approval number [1] 316716 0
Flinders University HREC 7771

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

Contacts
Principal investigator
Name 138766 0
Prof Tracey Wade
Address 138766 0
Flinders University, GPO Box 2100. Adelaide 5001, South Australia
Country 138766 0
Australia
Phone 138766 0
+61 8 82013736
Fax 138766 0
Email 138766 0
[email protected]
Contact person for public queries
Name 138767 0
Tracey Wade
Address 138767 0
Flinders University, GPO Box 2100. Adelaide 5001, South Australia
Country 138767 0
Australia
Phone 138767 0
+61 8 82013736
Fax 138767 0
Email 138767 0
[email protected]
Contact person for scientific queries
Name 138768 0
Tracey Wade
Address 138768 0
Flinders University, GPO Box 2100. Adelaide 5001, South Australia
Country 138768 0
Australia
Phone 138768 0
+61 8 82013736
Fax 138768 0
Email 138768 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:
• Anyone who wishes to access it.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified data will be made publicly available and stored permanently on Professor Tracey Wade's Open Science platform

What types of analyses could be done with individual participant data?
• Any.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be stored immediately after publication and will reside permanently on Professor Tracey Wade's Open Science Platform.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• By accessing Prof Tracey Wade's OSF page. (https://osf.io/rtzv3/)

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.