Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001383459
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
31/10/2025
Date registered
Help: Date registered
9/12/2025
Date last updated
Help: Date last updated
27/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/12/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Sequential Multiple Assignment Randomised Trial (SMART) of personalised treatment for Bulimia Nervosa and Binge Eating Disorder - TailorED
Scientific title
A Sequential Multiple Assignment Randomised Trial (SMART) of Personalised Treatment to Modify Objective Binge Eating Frequency in Bulimia Nervosa and Binge Eating Disorder - TailorED
Additional trial identifiers [1] 315238 0
None
Universal Trial Number (UTN)
Trial acronym
TailorED
Related trial records
This study is linked to the Holistic Understanding (HU) study (ACTRN12625000731493). The HU study is a longitudinal, biopsychosocial phenotyping and genotyping study designed to clarify the multi-level mechanisms underpinning eating disorders. Participants in the HU study will be invited to also participate in the TailorED Trial. Outcomes will be assessed using data collected through the HU study, in addition to additional outcome measurements unique to the TailorED Trial.

Health condition
Health condition(s) studied:
Bulimia Nervosa 338696 0
Binge Eating Disorder 339665 0
Condition category
Condition code
Mental Health 334979 334979 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a multi-centre sequential multiple-assignment randomised trial (SMART) design. All participants will commence with four weeks of first-line treatment; namely, cognitive-behavioural therapy (CBT) guided self help (GSH). The InsideOut Institute for Eating Disorders at the University of Sydney has developed an online CBT intervention called Binge Eating eTherapy (BEeT). Participants will commence with four weeks of BEeT(GSH) which will include weekly online eTherapy modules delivered alongside 30-minute weekly one-to-one telehealth sessions with a guide who is a registered or provisionally registered mental health professional.

Eligible participants who have completed baseline assessments for the Holistic Understanding Study (Trial Id: ACTRN12625000731493) will commence participation in the TailorED trial within 1 week of completing HU baseline assessments.

The first four weeks introduce participants to BEeT(GSH). Each weekly module consists of approximately 60 minutes of self-directed online eTherapy modules followed by a 30-minute weekly one-to-one telehealth sessions with a guide. Orientation covers program structure, treatment goals, pre-treatment review, safety planning, and weekly weighing. Core modules teach CBT principles, goal setting, the binge eating cycle, and self-monitoring. Subsequent sessions reinforce these foundations, focusing on personalised formulation, motivation to change, structured eating, and planning ahead. Participants learn to implement regular eating, identify triggers, use pleasant and distracting activities, and address compensatory behaviours. Week four consolidates coping strategies and includes a wrap-up call to determine next treatment steps.

After 4 weeks of BEeT(GSH), response to treatment will be assessed and participants will be categorised according to well established criteria as either rapid responders (RR) or non-rapid responders (NRR) to treatment (Russell et al., 2023, Thompson-Brenner et al., 2025). RR are defined as those reporting at least a 70% reduction in binge eating episodes. NRR are defined as those reporting less than a 70% reduction in binge eating episodes. All randomly allocated treatments continue immediately after the 4-weeks of first line treatment.

All RR after four weeks of first-line treatment will be randomly allocated to continue with a further six weeks of: a) BEeT(GSH) (online eTherapy modules approximately 60 minutes in length delivered alongside 30-minute weekly one-to-one telehealth sessions with a guide who is a registered or provisionally registered mental health professional), or b) weekly BEeT online eTherapy modules with one-to-one ‘light contact’ from a registered or provisionally registered mental health professional. ‘Light contact’ means 5-10 minutes of non-clinical contact per week between guide and participant via email, text message or phone to ensure participants have what they need to complete the program week.

All NRR after four weeks of first-line treatment will be randomly allocated to continue with 16 weeks of a) BEeT(GSH) (online eTherapy modules approximately 60 minutes in length delivered alongside 30-minute weekly one-to-one telehealth sessions with a guide who is a registered or provisionally registered mental health professional totalling 24 hours of intervention over 16 weeks), b) a personalised package of psychotherapy 90 minutes per week (totalling 24 hours of intervention over 16 weeks), or c) a learning enhanced transcranial magnetic stimulation (TMS) treatment package (totalling 24 hours of intervention over 16 weeks).

BEeT Therapy:
RR participants assigned to either the BEeT(GSH) or BEeT(LC) arms will continue on from the first-line treatment administered in the initial 4 weeks of treatment for an additional 6 weeks (10 weeks of BEeT total). The online content will be consistent between the two randomisation arms, with the only variant being the type and amount of guided support provided by the clinician. Sessions 5–10 extend CBT skills and deepen behavioural and cognitive strategies. Participants continue weekly check-ins and weighing, with ongoing review of self-monitoring accuracy. Session 5 introduces problem-solving and explores the role of emotions in binge eating, teaching skills for identifying and managing emotional triggers. Session 6 focuses on emotion regulation, including noticing, validating, and expressing feelings, and introduces monitoring thoughts and unhelpful thinking patterns. Session 7 builds on this by teaching thought-challenging techniques and practicing them using the Toolbox. Session 8 addresses feared foods and rigid food rules, introducing exposure strategies and creating hierarchies for challenging these fears. Session 9 shifts to body image concerns, avoidance and checking behaviours, and introduces urge surfing as a coping skill. Session 10 consolidates learning with relapse prevention planning, body acceptance, self-compassion, and identifying values and strengths, while reflecting on progress and preparing for long-term recovery.

NRR participants assigned to the BEeT(GSH) will continue on from the first-line treatment administered in the initial 4 weeks of treatment for an additional 16 weeks (20 weeks of BEeT(GSH) total). This content is consistent with that provided to the RR BEeT arms, with the same CBT-based modules but with greater depth, more gradual progression, and repeated practice. Additional sessions allow for troubleshooting barriers, reinforcing skills like emotion regulation and thought challenging, and expanding exposure work for food and body image concerns. The extended format also includes more time for reflection, values-based work, and relapse prevention planning to strengthen long-term recovery. This extended version of the online BEeT content has been specifically developed for this study.

Personalised Psychotherapy:
Participants randomised to personalised package of psychotherapy (PEP) will receive a highly personalised measurement-based care package delivered one-to-one by a psychologist via telehealth or face-to-face. Personalised psychotherapy will take a fully modularised approach, whereby components of evidence-based therapies will be delivered according to individual characteristics and collaboratively identified treatment targets. Modules are drawn from best-practice examples of evidence-based therapies in and beyond eating disorders and focus on a range of concepts relevant to Bulimia Nervosa (BN) and Binge Eating Disorder (BED). Eight modules are available, targeting: 1) lifestyle routines and self-care, 2) decision making and planning, 3) body image and weight stigma, 4) relationships and connection, 5) emotion regulation, 6) impulse control and cravings, 7) self-worth and self-compassion, and 8) motivation and commitment to change. Each module is designed to take approximately 360-minutes, which will be administered in four 90-minute sessions over four weeks.

PEP will commence with: development of an expanded, personalised shared formulation incorporating baseline data (this will be a live document throughout the intervention and informed by ongoing monitoring data (including Ecological Momentary Assessment [EMA], treatment response data, clinician and client perspective, and comprehensive problem-solving training, and comprehensive and repeated chain analysis. This information alongside collection of EMA items assessing symptom presence will be used during a shared decision-making meeting to decide on treatment targets and the assignment of modules to address them.

At the end of each module, EMA items will be collected again to determine if the current assigned modules should continue or other modules be assigned, and the formulation (based on ongoing data collection, problem solving, and chain analyses, and progress through therapy) will be updated and also taken into the shared decision making meeting for module assignment. PEP will end with 2 weeks of relapse prevention and discharge planning. Treatment will be delivered online and will be supported by written and/or online materials.

Transcranial Magnetic Stimulation Treatment Package:
The NRRs randomly allocated to the personalised Transcranial Magnetic Stimulation (TMS) package will receive a highly tailored, measurement-based care package comprised of motivational interviewing, cognitive exercises, and TMS modules. The TMS package modules are drawn from best-practice examples of evidence-based interventions in and beyond eating disorders and may focus a range of concepts relevant to BN and BED including difficulties with cognitive control and reward processing (Colton et al., 2023).

The motivational interviewing will be delivered weekly, beginning in the first week post randomisation (Week 5). Participants will undergo three sessions over a three-week period, to a total of 105 minutes. The aim of the motivational interviewing is to increase participants' readiness for TMS. The motivational interview will be administered by provisional or registered psychologists via videoconferencing platform (Zoom). During this clinician facing time, participants will also perform their weekly weigh-ins.

From the second week of the TMS package (Week 6), a pre-existing digital neurorehabilitation platform, NeuronUp (https://neuronup.us/), will be used to conduct personalised cognitive exercises. Participants will complete 30 minutes of training five times per week over a two-week period, to a total of 300 minutes. Training will be completed at home in the participants' time using the NeuronUp2Go feature, a tailored account for participants which can be accessed on their computer. The mode of intervention used in NeuronUp will be primarily games. These activities are organised in different levels of difficulty so that the participant will move forward or backward automatically depending on their successes/mistakes – in this way the program delivered is personalised to the person’s capacity. Games can also be customised to suit each participant's needs (e.g., timing, number of exercises, number of stimuli or targets, maximum errors allowed).

Both the motivational and NeuronUp content will be followed by five consecutive days of accelerated theta-burst stimulation (iTBS) delivered over the left dorsolateral prefrontal cortex, start in Week 8. This will occur at Royal Prince Alfred Hospital, Camperdown NSW and Monash University, School of Psychological Sciences, Clayton VIC. Participants recruited through the West Wodonga VIC site will be assisted to travel to the Clayton VIC site to complete iTBS intervention. The iTBS approach is modelled on the FDA-approved (K220177) Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol (Cole et al., 2020). We will mimic the stimulation parameters of this widely used protocol for the treatment of depression (up to 1,800 pulses per TMS dose at up to 110% of the resting motor threshold). Participants will undergo three iTBS doses each session (day), with 50 minutes between each dose. Each TMS dose will last approximately 20 minutes, including 5 minutes for preparation, 3 minutes for adaptation, and ~10 minutes of stimulation. The burst pattern consists of three pulses at 50 Hz, with 10 bursts delivered in two second trains (5 Hz) followed by an eight-second inter-train interval, for a total of 60 cycles. In the first TMS dose on Day one, the Resting Motor Threshold procedure will be conducted (~10 minutes). After each dose, a non-invasive brain stimulation poststimulation Interview (~10 minutes) will be administered. Therefore, participants will need to commit approximately 4.5-5 hours per day for 5 days of TMS treatment.

Following TMS (Weeks 9-20), participants will complete a further 12 weeks of cognitive training on NeuronUp, via the NeuronUp2Go feature, focused on generalisation of cognitive learnings into daily life activities. During these weeks, participants will also meet with a clinician for a brief 10-20 minute weekly check-in via Zoom to complete weigh-ins and discuss the weekly content and progress. For the final check-in at Week 20, discharge planning and relapse prevention will be covered.

Fidelity Checks:
Clinicians will complete session logs and fidelity checklists to document treatment delivery and adherence to the interventions. Between 10% and 50% of therapy sessions will be audio-recorded to assess treatment fidelity and support clinical supervision. Recordings will be reviewed using a standardised fidelity checklist to ensure adherence to the treatment model.
Intervention code [1] 331933 0
Treatment: Other
Description of the comparator or control
Cognitive-behavioural therapy (CBT) guided self help (GSH) is an established evidence based 'treatment as usual' which will act as an active comparator treatment.

CBT(GSH) interventions are recommended as the first line treatment for BN and BED (National Guideline Alliance, 2017; Russell et al., 2023). The InsideOut Institute for Eating Disorders at the University of Sydney has developed an online CBT program called Binge Eating eTherapy (BEeT). BEeT includes the core components and strategies of CBT proven to be effective in treating EDs and may be delivered as an unguided or guided intervention (Barakat, 2023). Core components of BEeT include: self monitoring, understanding the binge eating cycle, addressing binge eating and compensation behaviour, problem solving skills, ways to recognise and manage emotions, how to respond to unhelpful patterns, overcoming food rules, exposure challenges, strategies to address avoidance and checking behaviour, urge surfing, and relapse prevention.

In the GSH version of BEeT, individuals are assigned to a guide (a registered or provisionally registered mental health professional) who provides weekly, one-on-one 30-minute telemedicine sessions to check-in with the client and review their progress (Barakat et al., 2021). In the unguided 'light contact' approach BEeT(LC), weekly online eTherapy modules will be delivered along with one-to-one ‘light contact’ from a guide (a registered or provisionally registered mental health professional). ‘Light contact’ means 5-10 minutes of non-clinical contact per week between guide and participant via email, text message or phone to ensure participants have what they need to complete the program for the week.
Control group
Active

Outcomes
Primary outcome [1] 342740 0
Change in frequency of objective binge eating (OBE) symptoms
Timepoint [1] 342740 0
Randomisation (week 4).
Secondary outcome [1] 451958 0
Self-reported control of eating behaviours
Timepoint [1] 451958 0
Baseline, end of treatment (10 weeks for RR, and 20 weeks for NRRs), and six month follow-up (36 weeks for RR and 46 weeks for NRR).
Secondary outcome [2] 451959 0
Eating disorder psychopathology
Timepoint [2] 451959 0
Randomisation (week 4).
Secondary outcome [3] 452021 0
Clinician assessed functional recovery
Timepoint [3] 452021 0
End of treatment (10 weeks for RR, and 20 weeks for NRRs) and six month follow-up (36 weeks for RR and 46 weeks for NRR).
Secondary outcome [4] 453600 0
Self-reported functional recovery
Timepoint [4] 453600 0
Baseline, end of treatment (10 weeks for RR, and 20 weeks for NRRs), and six month follow-up (36 weeks for RR and 46 weeks for NRR).

Eligibility
Key inclusion criteria
- Participant is eligible and agrees to participate in the Holistic Understanding (HU) Study Protocol No. X24-0167 (ACTRN12625000731493).
- Aged between 16 and 60 years
- Full threshold BN or BED as primary diagnosis, as per DSM-5 criteria
- Suitable for outpatient treatment
- English speaking and reading proficiency
- Computer literacy skills
- Must agree to discontinue other active psychotherapies for the duration of study treatment period
- BMI greater than or equal to 19.5
- Medical practitioner (e.g. GP, paediatrician or psychiatrist) clearance to participate
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Medical instability (once resolved can re-present)
- Anorexia Nervosa or Atypical Anorexia Nervosa
- Active suicidality
- Active psychosis
- Current pregnancy or breastfeeding
- Substance use disorder
- Unable to access the study site for assessment and therapy
- GLP-1 agonist medication use within 6 months of study enrolment
- Stimulant medication use (e.g. dexamphetamine, modafinil, methylphenidate, lisdexamfetamine) within 6 months prior to enrolment to treat an eating disorder.
- Stimulant medication use (e.g., dexamphetamine, modafinil, methylphenidate, lisdexamfetamine) within 6 months prior to enrolment for indications other than an eating disorder, unless on a stable dose for at least 6 months before enrolment.
- Non-stimulant medication that may have appetite suppressing effects, including atomoxetine and viloxazine, unless on a stable dose for at least 6 months before enrolment.
- Bariatric Surgery within two years of study enrolment, or plans for bariatric surgery within 12 months after study enrolment
- TMS contraindicated medication (clozapine, high-dose benzodiazepine [Equivalent to diazepam 20mg or more per day], withdrawing from high-dose alprazolam [greater or equal to 2mg a day] or lorazepam [greater or equal to 4mg a day]). All other doses to be assessed by a medical professional and/or lead TMS clinician.
- History of seizures or epilepsy (including first-degree familial).
- Serious neurological condition (e.g., brain injury, stroke, brain lesion)
- All other TMS contraindications, including:
-- History of brain trauma (e.g., recent (less than six month) or frequent (greater than three) concussions),
-- loss of consciousness greater than 30 minutes
-- neurodegenerative illness, or any other neurological condition
-- past adverse response to brain stimulation
-- history of frequent fainting (unrelated to BN/BED symptomatology)
-- severe or recurrent headaches/migraines
-- implanted medical devices
-- Metal implants in the head (e.g., intracranial clips, Cochlear implants)

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)
Central randomisation by computer (REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation will be employed to allocate participants to treatment arms. The randomisation sequence will be stratified by clinical diagnosis (BN and BED) and by early treatment response status (rapid responders versus non-rapid responders). Within each stratum, block randomisation will be used, with block sizes of one or two selected at random to maintain allocation concealment. The randomisation sequence will be computer-generated using a pseudo-random number approach, with the reproducible randomisation seed maintained by an unblinded statistician not involved in participant enrolment or assessment. The final allocation sequence will be securely uploaded into the REDCap electronic data capture system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential and adaptive
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
A total sample size of 204 participants is recommended overall. This will ensure a minimum of 34 participants per adaptive intervention within the non-rapid responder group after accounting for an anticipated 30% attrition rate. The sample size calculation assumes a 50% non-response rate at 4 weeks, with a target power of 80% and a Type I error rate of 0.05. The design can accommodate an imbalance of up to 40% responders and 60% non-responders without compromising statistical power.

Analysis plan:
As per the recommendations of Almirall et al. (2014), a linear multiple regression with weighting and replication will be used to evaluate all hypotheses. A weighting scheme will be applied to rectify the underrepresentation of the non-rapid responders (with three possible second stage interventions) as compared to the rapid responders (with two second stage interventions). Prior to data analysis, all outcomes and covariates will be replicated for respondents in the non-rapid responder arm. Following the application of both weighting and replication, a standard linear regression model can be applied to analyse all hypotheses. Consistent with an estimands approach, intercurrent events such as missed assessment timepoints will be incorporated into the final analysis according to the treatment policy approach (ICH E9 R1). Accordingly, the study will be analysed on an intention-to-treat basis. Thus, missed assessment data will be imputed using multiple imputation. A sensitivity analysis will include a tipping point analysis using the delta method (adjusting each imputed value by single primary outcome measure increments) which will evaluate departures from an assumption of missing at random.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/12/2025
Actual
23/03/2026
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
3/07/2028
Actual
Sample size
Target
204
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 28442 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 28443 0
Monash University - School of Psychological Sciences - Clayton
Recruitment hospital [3] 28444 0
La Trobe University - School of Psychology and Public Health - Albury-Wodonga Campus - West Wodonga
Recruitment postcode(s) [1] 44671 0
2050 - Camperdown
Recruitment postcode(s) [2] 44672 0
3168 - Clayton
Recruitment postcode(s) [3] 44673 0
3690 - West Wodonga

Funding & Sponsors
Funding source category [1] 319804 0
Government body
Name [1] 319804 0
Commonwealth Department of Health National Leadership in Mental Health Program Grant ID P051002 - 4G0TT7NX
Country [1] 319804 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 322443 0
None
Name [1] 322443 0
Address [1] 322443 0
Country [1] 322443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318361 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 318361 0
Ethics committee country [1] 318361 0
Australia
Date submitted for ethics approval [1] 318361 0
26/08/2024
Approval date [1] 318361 0
13/02/2025
Ethics approval number [1] 318361 0
Protocol No. X24-0273 & 2024/ ETH01825

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

Contacts
Principal investigator
Name 143942 0
Prof Sarah Maguire
Address 143942 0
The University of Sydney, Level 2, The Charles Perkins Centre, D17 Johns Hopkins Dr, Camperdown NSW 2050
Country 143942 0
Australia
Phone 143942 0
+61 2 86271910
Fax 143942 0
Email 143942 0
[email protected]
Contact person for public queries
Name 143943 0
Project Manager
Address 143943 0
The University of Sydney, Level 2, The Charles Perkins Centre, D17 Johns Hopkins Dr, Camperdown NSW 2050
Country 143943 0
Australia
Phone 143943 0
+61 2 8627 5690
Fax 143943 0
Email 143943 0
[email protected]
Contact person for scientific queries
Name 143944 0
Project Manager
Address 143944 0
The University of Sydney, Level 2, The Charles Perkins Centre, D17 Johns Hopkins Dr, Camperdown NSW 2050
Country 143944 0
Australia
Phone 143944 0
+61 2 8627 5690
Fax 143944 0
Email 143944 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

• - Researchers from not-for-profit organisations
- Commercial Organisations

Conditions for requesting access:
• Only HREC approved studies may apply for access to trial data. All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information please contact [email protected].

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Any type of analysis, and will be assessed on a case-by-case basis.

When can requests for individual participant data be made (start and end dates)?
From:
12-months (embargo period) following formal trial conclusion

To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Please contact the Signature Studies team at [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.