ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000133336

Ethics application status

Approved

Date submitted

18/12/2025

Date registered

3/02/2026

Date last updated

23/06/2026

Date data sharing statement initially provided

3/02/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

For Me Trial: An N-of-1 Study to Evaluate a Personalised Package of Care for Young People with Anorexia Nervosa and their Carers

Scientific title

For Me Trial: A Pragmatic N-of-1 Multiple Baseline Single-Case Experimental Design (SCED) Study to Evaluate a Personalised Package of Care for Young People with Anorexia Nervosa and their Carers

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

For Me Trial

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 For Me Trial will also participate in the HU study. Outcomes will be assessed using data collected through the HU study, in addition to additional outcome measurements unique to the For Me Trial.

Health condition

Health condition(s) studied:

Anorexia Nervosa

Atypical Anorexia Nervosa

Condition category

Condition code

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention is an intensive and highly-supported personalised package of care for people with early-stage Anorexia Nervosa (AN) and, where involved, their carer/s. Treatment is organised into phases, each lasting four weeks, with a unique combination of evidence-based modules prescribed at the start of each phase. Participants complete a range of assessments, including an initial assessment (via the Holistic Understanding study, ACTRN12625000731493), weekly symptom monitoring and Ecological Momentary Assessment (EMA). This data, within a shared decision-making meeting, will inform the assignment of a highly personalised series of evidence-based treatment modules.

Eligible participants who have completed baseline assessments for the Holistic Understanding Study will commence participation in the For Me Trial within one week of completing HU baseline assessments.

Initially participants will be randomised to a control condition of 2, 4, 6 or 8 weeks. This will be followed by a washout period of 14 days (+/- 3 days) before commencing the active intervention. The duration of the active intervention will be 22, 20, 18 or 16 weeks, corresponding to the length of the initial control condition. Altogether, the treatment phase will span 26 weeks (including the washout period).

Participants will attend a total of 120 minutes of sessions per week, which will be delivered by a psychologist, or split between a psychologist, dietitian, and/or peer support worker, dependent on stage of treatment and assigned modules. Sessions will be primarily delivered in-person, however, there will be some flexibility to conduct sessions online when necessary, based on accessibility needs.

The first two weeks of treatment consist of an initial assessment and formulation session followed by a standardised set of core modules (including nutritional rehabilitation and psychoeducation). Thereafter, nutritional rehabilitation sessions will continue until the participant has worked through the RAVES nutritional rehabilitation framework, and evidence-informed treatment modules will be assigned at the start of each treatment phase during a clinical prescription meeting. Participants will complete five to six treatment phases, depending on the condition to which they are assigned.

The personalisation allocation of modules will be based on a review of participant data, including Ecological Momentary Assessment (EMA), in the clinical prescription meeting. The top drivers of core AN symptoms, as identified through the EMA data, will be reviewed using a shared-care decision-making tree to determine which modules will be assigned for the next treatment phase.

Modules are adapted from existing evidence-based therapeutic approaches and interventions, including the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), Maudsley Family Based Therapy (FBT), Enhanced Cognitive Behaviour Therapy for Eating Disorders (CBT-E), and Acceptance and Commitment Therapy (ACT). Modules include: motivation to change; fear of food and food exposure; body image work including exposure; interpersonal effectiveness; eating disorder cognitions, obsessionally and rigidity; emotional awareness and regulation; sense of self and identity; connectedness and self-care; addressing anxiety; addressing exercise; compensation; and relapse prevention planning. The intervention also uses an overarching trauma-informed, attachment-based framework focusing on connection and an attuned problem-solving stance.

Participants will have an account on the InsideOut Institute (IOI) digital platform, the eClinic, to access psychoeducation and between-session resources and homework tasks (i.e., self-monitoring tools), tailored to assigned modules.

Fidelity Checks: Psychologists will deliver the psychological therapy and dietitians the dietetic intervention. All will receive training on the protocol and attend regular supervision sessions to maintain fidelity. Between 10% - 50% of sessions will be audio recorded. Recordings will be independently coded by two members of the research team using a checklist of intervention content. Inter-rater reliability will be assessed between coders using Krippendorff’s alpha. Recordings will also be used in psychologist supervision to enhance clinical practice.

Intervention code [1]

Treatment: Other

Description of the comparator or control

The control treatment will be standardised, consisting of evidence-based general supportive counselling and dietetic support. For those aged 14-17 years, an FBT frame will be used. For individuals aged 18 years and older, the control treatment is informed by CBT-E and MANTRA principles and content. An active control condition was chosen and designed to mimic community-based treatment-as-usual as closely as possible, to enhance external validity of the study and ensure safety of the participants while in the control condition. The time (contact hours) and intensity of the control intervention will match that of the individualised treatment intervention (i.e., 120 minutes of sessions per week). This study is a multiple baseline single case experimental design. Participants will be randomised to receive 2-, 4-, 6-, or 8-weeks of treatment-as-usual (control condition), before commencing a personalised treatment package.

Control group

Active

Outcomes

Primary outcome [1]

Eating disorder psychopathology (weekly)

Timepoint [1]

Baseline, weekly during treatment period, end-of-treatment (primary timepoint), 6-month follow-up

Primary outcome [2]

Weight restoration

Timepoint [2]

Baseline, weekly during treatment period, end-of-treatment (primary outcome), 6-month follow-up

Secondary outcome [1]

Eating disorder psychopathology

Timepoint [1]

Baseline, washout, mid-treatment, end-of-treatment, 6-month follow-up

Secondary outcome [2]

Related psychopathology - Anxiety

Timepoint [2]

Baseline, fortnightly during treatment period, end-of-treatment, 6-month follow-up

Secondary outcome [3]

Related psychopathology - Depression

Timepoint [3]

Baseline, fortnightly during treatment period, end-of-treatment, 6-month follow-up

Secondary outcome [4]

Nutritional Rehabilitation

Timepoint [4]

Baseline, washout, end-of-treatment, 6-month follow-up

Secondary outcome [5]

Patient-reported outcome measure (PROM)

Timepoint [5]

Baseline, washout, end-of-treatment

Secondary outcome [6]

Feasibility of treatment

Timepoint [6]

Collected from study records

Secondary outcome [7]

Feasibility of treatment

Timepoint [7]

Collected from study records

Secondary outcome [8]

Feasibility of treatment

Timepoint [8]

Collected at end of control condition and end of active treatment

Secondary outcome [9]

Acceptability of treatment

Timepoint [9]

Collected from study records

Secondary outcome [10]

Acceptability of treatment

Timepoint [10]

Collected at end of control condition and end of active treatment

Secondary outcome [11]

Acceptability of treatment

Timepoint [11]

Collected at end of control condition and end of active treatment

Secondary outcome [12]

Acceptability of treatment

Timepoint [12]

Collected at end of control condition and end of active treatment.

Secondary outcome [13]

Acceptability of treatment

Timepoint [13]

Feedback is collected throughout the treatment period at the discretion of participants, carers, and clinicians. The feedback form is available via the study therapy platform, and feedback may be submitted at intervals determined by the respondent.

Eligibility

Key inclusion criteria

- Participant is eligible and agrees to participate in the Holistic Understanding study (ACTRN12625000731493)
- Age 14 – 25 years old
- Satisfies DSM-5 criteria for AN or OSFED atypical-AN (subthreshold AN)
- Illness onset within past 3 years
- English speaking and reading proficiency
- Access to mobile device or computer
- Computer literacy skills
- Not engaged in any outpatient psychological or dietetic treatment, and agrees not to start any such treatments during the study treatment period.
- Medical practitioner (e.g. GP or paediatrician) clearance confirming participant meets safety criteria for community treatment and will be medically monitored throughout the trial.

Minimum age

14 Years

Maximum age

25 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- Medical instability (once resolved can re-present)
- Active suicidality
- Active psychosis
- Substance Use Disorder
- 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.
- Unable to access the study site for assessment and therapy

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)

Randomised to receive 2-, 4-, 6-, or 8-weeks of treatment-as-usual (control condition) prior to a 14 day (+/-3 days) washout periods, prior to commencing the personalised treatment package. Allocation will be concealed via central randomisation by computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Stratification allocation was not employed in randomisation.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

This study uses a Single-Case Experimental Design (SCED) with multiple baselines across participants. Participants are randomly allocated to a baseline (control) phase of varying duration (2, 4, 6, or 8 weeks). This is followed by a washout period lasting 14 days (±3 days), after which they begin the intervention phase. Participants serve as their own controls, and the staggered start times allow for experimental control and assessment of intervention effects at the individual level.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size
Using an ANCOVA framework with 24 assessment timepoints and an overall effect size (Cohen’s d= 0.3) and using 10,000 simulations to power the study = 80% with Type-I error = 0.05, a target sample of 38 participants is required to achieve sufficient power for the primary aim of the study. To account for anticipated 30% attrition and rounded up to the nearest four (to allow for balanced randomisation across staggered commencement of treatment times), a target sample of 56 participants will be recruited.

Analysis plan
The Primary Outcome variable will be a co-primary measure including change in EDE-QS and BMI over time. Results will reflect positive participant outcomes as indicated by a decrease in EDE-QS scores and an increase in BMI over time. Assessment timepoints will occur weekly with the primary endpoint being 26-weeks post-baseline assessment.

Key demographic and clinical variables will be summarised and compared using Posterior Predictive Chi-Squared test of independence for categorical data or via the posterior distribution of the mean difference when comparing mean values between continuous measures.

A Bayesian mixed effects model will be used as the primary analysis model. This model will include fixed effects for time (measured as a continuous variable), non-linear time (accounting for the staggered commencement of treatment), phase (binary variable accounting for baseline versus treatment), controlling for age and adjusting for baseline EDE-QS and BMI scores (co-primary outcome measure). Random effects will also be modelled including a random intercept to account for variation between participants and a random slope to account for time trends per participant. Three levels of informative priors will be used to evaluate the primary assumptions of model efficacy including a vague, weakly informative and strongly informative priors. Model fit indices and joint posterior predictive plots ensure model robustness.

Joint posterior probabilities exceeding 95% will be used to evaluate efficacy for the co-primary endpoint. Bayes factors will be published to assist in interpretation of effects.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

30/03/2026

Actual

27/03/2026

Date of last participant enrolment

Anticipated

1/03/2027

Actual

Date of last data collection

Anticipated

1/03/2028

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Commonwealth Department of Health National Leadership in Mental Health Program Grant ID P051002 - 4G0TT7NX

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

https://www.slhd.nsw.gov.au/rpa/research/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/08/2024

Approval date [1]

30/09/2024

Ethics approval number [1]

Summary

Brief summary

This study aims to test how effective a highly-supported, personalised package of care is for young people (14-25 years) with anorexia nervosa or atypical anorexia nervosa and their carers. Treatment occurs in four-week phases. Prior to each phase, the clinical team consults with the participant (and their carer/s, where involved) to assign the modules for the next treatment phase. The modules are adapted from existing evidence-based approaches and address such therapeutic targets as motivation to change, fear of food, body image, and connectedness. Each participant’s symptoms are closely tracked throughout the study using regular assessments, which are also used to guide the personalisation of treatment modules. The study uses a single-case experimental design with multiple baselines. As such, prior to receiving the personalised package, participants first receive standard care. Each participant's symptoms are tracked closely between these two treatments, to determine whether the personalised care leads to better results than the standard treatment.

Trial website

https://www.eatingdisordersresearch.org.au/signature-studies/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sarah Maguire

Address

The University of Sydney, Level 2, The Charles Perkins Centre, D17 Johns Hopkins Dr, Camperdown NSW 2050

Country

Australia

Phone

+61 02 86271910

Fax

[email protected]

Contact person for public queries

Name

Signature Studies Trials Manager

Address

The University of Sydney, Level 2, The Charles Perkins Centre, D17 Johns Hopkins Dr, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8627 5690

Fax

[email protected]

Contact person for scientific queries

Name

Signature Studies Trials Manager

Address

The University of Sydney, Level 2, The Charles Perkins Centre, D17 Johns Hopkins Dr, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8627 5690

Fax

[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

• Data are potentially available to:
- Researchers from not-for-profit organisations
- Commercial Organisations
- Other

Based in:
- Any location

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?

• 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?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Statistical analysis plan	Iyer, R. (2026) Statistical Analysis Plan (SAP) - Prepared on behalf of ‘A Sequential Multiple Assignment Randomised Trial of personalised treatment for Bulimia Nervosa and Binge Eating Disorder (TailorED).				BN_SAP_v1_20.04.2026.pdf

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.

Trial Review

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