RecruitingACTRN12626000133336

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

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

Sponsor

The University of Sydney

Enrollment

56 participants

Start Date

Mar 30, 2026

Study Type

Interventional

Conditions

Anorexia Nervosa Atypical Anorexia Nervosa

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.

Eligibility

Sex: Both males and femalesMin Age: 14 YearssMax Age: 25 Yearss

Inclusion Criteria9

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.

Exclusion Criteria9

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

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Interventions

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.