RecruitingNot Applicable

Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)

Australia20 participantsStarted 2024-06-27

Plain-language summary

CBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID). The purpose of this evaluation is to determine the feasibility, acceptability and effectiveness of this treatment. It is hypothesised that this treatment will be feasible and acceptable to clinicians, carers and patients and will be effective in reducing symptoms of ARFID for patients.

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Current primary diagnosis of ARFID according to DSM-5 criteria as determined by the treating team (the eating disorders Orygen Specialist Program * Presenting for treatment in the eating disorders Orygen Specialist Program * If \<16yo, or \>16 but underweight (BMI \<18.5) and living with their parents/guardian, a parent/guardian should be involved in the treatment. Exclusion Criteria: * Current tube feeding * Inappropriateness for CBT-AR as determined by the clinicians (e.g. if there are more urgent issues to first manage such as high suicidal ideation, if participants do not have adequate comprehension capability, etc)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility

Timeframe: Upon conclusion of the study (week 18-30)

Acceptability: CTS

Timeframe: The CTS will be completed upon conclusion of the study (week 18-30)

Acceptability: CSQ

Timeframe: The CSQ will be completed upon conclusion of the study (week 18-30)

Acceptability: Adverse events

Timeframe: Adverse events will be collected weekly between baseline and the conclusion of the study (week 18-30)

Acceptability: Qualitative Feedback

Timeframe: Qualitative feedback will be collected at the conclusion of the study (end of stage 4, week 20-30)

Effectiveness: PARDI-AR-Q

Timeframe: The PARDI-AR-Q will be assessed at baseline, and at the conclusion of stages 2 (week 4-6) and 3 (week 18-28) and at conclusion of the study (week 18-30)

Effectiveness: FNS

Timeframe: The FNS will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)

Trial details

NCT IDNCT06463470

SponsorOrygen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-27

Contact for this trial

Andrea Phillipou

+61 3 9966 9100 andrea.phillipou@orygen.org.au

View on ClinicalTrials.gov More Avoidant/Restrictive Food Intake Disorder (ARFID) trials