Avoidant/Restrictive Food Intake Disorder (ARFID)CBT-ARNCT06463470
Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
A study testing Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) in people with Avoidant/Restrictive Food Intake Disorder (ARFID), run by Orygen at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Avoidant/Restrictive Food Intake Disorder (ARFID)
- What is being tested?
- Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesAustralia
- Study dates
- 27 Jun 2024to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Orygen Youth Health - Sunshine - Sunshine
Melbourne, Victoria, 3020
Orygen Youth Health - Parkville - Parkville
Melbourne, Victoria, 3052
About this study
Official title: Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR): An Evaluation of the Feasibility, Acceptability and Effectiveness in Individuals Aged 12 to 25 Years
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.
Read the detailed description
CBT-AR describes an adaption of cognitive behavioural therapy that is appropriate for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID). This therapy will be delivered by trained clinicians (e.g. psychologists, mental health nurses) and involves weekly sessions for 18-30 sessions (up to 30 sessions for underweight patients). This therapy will be delivered face-to-face whenever possible. If required (participant not able to travel for a session etc.) online or telephone sessions will be conducted.
This therapy involves four stages as described below.
- Stage 1 - Psychoeducation: This is covered in 2-4 sessions and involves explaining what ARFID is, educating patients and carers on food groups, nutrition and how to develop a balanced diet. Work is also done to increase eating volume for those who are underweight.
- Stage 2 - Treatment planning: This is covered in 2 sessions and involves matching the individuals needs to the correct exposure approach (examples provided in stage 3).
- Stage 3 - Graded exposure is covered for between 12 and 22 sessions (depending on the patient's needs) and describes slowly introducing more variety and volume of foods into the patient's diet. For those patients who are uncomfortable with strong tastes and textures, graded exposure might involve eating very small amounts of new foods during which time they are encouraged to describe the look, feel and taste of the food using neutral words to reduce a negative response. If they have a fear of choking, they might start by talking about that fear, followed by watching a video of someone choking and recovering, then they might eat a very small amount of food to reduce the risk of choking, followed by increases in portions over time.
- Stage 4 - Relapse prevention: This is covered in 2 sessions. In these sessions, individuals are taught to recognise triggers and indicators of relapse. They are then able to go back to the materials provided in treatment to guide their management of these relapsing thoughts/behaviours.
Clinicians will collect data on adherence weekly. A measure of patient, parent/guardian and clinician satisfaction will be collected at the end of stage 4.
Parents/guardians of individuals <16yrs, or parents/guardians of patients who are underweight and living at home irrespective of age are involved in therapy through attending psychoeducation sessions and supporting the completion of homework.
- Being tested
- Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
- Keywords
- Mental Health, Eating Disorders
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Psychological Well-Being, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)Behavioural
CBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) | Experimental | This therapy involves four stages.
* Stage 1 -Psychoeducation: This is covered in 2-4 sessions and involves explaining what ARFID is, educating patients and carers on food groups, nutrition and how to develop a balanced diet. Work is also done to increase eating volume for those who are underweight.
* Stage 2 -Treatment planning: This is covered in 2 sessions and involves matching the individuals needs to the correct exposure approach (examples provided in stage 3).
* Stage 3 -Graded exposure is covered for between 12 and 22 sessions (depending on the patient's needs) and describes slowly introducing more variety and volume of foods into the patient's diet.
* Stage 4 -Relapse prevention: This is covered in 2 sessions. In these sessions, individuals are taught to recognise triggers and indicators of relapse. They are then able to go back to the materials provided in treatment to guide their management of these relapsing thoughts/behaviours. Receives: Behavioral: Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be determined based on whether patients attended sessions. This information will be collected weekly.
Clinicians will also record if a patient drops out of therapy and why (if known)
Measured: Upon conclusion of the study (week 18-30)
Acceptability: CTS
This outcome will be measured using 'The Compliance to Treatment Schedule' (CTS).
Measured: The CTS will be completed upon conclusion of the study (week 18-30)
Acceptability: CSQ
This outcome will be measured using the 'Client Satisfaction Questionnaire' (CSQ). Scores range from 8-32, with higher scores indicative of greater satisfaction.
Measured: The CSQ will be completed upon conclusion of the study (week 18-30)
Acceptability: Adverse events
This outcome will be measured using recordings of adverse events. Adverse events will be monitored weekly. Participants will be asked open-ended questions to determine whether they have experienced an adverse event in the past week. If an adverse event is elicited, in addition to describing the event and associated treatments, clinicians will ask questions to determine the severity and seriousness of the event, the likelihood that it is related to CBT-AR, and the outcome of the event. Examples of possible events might include vomiting or an allergic reaction to food in session or heightened anxiety around eating between sessions.
Measured: Adverse events will be collected weekly between baseline and the conclusion of the study (week 18-30)
Acceptability: Qualitative Feedback
This outcome will be measured using recordings of qualitative feedback. Qualitatively, clinicians are given an open text box and invited to enter any comments they might have including comments relating to the acceptability of the treatment.
Measured: Qualitative feedback will be collected at the conclusion of the study (end of stage 4, week 20-30)
Effectiveness: PARDI-AR-Q
This outcome will be measured using the Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q). Scores range from 0-6 for each subscale of severity of impact, sensory based avoidance, lack of interest, and concern about aversive consequences, with higher scores indicating greater severity.
Measured: 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
This outcome will be measured using the Food Neophobia Scale (FNS). Scores range from 0-42 on the shortened FNS, with higher scores indicative of greater food neophobia.
Measured: The FNS will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Secondary outcomes (4)
Body Mass Index (BMI)
Calculated using weight and height Weight will be measured using digital scales and height measured using stadiometer
Measured: BMI will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Distress
Depression, Anxiety, Stress Scale for Youth (DASS-Y). Scores range from 0-42 on each subscale of depression, anxiety and stress, with higher scores indicating greater severity.
Measured: The DASS-Y will be assessed at baseline and at the conclusion of stages 2 and 3 and at conclusion of the study (week 18-30)
Quality of life (QoL)
Recovering Quality of Life Questionnaire (ReQol). Scores range from 0-40 with higher scores indicating higher quality of life.
Measured: The ReQol will be assessed at baseline and at the conclusion of stages 2 and 3 and at conclusion of the study (week 18-30)
Quality of the relationship between clinician and patient
Working Alliance Inventory - Short Revised (WAI-SR). Scores range from 4-20 on each of the subscales of agreement of tasks, goals and bond, with higher scores indicative of stronger therapeutic alliance.
Measured: This will be measured upon conclusion of the study (week 18-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start27 Jun 2024
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avoidant/Restrictive Food Intake Disorder (ARFID)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomised evaluation study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orygen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Andrea Phillipou, Principal investigator, Orygen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463470
- Sponsor's protocol ID
- ORY-P02-24-04
- Acronym
- CBT-AR
- Status last verified
- Jun 2026
- First submitted
- 30 May 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miles S, Phillipou A, Neill E, Newbigin A, Kim HW, Eddy KT, Thomas JJ. An evaluation of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) in a youth outpatient eating disorders service: A protocol paper. Contemp Clin Trials. 2025 Jan;148:107756. doi: 10.1016/j.cct.2024.107756. Epub 2024 Nov 19.
PubMed 39566719
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR): An Evaluation of the Feasibility, Acceptability and Effectiveness in Individuals Aged 12 to 25 Years
- ClinicalTrials.gov ID
- NCT06463470
- Acronym / sponsor ID
- CBT-AR / ORY-P02-24-04
- Keywords
- Mental Health, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- OrygenUniversity, hospital or other
- Collaborators
- University of Melbourne, Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CBT-AR describes an adaption of cognitive behavioural therapy that is appropriate for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID). This therapy will be delivered by trained clinicians (e.g. psychologists, mental health nurses) and involves weekly sessions for 18-30 sessions (up to 30 sessions for underweight patients). This therapy will be delivered face-to-face whenever possible. If required (participant not able to travel for a session etc.) online or telephone sessions will be conducted.
This therapy involves four stages as described below.
- Stage 1 - Psychoeducation: This is covered in 2-4 sessions and involves explaining what ARFID is, educating patients and carers on food groups, nutrition and how to develop a balanced diet. Work is also done to increase eating volume for those who are underweight.
- Stage 2 - Treatment planning: This is covered in 2 sessions and involves matching the individuals needs to the correct exposure approach (examples provided in stage 3).
- Stage 3 - Graded exposure is covered for between 12 and 22 sessions (depending on the patient's needs) and describes slowly introducing more variety and volume of foods into the patient's diet. For those patients who are uncomfortable with strong tastes and textures, graded exposure might involve eating very small amounts of new foods during which time they are encouraged to describe the look, feel and taste of the food using neutral words to reduce a negative response. If they have a fear of choking, they might start by talking about that fear, followed by watching a video of someone choking and recovering, then they might eat a very small amount of food to reduce the risk of choking, followed by increases in portions over time.
- Stage 4 - Relapse prevention: This is covered in 2 sessions. In these sessions, individuals are taught to recognise triggers and indicators of relapse. They are then able to go back to the materials provided in treatment to guide their management of these relapsing thoughts/behaviours.
Clinicians will collect data on adherence weekly. A measure of patient, parent/guardian and clinician satisfaction will be collected at the end of stage 4.
Parents/guardians of individuals <16yrs, or parents/guardians of patients who are underweight and living at home irrespective of age are involved in therapy through attending psychoeducation sessions and supporting the completion of homework.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomised evaluation study
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) | Experimental | Behavioral: Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)This therapy involves four stages. * Stage 1 -Psychoeducation: This is covered in 2-4 sessions and involves explaining what ARFID is, educating patients and carers on food groups, nutrition and how to develop a balanced diet. Work is also done to increase eating volume for those who are underweight. * Stage 2 -Treatment planning: This is covered in 2 sessions and involves matching the individuals needs to the correct exposure approach (examples provided in stage 3). * Stage 3 -Graded exposure is covered for between 12 and 22 sessions (depending on the patient's needs) and describes slowly introducing more variety and volume of foods into the patient's diet. * Stage 4 -Relapse prevention: This is covered in 2 sessions. In these sessions, individuals are taught to recognise triggers and indicators of relapse. They are then able to go back to the materials provided in treatment to guide their management of these relapsing thoughts/behaviours. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)CBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID). | Behavioural | Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) |
Primary outcome
Feasibility
Time frame: Upon conclusion of the study (week 18-30)
Feasibility will be determined based on whether patients attended sessions. This information will be collected weekly. Clinicians will also record if a patient drops out of therapy and why (if known)
Acceptability: CTS
Time frame: The CTS will be completed upon conclusion of the study (week 18-30)
This outcome will be measured using 'The Compliance to Treatment Schedule' (CTS).
Acceptability: CSQ
Time frame: The CSQ will be completed upon conclusion of the study (week 18-30)
This outcome will be measured using the 'Client Satisfaction Questionnaire' (CSQ). Scores range from 8-32, with higher scores indicative of greater satisfaction.
Acceptability: Adverse events
Time frame: Adverse events will be collected weekly between baseline and the conclusion of the study (week 18-30)
This outcome will be measured using recordings of adverse events. Adverse events will be monitored weekly. Participants will be asked open-ended questions to determine whether they have experienced an adverse event in the past week. If an adverse event is elicited, in addition to describing the event and associated treatments, clinicians will ask questions to determine the severity and seriousness of the event, the likelihood that it is related to CBT-AR, and the outcome of the event. Examples of possible events might include vomiting or an allergic reaction to food in session or heightened anxiety around eating between sessions.
Acceptability: Qualitative Feedback
Time frame: Qualitative feedback will be collected at the conclusion of the study (end of stage 4, week 20-30)
This outcome will be measured using recordings of qualitative feedback. Qualitatively, clinicians are given an open text box and invited to enter any comments they might have including comments relating to the acceptability of the treatment.
Effectiveness: PARDI-AR-Q
Time frame: 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)
This outcome will be measured using the Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q). Scores range from 0-6 for each subscale of severity of impact, sensory based avoidance, lack of interest, and concern about aversive consequences, with higher scores indicating greater severity.
Effectiveness: FNS
Time frame: The FNS will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
This outcome will be measured using the Food Neophobia Scale (FNS). Scores range from 0-42 on the shortened FNS, with higher scores indicative of greater food neophobia.
4 secondary outcomes
Body Mass Index (BMI)
Time frame: BMI will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Distress
Time frame: The DASS-Y will be assessed at baseline and at the conclusion of stages 2 and 3 and at conclusion of the study (week 18-30)
Quality of life (QoL)
Time frame: The ReQol will be assessed at baseline and at the conclusion of stages 2 and 3 and at conclusion of the study (week 18-30)
Quality of the relationship between clinician and patient
Time frame: This will be measured upon conclusion of the study (week 18-30)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 39566719Miles S, Phillipou A, Neill E, Newbigin A, Kim HW, Eddy KT, Thomas JJ. An evaluation of Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) in a youth outpatient eating disorders service: A protocol paper. Contemp Clin Trials. 2025 Jan;148:107756. doi: 10.1016/j.cct.2024.107756. Epub 2024 Nov 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Phillipou principal investigator
Orygen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR) in people with Avoidant/Restrictive Food Intake Disorder (ARFID), run by Orygen at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Upon conclusion of the study (week 18-30)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06463470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.