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

NCT06463470 | Recruiting

• 1 other identifier: ORY-P02-24-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Keywords

Mental Health; Eating Disorders

Outcome Measures

Primary Outcomes (7)

• 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)

  Upon conclusion of the study (week 18-30)

• Acceptability: CTS

  This outcome will be measured using 'The Compliance to Treatment Schedule' (CTS).

  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.

  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.

  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.

  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.

  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.

  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)

  BMI will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)

• Distress

  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)

  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

  This will be measured upon conclusion of the study (week 18-30)

Study Arms (1)

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.

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

Interventions

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

CBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID).

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

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Orygen: lead
• University of Melbourne: collaborator
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (2)

Orygen Youth Health - Sunshine - Sunshine

Melbourne, Victoria, 3020, Australia

RECRUITING

Orygen Youth Health - Parkville - Parkville

Melbourne, Victoria, 3052, Australia

RECRUITING

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder; Psychological Well-Being; Feeding and Eating Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrea Phillipou

  Orygen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Phillipou

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomised evaluation study

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 17, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): June 27, 2027
• Study Completion (Estimated): June 27, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)