Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
NCT Number: NCT06463470
Acronym: CBT-AR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
Interventions: BEHAVIORAL: Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
Sponsor: Orygen
Collaborators: University of Melbourne|Massachusetts General Hospital|Harvard Medical School (HMS and HSDM)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2026-03-31
Locations: Orygen Youth Health - Sunshine - Sunshine, Melbourne, Victoria, 3020, Australia|Orygen Youth Health - Parkville - Parkville, Melbourne, Victoria, 3052, Australia

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.

Primary Outcome Measures: 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 Outcome Measures: Body Mass Index (BMI), Calculated using weight and height Weight will be measured using digital scales and height measured using stadiometer, 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., 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., 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., This will be measured upon conclusion of the study (week 18-30)