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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06463470




Registration number
NCT06463470
Ethics application status
Date submitted
30/05/2024
Date registered
17/06/2024
Date last updated
28/08/2024

Titles & IDs
Public title
Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)
Scientific 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
Secondary ID [1] 0 0
ORY-P02-24-04
Universal Trial Number (UTN)
Trial acronym
CBT-AR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Avoidant/Restrictive Food Intake Disorder (ARFID) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)

Experimental: 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.


BEHAVIORAL: 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).
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility
Timepoint [1] 0 0
Upon conclusion of the study (week 18-30)
Primary outcome [2] 0 0
Acceptability: CTS
Timepoint [2] 0 0
The CTS will be completed upon conclusion of the study (week 18-30)
Primary outcome [3] 0 0
Acceptability: CSQ
Timepoint [3] 0 0
The CSQ will be completed upon conclusion of the study (week 18-30)
Primary outcome [4] 0 0
Acceptability: Adverse events
Timepoint [4] 0 0
Adverse events will be collected weekly between baseline and the conclusion of the study (week 18-30)
Primary outcome [5] 0 0
Acceptability: Qualitative Feedback
Timepoint [5] 0 0
Qualitative feedback will be collected at the conclusion of the study (end of stage 4, week 20-30)
Primary outcome [6] 0 0
Effectiveness: PARDI-AR-Q
Timepoint [6] 0 0
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)
Primary outcome [7] 0 0
Effectiveness: FNS
Timepoint [7] 0 0
The FNS will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Secondary outcome [1] 0 0
Body Mass Index (BMI)
Timepoint [1] 0 0
BMI will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Secondary outcome [2] 0 0
Distress
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Quality of life (QoL)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Quality of the relationship between clinician and patient
Timepoint [4] 0 0
This will be measured upon conclusion of the study (week 18-30)

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Orygen Youth Health - Sunshine - Sunshine - Melbourne
Recruitment hospital [2] 0 0
Orygen Youth Health - Parkville - Parkville - Melbourne
Recruitment postcode(s) [1] 0 0
3020 - Melbourne
Recruitment postcode(s) [2] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Orygen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massachusetts General Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Harvard Medical School (HMS and HSDM)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06463470
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Phillipou
Address 0 0
Orygen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrea Phillipou
Address 0 0
Country 0 0
Phone 0 0
+61 3 9966 9100
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06463470