Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000686505
Ethics application status
Approved
Date submitted
13/05/2024
Date registered
29/05/2024
Date last updated
29/05/2024
Date data sharing statement initially provided
29/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR): An Evaluation
Scientific title
Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR): An Evaluation of the Feasibility, Acceptability and Efficacy in Individuals aged 12 to 25 years
Secondary ID [1] 312111 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Avoidant/Restrictive Food Intake Disorder (ARFID) 333770 0
Condition category
Condition code
Mental Health 330445 330445 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328564 0
Treatment: Other
Comparator / control treatment
As this is an evaluation, there is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338206 0
Primary outcome 1: Feasibility
Timepoint [1] 338206 0
Upon conclusion of the study (week 18-30)
Primary outcome [2] 338207 0
Primary outcome 2: Acceptability - this will be assessed as a composite outcome
Timepoint [2] 338207 0
The CTS and the CSQ will be completed upon conclusion of the study (week 18-30)
Adverse events and qualitative feedback will be collected weekly between baseline and the conclusion of the study
Primary outcome [3] 338208 0
Primary outcome 3: Efficacy - this will be assessed as a composite outcome
Timepoint [3] 338208 0
The PARDI-AR-Q will be assessed at baseline and at the conclusion of stages 2 and 3 and at conclusion of the study (week 18-30)
The FNS will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Secondary outcome [1] 434985 0
Body Mass Index (BMI)
Timepoint [1] 434985 0
BMI will be assessed at baseline and weekly and upon conclusion of the study (week 18-30)
Secondary outcome [2] 434986 0
Distress
Timepoint [2] 434986 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] 434987 0
Quality of life
Timepoint [3] 434987 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] 434988 0
Quality of the relationship between clinician and patient
Timepoint [4] 434988 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 must 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
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
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] 26535 0
Orygen Youth Health - Parkville - Parkville
Recruitment hospital [2] 26536 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment postcode(s) [1] 42576 0
3052 - Parkville
Recruitment postcode(s) [2] 42577 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 316469 0
Self funded/Unfunded
Name [1] 316469 0
Researchers time
Country [1] 316469 0
Australia
Primary sponsor type
Other
Name
Orygen Youth Mental Health
Address
Country
Australia
Secondary sponsor category [1] 318644 0
None
Name [1] 318644 0
Address [1] 318644 0
Country [1] 318644 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315258 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315258 0
Ethics committee country [1] 315258 0
Australia
Date submitted for ethics approval [1] 315258 0
03/04/2024
Approval date [1] 315258 0
29/04/2024
Ethics approval number [1] 315258 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134158 0
A/Prof Andrea Phillipou
Address 134158 0
Orygen, 35 Poplar Rd, Parkville VIC 3052 Australia
Country 134158 0
Australia
Phone 134158 0
+61 401675741
Fax 134158 0
Email 134158 0
[email protected]
Contact person for public queries
Name 134159 0
Andrea Phillipou
Address 134159 0
Orygen, 35 Poplar Rd, Parkville VIC 3052 Australia
Country 134159 0
Australia
Phone 134159 0
+61 3 9966 9100
Fax 134159 0
Email 134159 0
[email protected]
Contact person for scientific queries
Name 134160 0
Andrea Phillipou
Address 134160 0
Orygen, 35 Poplar Rd, Parkville VIC 3052 Australia
Country 134160 0
Australia
Phone 134160 0
+61 401675741
Fax 134160 0
Email 134160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22383Ethical approval    387775-(Uploaded-13-05-2024-10-23-15)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.