Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000860763
Ethics application status
Approved
Date submitted
10/05/2022
Date registered
17/06/2022
Date last updated
17/06/2022
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Introduction of a new therapy to treat Avoidant Restrictive Food Intake Disorder (ARFID) for adults at the Sunshine Coast Eating Disorder Service
Scientific title
Clinical trial of feasibility and acceptability of Cognitive Behaviour Therapy- Avoidant/ Restrictive (CBT-AR) by a dietitian for adults living with ARFID (Avoidant Restrictive Food Intake Disorder) presenting to the Sunshine Coast Eating Disorder Service
Secondary ID [1] 307088 0
NIl Known
Universal Trial Number (UTN)
U1111-1278-1295
Trial acronym
CBT-AR Aus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Avoidant Restrictive Food Intake Disorder 326268 0
Condition category
Condition code
Mental Health 323571 323571 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of dietetic-led manualised Cognitive Behaviour Therapy- Avoidant Restrictive (CBT-AR) for the adult Australian population presenting to the Sunshine Coast Hospital and Health Service Eating Disorder Service. CBT-AR is a Cognitive Behaviour model focused on psychoeducation, nutritional rehabilitation and exposures. It will consist of 20-30 weekly sessions of 50minutes face to face or via telehealth. Number of sessions will depend if participants are needing to gain weight. The dietitian providing the intervention has extended scope in eating disorders. Adherence to CBT-AR is monitored through checklists provided in the manual and supervision.
Intervention code [1] 323559 0
Behaviour
Intervention code [2] 323772 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331326 0
Severity of Avoidant Restrictive Food Intake Disorder (ARFID). As per the PRADI-AR-Q (self report measure of ARFID symptomology) and psychiatric assessment.
Timepoint [1] 331326 0
After completion of CBT-AR.
Secondary outcome [1] 409537 0
Weight % Change assessed by digital scales and BMI (kg/m2) measured through stadiometer and digital scales. As a composite outcome.
Timepoint [1] 409537 0
Pre(week 0) and Post Therapy(week 20-30).
Secondary outcome [2] 410384 0
Food Neophobia Scale (FNS).
Timepoint [2] 410384 0
Pre (week 0) and Post (week 20-30) therapy
Secondary outcome [3] 410385 0
Clinical Impairment Scale (CIA).
Timepoint [3] 410385 0
Pre (week 0) and post (week 20-30) CBT-AR therapy.
Secondary outcome [4] 410386 0
Depression Anxiety Stress Scale-21 (DASS-21)
Timepoint [4] 410386 0
Pre (week 0) and post (week 20-30) of CBT-AR therapy.
Secondary outcome [5] 410387 0
Normal Eating Scale (NES)
Timepoint [5] 410387 0
Pre (week 0) and post (week 20-30) CBT-AR therapy.
Secondary outcome [6] 410388 0
Nutrition Blood Panel
Timepoint [6] 410388 0
Pre (week 0) and post (week 20-30) CBT-AR therapy.
Secondary outcome [7] 410389 0
Food Recall (dietary recall collected by dietitian)
Timepoint [7] 410389 0
Pre (week 0) and post (week 20-30) CBT-AR therapy.
Secondary outcome [8] 410390 0
Client Satisfaction Questionnaire (CSQ-8)
Timepoint [8] 410390 0
Post CBT-AR therapy
Secondary outcome [9] 410391 0
Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [9] 410391 0
Pre (week 0) CBT-AR therapy
Secondary outcome [10] 410392 0
Australian Core Food Score
Timepoint [10] 410392 0
Pre (week 0) and post (week 20-30) CBT-AR therapy.

Eligibility
Key inclusion criteria
Adult, living in the Sunshine Coast Hospital and Health Service region, diagnosis of ARFID, able to comprehend cognitive behavioural therapy,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other primary eating disorder diagnosis.
Currently accessing other interventions for ARFID
Unable to comprehend CBT-AR, ie due to intellectual disability.

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
1/07/2022
Actual
Date of last participant enrolment
Anticipated
1/11/2023
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22343 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 37504 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 311396 0
Hospital
Name [1] 311396 0
Sunshine Coast University Hospital (SCUH)
Country [1] 311396 0
Australia
Funding source category [2] 311580 0
University
Name [2] 311580 0
Queensland University of Technology
Country [2] 311580 0
Australia
Primary sponsor type
Individual
Name
Copeland Winten
Address
Sunshine Coast Hospital and Health Service, Community Health Hub Maroochydore, 60 Dalton Drive, Maroochydore, 4558, QLD.
Country
Australia
Secondary sponsor category [1] 312805 0
None
Name [1] 312805 0
None
Address [1] 312805 0
None
Country [1] 312805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310878 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 310878 0
627 Rode Rd, Chermside QLD 4032
Ethics committee country [1] 310878 0
Australia
Date submitted for ethics approval [1] 310878 0
03/05/2022
Approval date [1] 310878 0
05/05/2022
Ethics approval number [1] 310878 0
7695

Summary
Brief summary
Introduction of CBT-AR in a primary health care specialist eating disorder service for adults living with ARFID. Manualised therapy of CBT-AR provided by an extended scope eating disorder accredited practising dietitian.
It is hypothesised that people who complete CBT-AR will be in partial or complete remission of ARFID, as per DSM-5 and have improved psychosocial and physical symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119198 0
Miss Copeland Winten
Address 119198 0
Sunshine Hospital and Health Service, Maroochydore Community Health Hub, 60 Dalton Drive, Maroochydore, 4558, QLD
Country 119198 0
Australia
Phone 119198 0
+61 7 52029263
Fax 119198 0
Email 119198 0
copeland.winten@health.qld.gov.au
Contact person for public queries
Name 119199 0
Miss Copeland Winten
Address 119199 0
Sunshine Hospital and Health Service, Maroochydore Community Health Hub, 60 Dalton Drive, Maroochydore, 4558, QLD
Country 119199 0
Australia
Phone 119199 0
+61 7 52029623
Fax 119199 0
Email 119199 0
copeland.winten@health.qld.gov.au
Contact person for scientific queries
Name 119200 0
Miss Copeland Winten
Address 119200 0
Sunshine Hospital and Health Service, Maroochydore Community Health Hub, 60 Dalton Drive, Maroochydore, 4558, QLD
Country 119200 0
Australia
Phone 119200 0
+61 7 52029623
Fax 119200 0
Email 119200 0
copeland.winten@health.qld.gov.au

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
16007Informed consent form  copeland.winten@health.qld.gov.au For participants whilst attending clinic



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.