Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001495516
Ethics application status
Approved
Date submitted
28/11/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized trial of ten-session cognitive behaviour therapy (CBT-T) for eating disorders: Does personalisation of treatment lead to better outcomes?
Scientific title
A randomized open-label trial of ten-session cognitive behaviour therapy (CBT-T) for eating disorders in non-underweight individuals aged 15 years and over: Does stratified augmented treatment lead to better outcomes?
Secondary ID [1] 313487 0
Nil
Universal Trial Number (UTN)
U1111-1316-2818
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 335899 0
Condition category
Condition code
Mental Health 332493 332493 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Ten-session cognitive behaviour Therapy (CBT-T) protocol (described in the manual Brief Cognitive Behavioural Therapy for Non-Underweight Patients: CBT-T for Eating Disorders; Abingdon: Routledge, Taylor & Francis Group) forms the basis of both intervention arms. In brief, CBT- consists of 5 stages: (1) early dietary change and exposure, (2) behavioural experiments relating to food, (3) addressing emotional triggers, (4) body image work, (5) relapse prevention. The intervention comprises of ten weekly face-to-face 50-minute sessions with a trainee psychologist or clinical psychologist, with each session lasting approximately 50 minutes, delivered at the Flinders University Services for Eating Disorders (FUSED). The CBT-T protocol which describes the structure of each session in detail is available on the CBT-T website: https://cbt-t.sites.sheffield.ac.uk/resources. A further 3 face-to-face follow-up sessions of up to 50 minutes duration are conducted to ensure that progress is maintained – in the current study these will occur at 1-, 3- and 6-months post-treatment. The pre-treatment assessment is designed to encourage change and treatment retention and improve treatment outcome before treatment commences and includes motivational enhancement exercises. In the 2-week period between assessment and the first session of therapy participants will be asked to complete a single session intervention on behavioural activation (https://osf.io/xpqa8/) - a pdf which explores (1) connecting with people who make you feel good, (2) achieving goals that matter to you, (3) enjoying activities on your own, (4) feeding your brain, and takes around 30-60 minutes to complete. In CBT-T a review of engagement and progress is routinely conducted in session 4, where those who are not engaging in therapy (e.g., are not actively doing the therapy homework tasks every day between sessions, such as food monitoring, exposure tasks) are invited to step away from treatment until circumstances allow them to fully commit to doing therapy or to have one final attempt to engage by session 5. The number of sessions attended is recorded.
Arm 1 (intervention): CBT-T as usual.
Arm 2 (comparator): CBT-T augmented (CBT-TA).
Intervention code [1] 330064 0
Treatment: Other
Comparator / control treatment
The comparator is CBT-TA allowing for personalised augmentations to treatment for gradual responders that tackle obstacles to progress. CBT-TA involves all the components described for CBT-T (a 20-minute initial behavioural activation task; 10 face-to-face 50-minute sessions; 3 follow-up 50-minute sessions at 1-, 3- and 6-months post-treatment). CBT-TA will additionally give participants access to nine treatment augmentations (e.g., tackling social isolation, expanding areas which contribute to self-worth, perfectionism) in the form of an interactive document. The gradual responders (measured as achieving less than a drop of 1.13 points on the Eating Disorder Examination Questionnaire) will be engaged in discussion at session 4 to examine barriers to rapid change and which of the augmentations may best address these. The discussion and augmentations will be incorporated into ongoing therapy, with no extra time allocated for any session. Augmentations are in the form of interactive pdfs which can be emailed to the client or given in a hard copy, The rapid responders will be made aware of the treatment augmentations and how to locate them, but they will not be incorporated into ongoing therapy. Session 4 will be audio recorded and analysed for compliance to identifying obstacles and suitable augmentations.
Control group
Active

Outcomes
Primary outcome [1] 340021 0
Eating disorder psychopathology
Timepoint [1] 340021 0
Baseline, sessions 4 and 10 (primary timepoint), and at 3-and 6-month follow-up
Secondary outcome [1] 442708 0
Completion status (10 weekly sessions have been completed OR the therapist and client mutually agree that significant progress has been achieved before 10 sessions have been completed and there is no need for further sessions versus premature cessation of therapy before 10 sessions have been completed where progress is limited) will be assessed to establish the relative acceptability of the interventions,
Timepoint [1] 442708 0
session 10
Secondary outcome [2] 442355 0
General negative emotion
Timepoint [2] 442355 0
Baseline, sessions 4 and 10, and 3- and 6-month follow-up
Secondary outcome [3] 442353 0
Eating disorder behaviours
Timepoint [3] 442353 0
Baseline, sessions 4 and 10, and 3- and 6-month follow-up
Secondary outcome [4] 442357 0
Dispositional hope
Timepoint [4] 442357 0
Baseline, sessions 4 and 10, and 3- and 6-month follow-up
Secondary outcome [5] 442354 0
Clinical Impairment
Timepoint [5] 442354 0
Baseline, sessions 4 and 10, and 3- and 6-month follow-up
Secondary outcome [6] 442707 0
Health service utilisation
Timepoint [6] 442707 0
Baseline and 3-month follow-up.
Secondary outcome [7] 442356 0
Self-injury
Timepoint [7] 442356 0
Baseline, sessions 4 and 10, and 3- and 6-month follow-up
Secondary outcome [8] 442709 0
Client’s experiences of therapy in the form of qualitative feedback
Timepoint [8] 442709 0
Session 10

Eligibility
Key inclusion criteria
Eligible participants (1) are aged 15 years and over; (2) have any DSM-5 diagnosis of ED as determined by the EDA-5 online clinical interview: https://interview.eda5.org/index.html?t=eyJxIjoiZWRhNSIsIm1ham9yIjoxLCJtaW5vciI6ImN1cnJlbnQiLCJsYW5nIjoiZW4iLCJkZWJ1ZyI6ZmFsc2V9\, excluding anorexia nervosa and avoidant/restrictive feeding intake disorder for which no evidence of the efficacy of CBT-T exists; (3) consent to FUSED communicating regularly with their general practitioner; (4) reside in South Australia; and (5) can read independently at grade 2 level English.
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are not eligible if they report current life-threatening suicidal ideation, untreated psychosis, or substance dependence, or have a body mass index (BMI) < 18.5, or currently receiving a psychological therapy for an ED.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer (Qualtrics) - allocation will be concealed from therapists and participants until session 4.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Note: non-balanced randomisation ratio of 2.4:1 (CBT-TA:CBT-T) will be used to account for 42% of participants being eligible for the final analysis related to our primary aim i.e., based on a previous evaluation finding 58% of FUSED clients to meet criteria for rapid response.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
22/12/2028
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317926 0
Government body
Name [1] 317926 0
NHMRC
Country [1] 317926 0
Australia
Primary sponsor type
Individual
Name
Tracey Wade - Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320274 0
University
Name [1] 320274 0
Flinders University
Address [1] 320274 0
Country [1] 320274 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316611 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 316611 0
Ethics committee country [1] 316611 0
Australia
Date submitted for ethics approval [1] 316611 0
11/11/2024
Approval date [1] 316611 0
06/12/2024
Ethics approval number [1] 316611 0
7992

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

Contacts
Principal investigator
Name 138414 0
Prof Tracey Wade
Address 138414 0
Discipline of Psychology, Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 138414 0
Australia
Phone 138414 0
+61 882013736
Fax 138414 0
Email 138414 0
[email protected]
Contact person for public queries
Name 138415 0
Tracey Wade
Address 138415 0
Discipline of Psychology, Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 138415 0
Australia
Phone 138415 0
+61 882013736
Fax 138415 0
Email 138415 0
[email protected]
Contact person for scientific queries
Name 138416 0
Tracey Wade
Address 138416 0
Discipline of Psychology, Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 138416 0
Australia
Phone 138416 0
+61 882013736
Fax 138416 0
Email 138416 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified group means for the primary and secondary outcome variables across the 5 waves of data collection.

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
The data will be placed on OSF in June 2029 and remain there.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Tracey Wade's OSF site: osf.io/rtzv3

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.