Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000026628
Ethics application status
Approved
Date submitted
23/12/2022
Date registered
11/01/2023
Date last updated
17/01/2024
Date data sharing statement initially provided
11/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing and testing online cognitive behaviour therapy for eating disorders: A pilot study
Scientific title
A randomised trial of an online cognitive behaviour therapy for eating disorders: A pilot study in university students aged 17 to 25
Secondary ID [1] 308672 0
Nil Known
Universal Trial Number (UTN)
U1111-1286-4877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eating disorders 328598 0
Condition category
Condition code
Mental Health 325611 325611 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online 10-session cognitive behaviour therapy (CBT) for eating disorders that can be used for pure or guided self-help treatment. The protocol has been evaluated as a face-to-face protocol twice previously, as reported in Steele, A. L., & Wade, T. D. (2008). A randomised trial investigating guided self-help to reduce perfectionism and its impact on bulimia nervosa. Behaviour Research and Therapy, 46, 1316-1323 and ACTRN12621000111875. In addition to a waitlist control group, the active conditions contains 4 arms; guided self-help (GSH), pure self-help (PSH), GSH for participants with low motivation to change (GSH-low), PSH for participants with higher motivation to change (PSH-high). In this case high motivation means scoring 6 or more out of 10 on a Likert scale for the following question: “How ready are you to change your eating?” Participants in the GSH condition will receive an email each week asking if they have any questions or concerns or would like to let us know of their progress. Participants in the PSH will receive no email. The program will be administered over 5 weeks, 2 modules per week. The content will be delivered online via interactive powerpoint available on a Qualtrics platform which includes text, open response format, short videos, quizzes, and relevant pdf readings from the Centre for Clinical Interventions. The program can be accessed via laptop or mobile phone. Website analytics will be used to monitor use of the program.
Intervention code [1] 325141 0
Treatment: Other
Comparator / control treatment
Control group participants will be placed on a waitlist and offered PSH 10-weeks after the baseline evaluation.
Control group
Active

Outcomes
Primary outcome [1] 333446 0
Disordered eating measured with the Eating Disorder 15 (ED-15)
Tatham, M., Turner, H., Mountford, V. A., Tritt, A., Dyas, R., & Waller, G. (2015). Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviours: The ED-15. International Journal of Eating Disorders, 48, 1005-1015. doi: 10.1002/eat.22430
Timepoint [1] 333446 0
5 weeks after completion of therapy
Secondary outcome [1] 417143 0
Depression measured with the Patient Health Questionnaire (Löwe et al., 2004)
Timepoint [1] 417143 0
5 weeks after completion of therapy
Secondary outcome [2] 417144 0
Anxiety: Measured with the Generalized Anxiety Disorder (GAD-7; Dear et al., 2011)
Timepoint [2] 417144 0
5 weeks after completion of therapy
Secondary outcome [3] 417145 0
Quality of life: ReQoL – Recovering Quality of Life
Timepoint [3] 417145 0
5 weeks after completion of therapy

Eligibility
Key inclusion criteria
University students from Flinders University, aged 17 to 25 years, who meet the cut-off a score of 47 or above on the Weight Concerns Scale (WCS; Killen et al., 1994), which is a range considered to have good predictive validity for development of an ED (Jacobi et al., 2011).
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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 through Qualtrics
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
Linear Mixed Model (LMM) analyses, using IBM SPSS, Version 27, will be used to evaluate within group changes between conditions over the course of treatment. This type of analysis retains all participants in a condition, even if they are missing data across different time points. Time and condition and the interaction between these two terms will be entered as fixed effects. Generalized linear mixed modelling was used to analyse the count variables (disordered eating behaviours) using a negative binomial distribution and link=power.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
6/03/2023
Actual
2/02/2023
Date of last participant enrolment
Anticipated
4/09/2023
Actual
24/04/2023
Date of last data collection
Anticipated
24/04/2023
Actual
Sample size
Target
125
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312904 0
Charities/Societies/Foundations
Name [1] 312904 0
Breakthrough Mental Health Research Foundation
Country [1] 312904 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 314583 0
Individual
Name [1] 314583 0
Tracey Wade
Address [1] 314583 0
Flinders University, GPO Box 2100, Adelaide, 5001
Country [1] 314583 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312179 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 312179 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Ethics committee country [1] 312179 0
Australia
Date submitted for ethics approval [1] 312179 0
11/07/2022
Approval date [1] 312179 0
17/08/2022
Ethics approval number [1] 312179 0
5444

Summary
Brief summary
We propose to evaluate an online cognitive behavioural therapy for eating disorders in 125 university students with disordered eating that impairs their quality of life. We will adopt a novel design that can inform translational strategies, with random allocation of people to active conditions (N=100) and wait-list control (N=25). Of the 100 allocated to active conditions, 25 will be randomly allocated to guided self-help (GSH), 25 randomly allocated to pure self-help (PSH), and then the remaining 50 will be allocated to GSH if they have low motivation (GSH-low) and to PSH if they have higher levels of motivation (PSH-high).
Hypotheses
Significantly better outcomes at end of intervention and follow-up will be produced for the following comparisons, with the first group/s having better outcomes in each case: GSH, GSH-low, PSH-high vs PSH or control; GSH-low vs GSH; PSH-high vs PSH.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 123754 0
Prof Tracey Wade
Address 123754 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 123754 0
Australia
Phone 123754 0
+61 882013736
Fax 123754 0
+61882013877
Email 123754 0
tracey.wade@flinders.edu.au
Contact person for public queries
Name 123755 0
Prof Tracey Wade
Address 123755 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 123755 0
Australia
Phone 123755 0
+61 882013736
Fax 123755 0
+61882013877
Email 123755 0
tracey.wade@flinders.edu.au
Contact person for scientific queries
Name 123756 0
Prof Tracey Wade
Address 123756 0
Flinders University, GPO Box 2100, Adelaide, SA, 5001
Country 123756 0
Australia
Phone 123756 0
+61 882013736
Fax 123756 0
+61882013877
Email 123756 0
tracey.wade@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data relating to the outcome variables over time across the conditions.
When will data be available (start and end dates)?
December 2023 and then permanently available
Available to whom?
To researchers.
Available for what types of analyses?
To researchers wishing to conduct replication or meta-analytic studies.
How or where can data be obtained?
The data will be placed on Tracey Wade's Open Science Framework repository site: https://osf.io/rtzv3/


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.