Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000951954
Ethics application status
Approved
Date submitted
16/07/2020
Date registered
23/09/2020
Date last updated
11/01/2023
Date data sharing statement initially provided
23/09/2020
Date results information initially provided
11/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Perfectionism and Eating Disorders: An Online Treatment Program for Adolescent Females
Scientific title
Perfectionism and Eating Disorders: Piloting an Indicated Internet Prevention Program for Female Adolescents At-Risk for Eating Disorders
Secondary ID [1] 301789 0
Nil
Universal Trial Number (UTN)
U1111-1255-3879
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perfectionism 318264 0
Eating Disorders 318265 0
Condition category
Condition code
Mental Health 316277 316277 0 0
Eating disorders
Mental Health 316278 316278 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet-based Cognitive Behavioural Therapy for Perfectionism (ICBT-P) is being compared to a waitlist control condition in an online, indicated prevention trial for adolescents displaying at-risk symptoms of eating disorders. Participants will be randomly allocated via computer generated groups to the intervention or waitlist control group. Those in the intervention group will be sent a link and password whereby they can access the ICBT-P modules. The ICBT-P program consists of eight online video/audio and text-based modules based on the Shafran, Egan, and Wade (2018) self-help book. Module 1 defines perfectionism and explores maintaining factors, Module 2 looks at individualised formulations of perfectionism, Module 3 looks at enhancing motivation to change, Module 4 provides psychoeducation, discusses self-monitoring, and survey construction and completion, Module 5 covers behavioural experiments and challenging dichotomous thinking, Module 6 explores unhelpful thinking styles, Module 6 discusses procrastination and time management, and Module 8 covers self-criticism and self-compassion, and relapse prevention. Participants will be encouraged to complete one module every week (approximately no more than 30 minutes), with generic reminder emails being sent to participants over the course of the eight-week program, one per week at the commencement of the week. Participants will also be asked to rate each week how much time they spent on each module, and how many of the activities they completed, to assess fidelity. This is an unguided program, with modules ‘unlocked’ to allow participants to move between them at will. Participants will be requested to complete post-intervention measures after they have completed the eight-week intervention. Links to the follow-up questionnaires will also be sent to them at three- and six-months post-intervention.

Following completion of the study, those in the wait-list control group will have access to the treatment program, in line with the NHMRC chapter 3.1.5, which outlines control groups being ethical and appropriate where participants would otherwise have no recourse treatment that is known to be effective.
Intervention code [1] 318091 0
Prevention
Intervention code [2] 318092 0
Behaviour
Intervention code [3] 318093 0
Treatment: Other
Comparator / control treatment
Waitlist control (no treatment). Participants will be offered access to the program after the 6 month follow-up has been complete..
Control group
Active

Outcomes
Primary outcome [1] 324452 0
Eating Disorder symptoms as measured by global scores on the EDE-Q.
Timepoint [1] 324452 0
Pre-intervention (immediately before randomised allocation to a group), 8 weeks after being allocated to ICBT-P or waitlist control groups (post-intervention), 3 months post-intervention, and six months post-intervention.
Secondary outcome [1] 384708 0
Perfectionism symptoms as measured by the Clinical Perfectionism Questionnaire total score.
Timepoint [1] 384708 0
Pre-intervention (immediately prior to group random allocation), 8 weeks after being assigned to ICBT-P or waitlist control groups (post-intervention), 3 months post-intervention, and six months post-intervention.

Eligibility
Key inclusion criteria
Inclusion criteria are being female and aged 13- to 18-years, having reliable internet access, and reporting elevated symptoms of eating disorder psychopathology [An EDE-Q global score greater than 1.5, as per norms citing a mean EDE-Q global score of 1.5 in a community sample (Fairburn & Beglin, 1994)].
Minimum age
13 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are a MINI-Kid score indicating suicidality (module B1), an EDE-Q global score above three (O'Brien et al. (2016) found a mean EDE global score of 3.26 for a clinical paediatric population), and if the participant is currently receiving psychotherapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not able to be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated program to randomise each participant to the control or intervention condition.
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
An a priori power analyses using G*power (version 3.1.9.2) (Faul, Erdfelder, Lang, & Buchner, 2007), assuming a small effect size, with an adjusted alpha-level of .01 and 80% power indicates that 196 participants (98 per group) is required to adequately power this study. However, if there is difficulty in achieving 98 participants per group, based on previous RCTs conducted by Egan et al. (2014) and Shafran et al. (2017) 40 participants per group would be the minimum required to adequately power this study (based on finding a large effect size [d = .80], with an alpha level of 0.05, and at 80% power). Therefore whilst 196 participants is ideal, the minimum required to still perform the required statistical analyses is an overall sample of 80.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2021
Actual
6/10/2021
Date of last participant enrolment
Anticipated
31/08/2022
Actual
11/11/2022
Date of last data collection
Anticipated
28/02/2023
Actual
9/12/2022
Sample size
Target
196
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306223 0
University
Name [1] 306223 0
Curtin University
Country [1] 306223 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Kent Street, Bentley, W.A. 6102
School of Psychology, Building 102
Country
Australia
Secondary sponsor category [1] 306701 0
None
Name [1] 306701 0
nil
Address [1] 306701 0
nil
Country [1] 306701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306434 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 306434 0
Curtin University, Kent Street, Bentley, W.A. 6102
Office of Human Research Ethics Committee
Ethics committee country [1] 306434 0
Australia
Date submitted for ethics approval [1] 306434 0
15/07/2020
Approval date [1] 306434 0
04/08/2020
Ethics approval number [1] 306434 0

Summary
Brief summary
The aim of this study is to examine the efficacy of an ICBT-P program targeting perfectionism, in a sample of adolescents displaying elevated eating disorder symptoms as an indicated prevention study. It is hypothesised that after completion of the online Overcoming Perfectionism intervention, participants will report significantly fewer eating disorder and perfectionism symptoms than at pre-intervention. It is hypothesised that those in the ICBT-P program will score significantly lower on measures of perfectionism and eating disorder psychopathology when compared to a waitlist control. It is predicted that these results will be maintained at three month and six month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103858 0
Dr Sarah Egan
Address 103858 0
Curtin University, Kent Street, Bentley, W.A. 6102
School of Psychology, Building 102
Country 103858 0
Australia
Phone 103858 0
+61 08 9266 2464
Fax 103858 0
Email 103858 0
[email protected]
Contact person for public queries
Name 103859 0
Dr Sarah Egan
Address 103859 0
Curtin University, Kent Street, Bentley, W.A. 6102
School of Psychology, Building 102
Country 103859 0
Australia
Phone 103859 0
+61 08 9266 2464
Fax 103859 0
Email 103859 0
[email protected]
Contact person for scientific queries
Name 103860 0
Dr Sarah Egan
Address 103860 0
Curtin University, Kent Street, Bentley, W.A. 6102
School of Psychology, Building 102
Country 103860 0
Australia
Phone 103860 0
+61 08 9266 2464
Fax 103860 0
Email 103860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial can be made available after de-identification has occurred.
When will data be available (start and end dates)?
After publication and trial completion; no end date.
Available to whom?
By request, dependent on the applicant and purpose of request at the discretion of the chief investigator.
Available for what types of analyses?
All, dependent on request.
How or where can data be obtained?
Dependent on publishers. Data can be requested from the authors by emailing the Chief Investigator, [email protected].


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
SourceTitleYear of PublicationDOI
EmbaseA protocol for unguided internet self-help cognitive behaviour therapy for perfectionism in adolescents at-risk of eating disorders.2022https://dx.doi.org/10.1016/j.invent.2022.100565
N.B. These documents automatically identified may not have been verified by the study sponsor.