Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000562976
Ethics application status
Approved
Date submitted
21/04/2020
Date registered
14/05/2020
Date last updated
14/05/2020
Date data sharing statement initially provided
14/05/2020
Date results information initially provided
14/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet-based cognitive behaviour therapy for perfectionism: Impact on different measures of perfectionism and psychopathology
Scientific title
Internet-based cognitive behaviour therapy for perfectionism: Impact on different measures of perfectionism and psychopathology
Secondary ID [1] 301084 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perfectionism 317154 0
Condition category
Condition code
Mental Health 315304 315304 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the treatment group will be registered as users on the Overcoming Perfectionism intervention program website which delivers an Internet based CBT for perfectionism (ICBT-P; Egan et al., 2014) program. The program consists of eight modules which has previous positive evaluations (A Rozental et al., 2017; Shafran et al., 2017; Wade et al., 2019). The eight modules comprising the program include: (1) understanding perfectionism, (2) your perfectionism cycle, (3) surveys and experiments, (4) new ways of thinking, (5) useful skills for managing unhelpful perfectionism, (6) self-criticism or self-compassion?, (7) re-examining the way we define our self-worth, and (8) staying well: managing unhelpful perfectionism in the long-term. Participants were asked to complete module 1 and were then encouraged to complete as many modules as the liked over 4 weeks. Each module took approximately 30 minutes to complete and addressed specific target areas important in the treatment of perfectionism. Intervention adherence and fidelity is controlled by having set online modules which are delivered to each treatment group participant in an identical fashion. However, the number of modules completed and the order of completion is left entirely to each treatment group participant. No other external assessment is conducted to determine adherence and fidelity or control for how each treatment group participant completes the modules.
Intervention code [1] 317395 0
Behaviour
Intervention code [2] 317396 0
Treatment: Other
Comparator / control treatment
Wait list control group - given post study access to Overcoming Perfectionism book after the 8 week study completion timepoint.
Control group
Active

Outcomes
Primary outcome [1] 323547 0
Frost Multi-dimensional Perfectionism Scale (FMPS; Frost et al., 1990)
Personal Standards [PS] and Concern over Mistakes [CM] subscales
Timepoint [1] 323547 0
Primary time point -
Baseline (start of treatment), 2 weeks (after commencement of treatment), 4 weeks (end of treatment), 8 weeks (post treatment follow up)
Primary outcome [2] 323548 0
Almost Perfect Scale-Revised (APS-R; Rice et al, 2014)
Discrepancy (D) and High Standards (HS) subscales
Timepoint [2] 323548 0
Primary time point -
Baseline (start of treatment), 2 weeks (after commencement of treatment), 4 weeks (end of treatment), 8 weeks (post treatment follow up)
Primary outcome [3] 323549 0
Scale of Perfectionism and Excellencism (SCOPE; Gaudreau & Schellenberg, 2018)
Timepoint [3] 323549 0
Primary time point -
Baseline (start of treatment), 2 weeks (after commencement of treatment), 4 weeks (end of treatment), 8 weeks (post treatment follow up)
Secondary outcome [1] 382208 0
Depression, Anxiety and Stress Scales – Short Form (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [1] 382208 0
Baseline
Mid-treatment (2 weeks)
End of Treatment (4 weeks)
1 month follow up (8 weeks)
Secondary outcome [2] 382210 0
Body Image-Acceptance and Action Questionnaire (BI-AAQ; Sandoz, Wilson, Merwin, & Kellum, 2013)
Timepoint [2] 382210 0
Baseline
Mid-treatment (2 weeks)
End of Treatment (4 weeks)
1 month follow up (8 weeks)
Secondary outcome [3] 382211 0
Self-Compassion Scale – Short Form (SCS-SF; Raes, Pommier, Neff, & Van Gucht, 2011)
Timepoint [3] 382211 0
Baseline
Mid-treatment (2 weeks)
End of Treatment (4 weeks)
1 month follow up (8 weeks)

Eligibility
Key inclusion criteria
17 years of age or older, fluent in English, and self-reporting current struggles with perfectionism
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
past registration with the Overcoming Perfectionism website

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)
After selecting yes to the question "Would you like to proceed with the study and be randomised into treatment or control group?" the participant was randomly allocated to either the Treatment or Control groups using the Randomizer function within the Qualtrics data collection and analysis program. Using this function automates the selection process ensuring complete allocation concealment.
Link to Randomizer information page ... https://www.qualtrics.com/support/survey-platform/survey-module/survey-flow/standard-elements/randomizer/
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation via Qualtrics program
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A longitudinal designs power analysis (Hedecker, Gibbons, & Waternaux, 1999) was conducted using the between-group effect size previously obtained for depression (Johnson et al., 2019), rather than the larger effect sizes obtained for our primary outcome of perfectionism, to ensure power to detect differences for our secondary outcomes. Assuming three timepoints (adjusting for baseline observations), alpha = .05, power = 0.80, attrition rates of T1 = 25% and T2 = 5%, and d = 0.65, a minimum randomised sample size of 64 was estimated, 32 participants per group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
3/06/2019
Date of last participant enrolment
Anticipated
Actual
29/03/2020
Date of last data collection
Anticipated
24/05/2020
Actual
Sample size
Target
64
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305521 0
University
Name [1] 305521 0
Discipline of Psychology, Órama Institute and Blackbird Initiative, Flinders University, Adelaide, Australia
Country [1] 305521 0
Australia
Primary sponsor type
University
Name
Discipline of Psychology, Órama Institute and Blackbird Initiative, Flinders University, Adelaide, Australia
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 305927 0
None
Name [1] 305927 0
Address [1] 305927 0
Country [1] 305927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305833 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 305833 0
Sturt Rd, Bedford Park SA 5042
Ethics committee country [1] 305833 0
Australia
Date submitted for ethics approval [1] 305833 0
Approval date [1] 305833 0
30/04/2019
Ethics approval number [1] 305833 0
7971

Summary
Brief summary
To determine if an online cognitive-behaviour therapy intervention for perfectionism is effective in improving the variables of perfectionism, depression, anxiety, stress, body image inflexibility and self-compassion compared to those who are in a waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101754 0
Prof Tracey Wade
Address 101754 0
Flinders University,
Sturt Rd,
Bedford Park 5042
Adelaide, South Australia
Country 101754 0
Australia
Phone 101754 0
+61 8 82013736
Fax 101754 0
+61 8 82013877
Email 101754 0
[email protected]
Contact person for public queries
Name 101755 0
Prof Tracey Wade
Address 101755 0
Flinders University,
Sturt Rd,
Bedford Park 5042
Adelaide, South Australia
Country 101755 0
Australia
Phone 101755 0
+61 8 82013736
Fax 101755 0
+61 8 82013877
Email 101755 0
[email protected]
Contact person for scientific queries
Name 101756 0
Prof Tracey Wade
Address 101756 0
Flinders University,
Sturt Rd,
Bedford Park 5042
Adelaide, South Australia
Country 101756 0
Australia
Phone 101756 0
+61 8 82013736
Fax 101756 0
+61 8 82013877
Email 101756 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
This has not been approved by our HREC


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
EmbaseThe impact of internet-based cognitive behaviour therapy for perfectionism on different measures of perfectionism: a randomised controlled trial.2022https://dx.doi.org/10.1080/16506073.2021.1928276
N.B. These documents automatically identified may not have been verified by the study sponsor.