Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000881134
Ethics application status
Approved
Date submitted
13/06/2019
Date registered
20/06/2019
Date last updated
16/11/2023
Date data sharing statement initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does an Online Program for Perfectionism Reduce Psychological Distress in Adolescents?
Scientific title
Examining the Effectiveness of Internet-Delivered Cognitive-Behavioural Therapy for Perfectionism in a Non-Clinical Sample of Adolescents.
Secondary ID [1] 297063 0
Nil Known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 311065 0
Anxiety 311066 0
Eating Disorders 311067 0
Perfectionism 311068 0
Non-Suicidal Self-Injury 311069 0
Condition category
Condition code
Mental Health 309702 309702 0 0
Anxiety
Mental Health 309703 309703 0 0
Depression
Mental Health 309704 309704 0 0
Eating disorders
Mental Health 309705 309705 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is called 'Overcoming Perfectionism' and is based on the second edition of the book 'Overcoming perfectionism: a self-help guide using cognitive behavioural techniques' (Shafran, Egan, & Wade, 2018). The intervention is delivered through the website www.overcomingperfectionism.com.au, and participants randomised into the intervention group will log on once a week for 8-weeks to complete a total of 8-modules of cognitive-behavioural therapy for perfectionism (one module a week). Each module will take participants 30-60 minutes to complete and includes reading text, short quizzes, listening to audio examples, and completing activities in the form of tables. The intervention will be guided in that participants will receive brief and personalised weekly feedback on completed homework tasks. This feedback will take approximately 5-minutes for each participant. For the homework tasks we will ask participants to complete one blank worksheet per module that is related to the content for that week. Each homework sheet is one page and includes a blank table for participants to fill in using their own examples. Each homework sheet will take approximately 15-30 minutes to complete (included in the module completion time). The topics for the homework tasks are:

- Module 1: Identifying rewards of perfectionism
- Module 2: Drawing personalised perfectionism cycle
- Module 3: Identifying perfectionistic thoughts, feelings, and behaviours
- Module 4: Finding out facts about perfectionism by conducting a survey
- Module 5: Designing and conducting a behavioural experiment
- Module 6: Challenging unhelpful thinking
- Module 7: Identifying perfectionistic thoughts and procrastination behaviours
- Module 8: Identifying self-critical voice

In order to monitor adherence to the intervention participants will be asked to complete the Feedback Questionnaire which is a 4-item measure of compliance in completing the modules.
Intervention code [1] 313342 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 318671 0
Perfectionism as assessed by the Clinical Perfectionism Questionnaire.
Timepoint [1] 318671 0
Pre-intervention, post-intervention (primary timepoint), 3-month follow-up, and 6-month follow-up.
Secondary outcome [1] 365641 0
Depression symptoms as assessed by the Revised Child Anxiety and Depression Scale (depression sub scale).
Timepoint [1] 365641 0
Pre-intervention, post-intervention, 3-months follow-up, and 6-months follow-up.
Secondary outcome [2] 365642 0
Anxiety symptoms as assessed by the Revised Child Anxiety and Depression Scale (anxiety sub scale).
Timepoint [2] 365642 0
Pre-intervention, post-intervention, 3-months follow-up, and 6-months follow-up.
Secondary outcome [3] 365643 0
Eating disorder symptoms as assessed by the Eating Disorder Examination Questionnaire.
Timepoint [3] 365643 0
Pre-intervention, post-intervention, 3-months follow-up, and 6-months follow-up.
Secondary outcome [4] 365644 0
Non-suicidal self-injury as assessed by the Inventory of Statements about Self-Injury.
Timepoint [4] 365644 0
Pre-intervention, post-intervention, 3-months follow-up, and 6-months follow-up.
Secondary outcome [5] 371228 0
Well-being as assessed by the General Health Questionnaire-12.
Timepoint [5] 371228 0
Pre-intervention, post-intervention, 3-months follow-up, and 6-months follow-up.

Eligibility
Key inclusion criteria
Aged 13- to 18-years old currently residing in Australia.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Given the self-guided nature of the intervention, it is not appropriate for individuals at high risk of suicide to participate. Risk of suicide will be assessed using the Columbia Suicide Severity Rating Scale (Posner, 2008), and individuals with scores of 4 or higher (indicating active suicidal ideation with some intent to act on these thoughts) will be excluded from the study.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (blocks of x).
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 analysis was conducted to estimate the sample size using G*Power (Version 3.1; Faul, Erdfelder, Lang, & Buchner, 2007). To achieve 80% power at an alpha level of 0.01 with two groups, and four time points the required the sample size is 180 (90 per group). After accounting for 20% attrition 220 participants (110 per group) will be recruited. The estimation of 20% attrition is based on an RCT examining the efficacy of a guided Internet-delivered CBT for perfectionism in adults (Rozental et al., 2017).
Once data collection is complete, it will be downloaded into SPSS and Generalised Linear Mixed Models (GLMM) will be used to test for changes in outcomes between the intervention group and the waitlist control group. The GLMM will include one nominal random effect (participant), one categorical fixed effect (group: intervention, control), one ordinal fixed effect (time: pre-intervention, post-intervention, 3-month follow-up, 6-month follow-up), and the Group×Time interaction. To optimise the likelihood of convergence, a separate GLMM analysis will be run for each of the outcome measures (perfectionism, eating disorder symptoms, depression symptoms, anxiety symptoms, and well-being).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2019
Actual
6/08/2019
Date of last participant enrolment
Anticipated
1/05/2020
Actual
1/07/2020
Date of last data collection
Anticipated
1/12/2020
Actual
31/01/2021
Sample size
Target
220
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301633 0
University
Name [1] 301633 0
Curtin University
Country [1] 301633 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 301346 0
None
Name [1] 301346 0
Address [1] 301346 0
Country [1] 301346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302356 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 302356 0
Ethics committee country [1] 302356 0
Australia
Date submitted for ethics approval [1] 302356 0
22/01/2019
Approval date [1] 302356 0
12/03/2019
Ethics approval number [1] 302356 0
HREC2019-0112

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

Contacts
Principal investigator
Name 89942 0
Dr Trevor Mazzucchelli
Address 89942 0
Curtin University, Kent St, Bentley WA 6102
Country 89942 0
Australia
Phone 89942 0
+618 9266 7182
Fax 89942 0
Email 89942 0
[email protected]
Contact person for public queries
Name 89943 0
Trevor Mazzucchelli
Address 89943 0
Curtin University, Kent St, Bentley WA 6102
Country 89943 0
Australia
Phone 89943 0
+618 9266 7182
Fax 89943 0
Email 89943 0
[email protected]
Contact person for scientific queries
Name 89944 0
Trevor Mazzucchelli
Address 89944 0
Curtin University, Kent St, Bentley WA 6102
Country 89944 0
Australia
Phone 89944 0
+618 9266 7182
Fax 89944 0
Email 89944 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 of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Dependant on journal.
Data is likely to be made available on the Open Science Framework, or by request from the corresponding author.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Mechanism of availability will depend on journal policy. It is likely that data will be included as supplementary material.


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
EmbaseGuided Internet-delivered cognitive behaviour therapy for perfectionism in a non-clinical sample of adolescents: A study protocol for a randomised controlled trial.2020https://dx.doi.org/10.1016/j.invent.2020.100342
N.B. These documents automatically identified may not have been verified by the study sponsor.