Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000147189
Ethics application status
Approved
Date submitted
25/01/2019
Date registered
31/01/2019
Date last updated
31/01/2019
Date data sharing statement initially provided
31/01/2019
Date results information initially provided
31/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet-based cognitive behaviour therapy for perfectionism
Scientific title
Internet-based cognitive behaviour therapy for perfectionism: secondary impacts and modes of delivery
Secondary ID [1] 297216 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perfectionism 311261 0
depression 311262 0
anxiety 311263 0
body image 311264 0
Condition category
Condition code
Mental Health 309886 309886 0 0
Depression
Mental Health 309887 309887 0 0
Eating disorders
Mental Health 309907 309907 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet cognitive behaviour therapy for perfectionism (ICBT-P) comprises eight online modules for the treatment of clinical perfectionism delivered via a secure online platform wherever the participant had access to a computer. The modules are available for use in research, and each take about 30 minutes to complete. The intervention was unguided with just reminder emails sent by a university research student once a week. The modules involve reading and answering questions and trying out new ideas in practice in their own lives. In study 1 modules were completed once a week for 3 weeks, in Study 2 modules were completed around twice a week for 4 weeks. Adherence was assessed by accessing website analytics.
Module 1 (defining perfectionism) defines ‘unhelpful perfectionism’ and examines the impact it can have on your life. Module 2 (Your Perfectionism Cycle) identifies persistent perfectionistic behaviours and starts to combat them. Module 3 (Surveys and Experiments) ‘Reality check’: adjusts standards and re-examines beliefs according to others’ experiences with behaviours linked to your perfectionism. Module 4 (New Ways of Thinking) challenges and changes perfectionism related cognitions and moves towards a flexible thinking style. Module 5 (Using Skills for Managing Unhelpful Perfectionism) seeks to overcome procrastination and improve problem solving skills, learning to engage without feeling guilty over ‘wasted time’. Module 6 (Self-criticism or Self-compassion) teaches how to deal with ‘failure’; decreasing self-criticism and increasing self-compassion. Module 7 (Re-examining the way we define our self-worth) examines how you define your self-worth; self-worth is not defined by achievement. Module 8 (Staying Well) involves a brief review, and planning for the future –aspirations and preparing for possible setbacks.
Intervention code [1] 313464 0
Treatment: Other
Comparator / control treatment
Wait list control - in Study 1 participants were offered a self-help book at the end of the 3-week intervention period; in Study 2 participants were offered a self-help book at the end of the 4-week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 318828 0
Perfectionistic Concerns using the Concern over Mistakes subscale of the Frost Multidimensional Perfectionism Scale
Timepoint [1] 318828 0
Baseline and end of treatment
Primary outcome [2] 318829 0
Perfectionistic strivings using the Personal Standards subscales of the Frost Multidimensional Perfectionism Scale
Timepoint [2] 318829 0
Baseline and end of treatment
Secondary outcome [1] 366176 0
Negative affect (composite depression and anxiety) measured in Study 1 using 9-item Depression module of the Patient Health Questionnaire and the Generalized Anxiety Disorder Assessment (GAD-7). In Study 2 14 items from the 21-item Depression Anxiety and Stress Scale were used.
Timepoint [1] 366176 0
Baseline and end of treatment
Secondary outcome [2] 366177 0
Body Image-Acceptance and Action Questionnaire
Timepoint [2] 366177 0
Baseline and end of treatment

Eligibility
Key inclusion criteria
Anyone identifying as having problems with perfectionism
Minimum age
17 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not concurrently receiving treatment for perfectionism

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes - function provided by Qualtrics
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 Models - Intent to treat

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/04/2017
Date of last participant enrolment
Anticipated
Actual
26/10/2018
Date of last data collection
Anticipated
Actual
20/12/2018
Sample size
Target
100
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301765 0
University
Name [1] 301765 0
Flinders University
Country [1] 301765 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 301509 0
None
Name [1] 301509 0
Address [1] 301509 0
Country [1] 301509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302484 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 302484 0
Flinders University, GPO Box 2100, Adelaide, 5001, South Australia, Australia
Ethics committee country [1] 302484 0
Australia
Date submitted for ethics approval [1] 302484 0
01/03/2017
Approval date [1] 302484 0
28/04/2017
Ethics approval number [1] 302484 0
7630

Summary
Brief summary
It has been suggested that guided ICBT-P can substantially decrease perfectionism in low doses (3 or less modules) but appears to only impact secondary outcomes with higher doses of treatment. The current study addressed this question, as well as the best method to promote higher dosage use.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 90378 0
Prof Tracey Wade
Address 90378 0
School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001
Country 90378 0
Australia
Phone 90378 0
+61-8-82013736
Fax 90378 0
+61-8-8201 3877
Email 90378 0
[email protected]
Contact person for public queries
Name 90379 0
Prof Tracey Wade
Address 90379 0
School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001
Country 90379 0
Australia
Phone 90379 0
+61-8-82013736
Fax 90379 0
+61-8-8201 3877
Email 90379 0
[email protected]
Contact person for scientific queries
Name 90380 0
Prof Tracey Wade
Address 90380 0
School of Psychology, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001
Country 90380 0
Australia
Phone 90380 0
+61-8-82013736
Fax 90380 0
+61-8-8201 3877
Email 90380 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?
Anonymised data for the 5 main outcome variables
When will data be available (start and end dates)?
July 2019 to July 2029
Available to whom?
Any researcher who requests it
Available for what types of analyses?
Meta-analyses, re-analysis
How or where can data be obtained?
Open Science Framework


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.