Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000574943
Ethics application status
Approved
Date submitted
19/04/2020
Date registered
18/05/2020
Date last updated
19/11/2021
Date data sharing statement initially provided
18/05/2020
Date results information initially provided
16/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Consequences of Perfectionistic Behaviours in University Students: An Online Pilot Study
Scientific title
Intentional Imperfection: A Pilot Study on the Effect of an Online Psycho-educational Resource for Perfectionism
Secondary ID [1] 301067 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perfectionism 317127 0
Psychopathology 317128 0
Condition category
Condition code
Mental Health 315285 315285 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be assigned to engage with an educational resource titled 'Intentional Imperfection', which aims to target consequences of perfectionistic behaviour based on the Perfectionism Social Disconnection Model. The educational resource has modules on the following: perfectionism, rejection sensitivity, interpersonal hostility, social disconnection and summary. Each module introduces the concept via an informative video followed by strategies to manage these challenges. These strategies include emotion regulation, behaviour regulation, increasing interpersonal skills and relationship goal setting. These strategies are based on previous scientific research and have been verified with a clinical psychologist. This educational resource is to be delivered online in an individual format. The intervention is delivered once for a duration of 2 hours. Participants will be emailed a feedback survey two weeks after the completion of the educational resource and responses will help guide the development of this resource.
Intervention code [1] 317372 0
Treatment: Other
Intervention code [2] 317373 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323526 0
Brief Symptom Inventory (BSI; Derogatis, 1993)
Timepoint [1] 323526 0
Baseline and at 2 week post-intervention assessment
Primary outcome [2] 323527 0
Rejection Sensitivity Questionnaire (RSQ; Downey & Feldman, 1996)
Timepoint [2] 323527 0
Baseline and 2-week post-intervention assessment
Primary outcome [3] 323528 0
Multidimensional Scale of Perceived Social Support (MSPSS; Zimet, Dahlem, Zimet & Farley, 1988)
Timepoint [3] 323528 0
Baseline and 2-week post-intervention assessment
Secondary outcome [1] 382163 0
Hewitt & Flett Multidimensional Perfectionism Scale (Hewitt &. Flett, 2004)
Timepoint [1] 382163 0
Baseline and 2-week post-intervention assessment
Secondary outcome [2] 382164 0
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001)
Timepoint [2] 382164 0
Baseline and 2-week post-intervention assessment
Secondary outcome [3] 382165 0
Behavioural Emotion Regulation Questionnaire (BERQ; Kraaij & Garnefski, 2019)
Timepoint [3] 382165 0
Baseline and 2-week post-intervention assessment
Secondary outcome [4] 382166 0
Inventory of Socially Supportive Behaviours (ISSB; Berrera, Sandler, & Ramsey, 1981)
Timepoint [4] 382166 0
Baseline and 2-week post-intervention assessment
Secondary outcome [5] 382167 0
Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985).
Timepoint [5] 382167 0
Baseline and 2-week post-intervention assessment

Eligibility
Key inclusion criteria
To participate in this study, participants must be greater than or equal to 17 years of age, proficient in English, and have a score greater than or equal to 36 on the Clinical Perfectionism Questionnaire. (Dickie, Surgenor, Wilson, & McDowall, 2012; Fairburn et al., 2003). Scores of 36 and higher indicate that an individual is at least moderately perfectionistic.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not pass the reading validity question in the prescreener will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample will require 53 participants (90% power, a=0.05) in order to detect small pre-post differences, whilst 148 participants are needed to detect correlations of a small magnitude, controlling for Type 1 error (90% power, a=0.01). To analyse data, Pearons' bivariate correlations will be used to examine associations between variables of interest. In addition, t-tests will be used to assess differences in variables of interest post-engagement with the educational resource.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We were unable to recruit more participants during the allotted time period.
Date of first participant enrolment
Anticipated
1/06/2020
Actual
1/06/2020
Date of last participant enrolment
Anticipated
7/03/2021
Actual
1/10/2020
Date of last data collection
Anticipated
4/04/2021
Actual
15/10/2020
Sample size
Target
185
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305509 0
University
Name [1] 305509 0
Macquarie University
Country [1] 305509 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 305910 0
None
Name [1] 305910 0
Address [1] 305910 0
Country [1] 305910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305820 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 305820 0
Level 3, C5C Building
Macquarie University, NSW 2109, Australia
Ethics committee country [1] 305820 0
Australia
Date submitted for ethics approval [1] 305820 0
19/04/2020
Approval date [1] 305820 0
30/04/2020
Ethics approval number [1] 305820 0
52020661315264

Summary
Brief summary
Extensive research suggests that high levels of perfectionism are associated with various mental health issues and that many university students possess perfectionistic traits. This study aims to assess the feasibility of Intentional Imperfection, an educational resource for university students that targets consequences of perfectionistic behaviours based on the Perfectionism Social Disconnection Model. Eligible participants must be aged 17 or above and score 36 or above on the Clinical Perfectionism Questionnaire. Eligible participants will complete several baseline measures followed by engagement with the educational resource, which teaches emotion regulation strategies, social skills, and relationship goal setting. Participants will be contacted two weeks later to a complete post-intervention assessment and a feedback survey. We expect engagement with the resource will increase participants interpersonal, cognitive and emotion regulation skills, and decrease rejection sensitivity, interpersonal hostility, actual/perceived social disconnection and thus risk for psychopathology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101714 0
A/Prof Melissa Norberg
Address 101714 0
Macquarie University, 4 First Walk, Room 714, Macquarie Park, NSW, 2109
Country 101714 0
Australia
Phone 101714 0
+612 9850 8127
Fax 101714 0
Email 101714 0
melissa.norberg@mq.edu.au
Contact person for public queries
Name 101715 0
Melissa Norberg
Address 101715 0
Macquarie University, 4 First Walk, Room 714, Macquarie Park, NSW, 2109
Country 101715 0
Australia
Phone 101715 0
+612 9850 8127
Fax 101715 0
Email 101715 0
melissa.norberg@mq.edu.au
Contact person for scientific queries
Name 101716 0
Melissa Norberg
Address 101716 0
Macquarie University, 4 First Walk, Room 714, Macquarie Park, NSW, 2109
Country 101716 0
Australia
Phone 101716 0
+612 9850 8127
Fax 101716 0
Email 101716 0
melissa.norberg@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be de-identified and analysed as a group. No participants will be identified in the study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4794Study results articleYes Visvalingam, S., McHardy, H. L., Norder, S. J., Ma... [More Details]

Documents added automatically
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