ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perfectionism

Psychopathology

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Brief Symptom Inventory (BSI; Derogatis, 1993)

Timepoint [1]

Baseline and at 2 week post-intervention assessment

Primary outcome [2]

Rejection Sensitivity Questionnaire (RSQ; Downey & Feldman, 1996)

Timepoint [2]

Baseline and 2-week post-intervention assessment

Primary outcome [3]

Multidimensional Scale of Perceived Social Support (MSPSS; Zimet, Dahlem, Zimet & Farley, 1988)

Timepoint [3]

Baseline and 2-week post-intervention assessment

Secondary outcome [1]

Hewitt & Flett Multidimensional Perfectionism Scale (Hewitt &. Flett, 2004)

Timepoint [1]

Baseline and 2-week post-intervention assessment

Secondary outcome [2]

Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001)

Timepoint [2]

Baseline and 2-week post-intervention assessment

Secondary outcome [3]

Behavioural Emotion Regulation Questionnaire (BERQ; Kraaij & Garnefski, 2019)

Timepoint [3]

Baseline and 2-week post-intervention assessment

Secondary outcome [4]

Inventory of Socially Supportive Behaviours (ISSB; Berrera, Sandler, & Ramsey, 1981)

Timepoint [4]

Baseline and 2-week post-intervention assessment

Secondary outcome [5]

Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985).

Timepoint [5]

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]

University

Name [1]

Macquarie University

Address [1]

Balaclava Rd, Macquarie Park NSW 2109

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd, Macquarie Park NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee (Medical Sciences)

Ethics committee address [1]

Level 3, C5C Building
Macquarie University, NSW 2109, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/04/2020

Approval date [1]

30/04/2020

Ethics approval number [1]

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

A/Prof Melissa Norberg

Address

Macquarie University, 4 First Walk, Room 714, Macquarie Park, NSW, 2109

Country

Australia

Phone

+612 9850 8127

Fax

Email

[email protected]

Contact person for public queries

Name

Melissa Norberg

Address

Macquarie University, 4 First Walk, Room 714, Macquarie Park, NSW, 2109

Country

Australia

Phone

+612 9850 8127

Fax

Email

[email protected]

Contact person for scientific queries

Name

Melissa Norberg

Address

Macquarie University, 4 First Walk, Room 714, Macquarie Park, NSW, 2109

Country

Australia

Phone

+612 9850 8127

Fax

Email

[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

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Visvalingam, S., McHardy, H. L., Norder, S. J., Ma... [More Details]

Documents added automatically

No additional documents have been identified.