Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000960752
Ethics application status
Approved
Date submitted
4/07/2022
Date registered
7/07/2022
Date last updated
21/07/2024
Date data sharing statement initially provided
7/07/2022
Date results provided
1/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of A Pilot Randomised Controlled Trial Comparing Two Online Interventions on Mental Health in University Students
Scientific title
Efficacy of A Pilot Randomised Controlled Trial Comparing Two Online Interventions on Mental Health in University Students
Secondary ID [1] 306964 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up of this record (ACTRN12620000574943).

Health condition
Health condition(s) or problem(s) studied:
Pefectionism 326122 0
Psychopathology 326234 0
Condition category
Condition code
Mental Health 323445 323445 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to the intervention condition will engage with the 'Intentional Imperfection' educational resource which will be delivered online. The resource consists of 2.5 hours of content and involves learning modules which each address specific components of the Perfectionism Social Disconnection Model. These learning modules include psychoeducation on perfectionism, interpersonal sensitivity, interpersonal hostility and social disconnection. Each learning module is followed by a worksheet in which participants reflect on what they have learnt. Participants will be able to complete the educational resource flexibly over the span of a week.

Adherence will be assessed by using available website data on the number of modules completed by each participant, as well as the time spent on the site.
Intervention code [1] 323448 0
Behaviour
Intervention code [2] 323528 0
Treatment: Other
Comparator / control treatment
Participants assigned to the control condition will undergo the "Healthy Mind and Body" educational resource, which is developed based on recommended advice from the Australian Government. This resource is delivered online and consists of 2.5 hours of content. There are four content modules which include psychoeducation on the link between physical and mental health as well as modules which aid the development of the participants health in three key areas: nutrition, fitness and sleep. Each learning module is followed by a worksheet in which participants reflect on what they have learnt and apply this knowledge. Participants will be able to complete the educational resource flexibly over the span of a week.

Adherence will be assessed by using available website data on the number of modules completed by each participant, as well as the time spent on the site.
Control group
Active

Outcomes
Primary outcome [1] 331305 0
The Kessler Psychological Distress Scale (K-10; Kessler et al., 2003)
Timepoint [1] 331305 0
1 month follow-up after starting treatment
Secondary outcome [1] 409482 0
Hewitt and Flett Multidimensional Perfectionism Scale (HF-MPS-45; Hewitt & Flett, 1991)
Timepoint [1] 409482 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [2] 409483 0
Frost Multidimensional Perfectionism Scale (Frost & Marten, 1990)
Timepoint [2] 409483 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [3] 409484 0
The Rejection Sensitivity Questionnaire (Downey & Feldman, 1996)
Timepoint [3] 409484 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [4] 409485 0
The Buss Perry Aggression Questionnaire (BPAQ; Buss & Perry, 1992)
Timepoint [4] 409485 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [5] 409486 0
The UCLA Loneliness Scale (UCLALS; Russell et al., 1996)
Timepoint [5] 409486 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [6] 409487 0
The Internalised Shame Scale (ISS; Cook et al., 1986)
Timepoint [6] 409487 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [7] 409488 0
The Self-Compassion Scale-Short Form (SCS-SF; Raes et al., 2011)
Timepoint [7] 409488 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [8] 409489 0
The Distress Tolerance Scale (DTS; Simons & Gaher, 2005)
Timepoint [8] 409489 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [9] 409490 0
The Toronto Mindfulness Scale – Trait Version (TMS-TV; David et al., 2009)
Timepoint [9] 409490 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [10] 411385 0
The Academic Resilience Scale (Cassidy, 2015)
Timepoint [10] 411385 0
1 month and 3 months follow-up after starting treatment
Secondary outcome [11] 411386 0
Kessler Psychological Distress Scale (K-10; Kessler et al., 2003)
Timepoint [11] 411386 0
3 months follow-up after starting treatment
Secondary outcome [12] 411509 0
The Client Satisfaction Questionnaire adapted to internet-based interventions (CSQ-I; Schroeder et al., 2015)
Timepoint [12] 411509 0
1 month follow-up after starting treatment

Eligibility
Key inclusion criteria
To participate in this study, participants must be university students, 17 years of age or older, and report high levels of perfectionism.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are engaging in current treatment for perfectionism or have been engaging in treatment for perfectionism within the past month. In addition, participants will be excluded if they have been taking any psychotropic medication for less than one month.

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 providing informed consent, participants will complete the baseline assessment. If a participant meets eligibility criteria and consents to being randomised, they will be randomly allocated to either intervention or control. A researcher external to the study will generate the allocation sequence using block randomisation procedures (computerised random sequence generated by www.sealedenvelope.com) to 1 of 2 treatment groups. An investigator who will not be involved in data analysis will be responsible for implementation by enrolling eligible participants to the respective online treatment. The allocation sequence will not be viewed by the other co-investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using block randomisation procedures (computerised random sequence generated by www.sealedenvelope.com) to 1 of 2 treatment groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on Stallman and colleagues (2020) research on web-based interventions for university students, we expect a small between groups effect size for K-10 scores in a larger trial comparing our two interventions. Whitehead et al. (2016) and Bell et al. (2018) provided estimates for the optimum sample size of pilot studies based on the target effect size and the size of a future larger trial, which minimises the number of participants recruited across both studies. Using their rule of thumb for an expected small difference between groups (0.1 < d < 0.3), we will assign 25 individuals per group in the pilot study. To allow for an attrition rate of 20%, we will assign 35 participants per arm.

Descriptive statistics will be used to examine participant characteristics and chi-square tests and t-tests will be used to assess for differences at baseline between groups (i.e., intervention vs control, completers vs non-completers). Linear mixed effects models using intent to treat procedures will be used to examine the effect of the interventions on outcomes over time. An ANOVA will be used to examine the difference in client satisfaction between the interventions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2023
Actual
13/03/2023
Date of last participant enrolment
Anticipated
30/09/2023
Actual
30/04/2023
Date of last data collection
Anticipated
30/12/2023
Actual
30/07/2023
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37753 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 311280 0
University
Name [1] 311280 0
Macquarie University
Country [1] 311280 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 312640 0
None
Name [1] 312640 0
Address [1] 312640 0
Country [1] 312640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310787 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 310787 0
Ethics committee country [1] 310787 0
Australia
Date submitted for ethics approval [1] 310787 0
22/04/2022
Approval date [1] 310787 0
21/06/2022
Ethics approval number [1] 310787 0

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

Contacts
Principal investigator
Name 118862 0
A/Prof Melissa Norberg
Address 118862 0
Room 714, 4 First Walk (4FW) Macquarie University, Macquarie Park, NSW 2109, Australia
Country 118862 0
Australia
Phone 118862 0
+61 2 9850 8127
Fax 118862 0
Email 118862 0
[email protected]
Contact person for public queries
Name 118863 0
Melissa Norberg
Address 118863 0
Room 714, 4 First Walk (4FW) Macquarie University, Macquarie Park, NSW 2109, Australia
Country 118863 0
Australia
Phone 118863 0
+61 2 9850 8127
Fax 118863 0
Email 118863 0
[email protected]
Contact person for scientific queries
Name 118864 0
Melissa Norberg
Address 118864 0
Room 714, 4 First Walk (4FW) Macquarie University, Macquarie Park, NSW 2109, Australia
Country 118864 0
Australia
Phone 118864 0
+61 2 9850 8127
Fax 118864 0
Email 118864 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case by case basis at the discretion of the principal investigator.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified individual line-by-line data.

What types of analyses could be done with individual participant data?
• Any purpose.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• The de-identified data has been uploaded to the Open Science Framework Repository to be made available to other researchers. The principal investigator can also be contacted for the dataset via email [email protected].



Are there extra considerations when requesting access to individual participant data?
No


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.