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Trial registered on ANZCTR


Registration number
ACTRN12623000943640
Ethics application status
Approved
Date submitted
26/06/2023
Date registered
1/09/2023
Date last updated
1/09/2023
Date data sharing statement initially provided
1/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Sharper Minds: A Digital Mental Health Prevention Package for University Students Targeting Multiple Health Behaviours
Scientific title
Effectiveness of Sharper Minds: A Digital Mental Health Prevention Package for University Students Targeting Multiple Health Behaviours
Secondary ID [1] 309981 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is the parent study with several sub-studies:
ACTRN12622001432707 Fit 4 Study: Creating healthy habits through physical activity and exercise for University Students;
ACTRN12622000819729 Tuned In University Students: An emotion regulation program using music listening

Health condition
Health condition(s) or problem(s) studied:
Anxiety 330476 0
Depression 330477 0
Somatic symptoms 330478 0
Condition category
Condition code
Mental Health 327327 327327 0 0
Anxiety
Mental Health 327328 327328 0 0
Depression
Mental Health 327329 327329 0 0
Other mental health disorders
Mental Health 327330 327330 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sharper Minds package aims to prevent mental health problems from developing in undergraduate students and it was co-designed by students, researchers, and health professionals at the University of Queensland. The co-design phase involved 3 focus groups with the students (16/10/2020; 27/10/20; 25/01/21), 3 with the UQ healthcare (09/09/20; 18/11/20; 5/01/21) and 1 with the Learning Systems Advisory Panel (29/10/2020). Areas of discussion included how best to engage students with the Sharper Minds project, ideas for the eTool interface, design, functions, frequency of tracking, SMS support, as well as suggestions on incentives for tracking and attending group courses. Our student advisory team was comprised of a diverse group of students aged between 18 to 33 (including international students and domestic students from various faculties). The package was designed to address students' knowledge and use of strategies across six domains: study, physical activity, healthy eating, social connection, emotion regulation, and sleep. There is a website with information, tip sheets and short videos on strategies to address the six domains in everyday life which students can access at their discretion, once or multiple times during semester. There is a weekly self-monitoring eTool that asks students how they are going that week in each of the six domains (each rated on a single item 7-point scale with emoji faces from very positive to very negative) and gives personalised feedback about the students' progress across semester. Students sign up for this via the website and then receive a link once a week by email that they can click on and complete the eTool. There are also short courses teaching skills and strategies to support university students’ mental health across the six domains (students can opt in to one course per semester). Each short course was developed by researchers from the University with relevant expertise on the target behaviour. Courses consist of 4 -5 sessions (weekly sessions of 45-60 mins), delivered online (synchronously) or in-person (participants have a choice of delivery mode) by trained postgraduate students to small groups of around 6 undergraduate students. Workbooks and online materials are provided to supplement what the students are learning during the group discussions. Workbooks were developed specifically for this Sharper Minds package, although some were adapted from existing programs (i.e., Tuned In University Students was adapted from the original Tuned In program by Dingle & Fay, 2017; Dingle et al., 2015;, the Groups 4 Education program was adapted from the Groups 4 Health program by Haslam et al., 2016; 2019; and the GRUNT program was adapted from the Grit Wellbeing program by Quinn, Walter, de Andrade, Dingle, Haslam & Hides, 2022.
The total duration of the package is 12 weeks (the duration of each academic semester), however, rolling recruitment means that students can start at various times in semester, and the interval between pre- and post-surveys varies from 6 to 10 weeks. Participants' access to the various aspects of the Sharper Minds package will be assessed by asking students which components of the package they engaged with in the post-survey as well as data collected on their entries in the weekly eTool, and attendance at the short courses.

In this level 1 trial, we aim to compare effectiveness of the package between students who opt to use one intervention (either min 6 entries on the weekly self-monitoring eTool or completion of one group course) with students who opt to use two intervention components (min 6 entries on the weekly eTool and completion of a group course simultaneously), both in comparison to a no intervention control condition (pre- and post-surveys only).
Intervention code [1] 326402 0
Prevention
Intervention code [2] 326787 0
Treatment: Other
Comparator / control treatment
Convenience sample drawn from the same population of university undergraduate students, who opt to complete pre- and post-surveys only but do not engage with the intervention components.
Control group
Active

Outcomes
Primary outcome [1] 335196 0
% positive on the PsyCheck mental health screener (i.e., scores >5 out of 20)
Timepoint [1] 335196 0
Baseline (upon commencement), and post-survey (Week 8 - 12 of semester). Post-survey occurs an average of 6 weeks after baseline.
Primary outcome [2] 335199 0
Depression symptoms (sum of 4 items from the PsyCheck)
Timepoint [2] 335199 0
Baseline (upon commencement), and post-survey (Week 8 - 12 of semester). Post-survey occurs an average of 6 weeks after baseline.
Primary outcome [3] 335200 0
Anxiety symptoms (sum of 4 items from the PsyCheck)
Timepoint [3] 335200 0
Baseline (upon commencement), and post-survey (Week 8 - 12 of semester). Post-survey occurs an average of 6 weeks after baseline.
Secondary outcome [1] 423430 0
Somatic symptoms (sum of 4 items from the PsyCheck)
Timepoint [1] 423430 0
Baseline (upon commencement), and post-survey (Week 8 - 12 of semester). Post-survey occurs an average of 6 weeks after baseline.
Secondary outcome [2] 423431 0
Wellbeing (Short Warwick Edinburgh Mental Wellbeing Scale scores)
Timepoint [2] 423431 0
Baseline (upon commencement), and post-survey (Week 8 - 12 of semester). Post-survey occurs an average of 6 weeks after baseline.
Secondary outcome [3] 423432 0
Academic motivation (sum of 4 purpose written items)
Timepoint [3] 423432 0
Baseline (upon commencement), and post-survey (Week 8 - 12 of semester). Post-survey occurs an average of 6 weeks after baseline.
Secondary outcome [4] 423433 0
Semester grade point average (average of grades out of 7 for all courses completed that semester) will be collected via data linkage to academic records.
Timepoint [4] 423433 0
End of semester
Secondary outcome [5] 423434 0
% students who rate agree or strongly agree to purpose written items in the baseline and post-surveys about current use of sleeping well to support their mental health
Timepoint [5] 423434 0
At conclusion of the study
Secondary outcome [6] 425499 0
% students who rate agree or strongly agree to purpose written items in the baseline and post-surveys about current use of healthy eating to support their mental health
Timepoint [6] 425499 0
At the conclusion of the study
Secondary outcome [7] 425500 0
% students who rate agree or strongly agree to purpose written items in the baseline and post-surveys about currently using social connections to support their mental health
Timepoint [7] 425500 0
At the conclusion of the study
Secondary outcome [8] 425501 0
% students who rate agree or strongly agree to purpose written items in the baseline and post-surveys about currently engaging in physical activity to support their mental health
Timepoint [8] 425501 0
At the conclusion of the study
Secondary outcome [9] 425502 0
% students who rate agree or strongly agree to purpose written items in the baseline and post-surveys about listening to music to support their mental health
Timepoint [9] 425502 0
At the conclusion of the study
Secondary outcome [10] 425503 0
% students who rate agree or strongly agree to purpose written items in the baseline and post-surveys about currently using mood regulation strategies to support their mental health
Timepoint [10] 425503 0
At the conclusion of the study

Eligibility
Key inclusion criteria
This is a university-wide prevention and early intervention program, so there is no screening for eligibility. Any undergraduate student enrolled at the University of Queensland is eligible. They will be of any age, gender, and enrolled as domestic or international students. English proficiency that is sufficient for the student to engage in the group discussions and complete the assessments (with optional support from the researchers).
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who are seeking treatment for an acute mental health episode (e.g., anxiety disorder, depression, substance use, psychosis). It will be clear in the participant information forms and on the Sharper Minds website that this is a prevention program NOT therapy. Students will be provided with a range of options for more suitable services in person and/or via the Sharper Minds website.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Main statistical analysis will be 3 x 2 analyses of variance, comparing participants in the 3 conditions across 2 time points on the primary and secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2022
Date of last participant enrolment
Anticipated
15/09/2023
Actual
Date of last data collection
Anticipated
27/10/2023
Actual
Sample size
Target
390
Accrual to date
264
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 40645 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 314156 0
University
Name [1] 314156 0
The University of Queensland (Vice Chancellors strategic funding)
Country [1] 314156 0
Australia
Funding source category [2] 314162 0
University
Name [2] 314162 0
The University of Queensland (DVC(Academic) Student Support and Activities Fund)
Country [2] 314162 0
Australia
Funding source category [3] 314165 0
Commercial sector/Industry
Name [3] 314165 0
Allianz Care Australia
Country [3] 314165 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Psychology,
University of QLD
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 316081 0
None
Name [1] 316081 0
Address [1] 316081 0
Country [1] 316081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313290 0
University of Queensland Human Research Ethics LNR Committee
Ethics committee address [1] 313290 0
Ethics committee country [1] 313290 0
Australia
Date submitted for ethics approval [1] 313290 0
18/02/2021
Approval date [1] 313290 0
16/03/2021
Ethics approval number [1] 313290 0

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

Contacts
Principal investigator
Name 127622 0
Prof Genevieve Dingle
Address 127622 0
School of PsychologyThe University of QueenslandSt Lucia QLD 4072
Country 127622 0
Australia
Phone 127622 0
+61733657295
Fax 127622 0
Email 127622 0
[email protected]
Contact person for public queries
Name 127623 0
Genevieve Dingle
Address 127623 0
School of PsychologyThe University of QueenslandSt Lucia QLD 4072
Country 127623 0
Australia
Phone 127623 0
+61733657295
Fax 127623 0
Email 127623 0
[email protected]
Contact person for scientific queries
Name 127624 0
Genevieve Dingle
Address 127624 0
School of PsychologyThe University of QueenslandSt Lucia QLD 4072
Country 127624 0
Australia
Phone 127624 0
+61733657295
Fax 127624 0
Email 127624 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?
Data used in the analyses of the hypotheses.
When will data be available (start and end dates)?
Available at conclusion of the study until 5 years following publication of the main findings.
Available to whom?
Researchers providing a sound reason for accessing the data, e.g., for a meta-analysis.
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
By contacting the principal investigator (email: [email protected])


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.