ANZCTR - Registration

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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]

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

Depression

Somatic symptoms

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Mental Health

Other mental health disorders

Mental Health

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]

Prevention

Intervention code [2]

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]

% positive on the PsyCheck mental health screener (i.e., scores >5 out of 20)

Timepoint [1]