Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000308493
Ethics application status
Approved
Date submitted
13/02/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility and efficacy of the UPLIFT program: Does exercise improve the wellbeing of university students experiencing mental ill-health?
Scientific title
Investigating the feasibility and efficacy of the UPLIFT program: Does exercise improve the wellbeing of university students experiencing mental ill-health?
Secondary ID [1] 313653 0
Nil known
Universal Trial Number (UTN)
Trial acronym
UPLIFT (University students’ physical activity for Lasting Improvement in Fitness and Thought)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 336222 0
Anxiety 336873 0
Stress 336874 0
Condition category
Condition code
Mental Health 332759 332759 0 0
Depression
Mental Health 332760 332760 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an 8-week exercise program designed to improve the mental health and wellbeing of university students experiencing at least moderate levels of psychological distress. Participants will be paired with a 'mentor' who will provide physical activity-related guidance over the 8 weeks. Participants will have weekly face-to-face sessions with their mentor and the program is flexible in nature which means that participants have the autonomy to perform whichever forms of exercise they enjoy most ranging from yoga, pilates, strength training and/or aerobic exercise. Moreover, the mentor can offer support to help participants by providing advice related to becoming more physically active outside sessions and beyond program completion.

Additional details about the program and its delivery include the following:
- Exercise sessions will be delivered by the student investigator who is a qualified personal trainer.
- Sessions will be conducted one-on-one (i.e. participant and mentor).
- Sessions will occur on the university campus, primarily within the strength research Laboratory.
- Level of intensity can be considered by asking a participant about their rate of perceived exertion (RPE) following an exercise session. This will be assessed via the modified CR-10 (Foster et al. 2001).
- Sessions will occur once per week with each session lasting approximately 1 hour.
- Adherence and session details will be monitored by the mentor.
- The program mentor has undergone training in first aid and mental health first aid ahead of program delivery.
Intervention code [1] 330256 0
Treatment: Other
Comparator / control treatment
This study will use a waitlist control. Those allocated to the control group will complete the intervention at the end of participation in the 8 week data collection period (i.e. accelerometery and data collection surveys at three timepoints).
Control group
Active

Outcomes
Primary outcome [1] 340288 0
Mental Health
Timepoint [1] 340288 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Primary outcome [2] 340932 0
Feasibility
Timepoint [2] 340932 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [1] 443624 0
Physical Activity
Timepoint [1] 443624 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [2] 443625 0
Sleep
Timepoint [2] 443625 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [3] 443626 0
Mental Health related Quality of Life
Timepoint [3] 443626 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [4] 443627 0
Self-efficacy related to exercise
Timepoint [4] 443627 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [5] 443628 0
Resilience
Timepoint [5] 443628 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [6] 443629 0
Loneliness
Timepoint [6] 443629 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [7] 443630 0
Enjoyment of physical activity
Timepoint [7] 443630 0
Baseline (pre-randomisation), midpoint (end of week 4) and final follow-up (end of week 8) post-intervention commencement
Secondary outcome [8] 443634 0
Perceived environmental support (i.e. support from UPLIFT mentor)
Timepoint [8] 443634 0
This will be assessed at final follow-up (end of week 8) post-intervention commencement and administered to those in the intervention group.
Secondary outcome [9] 445511 0
Accelerometery
Timepoint [9] 445511 0
Baseline (pre-randomisation), Start of week 4 and Start of Week 8 post-intervention commencement

Eligibility
Key inclusion criteria
- Those aged 18 years or older
- Currently enrolled at the University (i.e. Deakin)
- Those experiencing at least moderate levels of psychological distress (equal to or greater than 16 on the K10)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant (or recently given birth)
- Exercise deemed unsafe (as per stage one of the Adult Pre-Exercise Screening System)
- Those engaging in 150 or more minutes of moderate-to-vigorous physical activity per week

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)
Primary supervisor will manage randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator list
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
6/07/2026
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318119 0
University
Name [1] 318119 0
Deakin University PhD Scholarship funding
Country [1] 318119 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320499 0
None
Name [1] 320499 0
Address [1] 320499 0
Country [1] 320499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316764 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 316764 0
Ethics committee country [1] 316764 0
Australia
Date submitted for ethics approval [1] 316764 0
14/11/2024
Approval date [1] 316764 0
04/04/2025
Ethics approval number [1] 316764 0

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

Contacts
Principal investigator
Name 138942 0
A/Prof Megan Teychenne
Address 138942 0
Deakin University Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125.
Country 138942 0
Australia
Phone 138942 0
+61 3 92446910
Fax 138942 0
Email 138942 0
[email protected]
Contact person for public queries
Name 138943 0
Gary Skinner
Address 138943 0
Deakin University Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125.
Country 138943 0
Australia
Phone 138943 0
+61 3 92446910
Fax 138943 0
Email 138943 0
[email protected]
Contact person for scientific queries
Name 138944 0
Gary Skinner
Address 138944 0
Deakin University Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125.
Country 138944 0
Australia
Phone 138944 0
+61 3 92446910
Fax 138944 0
Email 138944 0
[email protected]

Data sharing statement
Will the study consider sharing 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.