Exercise and Mindfulness Study

You are not eligible to participate in this study if you already engage in a consistent (once per week or more) meditative or mindfulness practice (e.g. yoga, meditation, mindfulness apps), your medication has changed in the last 4 weeks, are unable to speak, read or write in English, have a physical or cognitive impairment (e.g. prosthetic) that would hinder or restrict any part of the study requirements or if you have a diagnosed mental disorder that would impair your ability to give informed consent, comprehend reading/writing tasks and/or participate reliably. Screening by the research team will determine whether moderate intensity conditions are appropriate and safe. Referral to a GP will be made for exercise clearance if any physiological health conditions (such as high blood pressure) are uncontrolled or outside of appropriate ranges for exercise engagement.

What will I be required to do?

In this study, you will participate in five different study conditions. Your participation will last 6 weeks, with 1 visit each week to the University. The total time involved in the study will be 7-7.5 hours.

If you take part in this study, you go through the following steps: 1) Baseline assessment and familiarisation session Before you can start the interventions, you will be required to attend an initial consultation appointment. This appointment is to collect baseline information about you and to overview the procedures of the remaining sessions to ensure you feel familiar and comfortable with what to expect.

This appointment will consist of the following: Opportunity to ask any questions; Signing the consent form; Completing questionnaires (approx. 20 minutes); Demographic information (information about yourself such as gender, date of birth, ethnicity, income); SCID-5-CV; Depression, Anxiety & Stress Symptoms (DASS-21); Pittsburgh Sleep Quality Index (PSIQ); Physical health measures (approx. 20 minutes); Height, weight, waist circumference; Aerobic capacity (PWC-170); Blood pressure; Heart rate; Blood glucose (finger prick); Familiarisation with exercise conditions (approx. 30 minutes); Familiarisation with acute mood state scale (POMS).

2) Intervention Session 1, 2, 3 & 4 Each of the subsequent intervention sessions will consist of the following: Explanation of the session; what to expect, safety; Opportunity for questions; Pre-session measures: (approx. 15 minutes); Profile of Mood States (POMS) questionnaire; Sleep questionnaire; Physical health measures (same as baseline assessment); Intervention condition (exercise/mindfulness – 30 minutes); Post-session measures: (approx. 15 minutes) ; Profile of Mood States (POMS) questionnaire; Physical health measures (same as baseline assessment). You will be prompted via a text message reminder to fill out two questionnaires (POMS, sleep) again 24 hours after you’ve finished, we will provide hard copies for you to take home.

3) Intervention Session 5 (final session) The final session will include both an intervention which will follow the same format as the previous sessions but will then also include again collecting the measures taken during the initial consultation appointment.

All exercise sessions involve body weight movements with an emphasis on control and balance and are guided by a qualified instructor. Some sessions will involve paying attention to uncomfortable thoughts and sensations within the body. Each session will be supervised by an accredited clinical exercise physiologist who is also an accredited yoga teacher; she will be able to work individually with you to make any changes based on physical limitations you may have. Please wear light, comfortable clothing to exercise in and bring a towel and water with you. As we are measuring your blood glucose response to these sessions, we will ask that you eat the same thing each morning before testing and that you refrain from any vigorous exercise for 24 hours beforehand.

Where is the study being conducted?

UniSA City West Health Clinic – located at UniSA City West campus at 27-29 North Terrace, Adelaide, 5000. You can access to building off of Gray street. Please let front desk staff know when you have arrived. Public transport options are within walking distance of the clinic, including tram and buses. Tram: “Park n Ride” – park your car at the Adelaide Entertainment Centre or in the Parklands (4 hours) at Thebarton and catch the free tram from 1 stop away. Please visit adelaidemetro.com.au for further details.

How will privacy be maintained?

All personally identifying details will be removed and replaced with a participant number. Personal information will remain confidential and no information which could lead to identification of you will be released, unless required by law. Hardcopies of research data will be stored in the Primary Supervisor's office, at Uni SA City East Campus, in a locked filing cabinet. Electronic data will be stored on UniSA’s secure servers.

What will happen to your information following the study?

Following completion of this project, all data will be archived securely at an off-site storage facility maintained by the University of South Australia for a minimum period of five years.

Are there any risks?

It is not anticipated that there are any risks to participation in this study beyond those encountered during everyday life. All exercise carries some level of risk for discomfort and injury, however, the exercises involved in this study are deemed to be of low-risk and are relatively brief (30 minutes). All sessions are supervised and/or instructed by an accredited Clinical Exercise Physiologist with Mental Health First Aid training. You may feel temporary discomfort when responding to questions about your mental and emotional health. If you would like information related to mental health community resources after responding to the questions, these can be made available to you. If you require immediate assistance, a staff clinical psychologist who is involved in this study can assist. In case of an extreme adverse event, referral to the Royal Adelaide Hospital Emergency Department will be made.

What about COVID-19?

During all appointments we will strictly implement the Australian government COVID-19 protocols and recommendations. This will include thorough cleaning and sanitisation of all equipment you come into contact with. Safe hygiene including hand washing at the start and end of each appointment by yourself and the researcher. Physical distancing will be implemented, and capacity limits will be maintained. We also ask that you have the COVID-safe app downloaded and on while you attend your appointments. You will also be contacted within 24 hours of your appointment and screened over the phone for any risk factors, signs or symptoms. If you don’t feel well on the day of your appointment, please call us to reschedule and stay home.

What are the possible benefits of this study?

We cannot guarantee that you will receive any direct personal mental health or physical health benefits from being part of this trial. However, it has been demonstrated in the literature that exercise and mindfulness may help improve symptoms of depression and anxiety. Regardless of whether your mental or physical health improves, you will be contributing to the scientific literature on the effects of mindfulness and exercise, and this information may ultimately help improve the fitness and mental health of others. The information obtained from this trial may help to determine whether adding components - such as mindfulness – to exercise produces greater relief from symptoms of depression and anxiety and greater increases in positive moods. The results may inform future exercise treatment guidelines for depressive and anxiety disorders.

How will I find out about the results?

A summary of your baseline measures including answers to mental health questionnaires and results from physical health tests can be provided to you via email upon request. You may also request to be sent a summary of the final results once the study has been completed.

Can I withdraw?

Your decision to take part in this study is voluntary. You may refuse to participate, or you may withdraw from the study at any time. Your decision not to participate or to withdraw from the study will not affect your ability to access any care or services. If a study staff member decides that it is in your best physical or mental health interests that you withdraw from the study, they will remove you without your consent. If new information is discovered during the course of this study that suggests your participation in this study may adversely affect your health, welfare or willingness to participate, you will be told immediately. If you withdraw your data may still be used in the study.

Who can I contact for questions?

For any questions about the project, please email Jacinta, the head researcher on this project (brijy012@mymail.unisa.edu.au). This project has been approved by the University of South Australia's Human Research Ethics Committee. If you have any ethical concerns about the project or questions about your rights as a participant, please contact the Executive Officer of these Committees. Uni SA, Vicki Allen, 8302 3118, vicki.allen@unisa.edu.au.

Complaints Process:

Participants or third parties who wish to lodge a complaint about either the study or the way it is being conducted should contact the Executive Officer of UniSA HREC in the first instance, email: humanethics@unisa.edu.au or tel: 8302 3118.