Study contact: PA.TRD@unityhealth.to

Overview: 

Physical activity (PA) has been associated with improvements in mood and mental health in both clinical and non-clinical populations. Recent research suggests that low doses and enjoyability of PA underlie its’ protective effect on mental health and well-being. As a result, in this study, we seek to explore the impact of a 4-week remotely delivered individualized one-on-one PA programme in addition to treatment as usual (TAU) on depressive symptoms of participants with treatment-resistant depression (TRD). At this time, we aim to conduct a pilot study with 30 participants wherein 20 will be randomized to the PA group and 10 will be in the control group.

Inclusion Criteria: 

• Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous physical activity per week) between the age of 18 and 65 years, inclusive, capable of giving informed consent.
• Participants meeting diagnostic criteria for major depressive disorder (MDD) without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders – 5th Ed. (DSM-5) and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI).
• A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 7 at screening (mild to severe MDE).
• Failure of at least two trials of antidepressant therapy of adequate dose and duration during the current episode as established by the Antidepressant Treatment History Form (ATHF) and self-report.
• Receiving treatments congruent with the Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines with no changes to treatments one month before screening (28 days), during the randomized intervention phase (28 days), and during the follow-up phase (42 days).

Exclusion Criteria:

• Current symptoms of mania, hypomania, mixed episodes, or psychosis.
• Have received a diagnosis of alcohol or a substance use disorder within the past 3 months or as confirmed by the MINI. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma-related disorders, etc.) will not be excluded.
• Pregnant females.
• Acute risk for a cardiovascular event (i.e., cardiovascular event within the past 12 months).
• Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire (PAR-Q).
• Self-reported balance, gait, or locomotion difficulties that would preclude participation in a physical activity programme.
• Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject’s ability to complete the study or its measures.
• Have exercise-induced asthma.
• Taking medication that interferes with heart rate response to exercise, such as beta blockers.
• Do not own a smartphone.
• Do not have reliable access to the Internet.
• Have previously received intravenous ketamine treatment in the last 2 months.
• Non-English-speaking individuals are excluded because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary.

Treatment Description

• Upon confirming eligibility in the study, participants will be randomized to the PA group (PA programme plus TAU) or the control group (no PA programme, only TAU).
• All participants will receive an Oura Ring which will collect passive physiological data (e.g. sleep, activity and readiness) throughout the course of the study.
• On a daily and weekly basis, participants will complete self-report questionnaires relevant to mental health and quality of life.
• Participants in the PA group will meet with their program trainer once a week for 4 weeks for a supervised PA session and engage in PA outside of the supervised session.
• Participants will be followed up with for 6 weeks after the intervention period.
• At the end of their participation in the study, participants who were randomized to the control group will have access to at least one session with a program trainer.

Recruitment for this study has come to an end. Thank you for your interest. We thank those who are participating!

Overview: 

The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality-VR, a web-based platform, and a wearable-Oura Ring) to understand and reduce the experience of stress/distress faced by nursing professionals.

Stress, anxiety, distress, and burnout are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Understanding factors underlying distress and resilience in complex workplace contexts are limited, and there are limited evidence-based interventions for stress and moral distress among frontline healthcare workers.

The purpose of this study is to use a Digital Intervention Suite (a combination of Virtual Reality-VR, a web-based platform, and a wearable-Oura Ring) to understand and reduce the experience of stress/distress faced by nursing professionals. This study involves participation in an in-person VR set up and use of an app and a wearable over the duration of the study (14+ weeks). The immersive VR component of the study involves a virtual experience of navigating a challenging workplace scenario to understand stress response and provide an overview of interventions that can be used to reduce workplace stress. Upon completion of the in-person VR visit, participants will continue to use the app and the wearable for the study duration to understand stress response in their actual workplaces. Participants will have real-time access to their essential data on wellness collected through the app and wearable (e.g., sleep, activity, physiological signals, anxiety symptoms). The Digital Intervention Suite (combined use of these three components: VR, app, and wearable) is essential for a thorough understanding of stress and moral distress. This is a de-identified study, and the team will only have access to deidentified data for analysis at the end of the study.

Eligibility: 

• Registered nurses (RNs) or registered practical nurses (RPNs) who are currently employed at a healthcare institution in Ontario.
• Ownership of a smartphone.

Time Commitment:

• You must attend one (1) in-person screening appointment (approx. 1hr) in downtown Toronto
• You must wear an Oura Ring every day for the duration of the study (14+ weeks) to track physiological changes
• You must answer online surveys three (3) times per week (Mondays, Thursdays, and Saturdays) for the duration of the study (14+ weeks). These should not take longer than 15 minutes.
• You must attend one (1) in-person Virtual Reality (VR) session (approx. 1hr) in downtown Toronto
• You must participate in one (1) online Zoom exit interview at the end of the study

Compensation will be provided for in-person visits. You may receive up to $370 CAD and may be eligible to keep the Oura Ring (valued at $415 CAD) upon full study participation.