Tests a remote physical activity program for hard-to-treat depression
Tests a home-based, personal exercise program in adults with treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Physical Activity Program for TRD
Key facts
- Where
- Toronto, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06404320, who can take part
Where in Canada
- St. Michael's Hospital, Unity Health TorontoToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unity Health Toronto
- Trial code
- NCT06404320
- Record updated
- 30 April 2025
- Original description
This is a pilot study examining the delivery of a remotely delivered, one-on-one, individualized physical activity (PA) program in adult participants with treatment-resistant depression (TRD).Read full original descriptionShow less
Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial
This is a pilot study examining the delivery of a remotely delivered, one-on-one, individualized physical activity (PA) program in adult participants with treatment-resistant depression (TRD).
Inclusion: Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous PA per week) between the ages of 18 and 65 years, inclusive, capable of giving informed consent; Participants meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Ed. and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI); A Montgomery-Åsberg Depression Rating Scale 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 and self-report; Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no changes to treatments one month before screening (28 days).
Exclusion: 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; 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; 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; Taking medication that interferes with heart rate response to exercise, such as beta blockers; Current symptoms of mania, hypomania, mixed episodes, or psychosis; Pregnant females; Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months); Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire; Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program; Have exercise-induced asthma; Do not own a smartphone; Do not have reliable access to the Internet.