Physical Activity Program for TRD
Recruiting · NCT06404320 · Interventional (participants receive a specific treatment) · Lead sponsor: Unity Health Toronto
View the official record on ClinicalTrials.gov →Interventions studied
PA program - MoveU.HappyU
What this trial is about
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).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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 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 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.
Where it is running
1 location listed.
- St. Michael's Hospital, Unity Health Toronto - Toronto, Ontario, Canada