Individualized physical activity program for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates a remotely delivered, one-on-one individualized physical activity program designed for adults with treatment-resistant depression (TRD). Participants will be randomized to receive either the physical activity program alongside standard treatment or standard treatment alone. The program, called MoveU.HappyU, tailors physical activity to individual preferences and aims to improve depressive symptoms and quality of life. The study will also utilize a digital platform to monitor physiological data through wearable devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. 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).
3. A Montgomery-Åsberg Depression Rating Scale total score of ≥ 7 at screening (mild-to-severe MDE).
4. 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.
5. 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:

1. Current symptoms of mania, hypomania, mixed episodes, or psychosis.
2. 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.
3. Pregnant females.
4. Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months).
5. Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire.
6. Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program.
7. 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.
8. Have exercise-induced asthma.
9. Taking medication that interferes with heart rate response to exercise, such as beta blockers.
10. Do not own a smartphone.
11. Do not have reliable access to the Internet.
12. 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's running

• St. Michael's Hospital, Unity Health Toronto
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Venkat Bhat
• Email: venkat.bhat@utoronto.ca
• Phone: 416-360-4000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study is testing if deep brain stimulation can help people with severe depression who haven't found relief from regular treatments by looking for brain signals that could predict their mood changes.

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• Using gamma oscillations to predict ketamine therapy outcomes in depression

  This study is testing if brain activity measured during ketamine treatment can help predict how well it will work for people with depression that hasn't responded to other treatments.

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• Understanding the impact of mood disorders and treatment responses

  This study is trying to learn more about how people with depression and bipolar disorder respond to treatment by talking to them weekly for up to 12 weeks to improve future care and predict how well medications might work.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06462196

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.