RecruitingNot ApplicableNCT06404320

Physical Activity Program for TRD

Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial


Sponsor

Unity Health Toronto

Enrollment

30 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a structured physical activity program can help people with treatment-resistant depression (TRD) — depression that hasn't improved after trying at least two antidepressants. Participants are currently sedentary (less than 60 minutes of moderate exercise per week) and are still on their current treatments. **You may be eligible if...** - You are between 18 and 65 years old and currently sedentary (very little regular exercise) - You have been diagnosed with major depressive disorder (not psychotic) and are in a current depressive episode - Your depression has not improved after at least two adequate antidepressant treatments - Your current treatments have been stable for at least one month - Your depression symptoms are at least mild (MADRS score of 7 or higher) **You may NOT be eligible if...** - You have current mania, hypomania, mixed episodes, or psychosis - You have had a substance or alcohol use disorder in the past 3 months - You are pregnant - You have had a cardiovascular event (heart attack, stroke) in the past 12 months - You have a medical condition that makes exercise unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPA program - MoveU.HappyU

Participants will meet with their program trainer once a week virtually for 4 weeks to engage in 30 minutes of behavioral change coaching and 30 minutes of a structured PA program that is tailored to their needs and goals. The intensity of the PA sessions will be self-selected. PA sessions will involve a warmup, a conditioning component consisting of individualized aerobic or resistance exercises, and a cool down/stretch. Participants will also be instructed to independently engage in PA (outside of their session with the trainer) for 120 minutes at 50-65% of their maximum work capacity. This can be done by engaging in PA between 3-5 times per week.


Locations(1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

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NCT06404320


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