Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06404320

Physical Activity Program for TRD

Led by Unity Health Toronto · Updated on 2025-04-30

30

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

Sponsors

U

Unity Health Toronto

Lead Sponsor

U

University of Toronto

Collaborating Sponsor

AI-Summary

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).

CONDITIONS

Official Title

Physical Activity Program for TRD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years who are sedentary, doing less than 60 minutes of moderate-to-vigorous physical activity per week
  • Diagnosed with major depressive disorder without psychotic symptoms and currently experiencing a major depressive episode confirmed by a clinical interview
  • Have a Montgomery-Åsberg Depression Rating Scale score of 7 or higher at screening
  • Have not responded adequately to at least two antidepressant treatments of proper dose and duration during the current episode
  • Receiving treatment that follows Canadian guidelines with no medication changes in the 28 days before screening
Not Eligible

You will not qualify if you...

  • Current symptoms of mania, hypomania, mixed episodes, or psychosis
  • Diagnosis of alcohol or substance use disorder within the past 3 months
  • Pregnant females
  • Recent cardiovascular event within the past 12 months
  • Medical conditions that contraindicate exercise based on a readiness questionnaire
  • Balance, gait, or movement problems that prevent physical activity participation
  • Other conditions deemed by investigators to interfere with study completion
  • Exercise-induced asthma
  • Use of medications like beta blockers that affect heart rate during exercise
  • No ownership of a smartphone
  • No reliable internet access
  • Received intravenous ketamine treatment in the last 2 months
  • Non-English speakers due to communication and consent requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

Actively Recruiting

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Research Team

V

Venkat Bhat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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