Recruiting

Physical Activity

Sponsor:

Unity Health Toronto

Code:

NCT06404320

Conditions

Treatment-resistant Depression

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

PA program - MoveU.HappyU

Study Details

Brief 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).

Conditions

Treatment-resistant Depression

Major Depressive Disorder

Study ID

NCT06404320

Start date

Sep 19, 2024

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PA program

Participants in the PA group will receive a 4-week remotely delivered one-on-one individualized PA program adjunct to TAU.

no intervention: TAU

Participants in the TAU group will be given a handout with the Canadian 24-hour movement guidelines and be told that they are encouraged to engage in PA.

Interventions

PA 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.

Primary outcome measure

  • Feasibility [ Time Frame: 13 weeks ]
  • Acceptability [ Time Frame: 13 weeks ]
  • Acceptability [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital, Unity Health Toronto

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Keywords

  • Major Depressive Disorder
  • Physical Activity
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2025-04-30.