Physical Activity Program for TRD

NCT06404320 | Recruiting

• 1 other identifier: 23-069
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Major Depressive Disorder; Physical Activity; Exercise

Outcome Measures

Primary Outcomes (3)

• Feasibility

  Recruitment rate, withdrawal rate, adherence rate, and data completion rate

  13 weeks

• Acceptability

  Responses to an exit survey

  13 weeks

• Acceptability

  Responses to semi-structured qualitative interviews

  13 weeks

Secondary Outcomes (4)

• Hamilton Depression Rating Scale-17

  13 weeks

• Patient Health Questionnaire-9

  13 weeks

• General Anxiety Disorder-7

  13 weeks

• World Health Organization - Five Well-Being Index

  13 weeks

Other Outcomes (3)

• Total duration of sleep; awake, light, rapid eye movement, and deep sleep durations

  13 weeks

• Metabolic equivalent minutes

  13 weeks

• Readiness (interpreted from sleep, activity, resting heart rate, heart rate variability, recovery index, and body temperature scores)

  13 weeks

Study Arms (2)

PA program

EXPERIMENTAL

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

Behavioral: PA program - MoveU.HappyU

TAU

NO INTERVENTION

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 BEHAVIORAL

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.

PA program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• Tassone VK, Quesnel DA, Parkington K, Rueda A, Martin J, Lee GH, Teixeira A, deJonge ML, Lou W, Wiljer D, Mulsant BH, Sabiston CM, Bhat V. Improving adherence to physical activity in treatment-resistant depression: Protocol for a pilot randomized controlled trial of a remotely delivered program. PLoS One. 2025 Sep 2;20(9):e0330848. doi: 10.1371/journal.pone.0330848. eCollection 2025.

  PMID: 40892783 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Motor Activity

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Central Study Contacts

Venkat Bhat

CONTACT

416-360-4000; venkat.bhat@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: September 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)