Individualized physical activity program for treatment-resistant depression

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

This study is testing a personalized exercise program to see if it can help adults with treatment-resistant depression feel better when combined with their usual treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Unity Health Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06404320 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are sedentary adults aged 18 to 65 with major depressive disorder who have not responded to at least two antidepressant treatments.

Not a fit: Patients with psychotic symptoms or those who are currently engaged in regular physical activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could provide an effective alternative treatment option for patients suffering from treatment-resistant depression.

How similar studies have performed: Previous studies have shown positive associations between physical activity and improvements in mood, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Toronto, Ontario

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

Study contacts

• Study coordinator: Venkat Bhat

Conditions Treatment-resistant Depression; Major Depressive Disorder; Physical Activity; Exercise