Actively Recruiting
Led by Unity Health Toronto · Updated on 2025-04-30
30
Participants Needed
1
Research Sites
N/A
Total Duration
U
Unity Health Toronto
Lead Sponsor
U
University of Toronto
Collaborating Sponsor
Researchers are studying adults with treatment-resistant depression (TRD), a condition where people do not respond to at least two antidepressant medications. This pilot randomized controlled trial aims to evaluate the feasibility and acceptability of a remotely delivered, personalized physical activity (PA) program called MoveU.HappyU, combined with usual treatment, compared to usual treatment alone. The study also monitors the program's impact on depression, anxiety, and quality of life using wearable devices and questionnaires. Participants will be randomly assigned in a 2:1 ratio to either receive a 4-week individualized PA program plus their usual treatment or just their usual treatment. The PA program involves weekly virtual sessions with a trainer including 30 minutes of behavioral coaching and 30 minutes of tailored aerobic or resistance exercise. Participants are also encouraged to do additional exercise independently for 120 minutes weekly at moderate intensity. Those not in the PA group will receive educational material about physical activity recommendations. During the study, participants will complete mental health assessments, wear a device that collects physiological data, and use self-report questionnaires. After the 4-week intervention, there is a 6-week follow-up period to observe lasting effects. The main outcomes measured include the program's feasibility and acceptability over 13 weeks, along with changes in depression and anxiety symptoms and well-being. The total participation time spans approximately 10 weeks from intervention start through follow-up.
CONDITIONS
Physical Activity Program for TRD
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for eligibility assessment
Duration - 4 weeks
Participants in the PA group will engage in a 4-week remotely delivered, one-on-one individualized physical activity program alongside treatment as usual (TAU). This includes weekly virtual sessions with a trainer and independent physical activity. Participants in the TAU group will receive PA guidelines and encouragement to exercise.
Weekly virtual visits for 4 weeks for the PA group; TAU group receives handout and encouragement
Duration - 6 weeks
Participants enter a 6-week observational follow-up period to monitor depressive and anxiety symptoms, quality of life, and physiological data collected via a wearable device.
Assessments and wearable device data collection during follow-up period
Total: 1 location
1
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada
Actively Recruiting
V
Venkat Bhat
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Vanessa K Tassone, Danika A Quesnel, Karisa Parkington...
https://pubmed.ncbi.nlm.nih.gov/40892783