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Behavioral Intervention
Physical Activity Program for Depression
N/A
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failure of at least two trials of antidepressant therapy
Patients meeting diagnostic criteria for major depressive disorder without psychotic symptoms and currently experiencing a major depressive episode
Must not have
Exercise-induced asthma
Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
Summary
This trial is testing a personalized physical activity program delivered remotely to adults with treatment-resistant depression.
Who is the study for?
This trial is for adults with treatment-resistant depression, meaning their condition didn't improve after trying at least two different treatments. Participants should be able to engage in physical activity and have access to the internet for remote sessions.
What is being tested?
The study is testing a program called MoveU.HappyU, which is a personalized physical activity (PA) regimen delivered remotely on a one-on-one basis to see if it can help people with TRD feel better.
What are the potential side effects?
Since this program involves physical activity, potential side effects may include muscle soreness, fatigue, or injury related to exercise. The intensity of the PA will be tailored individually to minimize risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least two antidepressants without success.
Select...
I am currently experiencing a major depressive episode without psychosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have asthma that worsens with exercise.
Select...
I have diabetes.
Select...
I am experiencing symptoms of mania, hypomania, mixed episodes, or psychosis.
Select...
I am taking medication that affects my heart's response to exercise.
Select...
I have not received ketamine through an IV in the last 2 months.
Select...
I have been at high risk for a heart problem in the last year.
Select...
I have trouble walking or keeping my balance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability
Feasibility
Secondary outcome measures
General Anxiety Disorder-7
Hamilton Depression Rating Scale-17
Patient Health Questionnaire-9
+1 moreOther outcome measures
Metabolic equivalent minutes
Readiness (interpreted from sleep, activity, resting heart rate, heart rate variability, recovery index, and body temperature scores)
Total duration of sleep; awake, light, rapid eye movement, and deep sleep durations
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PA programExperimental Treatment1 Intervention
TAU with a 4-week remotely delivered one-on-one individualized PA program add-on.
Group II: TAUActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of TorontoOTHER
698 Previous Clinical Trials
1,020,572 Total Patients Enrolled
25 Trials studying Depression
50,042 Patients Enrolled for Depression
Unity Health TorontoLead Sponsor
549 Previous Clinical Trials
451,044 Total Patients Enrolled
17 Trials studying Depression
3,075 Patients Enrolled for Depression
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