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Behavioral Intervention

Physical Activity Program for Depression

N/A

Recruiting

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

No Placebo-Only Group

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 below

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I have tried at least two antidepressants without success.

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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:

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I have asthma that worsens with exercise.

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I have diabetes.

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I am experiencing symptoms of mania, hypomania, mixed episodes, or psychosis.

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I am taking medication that affects my heart's response to exercise.

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I have not received ketamine through an IV in the last 2 months.

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I have been at high risk for a heart problem in the last year.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility

Secondary study objectives

General Anxiety Disorder-7

Hamilton Depression Rating Scale-17

Patient Health Questionnaire-9

+1 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PA programExperimental Treatment1 Intervention

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

Group II: TAUActive Control1 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.

0 / 9Eligibility criteria met