Physical Activity Program for Depression

Overseen By Venkat Bhat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must be taking: Antidepressants

Must not be taking: Beta blockers

Disqualifiers: Mania, Psychosis, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires no changes to your treatments one month before screening and throughout the study.

What data supports the effectiveness of the treatment MoveU.HappyU for depression?

Research shows that exercise can help reduce symptoms of depression, especially in mild to moderate cases. Many patients find exercise to be a valuable part of their treatment, and those who continue exercising often experience lower depression levels. ^{1 2 3 4 5}

Is the physical activity program for depression safe for humans?

Exercise programs for depression are generally safe, with any adverse events being manageable. However, more well-designed studies are needed to provide clearer insights into their safety and benefits. ^{4 5 6 7 8}

How is the MoveU.HappyU treatment different from other treatments for depression?

MoveU.HappyU is unique because it focuses on physical activity as a treatment for depression, which is shown to have a moderate antidepressant effect, especially when sessions are at least moderately intense. Unlike traditional treatments like medication or therapy, this approach emphasizes exercise, which is well-accepted and can enhance mood without the side effects associated with drugs. ^{4 9 10 11 12}

What is the purpose of this trial?

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).

Eligibility Criteria

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.

Inclusion Criteria

I am currently experiencing a major depressive episode without psychosis.

My treatment follows the Canadian guidelines for mood and anxiety without recent changes.

I have tried at least two antidepressants without success.

Exclusion Criteria

Non-English-speaking individuals

I have diabetes.

Diagnosis of alcohol or substance use disorder within the past 3 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week remotely delivered one-on-one individualized physical activity program adjunct to treatment as usual

4 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• MoveU.HappyU

Trial Overview 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.

Participant Groups

Group I: PA program Experimental Treatment 1 Intervention

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

Group II: TAU Active Control 1 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.

MoveU.HappyU is already approved in Canada for the following indications:

Approved in Canada as MoveU.HappyU for:

• Treatment-resistant depression (TRD)
• Stress management
• Anxiety reduction

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Findings from Research

A 12-week home-based exercise program added to usual medical care did not significantly improve depression outcomes in 200 older adults, with remission rates being similar between the exercise group (63%) and the control group (59%).

The study found no improvement in objective fitness measures among participants in the exercise group, suggesting that the lack of supervision may have hindered compliance and engagement with the exercise program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACTIVEDEP: a randomised, controlled trial of a home-based exercise intervention to alleviate depression in middle-aged and older adults. Pfaff, JJ., Alfonso, H., Newton, RU., et al.[2014]

Exercise significantly reduces symptoms of depression compared to no treatment, with a large effect size of -1.1 based on a systematic review of 14 studies.

However, the overall effectiveness of exercise as a treatment for depression is uncertain due to methodological weaknesses in the studies, such as inadequate randomization and follow-up, indicating a need for higher quality research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise as an intervention in the management of depression: systematic review and meta-regression analysis of randomised controlled trials. Lawlor, DA., Hopker, SW.[2022]

This study is testing a Behavioral Activation teletherapy intervention designed to increase physical activity in adults aged 18-64 with moderate to severe depression, involving a preliminary pilot study with 15 participants to refine the approach.

The intervention consists of 8 weekly sessions and aims to assess both the feasibility of implementation and preliminary efficacy in reducing depressive symptoms and increasing physical activity, setting the stage for a future randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaption of tele-behavioral activation to increase physical activity in depression: Protocol for iterative development and evaluation. Rethorst, CD., Trombello, JM., Chen, P., et al.[2023]

Depressed patients often have low physical fitness due to inactivity, suggesting that incorporating physical fitness training into treatment for depression could be beneficial.

Exercise, including both aerobic and nonaerobic forms, has been shown to have antidepressant effects in patients with mild to moderate depression, and many patients continue exercising after treatment, leading to lower depression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of exercise for the treatment of depression. Martinsen, EW.[2022]

In a study of 165 adults with unipolar depression, strength training significantly improved work capacity, reducing absenteeism by 12.1% compared to relaxation training, while aerobic training showed no significant effect on work absence.

Despite improvements in physical strength and aerobic capacity, neither strength nor aerobic training led to significant reductions in depression severity as measured by the Hamilton Rating Scale for Depression (HAM-D(17)) at 4 or 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression. Krogh, J., Saltin, B., Gluud, C., et al.[2019]

A systematic review of 9 randomized controlled trials involving 678 adults with major depressive disorder found a small clinical effect favoring exercise for reducing depressive symptoms, but this was not statistically significant (SMD = 0.27, P = 0.09).

The study indicated that while exercise may help manage depression symptoms, there were no significant differences in outcomes when compared to second-generation antidepressants or body-mind exercises, highlighting the need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise and major depressive disorder in adults: systematic review and meta-analysis. Pérez Bedoya, ÉA., Puerta-López, LF., López Galvis, DA., et al.[2023]

Exercise interventions have shown positive health outcomes for hospitalized patients with depression, based on a systematic review of eight studies, indicating that exercise can be beneficial in acute mental health settings.

However, the evidence for the effectiveness of exercise in hospitalized patients with schizophrenia, bipolar disorder, or anxiety disorders is limited, highlighting a need for more research to determine the best exercise approaches for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. Stanton, R., Happell, B.[2018]

In a study of 64 clinically diagnosed depressed adolescents, exercise interventions like Whole Body Vibration (WBV) and bicycle ergometer training showed significant effects on reducing depression severity, particularly linked to changes in the pro-inflammatory cytokine IL-6.

The study found that while IL-6 levels decreased during the exercise intervention, they increased again post-intervention, suggesting that the benefits of exercise on depression may involve immunomodulatory effects, although the small sample size and non-randomized controls limit the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunological Effects of an Add-On Physical Exercise Therapy in Depressed Adolescents and Its Interplay with Depression Severity. Wunram, HL., Oberste, M., Hamacher, S., et al.[2023]

Physical activity interventions have a moderate and significant antidepressant effect on adolescents with depression, with an effect size of -0.47 based on a meta-analysis of 9 studies involving 431 participants.

To maximize effectiveness, physical activity sessions should be of at least moderate intensity, and while the treatments are generally well accepted, the low quality of the studies suggests that further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. Oberste, M., Medele, M., Javelle, F., et al.[2023]

A review of 67 studies found that both shorter and longer durations of physical activity (PA) are associated with a reduced likelihood of depression, indicating that engaging in any amount of PA can be beneficial.

Vigorous-intensity physical activity was more strongly linked to lower depression rates compared to lower-intensity activities, suggesting that higher intensity workouts may offer greater protective effects against depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and likelihood of depression in adults: a review. Teychenne, M., Ball, K., Salmon, J.[2022]

Physical activity can effectively help prevent and alleviate symptoms of depression, making it a valuable addition to medication and therapy.

To maximize the benefits of exercise for depressed patients, it's important to create a flexible and enjoyable program, such as walking alone or in groups, while considering individual challenges like hopelessness and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise against depression. Artal, M.[2010]

The systematic review found a strong inverse correlation between physical activity and depressive symptoms in adolescents, suggesting that increased physical activity may help reduce depression in this age group.

Despite only one randomized controlled trial being identified, the evidence supports the need for healthcare providers to promote physical activity as a potential treatment option for adolescent depression, emphasizing the importance of health education and wellness initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between physical activity and depressive symptoms in adolescents: a systematic review. Bursnall, P.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

ACTIVEDEP: a randomised, controlled trial of a home-based exercise intervention to alleviate depression in middle-aged and older adults. [2014]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise as an intervention in the management of depression: systematic review and meta-regression analysis of randomised controlled trials. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adaption of tele-behavioral activation to increase physical activity in depression: Protocol for iterative development and evaluation. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Benefits of exercise for the treatment of depression. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Physical exercise and major depressive disorder in adults: systematic review and meta-analysis. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Immunological Effects of an Add-On Physical Exercise Therapy in Depressed Adolescents and Its Interplay with Depression Severity. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Physical activity and likelihood of depression in adults: a review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Exercise against depression. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

The relationship between physical activity and depressive symptoms in adolescents: a systematic review. [2018]