Mindfulness or Exercise for Mental Health

Overseen By Johannes Thrul

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Under 18, Not JHU student, others

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

Compensation: Varies

Number of Visits: 2

140 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for mental health?

Research shows that mindfulness-based interventions, like mindfulness-based stress reduction and mindfulness-based cognitive therapy, can help improve mental health by reducing symptoms of stress, anxiety, and depression. These treatments are effective for both clinical and non-clinical populations, and they are safe, cost-effective, and can be used alongside standard care for conditions like depression and PTSD. ^{1 2 3 4 5}

Is mindfulness or exercise generally safe for mental health treatment?

Mindfulness-based interventions (MBIs) and exercise are generally considered safe for mental health treatment, with studies showing they can improve symptoms of stress, anxiety, and depression. MBIs are safe, portable, and cost-effective, and can be recommended as an adjunct to standard care for conditions like major depressive disorder and PTSD. ^{2 4 6 7 8}

How is the Mindfulness, Social Media Reduction + Exercise treatment different from other mental health treatments?

This treatment is unique because it combines mindfulness practices, reducing social media use, and increasing physical exercise, which together may enhance mental health by reducing stress, anxiety, and depression. Unlike traditional treatments that might focus on medication or therapy alone, this approach integrates lifestyle changes to improve overall well-being. ^{2 3 7 9 10}

What is the purpose of this trial?

The investigators will be randomizing 150 college student participants with high levels of social media use into either a 1) control condition (no intervention), a 2) mindfulness meditation cognitive intervention, or 3) a social media reduction + exercise replacement intervention. Participants complete intervention activities daily for one week. The investigators will collect self-report and behavioral measures of social media use and related psychological constructs at three time points: baseline, immediately after the intervention period, and one-week after the intervention period.

Research Team

Johannes Thrul

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

This trial is for Johns Hopkins University students aged 18 or older who use social media over an hour daily and exercise no more than an hour on average. They must own a smartphone, agree to share usage data, and consent to participate.

Inclusion Criteria

Owning an iPhone or Android smartphone, with frequent use of social media use daily (> 1 hour)

The participant must be a Johns Hopkins University student

Only exercising 1 hour or less daily, on average

Exclusion Criteria

Exercises more than 1 hour daily

Doesn't own a smart phone

Not a Johns Hopkins University Student

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants are randomized into one of three groups: control, mindfulness meditation, or social media reduction with exercise. Interventions are conducted daily for one week.

1 week

Daily self-administered activities

Immediate Post-Intervention Assessment

Participants complete self-report and behavioral measures immediately after the intervention period.

1 week

1 visit (virtual or in-person)

Follow-up

Participants are monitored for changes in social media use and psychological constructs one week after the intervention period.

1 week

1 visit (virtual or in-person)

Treatment Details

Interventions

• Mindfulness
• Social Media Reduction + Exercise

Trial Overview The study examines the effects of a one-week intervention on college students' well-being by comparing mindfulness meditation, social media reduction combined with exercise, and no intervention at all. Participants are randomly assigned to these groups.

Participant Groups

Group I: Social Media Reduction + Exercise Experimental Treatment 1 Intervention

Participants will reduce their social media use by at least 30 minutes daily for one week. Simultaneously, participants will exercise at least 30 minutes daily. Participants are given examples of common exercises (walking, yoga, strength training, etc.), but they are allowed to choose any type, although they are dissuaded from activities with high potential for injury.

Group II: Mindfulness Experimental Treatment 1 Intervention

Approximately 12-minute mindfulness-style meditations will be completed daily for one week through the Calm platform. Participants can listen to the exercise on the web-enabled version of Calm, or through the smartphone app. The course is entitled "7 Days of Gratitude" and centers around noticing and appreciating things in daily life.

Group III: Control Active Control 1 Intervention

Participants will not receive an intervention. They will receive instructions to use their social media use as usual.

Mindfulness is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Interventions for:

• Substance Abuse Treatment
• Anxiety Disorders
• Depression

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress Management
• Anxiety Disorders
• Chronic Pain

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Findings from Research

Mindfulness-based therapies, particularly Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), have been shown to effectively improve psychological health, manage pain, and reduce anxiety symptoms.

MBCT is specifically recommended as an additional treatment for unipolar depression, highlighting its role in supporting mental health alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. Marchand, WR.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

Web-based mindfulness interventions were effective in reducing depression and anxiety in clinical populations, with significant improvements noted in overall anxiety (g=-0.433) and in the anxiety disorder subgroup (g=-0.719) based on a systematic review of 12 studies involving 756 participants.

These interventions also enhanced quality of life and mindfulness skills, particularly benefiting those with clinical anxiety, although they showed limited effectiveness for depression specifically in the depression disorder subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. Sevilla-Llewellyn-Jones, J., Santesteban-Echarri, O., Pryor, I., et al.[2020]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

A systematic review of ten studies on technology-based mindfulness interventions found significant clinical effects on stress, depression, and anxiety, with large effect sizes reported for stress (d = 1.57) and depression (d = 0.95).

Despite promising results, the studies had methodological limitations such as selection bias and lack of control groups, indicating that further research is needed to refine these interventions and establish their effectiveness more reliably.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? Fish, J., Brimson, J., Lynch, S.[2022]

Participation in a short-form mindfulness-based stress reduction course significantly reduced anxiety levels in 23 patients, as evidenced by a decrease in scores on the Generalized Anxiety Disorder scale (from 7.8 to 4.4; P = .005).

The course also led to notable improvements in health-related quality of life, with significant enhancements in various areas such as mental health (+15.6; P < .001) and vitality (+16.1; P = .001), indicating its potential effectiveness in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-form mindfulness-based stress reduction reduces anxiety and improves health-related quality of life in an inner-city population. Smith, B., Metzker, K., Waite, R., et al.[2022]

In a study of 66 healthy adults, 8 weeks of aerobic exercise training (AET) significantly increased the time spent in moderate-to-vigorous physical activity (MVPA) compared to a no-treatment control, suggesting AET is effective for enhancing physical activity levels.

Mindfulness-based stress reduction (MBSR) training appeared to help mitigate the decrease in physical activity typically associated with shorter days and cooler weather, indicating its potential role in maintaining exercise participation during challenging seasonal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. Meyer, JD., Torres, ER., Grabow, ML., et al.[2020]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

A meta-analysis of 15 studies involving clinically depressed adults found that exercise has a significant large effect in reducing depression symptoms, especially when compared to no treatment or placebo conditions.

However, when only high-quality studies were considered, the effect size was reduced to a moderate level, suggesting that while exercise is beneficial, its efficacy may vary based on study quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise intervention in depressive disorders: meta-analysis and systematic review. Josefsson, T., Lindwall, M., Archer, T.[2022]

Mindfulness yoga significantly reduces depression severity in patients with major depressive disorder (MDD), with a moderate effect size based on a meta-analysis of nine randomized controlled trials involving 581 participants.

The intervention also appears to alleviate anxiety levels in MDD patients, although it did not show a significant impact on rumination immediately after the intervention, suggesting potential benefits in the longer term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness yoga on patients with major depressive disorder: a systematic review and meta-analysis of randomized controlled trials. Miao, C., Gao, Y., Li, X., et al.[2023]

References

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

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. [2018]

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

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? [2022]

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

Short-form mindfulness-based stress reduction reduces anxiety and improves health-related quality of life in an inner-city population. [2022]

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

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. [2020]

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

Physical exercise intervention in depressive disorders: meta-analysis and systematic review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness yoga on patients with major depressive disorder: a systematic review and meta-analysis of randomized controlled trials. [2023]