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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the impact of mindfulness meditation or reduced social media time combined with exercise on mental health. Researchers will divide participants into three groups: one with no changes, one practicing mindfulness meditation (also known as Mindfulness-Based Interventions), and another reducing social media use while adding exercise. The goal is to assess how these activities affect social media habits and psychological well-being. Johns Hopkins students who frequently use social media and do not exercise much may be suitable candidates. Participants will track their progress over a few weeks to help understand the effects of these interventions. As an unphased trial, this study offers a unique opportunity to contribute to understanding mental health interventions and their impact on well-being.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mindfulness practices are generally safe for most people. Studies have found that mindfulness can help with anxiety and depression without causing serious side effects. Most people handle mindfulness exercises well, as they often involve simple activities like breathing exercises or guided meditation.

Evidence suggests that the social media reduction and exercise intervention is also safe. Reducing social media use can improve mental health by lowering stress and enhancing sleep, without negative effects. Adding exercise to a routine is known to boost physical health and well-being. Common exercises, such as walking or yoga, are low-risk and beneficial for mental health.

Overall, both mindfulness and the combination of reducing social media with exercise are considered safe and well-tolerated based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore innovative, non-pharmaceutical approaches to improving mental health. Unlike standard treatments that often involve medication or long-term therapy, these methods offer a more accessible way to enhance well-being. The mindfulness practice, delivered through the Calm app, emphasizes gratitude, which can be easily integrated into daily life and practiced independently. The Social Media Reduction + Exercise regimen encourages healthier habits by reducing digital consumption and increasing physical activity, aiming to create immediate, positive changes in mental health. These methods offer flexibility and empower individuals to take charge of their mental health with simple, everyday actions.

What evidence suggests that this trial's treatments could be effective for mental health?

Research has shown that mindfulness practices, which participants in this trial may engage in, can greatly reduce feelings of depression, anxiety, and stress. Mindfulness-based cognitive therapy (MBCT) improves mental health by increasing self-awareness and helping people manage their emotions better.

For participants in the social media reduction and exercise intervention arm of this trial, studies have found that using social media less can improve well-being and lower feelings of depression. Adding regular exercise further enhances mental health by reducing stress and increasing overall happiness. Together, these methods offer promising ways to improve mental health for frequent social media users. ^{1 3 6 7 8}

Who Is on the Research Team?

Johannes Thrul

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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-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]

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]

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]

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]

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]

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]

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]

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 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]

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