Exercise for Adolescent Anxiety

(BRAINS Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Cannabis, Oral contraceptives

Disqualifiers: Neurological, Psychotic, Bipolar, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 days

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether moderate exercise (also known as moderate-intensity exercise) can help teens manage anxiety by improving brain activity and signaling related to fear regulation. Participants will either engage in moderate exercise or a control activity, such as coloring, to determine which is more effective. The goal is to discover new ways to assist adolescents who struggle with anxiety. Teens aged 14-17, who are generally healthy and right-handed, may be suitable for this study. As an unphased trial, this study provides a unique opportunity for teens to contribute to innovative research that could lead to new anxiety management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop using cannabis or cannabinoid products for at least 4 weeks before joining the study.

What prior data suggests that moderate intensity exercise is safe for adolescents with anxiety?

Research shows that moderate exercise is generally safe and manageable. Studies suggest that about 60 minutes of moderate-to-vigorous exercise daily benefits teenagers' health. This type of exercise is associated with improved mental health, including reduced anxiety and depression.

Evidence from various studies confirms that exercise is a common and safe method to enhance mental health. Exercise programs often yield positive effects without serious side effects. Thus, moderate exercise is a safe and promising approach to reducing anxiety in teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using moderate-intensity exercise to treat adolescent anxiety because it offers a non-pharmacological approach, which means no medication side effects. While traditional treatments often rely on medication and therapy, exercise provides a natural way to potentially reduce anxiety symptoms. Additionally, exercise can boost mood and overall well-being, offering benefits beyond just anxiety relief. This approach could appeal to teens looking for a more active and holistic intervention.

What evidence suggests that moderate intensity exercise might be an effective treatment for adolescent anxiety?

Research has shown that exercise can help reduce anxiety symptoms in teenagers. In this trial, participants will either engage in moderate-intensity exercise or participate in a control activity, such as coloring. A large review found that exercise, especially activities that are not too intense, helps lower anxiety and depression in young people. Another study noted that while children might not always notice the change, parents often see a significant improvement in anxiety symptoms after their children engage in physical activities. Overall, exercise boosts mental health and well-being in various ways, making it a promising approach for managing anxiety in teenagers. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adolescents who may be experiencing anxiety, as it explores how exercise can impact fear regulation. Specific eligibility criteria are not provided, but typically participants would need to be in good health and able to perform moderate intensity exercise.

Inclusion Criteria

I am between 14 and 17 years old.

Provision of signed and dated informed consent form

Right-handed

Exclusion Criteria

Currently pregnant, lactating, or positive pregnancy test at screening visit

I have been using oral contraceptives in the past 6 weeks.

I have ongoing symptoms from a traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo either moderate intensity exercise or a sedentary control condition to assess fear regulation and endocannabinoid signaling

3 days

Daily visits for 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Moderate Intensity Exercise

Trial Overview

The study investigates whether moderate intensity exercise can improve the ability of adolescents to regulate fear by enhancing brain activity and endocannabinoid signaling, which could lead to better treatments for anxiety.

How Is the Trial Designed?

Group I: Moderate Intensity Exercise Experimental Treatment 1 Intervention

Group II: Control (Coloring) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A systematic review and meta-analysis of 13 studies (8 randomized controlled trials and 5 non-RCTs) found that physical activity significantly reduces anxiety symptoms in older adults aged 65 and above, with a standardized mean difference of -0.41.

All dimensions of physical activity, including type, session time, frequency, and intervention period, showed significant effects on anxiety reduction, although the optimal intensity and mode of physical activity for maximum benefit remain uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dimensions of Physical Activity Are Important in Managing Anxiety in Older Adults: A Systematic Review and Meta-Analysis. Ofosu, EF., de Nys, L., Connelly, J., et al.[2023]

A systematic review and meta-analysis of six randomized control trials involving 262 adults found that exercise significantly reduces anxiety symptoms compared to control conditions, with a moderate effect size.

The results support exercise as an effective treatment option for individuals with anxiety and stress-related disorders, highlighting its additional benefits for overall well-being and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of the anxiolytic effects of exercise for people with anxiety and stress-related disorders: A meta-analysis. Stubbs, B., Vancampfort, D., Rosenbaum, S., et al.[2019]

In a study of 481 adolescents in Ireland, those who engaged in moderate (3-4 days/week) and high (5-7 days/week) physical activity reported significantly lower levels of depression and anxiety compared to those with low physical activity (0-2 days/week).

Specifically, adolescents with moderate physical activity had a 30% lower risk of depression and a 46% lower risk of high trait anxiety, while those with high physical activity had a 56% lower risk of depression and a 47% lower risk of high trait anxiety, highlighting the mental health benefits of regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: Associations of physical activity with anxiety and depression symptoms and status among adolescents. McDowell, CP., MacDonncha, C., Herring, MP.[2019]

A study of 500 adolescents in Southwest China found that a positive subjective exercise experience is linked to lower levels of trait anxiety, indicating that how adolescents feel about exercise can impact their mental health.

Exercise behavior mediates this relationship, with moderate levels of exercise showing the strongest effect in reducing anxiety, suggesting that encouraging positive exercise experiences can enhance both physical activity and mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship among subjective exercise experience, exercise behavior, and trait anxiety in adolescents. Luo, S., Feng, L., Zhao, J.[2023]

Aerobic exercise is associated with significant reductions in both state and trait anxiety, with effects comparable to other anxiety-reducing treatments like relaxation techniques.

To achieve meaningful reductions in anxiety, exercise programs should last at least 10 weeks and include sessions of at least 21 minutes, although the exact minimum duration for effective anxiety reduction is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis on the anxiety-reducing effects of acute and chronic exercise. Outcomes and mechanisms. Petruzzello, SJ., Landers, DM., Hatfield, BD., et al.[2022]

A brief aerobic exercise intervention significantly reduced anxiety sensitivity in 24 participants with high anxiety sensitivity scores, indicating its potential as a therapeutic approach for anxiety-related issues.

In contrast, participants who did not engage in exercise showed no significant change in their anxiety sensitivity, highlighting the efficacy of aerobic exercise in managing anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a brief aerobic exercise intervention for high anxiety sensitivity. Broman-Fulks, JJ., Storey, KM.[2022]

A randomized-controlled trial with 33 patients showed that high-intensity interval training (HIIT) was significantly more effective than lower intensity training (LIT) in reducing symptoms of generalized anxiety disorder (GAD), with effects about twice as high for HIIT.

HIIT not only improved anxiety symptoms but also positively influenced perceived control over anxiety-related stimuli, suggesting it could be a valuable addition to standard treatments for GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder. Plag, J., Schmidt-Hellinger, P., Klippstein, T., et al.[2021]

A systematic review of 22 randomized controlled trials involving children and young people found that physical activity significantly reduces anxiety symptoms, with a moderate effect size of 0.54, indicating that it can be an effective intervention.

Physical activity was particularly effective compared to minimal intervention controls and showed superior effects over groups that received time and attention, suggesting its potential as a beneficial treatment for anxiety in young populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of physical activity on anxiety in children and young people: a systematic review and meta-analysis. Carter, T., Pascoe, M., Bastounis, A., et al.[2021]

A study involving 15 adolescent girls with PTSD showed that an 8-week aerobic exercise program significantly reduced symptoms of PTSD, depression, and anxiety, with fewer participants meeting full criteria for PTSD after the intervention.

The exercise program consisted of 40 minutes of aerobic activity three times a week, indicating that regular physical activity can be an effective method for improving mental health in children and adolescents with trauma-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of aerobic exercise on childhood PTSD, anxiety, and depression. Newman, CL., Motta, RW.[2019]

In a study of 100,648 Brazilian students aged 11-18, higher physical activity during transport was linked to increased anxiety-induced sleep disturbance (AISD), suggesting that the context of physical activity matters.

Conversely, physical activity during physical education classes was associated with lower odds of AISD, and outdoor physical activity reduced AISD specifically among boys, indicating that where and how students engage in physical activity can influence their sleep quality related to anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between different contexts of physical activity and anxiety-induced sleep disturbance among 100,648 Brazilian adolescents: Brazilian school-based health survey. Werneck, AO., Schuch, FB., Ferrari, G., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7878276/

The roles of physical activity, exercise, and fitness in ...

The existing literature suggests that physical activity (PA), exercise, and aerobic fitness promote well-being and reduce risk of mental health problems.

2.

who.int

who.int/news-room/fact-sheets/detail/physical-activity

Physical activity

Regular physical activity is associated with: in children and adolescents, improved physical fitness, cardiometabolic health, bone health, ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0890856725002084

Systematic Umbrella Review and Meta-Meta-Analysis ...

This meta-meta-analysis finds that exercise reduces depression and anxiety symptoms in children and adolescents.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11138150/

The effect of physical activity on anxiety symptoms among ...

Youths did not report any effect on anxiety symptoms after participation in CAHY, however, their parents report a significant reduction in ...

5.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22690-8

The effects of physical activity on the mental health of typically ...

The findings indicated that physical activity interventions significantly improved multiple dimensions of mental health, including anxiety, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12431891/

A scoping review of physical activity interventions to ...

References were screened and included for data extraction if they reported the effects of a physical activity-based intervention on mental ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7719906/

World Health Organization 2020 guidelines on physical ...

Among children and adolescents, an average of 60 min/day of moderate-to-vigorous intensity aerobic physical activity across the week provides health benefits.

8.

bjsm.bmj.com

bjsm.bmj.com/content/57/18/1203

Effectiveness of physical activity interventions for improving ...

All PA modes were effective, and higher intensity exercise was associated with greater improvements for depression and anxiety. Longer duration interventions ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05029388

Aerobic Exercise and High-Intensity Interval Training

Recent evidence has confirmed that physical exercise provides a positive effect on mental health outcomes for youth through physiological and psychological ...