Exercise for Adolescent Anxiety

(BRAINS Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wayne State University

Must not be taking: Cannabis, Oral contraceptives

Disqualifiers: Neurological, Psychotic, Bipolar, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.

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 data supports the effectiveness of this treatment for adolescent anxiety?

Research shows that regular physical activity, including moderate and aerobic exercise, is linked to lower levels of anxiety and depression in adolescents. Studies indicate that engaging in moderate to high levels of physical activity can significantly reduce the risk of anxiety and depressive symptoms. ^{1 2 3 4 5}

Is exercise safe for adolescents with anxiety?

Research shows that moderate and high levels of physical activity are generally safe for adolescents and can help reduce anxiety and depression symptoms. Exercise is also associated with overall well-being and cardiovascular health benefits. ^{2 3 4 6 7}

How is moderate intensity exercise different from other treatments for adolescent anxiety?

Moderate intensity exercise, like aerobic exercise, is unique because it involves physical activity that can mimic the body's natural anxiety responses, helping to reduce anxiety sensitivity. Unlike medication or therapy, it uses the body's own physiological cues to manage anxiety symptoms. ^{3 5 8 9 10}

Research Team

Eligibility Criteria

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.

Right-handed

Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

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.

Trial Timeline

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

Treatment Details

Interventions

• Moderate Intensity Exercise (Behavioural Intervention)

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.

Participant Groups

Group I: Moderate Intensity Exercise Experimental Treatment 1 Intervention

Group II: Control (Coloring) Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tolan Park Medical Building Detroit, MI

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Patients Recruited

111,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3007

Patients Recruited

2,852,000+

Findings from Research

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 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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

References

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

A meta-analysis on the anxiety-reducing effects of acute and chronic exercise. Outcomes and mechanisms. [2022]

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

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

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

The effect of physical activity on anxiety in children and young people: a systematic review and meta-analysis. [2021]

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

Brief report: Associations of physical activity with anxiety and depression symptoms and status among adolescents. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Relationship among subjective exercise experience, exercise behavior, and trait anxiety in adolescents. [2023]

6. Ireland 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. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

An examination of the anxiolytic effects of exercise for people with anxiety and stress-related disorders: A meta-analysis. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of a brief aerobic exercise intervention for high anxiety sensitivity. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder. [2021]

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

Dimensions of Physical Activity Are Important in Managing Anxiety in Older Adults: A Systematic Review and Meta-Analysis. [2023]