Exercise for Anxiety Disorders

Overseen By Giselle Cornejo

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Benzodiazepines

Disqualifiers: Bipolar, 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: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise might help reduce anxiety in people with anxiety disorders. Researchers aim to determine if exercising after a learning session improves anxiety management compared to sitting. The study examines how exercise affects stress markers and emotional responses. Suitable participants include those with generalized anxiety disorder, panic disorder, or social anxiety disorder who have high anxiety sensitivity, meaning they react strongly to anxiety symptoms. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on non-medication-based anxiety management strategies.

Will I have to stop taking my current medications?

The trial requires that you have been on stable psychiatric medications for at least 4 weeks before starting. However, you cannot participate if you are using benzodiazepines.

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

Research shows that exercise safely and effectively manages anxiety. Studies have found that people who exercise regularly often experience fewer symptoms of anxiety and depression. Exercise is widely supported as a safe method, offering benefits like better mood and improved mental health. Ample evidence indicates that exercise can enhance well-being without major side effects. Therefore, for those considering joining a trial involving exercise, the treatment is generally well-tolerated and provides many positive health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise for treating anxiety disorders because it's a natural and accessible option compared to standard treatments like medication and therapy. Unlike medications, which can have side effects, exercise offers a holistic approach that can improve overall well-being. Additionally, engaging in moderate intensity exercise has the potential to provide immediate stress relief and mood enhancement, which current treatments may take longer to achieve. This trial could help establish exercise as a viable and beneficial addition to the treatment landscape for anxiety.

What evidence suggests that exercise might be an effective treatment for anxiety disorders?

Research shows that exercise can help reduce anxiety. In this trial, participants in the Exercise Group will engage in moderate-intensity exercise, which studies have found can lower anxiety symptoms. Both aerobic exercise, such as running or swimming, and resistance training, like weightlifting, have been shown to reduce sensitivity to anxiety, making it less bothersome. Exercise also links to improved mood and better overall mental health. These findings suggest that exercise might help manage anxiety disorders by boosting mood and reducing stress. Meanwhile, participants in the Seated Group will be randomized to sitting, serving as a sham comparator. ^{1 3 4 5 6}

Who Is on the Research Team?

Kristin Szuhany, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with a primary diagnosis of an anxiety disorder (generalized, panic, or social) and high anxiety sensitivity. Participants must be able to exercise safely and not be pregnant, using benzodiazepines, or have recent substance abuse issues. Stable psychiatric medication use for at least 4 weeks prior is required.

Inclusion Criteria

Able and willing to provide informed consent

I have been diagnosed with an anxiety disorder like GAD, panic, or social anxiety.

Anxiety Sensitivity Index-3 score of ≥23

Exclusion Criteria

I do not have current PTSD but had it more than 6 months ago.

Past 3 months substance use disorder or eating disorder

I have been diagnosed with Bipolar Disorder or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Emotional Learning Paradigm

Participants undergo an emotional learning paradigm followed by randomization to exercise or sitting

1 day

1 visit (in-person)

Exercise/Sitting Intervention

Participants engage in either moderate intensity exercise or sitting for 20 minutes

20 minutes

1 visit (in-person)

Testing of Emotional Learning

Testing of emotional learning and measurement of physiological arousal

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Sitting

Trial Overview The study compares the effects of physical activity versus sitting on fear learning in people with high anxiety sensitivity and disorders. It looks into how these activities affect their expectations, emotions, and stress responses after learning to overcome fear.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 1 Intervention

Participants who will be randomized to moderate intensity exercise after extinction (Day 1)

Group II: Seated group Placebo Group 1 Intervention

Participants who will be randomized to sitting after extinction (Day 1)

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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 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 376 patients aged 18 to 75 diagnosed with anxiety and/or depression, 58.5% reported engaging in physical exercise, which is comparable to the general population, but suggests that more patients could benefit from exercise as a therapeutic intervention.

Only 59.18% of participants received a prescription for exercise from healthcare providers, indicating a need for improved communication and encouragement from health personnel to promote physical activity as part of treatment for anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevalence of performing and prescribing physical exercise in patients diagnosed with anxiety and depression]. Iglesias Martínez, B., Olaya Velázquez, I., Gómez Castro, MJ.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3632802/

Effects of Exercise and Physical Activity on Anxiety - PMC A number of research studies have pointed to the effectiveness of short-term aerobic exercise to reduce anxiety sensitivity (Broman-Fulks and Storey, 2008; ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625001052

Research progress on the mechanism of exercise against ... Both aerobic exercise and resistance training have shown significant anxiety-reducing effects across various populations. The mechanisms of ...

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

Effectiveness of physical activity interventions for improving ... Results showed that physical activity is effective for reducing mild-to-moderate symptoms of depression, anxiety and psychological distress (median effect size ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9902068/

Role of Physical Activity on Mental Health and Well-Being Physical activity was shown to help with sleep and improve various psychiatric disorders. Exercise in general is associated with a better mood and improved ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1136900/full

The effects of physical exercise on anxiety symptoms of ... Conclusion: Physical activity interventions were shown to have a positive effect on alleviating anxiety in college students. Aerobic exercise ...

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

Physical activity WHO fact sheet on physical activity provides key facts and information on benefits, risks of inactivity, reasons for physical inactivity and ...