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

Trial Summary

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.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training, Sitting for anxiety disorders?

Research suggests that exercise can help reduce anxiety symptoms, with studies showing consistent beneficial effects on anxiety. Although more research is needed, exercise is considered a promising alternative approach for treating anxiety disorders. ^{1 2 3 4 5}

Is exercise safe for people with anxiety disorders?

Exercise is generally safe for people with anxiety disorders and can help reduce anxiety symptoms. It also offers additional health benefits, such as improving cardiovascular health, without the risks associated with medications or therapy. ^{6 7 8 9 10}

How does exercise differ from other treatments for anxiety disorders?

Exercise is unique as a treatment for anxiety disorders because it involves physical activity, which can reduce anxiety symptoms through both biological and psychological mechanisms. Unlike medications or psychotherapy, exercise offers additional benefits such as improved cardiovascular health and overall well-being, without the risks or costs associated with drug therapy. ^{1 6 8 10 11}

What is the purpose of this trial?

The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.

Research Team

Kristin Szuhany, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

Past 3 months substance use disorder or eating disorder

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

I have been diagnosed with Bipolar Disorder or psychosis.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Is exercise a viable therapy for anxiety? Systematic review of recent literature and critical analysis. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

[Prevalence of performing and prescribing physical exercise in patients diagnosed with anxiety and depression]. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of exercise training for the short-term treatment of generalized anxiety disorder: a randomized controlled trial. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Process evaluation in an intervention designed to promote physical activity among adults with anxiety disorders: evidence of acceptability and adherence. [2019]

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

Exploring exercise as an avenue for the treatment of anxiety disorders. [2021]

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

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dropout from exercise randomized controlled trials among people with anxiety and stress-related disorders: A meta-analysis and meta-regression. [2021]

8. 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]

9. Ireland pubmed.ncbi.nlm.nih.gov

The anxiolytic effects of exercise for people with anxiety and related disorders: An update of the available meta-analytic evidence. [2023]

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

Exercise and Anxiety. [2021]

11. Hungary pubmed.ncbi.nlm.nih.gov

[The role of regular physical activity in the prevention and intervention of symptoms of anxiety and anxiety disorders]. [2018]