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Exercise Intensity for Anxiety

N/A
Recruiting
Led By Kristin Szuhany, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
Males and females ages 18-65
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 4, week 8, week 12, week 20
Awards & highlights

Study Summary

This trial will test the effects of two different types of exercise on people with anxiety disorders and high anxiety sensitivity. The first group will do low intensity exercise while the second group will do high intensity exercise. The trial will use heart rate as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (EMA) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.

Who is the study for?
This trial is for sedentary adults aged 18-65 with high anxiety sensitivity and a primary diagnosis of generalized anxiety disorder, social anxiety disorder, or panic disorder. Participants must have a BMI under 40 and exercise less than an hour per week. Those with recent eating disorders, substance abuse, bipolar or psychotic disorders, high suicide risk, or current PTSD cannot join.Check my eligibility
What is being tested?
The study compares the effects of low intensity exercise versus gradually increasing to high intensity exercise on individuals with anxiety disorders over 8 weeks. It includes follow-ups at one and three months post-treatment and uses heart rate monitoring and other tasks to understand how mood changes affect anxiety outcomes.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from starting an exercise regimen can include muscle soreness, fatigue, increased heart rate during activity, joint stress if not done properly; however these are generally mild and decrease as fitness improves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My primary diagnosis is an anxiety disorder.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 4, week 8, week 12, week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 4, week 8, week 12, week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anxiety Sensitivity Index-3 (ASI-3) score
Change in Clinical Global Impressions/Severity Scale score
Secondary outcome measures
7 Day Physical Activity Recall Questionnaire (PAR) Score
Adherence
Barriers Specific-Self-Efficacy Scale (BARSE) Score
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Titration to high intensity exerciseExperimental Treatment1 Intervention
Group II: Low intensity exerciseActive Control1 Intervention

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,636 Total Patients Enrolled
7 Trials studying Anxiety
662 Patients Enrolled for Anxiety
Kristin Szuhany, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04638946 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollment opportunities for this research initiative?

"Affirmative. According to the clinicaltrials.gov website, this medical study is currently looking for participants; it was first listed on June 30th 2021 and has been revised as recently as March 31st 2022. 90 subjects are required from a single site in order to complete the trial's objectives."

Answered by AI

Is this research program open to adults aged 18 and older?

"The criterion for inclusion in this trial necessitates that patients are between 18 and 65. However, there exist 147 trials catering to minors and 441 clinical studies available for those above the age of retirement."

Answered by AI

Who is eligible to partake in this clinical investigation?

"90 individuals that have anxiety, meet the age range of 18-65 years old and satisfy other prerequisites will be accepted. These include having a BMI lower than 40, voluntarily consenting to participate in the trial, exhibiting anxiety sensitivity with an Anxiety Sensitivity Index-3 score of at least 23 points or higher as well as being physically inactive for 3 months prior (less than 60 minutes per week)."

Answered by AI

What are the major aims of this clinical test?

"This clinical trial will primarily monitor the Change in Anxiety Sensitivity Index-3 (ASI-3) Score from Baseline to Week 8. Secondary outcomes of this study include the Multidimensional Assessment of Interoceptive Awareness (MAIA-2), 7 Day Physical Activity Recall Questionnaire (PAR), and Barriers Specific Self Efficacy Scale (BARSE)."

Answered by AI

What is the projected enrollment size of this clinical trial?

"Affirmative, according to clinicaltrials.gov's records this trial is still recruiting participants. It was first advertised on June 30th 2021 and the last update happened on March 31st 2022. The study requires 90 volunteers from a single site for enrollment."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
NYU Langone Health
How many prior treatments have patients received?
1

Why did patients apply to this trial?

What questions have other patients asked about this trial?

Do you have availability after 5 PM on weekdays?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Exercise for Anxiety
2021. "Exercise for Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04638946.
~28 spots leftby Jul 2025
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