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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
No Placebo-Only Group
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.
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.
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 belowSelect...
My primary diagnosis is an anxiety disorder.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 4, week 8, week 12, week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 4, week 8, week 12, week 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Anxiety Sensitivity Index-3 (ASI-3) score
Change in Clinical Global Impressions/Severity Scale score
Secondary study objectives
7 Day Physical Activity Recall Questionnaire (PAR) Score
Adherence
Barriers Specific-Self-Efficacy Scale (BARSE) Score
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,415 Previous Clinical Trials
856,292 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had problems with using drugs or alcohol in the past 3 months.You have a high level of anxiety sensitivity, as indicated by a score of 23 or higher on the Anxiety Sensitivity Index-3.Your body mass index (BMI) is less than 40.You have been diagnosed with bipolar disorder or any type of psychotic disorder at any time in your life.My primary diagnosis is an anxiety disorder.You have had bulimia or anorexia in the past 6 months.I am between 18 and 65 years old.You currently have PTSD (post-traumatic stress disorder).