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.
- Anxiety
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 15 Secondary · Reporting Duration: Week 1, Week 4, Week 8, Week 12, Week 20
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Low intensity exercise
1 of 2
Titration to high intensity exercise
1 of 2
Active Control
Experimental Treatment
90 Total Participants · 2 Treatment Groups
Primary Treatment: Titration to high intensity exercise (T-HIE) · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor