Titration to high intensity exercise (T-HIE) for Anxiety

NYU Langone Health, New York, NY
AnxietyTitration to high intensity exercise (T-HIE) - Behavioral
18 - 65
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Anxiety

Treatment Effectiveness

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Week 1, Week 4, Week 8, Week 12, Week 20

Baseline, Week 8
Change in Anxiety Sensitivity Index-3 (ASI-3) score
Change in Clinical Global Impressions/Severity Scale score
Week 20
Barriers Specific-Self-Efficacy Scale (BARSE) Score
Heartrate by Heartbeat Detection Task
Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score
Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise
Overall Anxiety Severity and Impairment Scale (OASIS) Score
Physical Activity Enjoyment Scale (PACES)
Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score
Score on Montgomery-Asberg Depression Rating Scale (MADRS)
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
Work and Social Adjustment Scale (WSAS) Score
Week 12, Week 20
Week 20
Week 20
7 Day Physical Activity Recall Questionnaire (PAR) Score
Week 20
Ecological Momentary Assessment (EMA) Score

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Titration to high intensity exercise
Experimental Group · 1 Intervention: Titration to high intensity exercise (T-HIE) · Intervention Types: Behavioral
Low intensity exercise
ActiveComparator Group · 1 Intervention: Low intensity exercise prescription · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 1, week 4, week 8, week 12, week 20

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,303 Previous Clinical Trials
757,773 Total Patients Enrolled
6 Trials studying Anxiety
542 Patients Enrolled for Anxiety
Kristin Szuhany, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
9 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index is less than 40.
You have not engaged in moderate exercise for at least 60 minutes per week in the past 3 months.
You have been diagnosed with certain anxiety disorders such as generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder as your primary psychiatric diagnosis.
You have a high level of anxiety sensitivity based on your score of 23 or higher on the Anxiety Sensitivity Index-3.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.