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AzTrials

AnxietyNCT04638946

Exercise for Anxiety

A study testing Titration to high intensity exercise (T-HIE) and Low intensity exercise prescription in people with Anxiety, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anxiety
What is being tested?
Titration to high intensity exercise (T-HIE) and Low intensity exercise prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
30 Jun 2021to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females ages 18-65
  • Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
  • Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
  • Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
  • Body mass index <40
  • Able and willing to provide informed consent

Who cannot join

  • Lifetime history of Bipolar I or II or any psychotic disorder
  • Bulimia or anorexia in the past 6 months
  • Substance use disorder in the past 3 months
  • Current PTSD (past PTSD is allowed)
  • High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: Optimizing Exercise for the Treatment of Anxiety

90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (HIE). Blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. To better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (HR) 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.

Conditions
Anxiety
Being tested
Titration to high intensity exercise (T-HIE), Low intensity exercise prescription
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Titration to high intensity exercise (T-HIE)Behavioural

    All participants will receive psychoeducation regarding the rationale for using exercise as a strategy to create immediate changes in mood and anxiety. Participants will be instructed in basic motivational principles (e.g., breaking up goals into smaller parts, using rewards) based on information in Exercise for Mood and Anxiety. Participants will begin at low intensity with the goal of titrating to high intensity by 2 weeks prior to the end of trial (Week 6). If a participant achieves at least 70% of the duration goal at the target heart rate, he/she will be titrated to the next dose level (moderate intensity). This will continue until high intensity exercise is achieved. Prescription is based on heart rate reserve((maximum heart rate [220-age] - resting heart rate)*intensity percent - resting heart rate. Intensity percent lower/upper limits for moderate intensity are 40-59% and for high intensity are 60-84%.

  • Low intensity exercise prescriptionBehavioural

    All participants will receive psychoeducation regarding the rationale for using exercise as a strategy to create immediate changes in mood and anxiety. Participants will be instructed in basic motivational principles (e.g., breaking up goals into smaller parts, using rewards) based on information in Exercise for Mood and Anxiety. Prescription is based on heart rate reserve ((maximum heart rate [220-age] - resting heart rate)*30-39% (lower/upper limit of zone) - resting heart rate.

Study groups in NCT04638946
Study groupRoleWhat they receive
Titration to high intensity exerciseExperimentalNot described
Receives: Behavioral: Titration to high intensity exercise (T-HIE)
Low intensity exerciseActive comparatorNot described
Receives: Behavioral: Low intensity exercise prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Anxiety Sensitivity Index-3 (ASI-3) score

    The ASI-3 is an 18-item measure of fear of anxiety sensations with three subscales (physical, cognitive, social concerns). The total score ranges from 0 (lowest anxiety sensitivity) to 72 (highest anxiety sensitivity).

    Measured: Baseline, Week 8

  2. Change in Clinical Global Impressions/Severity Scale score

    A validated Clinical Global Impressions/Severity Scale (CGI) anchored for anxiety disorders measures overall functioning and clinical improvement. CGI-S is rated from 1 (least disordered) to 7 (most disordered).Scores of 1 or 2 on the CGI-I at post-treatment will represent significant response.

    Measured: Baseline, Week 8

Secondary outcomes (15)

  1. Engagement

    Completion of exercise of any intensity (proportion of 75min assigned)

    Measured: Week 12, Week 20

  2. Adherence

    Percentage of duration goals achieving target heart rate

    Measured: Week 8, Week 12, Week 20

  3. Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score

    14-item clinician-rated measure of severity of anxiety symptoms; The total score ranges from 0 (least severe anxiety symptoms) to 56 (most severe anxiety symptoms).

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  4. Work and Social Adjustment Scale (WSAS) Score

    5 item self-report scale measing impairment in functioning with total score ranging from 0 (no impairment) to 40 (severe impairment).

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  5. Overall Anxiety Severity and Impairment Scale (OASIS) Score

    A 5-item self-report scale measuring anxiety symptom severity and impairment due to anxiety; response items are coded from 0 to 4 and can be summed to obtain a total score range from 0 (least severity and impairment) to 20 (most severity and impairment).

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  6. Multidimensional Assessment of Interoceptive Awareness (MAIA-2) Score

    A 37-item measure with 8 subscales assessing noticing bodily sensations, not distracting from bodily sensations, not worry about bodily sensations, attention regulation, emotional awareness (awareness of connection between emotions and bodily sensations), self-regulation of distress by body sensations, body listening, and trusting one's body.

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  7. Score on Montgomery-Asberg Depression Rating Scale (MADRS)

    A 10-item clinician-rated measure of depression severity. Total score ranges from 0 (normal/no symptoms) to 60 (severe depression).

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  8. 7 Day Physical Activity Recall Questionnaire (PAR) Score

    interviewer-administered measure of self-reported weekly physical activity

    Measured: Weekly from Week 0 (screening) to Week 20

  9. Barriers Specific-Self-Efficacy Scale (BARSE) Score

    13-item measure, will assess barriers to exercise and will be used as a covariate predicting exercise engagement

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  10. Physical Activity Enjoyment Scale (PACES)

    18-item measure assessing enjoyment of exercise

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  11. Preferences for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q) Score

    16-item measure assessing preferences for different exercise intensities, with strong ability to differentiate preferences for HIE vs. LIE.

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  12. Heartrate

    Measured by the Fitbit Charge 3

    Measured: Weekly from week 1 to week 20

  13. Ecological Momentary Assessment (EMA) Score

    Surveys will consist of five 0-100 Likert scale items assessing mood, anxiety, motivation, energy, and enjoyment.

    Measured: Weekly from week 1 to week 20

  14. Neuroeconomics willingness-to-pay (WTP) auction task adapted for exercise

    will evaluate the subjective threshold between an option's anticipated value and its cost (maximum amount WTP for an expected outcome) and is based on the Becker-DeGroot-Marschak (BDM) auction task68, modified for exercise. Participants will have the opportunity to avoid exercising for a specific timeframe (e.g., 1min, 15min) at a specific intensity (low, moderate, high). The task will first be administered on paper (21-item questionnaire), which will be computerized in line with training aims.

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

  15. Heartrate by Heartbeat Detection Task

    Participants silently count their heartbeats for 6 trials of approximately 20-30 seconds (~5 minutes) while being monitored on an EKG to assess accuracy of reporting. This will assess interoceptive accuracy and will be used as a covariate at baseline and change with intervention will be assessed over time.

    Measured: Week 1, Week 4, Week 8, Week 12, Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start30 Jun 2021
  3. Primary completion31 Jan 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638946
Sponsor's protocol ID
20-01348
Status last verified
May 2026
First submitted
2 Nov 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A study testing Titration to high intensity exercise (T-HIE) and Low intensity exercise prescription in people with Anxiety, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Anxiety Sensitivity Index-3 (ASI-3) score (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638946.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.

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