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Completed

NCT Number: NCT04638946

Exercise for 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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Titration to high intensity exercise (T-HIE)

Behavioral

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 prescription

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline, Week 8

    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).

  2. Change in Clinical Global Impressions/Severity Scale score

    Time frame: Baseline, Week 8

    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.

Secondary outcomes

  1. Engagement

    Time frame: Week 12, Week 20

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

  2. Adherence

    Time frame: Week 8, Week 12, Week 20

    Percentage of duration goals achieving target heart rate

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

    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).

  4. Work and Social Adjustment Scale (WSAS) Score

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

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

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

    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).

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

    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.

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

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

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

    Time frame: Weekly from Week 0 (screening) to Week 20

    interviewer-administered measure of self-reported weekly physical activity

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

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

  10. Physical Activity Enjoyment Scale (PACES)

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

    18-item measure assessing enjoyment of exercise

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

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

  12. Heartrate

    Time frame: Weekly from week 1 to week 20

    Measured by the Fitbit Charge 3

  13. Ecological Momentary Assessment (EMA) Score

    Time frame: Weekly from week 1 to week 20

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

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

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

    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.

  15. Heartrate by Heartbeat Detection Task

    Time frame: Week 1, Week 4, Week 8, Week 12, Week 20

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Optimizing Exercise for the Treatment of Anxiety

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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