Exercise for Anxiety

NCT04638946 | Completed DMC

• 1 other identifier: 20-01348
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline, Week 8

• 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.

  Baseline, Week 8

Secondary Outcomes (15)

• Engagement

  Week 12, Week 20

• Adherence

  Week 8, Week 12, Week 20

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

  Week 1, Week 4, Week 8, Week 12, Week 20

• Work and Social Adjustment Scale (WSAS) Score

  Week 1, Week 4, Week 8, Week 12, Week 20

• Overall Anxiety Severity and Impairment Scale (OASIS) Score

  Week 1, Week 4, Week 8, Week 12, Week 20

Study Arms (2)

Titration to high intensity exercise

EXPERIMENTAL

Behavioral: Titration to high intensity exercise (T-HIE)

Low intensity exercise

ACTIVE COMPARATOR

Behavioral: Low intensity exercise prescription

Interventions

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%.

Titration to high intensity exercise

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.

Low intensity exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kristin Szuhany, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 20, 2020
• Study Start: June 30, 2021
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication
• Access Criteria: Requests may be directed to the PI

Locations

US (1)