Level of Physical Activity and Fear Learning

Not Applicable

Recruiting

• Conditions: Social Anxiety Disorder; Panic Disorder; Generalized Anxiety Disorder
• Interventions: Behavioral: Exercise; Behavioral: Sitting

• Registration Number: NCT05203731
• Lead Sponsor: NYU Langone Health

Brief Summary

The proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high AS and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.

Detailed Description

This is an experimental study (not a treatment study) aiming to examine the effects of acute exercise vs. sitting on fear extinction learning in a 2-day paradigm. 50 eligible (after screening) men and women ages 18-60 with high anxiety sensitivity (AS) and an anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) will participate in a consecutive 2-day paradigm. Participants will be randomized to 1 of 2 conditions immediately following the emotional learning paradigm: 1) moderate intensity exercise (n=25) or 2) sitting(n=25), for 20 minutes. Day 2 will include testing of emotional learning. Primary outcomes are physiological arousal (skin conductance, heart rate) during Day 2 procedures. Mechanistic factors, including expected negative consequences of exercise, affect during exercise, threat/shock expectancy, and changes pre-post exercise in stress related neuroendocrine markers (cortisol and alpha-amylase) and their effects on extinction recall will be measured.

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-24
• Study Start: 2023-01-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Males and females ages 18-60
• A primary diagnosis of a DSM-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder)
• Anxiety Sensitivity Index-3 score of ≥23 (i.e., high anxiety sensitivity)
• Able and willing to provide informed consent

Exclusion Criteria

• Lifetime Bipolar Disorder or psychosis
• Past 3 months substance use disorder or eating disorder
• Current PTSD (past PTSD > 6 months prior to screening is allowed)
• High risk for exercise according to the Physical Activity Readiness Questionnaire and American College of Sports Medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
• Women who are currently pregnant
• Acute 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)
• Benzodiazepine use
• Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
• Stable psychiatric medications for at least 4 weeks prior to experimental procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise	Participants who will be randomized to moderate intensity exercise after extinction (Day 1)
Seated group	Sitting	Participants who will be randomized to sitting after extinction (Day 1)

Primary Outcome Measures

Name	Time	Method
Heart rate (HR)	Day 2 Visit	HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.
Skin Conductance Response (SCR)	Day 2 Visit	SCR will be computed for each trial by subtracting the mean skin conductance level observed during the last two seconds of context presentation from the maximal skin conductance level reached during CS presentation. All SCR values will be square-root transformed prior to any statistical analyses. To evaluate extinction recall, an extinction retention index (ERI) will be computed for each individual using the following formula: 100 - (mean SCR to the first 4 CS+E trials during recall / maximum SCR reached during conditioning for this same cue) \* 100

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States