Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Exercise Group
Participants who will be randomized to moderate intensity exercise after extinction (Day 1)
  • Behavioral: Exercise
    Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.
Sham Comparator
Seated group
Participants who will be randomized to sitting after extinction (Day 1)
  • Behavioral: Sitting
    Sitting will occur for 20 minutes after the emotional learning procedures on Day 1.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Kristin Szuhany, MD
646-754-5161
Kristin.szuhany@nyulangone.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.