Level of Physical Activity and Fear Learning

Generalized Anxiety Disorder Clinical Trial

Official title:

The Role of Exercise in the Consolidation of Fear Extinction Learning in Adults With High Anxiety Sensitivity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203731
• Other study ID #: 21-01657
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: January 14, 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Kristin Szuhany, MD
• Phone: 646-754-5161
• Email: Kristin.szuhany[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 14, 2025
• Est. primary completion date: January 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.
• Sitting
Sitting will occur for 20 minutes after the emotional learning procedures on Day 1.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Conductance Response (SCR)	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	Day 2 Visit
Primary	Heart rate (HR)	HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures.	Day 2 Visit