Clinical trial NCT05203731: Level of Physical Activity and Fear Learning
Official title: The Role of Exercise in the Consolidation of Fear Extinction Learning in Adults With High Anxiety Sensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Conductance Response (SCR)
timeFrame: Day 2 Visit
measure: Heart rate (HR)
timeFrame: Day 2 Visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kristin Szuhany, MD
role: PRINCIPAL_INVESTIGATOR
References: