Level of Physical Activity and Fear Learning

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Sitting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>Participants who will be randomized to moderate intensity exercise after extinction (Day 1) | Behavioral: Exercise<br>* Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.<br>|
| Sham Comparator: Seated group<br>Participants who will be randomized to sitting after extinction (Day 1) | Behavioral: Sitting<br>* Sitting will occur for 20 minutes after the emotional learning procedures on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Heart rate (HR) | HR will be computed for each trial by collecting Heart rate measurements during the psychophysiological procedures. | Day 2 Visit |