Level of Physical Activity and Fear Learning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-06-30

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.

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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.

Conditions

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Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exercise Group

Participants who will be randomized to moderate intensity exercise after extinction (Day 1)

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.

Seated group

Participants who will be randomized to sitting after extinction (Day 1)

Group Type SHAM_COMPARATOR

Sitting

Intervention Type BEHAVIORAL

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

Interventions

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Exercise

Moderate intensity exercise (typically a brisk walk or light run) will occur for 20 minutes after the emotional learning procedures on Day 1.

Intervention Type BEHAVIORAL

Sitting

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No