- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05643716
The Effects of Exercise on Emotion Regulation and Cognitive Control in PTSD
The Effects of a Single Bout of Aerobic Exercise on Emotion Regulation and Cognitive Control in Individuals With Clinically Significant Post-Traumatic Stress Disorder Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jason S Moser, Ph.D.
- Phone Number: 517-355-2159
- Email: jmoser@msu.edu
Study Contact Backup
- Name: Christopher T Webster, M.A.
- Phone Number: 908-274-9748
- Email: webst230@msu.edu
Study Locations
-
-
Michigan
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East Lansing, Michigan, United States, 48823
- Recruiting
- Michigan State University
-
Contact:
- Jason S Moser, Ph.D.
- Phone Number: 517-355-2159
- Email: jmoser@msu.edu
-
Contact:
- Christopher T Webster, M.A.
- Phone Number: 908-274-9748
- Email: webst230@msu.edu
-
Principal Investigator:
- Jason S Moser, Ph.D.
-
Sub-Investigator:
- Christopher T Webster, M.A.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female Adults who are currently experiencing clinically significant PTSD symptoms. Participants will be screened via Qualtrics using the Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5; Weathers et al., 2013). The PCL-5 is a 20-item self-administered questionnaire designed to screen for PTSD. The PCL-5 asks about the frequency of PTSD symptoms experienced in the past month using a 5-point Likert scale. Participants with a total score > 30 on the PCL-5 will be eligible to participate.
Exclusion Criteria:
- Using the Physical Activity Readiness Questionnaire (PAR-Q; Adams, 1999), participants will be excluded if they endorse any history of cardiovascular (e.g., Coronary Artery Disease, Heart Failure, High Blood Pressure) or metabolic disease (e.g., Diabetes), or any orthopedic limitations (e.g., Osteoporosis) that may interfere with participating in aerobic exercise.
- Additionally, participants must not have a history of head trauma resulting in loss of consciousness for more than 5 min, epilepsy, or hearing, visual, or other physical or mental impairments that could interfere with the collection of quality neurocognitive data.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic Exercise
During this single session, participants will walk on a treadmill at a moderate-vigorous intensity (65-75% age-predicted HRmax) for 20 minutes.
While walking on the treadmill, participants will also watch a 20-minute video clip to match the control condition.
Exercise intensity will be continuously monitored using a Polar OH1 heart rate monitor, which will be strapped to the participant's chest prior to starting the exercise session.
Age-predicted HRmax will be calculated for each participant using the following formula: (HRmax = 220 - Age).
Subjective units of distress related to their perceived exercise intensity will be measured in 3-minute intervals.
Following the exercise session, participants will rest until their heart rate returns to within 10% of their resting heart rate (approximately 5 minutes) before starting the post-assessments.
|
The aerobic exercise intervention is described in the Aerobic Exercise Arm description.
|
No Intervention: Silent Sitting
Participants will be guided by a research assistant through a single silent sitting session, which will serve as a time-matched control.
During the sitting session, participants will watch a 20-minute video clip while sitting silently.
Similar to the aerobic exercise group, participants' heart rate will be continuously monitored via a Polar OH1 heart rate monitor.
Following the sitting session, participants will rest for 5 minutes to match the exercise group before starting the post-assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotion Regulation (Late Positive Potential)
Time Frame: Immediately after Exercise or Sitting
|
Participants will be presented with a series of negative high arousing and neutral low-arousing images from the International Affective Picture System. Prior to being presented with each image, participants will be cued to either passively view the upcoming image or to use reappraisal to "reinterpret aspects of the upcoming image in order to adopt a more neutral or positive perspective." During the emotion regulation task, "online" emotional arousal during reappraisal and passive view trials will be measured via the late positive potential (LPP). The LPP is a positive deflecting waveform that has been shown to be activated when viewing highly arousing negative images. In this study, emotion regulation will be measured as the difference in LPP amplitude between reappraise-negative and view-negative trials. Greater view-negative minus reappraise-negative LPP difference scores will reflect greater emotion regulation. |
Immediately after Exercise or Sitting
|
Emotion Regulation (Self-Reported)
Time Frame: Immediately after Exercise or Sitting
|
Participants will be presented with a series of negative high arousing and neutral low-arousing images from the International Affective Picture System. Prior to being presented with each image, participants will be cued to either passively view the upcoming image or to use reappraisal to "reinterpret aspects of the upcoming image in order to adopt a more neutral or positive perspective." At the end of the emotion regulation picture viewing task, participants will be asked to rate their emotional arousal during reappraisal and passive view using a 1 (Very Weak) to 7 (Very Strong) Likert scale. Self-reported emotional arousal will be measured as the difference in emotional arousal scores between reappraise-negative and view-negative trials. Greater view-negative minus reappraise-negative trials will reflect greater self-reported emotion regulation. |
Immediately after Exercise or Sitting
|
Cognitive Control (Error-Related Negativity, Error Positivity, P300)
Time Frame: Immediately after Exercise or Sitting
|
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP"). Neurophysiological indices of cognitive control during the flanker task will be measured using error-related negativity (ERN), error positivity (Pe), and P300. The ERN, Pe, and P300 are common metrics of cognitive control. The ERN, Pe, and P300 will be measured as the difference in amplitude between error and correct trials. Greater error minus correct difference scores will reflect greater cognitive control. |
Immediately after Exercise or Sitting
|
Cognitive Control (Response accuracy)
Time Frame: Immediately after Exercise or Sitting
|
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP"). Response accuracy will be measured as the percent of trials the participant responded correctly [(correct trials / total trials) x 100%]. Greater percentages will reflect greater response accuracy. |
Immediately after Exercise or Sitting
|
Cognitive Control (Reaction Time)
Time Frame: Immediately after Exercise or Sitting
|
The letter flanker task consists of a series of five letters presented in rapid succession. Participants will be instructed to identify the centrally presented letter amid congruent ('UUUUU') and incongruent ('UUVUU') flanking letters via a button click. The letter flanker task consists of 480 trials grouped into six blocks of 80 trials. Each block consists of a different pair of perceptually similar letters (i.e., "MMNMM", "PPRPP"). Reaction Time will be measured as the average response time on each trial in milliseconds (ms). Reaction time will be calculated for all trails, correct trials, and error trials. Greater values will reflect slower reaction times. |
Immediately after Exercise or Sitting
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00008486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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