Exercise and Emotional Learning in Posttraumatic Stress Disorder

The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Moderate Intensity Exercise; Behavioral: Low Intensity Exercise

Detailed Description

The proposed project would build on our published pilot data and animal models to demonstrate that moderate intensity physical exercise delivered after exposure therapy engages fear circuitry and enhances the consolidation of therapeutic safety learning, thereby enabling enhanced symptom reduction for PTSD. Adults with PTSD related to interpersonal violence (IPV) exposure would complete an initial session of imaginal exposure to traumatic memory cues adapted for an MRI setting. This would be followed by 30-mins of moderate intensity exercise or low intensity exercise control. Participants would return 24-hrs later to complete a second session of imaginal exposure with MRI.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christal G Badour, PhD; Phone Number: 859-323-3817; Email: christal.badour@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University Of Kentucky
      • Contact: Thomas G Adams, PhD; Email: tom.adams@uky.edu
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • University of Texas
      • Contact: Josh Cisler, PhD; Phone Number: 512-495-5162; Email: josh.cisler@austin.utexas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with PTSD related to interpersonal violence

Exclusion Criteria:

• Active or recent (within the last 3 months) severe substance use disorder(s)
• Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes
• Significant developmental disabilities
• Current daily benzodiazepine or stimulant use with inability to abstain for study sessions
• Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)
• Medical condition(s) that prohibit exercise
• History of traumatic brain injury (TBI) with loss of consciousness > 30 mins
• Magnetic resonance imaging (MRI) contraindication(s)
• Positive pregnancy test
• History of seizure disorder
• Spontaneous seizure(s) within the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Intensity Exercise; Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Moderate-Intensity Exercise (30-min at 70-75% max HR with 5-min warm-up and 5-min cool-down at 40-50% max HR), on a stationary bike. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding.	Behavioral: Moderate Intensity Exercise; Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 5 minutes, then slowly cycle on a stationary bike for 30 minutes, then cycle on the stationary bike at a slow speed for 5 minutes.
Active Comparator: Low Intensity Exercise; Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Low-Intensity Exercise (control; 40-mins at 40-50% max HR),on a stationary bike. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding.	Behavioral: Low Intensity Exercise; Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participant subjective emotional ratings	Participant anxiety will be measured at baseline and after each imagery trial using a 10-point Likert-type scale with higher scores indicative of more subjective anxiety.	24 hours
Change in Heart Rate	Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system	24 hours
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response	Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial	48 hours

Collaborators and Investigators

• Sponsor: Christal L Badour
• Collaborators: National Institute of Mental Health (NIMH); University of Texas at Austin
• Investigators: Principal Investigator: Christal Badour, PhD, University Of Kentucky; Principal Investigator: Thomas G Adams, Jr., PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Interpersonal Violence
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Behavior; Stress Disorders, Post-Traumatic; Motor Activity
• Other Study ID Numbers: 90369; R61MH132722 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographic, clinical, psychophysiological, and MRI data will be acquired from adults with PTSD related to interpersonal violence (IPV). All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the National Institute of Mental Health (NIMH) Data Archive (NDA) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NIMH requires data measured from human subjects to be shared using the NDA.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No