Exercise and Emotional Learning in Posttraumatic Stress Disorder

NCT ID: NCT06127342

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2026-11-30

Brief Summary

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.

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Moderate Intensity Exercise

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Low Intensity Exercise

Intervention Type: BEHAVIORAL

Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.

Interventions

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.

Intervention Type: BEHAVIORAL

Low Intensity Exercise

Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Christal L Badour

OTHER

Sponsor Role: lead

Responsible Party

Christal L Badour

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas G Adams, Jr., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Christal Badour, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

University of Texas

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christal G Badour, PhD

Role: CONTACT

christal.badour@uky.edu

859-323-3817

Facility Contacts

Thomas G Adams, PhD

Role: primary

tom.adams@uky.edu

Josh Cisler, PhD

Role: primary

josh.cisler@austin.utexas

512-495-5162

Other Identifiers

R61MH132722

Identifier Type: NIH

Identifier Source: secondary_id

View Link

90369

Identifier Type: -

Identifier Source: org_study_id