Exercise and Emotional Learning in Posttraumatic Stress Disorder

NCT06127342 | Recruiting

• 2 other identifiers: 90369R61MH132722
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

PTSD

Keywords

Interpersonal Violence; Exercise

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Moderate Intensity Exercise

EXPERIMENTAL

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

Low Intensity Exercise

ACTIVE COMPARATOR

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

Interventions

Moderate Intensity Exercise 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.

Moderate Intensity Exercise

Low Intensity Exercise BEHAVIORAL

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

Low Intensity Exercise

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults with PTSD related to interpersonal violence

You may not qualify if:

• 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

Sponsors & Collaborators

• Christal L Badour: lead
• University of Texas at Austin: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

University of Texas

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Study Officials

• Thomas G Adams, Jr., PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Christal Badour, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christal G Badour, PhD

CONTACT

859-323-3817; christal.badour@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: May 13, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

US (2)