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Clinical Trial NCT06127342 for PTSD is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Exercise and Emotional Learning in Posttraumatic Stress Disorder
Clinical Trial NCT06127342 is an interventional study for PTSD that is recruiting. It started on 13 May 2024 with plans to enroll 100 participants. Led by Christal L Badour, it is expected to complete by 30 November 2026. The latest data from ClinicalTrials.gov was last updated on 3 September 2025.
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.
Official Title
Exercise and Emotional Learning in Posttraumatic Stress Disorder
Conditions
PTSDOther Study IDs
NCT ID Number
Start Date (Actual)
2024-05-13
Last Update Posted
2025-09-03
Completion Date (Estimated)
2026-11-30
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Interpersonal Violence
Exercise
Exercise
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalModerate 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. | 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 ComparatorLow 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. | Low Intensity Exercise Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes. |
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 |
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adults with PTSD related to interpersonal violence
- 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
Christal L Badour- University of Texas at Austin
- National Institute of Mental Health (NIMH)
Study Responsible Party
Christal L Badour, Sponsor-Investigator, Associate Professor, University of Kentucky
Study Central Contact
Contact: Christal G Badour, PhD, 859-323-3817, [email protected]
2 Study Locations in 1 Countries
Kentucky
University of Kentucky, Lexington, Kentucky, 40506, United States
Thomas G Adams, PhD, Contact, [email protected]
Recruiting
Texas
University of Texas, Austin, Texas, 78712, United States
Josh Cisler, PhD, Contact, 512-495-5162, [email protected]
Recruiting