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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH132722 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Texas at Austin | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christal G Badour, PhD | Contact | 859-323-3817 | christal.badour@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas G Adams, Jr., PhD | University of Kentucky | Principal Investigator |
| Christal Badour, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
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.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Low Intensity Exercise | Behavioral | Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes. |
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| University of Texas | Recruiting | Austin | Texas | 78712 | United States |
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