Exercise and Emotional Learning in Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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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 walking. Participants will complete a second session of imaginal exposure with MRI 24 hours later.

Detailed Description
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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 walking control. Participants would return 24-hrs later to complete a second session of imaginal exposure with MRI.

Official Title
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Exercise and Emotional Learning in Posttraumatic Stress Disorder

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Moderate Intensity Exercise
* Behavioral: Low Intensity Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with PTSD related to interpersonal violence Exclusion Criteria: active severe substance use disorder(s) acute suicidality history of bipolar or psychotic disorder(s) significant developmental disabilities current daily benzodiazepine or stimulant use recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks) medical condition(s) that prohibit exercise loss of consciousness > 10 mins history of traumatic brain injury (TBI) Magnetic resonance imaging (MRI) contraindication(s) positive pregnancy test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Intensity Exercise<br>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 treadmill. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | Behavioral: Moderate Intensity Exercise<br>* Participants will wear a heartrate monitor and walk on a treadmill at a slow speed for 5 minutes, then slowly jog on a treadmill for 30 minutes, then walk on the treadmill at a slow speed for 5 minutes.<br>|
| Active Comparator: Low Intensity Exercise<br>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 (walking control; 40-mins at 40-50% max HR),on a treadmill. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | Behavioral: Low Intensity Exercise<br>* Participants will wear a heartrate monitor and walk on a treadmill at a slow speed for 40 minutes.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interpersonal Violence, Exercise