Exercise and Emotional Learning in Posttraumatic Stress Disorder

Sponsor

Thomas Adams (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06127342

Collaborator

University of Texas at Austin (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Moderate Intensity Exercise Behavioral: Low Intensity Exercise	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Exercise and Emotional Learning in Posttraumatic Stress Disorder

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 treadmill. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding.	Behavioral: Moderate Intensity Exercise 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.
Active Comparator: 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 (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 Participants will wear a heartrate monitor and walk on a treadmill at a slow speed for 40 minutes.

Arm

Intervention/Treatment

Experimental: 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 treadmill. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding.

Behavioral: Moderate Intensity Exercise

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.

Active Comparator: 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 (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

Participants will wear a heartrate monitor and walk on a treadmill at a slow speed for 40 minutes.

Outcome Measures

Primary Outcome Measures

Change in participant subjective emotional ratings [24 hours]
Participant anxiety will be measured at baseline and after each imagery trial using a Likert-type scale with higher scores indicative of more subjective anxiety.
Change in Heart Rate [24 hours]
Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response [48 hours]
Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40506
2	University of Texas	Austin	Texas	United States	78712

Sponsors and Collaborators

Thomas Adams
University of Texas at Austin

Investigators

Principal Investigator: Thomas G Adams, Jr., PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Adams, Assistant Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT06127342

Other Study ID Numbers:

90369

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Adams, Assistant Professor, University of Kentucky

Interpersonal Violence

Exercise

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Nov 13, 2023