Exercise and Emotional Learning in Posttraumatic Stress Disorder

PTSD Clinical Trial

Official title:

Exercise and Emotional Learning in Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127342
• Other study ID #: 90369
• Secondary ID: R61MH132722
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Thomas G Adams, Jr., PhD
• Phone: 859-257-6841
• Email: tom.adams[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.
• Low Intensity Exercise
Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.

Locations

Country	Name	City	State
United States	University of Texas	Austin	Texas
United States	University of Kentucky	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Adams	National Institute of Mental Health (NIMH), University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Heart Rate	Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system	24 hours
Primary	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