Exercise and Emotional Learning in Posttraumatic Stress Disorder

Christal L Badour

Status: Enrolling

Conditions: PTSD

Treatments: Behavioral: Moderate Intensity Exercise; Behavioral: Low Intensity Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06127342

90369

R61MH132722 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with PTSD related to interpersonal violence

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Moderate Intensity Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Moderate Intensity Exercise

Low Intensity Exercise

Active Comparator group

Description:

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.

Treatment:

Behavioral: Low Intensity Exercise