Clinical trial NCT06127342: Exercise and Emotional Learning in Posttraumatic Stress Disorder
Official title: Exercise and Emotional Learning in Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Interpersonal Violence
Exercise
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: National Institute of Mental Health (NIMH)
First posted: 2023-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in participant subjective emotional ratings
timeFrame: 24 hours
measure: Change in Heart Rate
timeFrame: 24 hours
measure: Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Austin
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: University of Kentucky
name: Thomas G Adams, Jr., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Christal Badour, PhD
role: PRINCIPAL_INVESTIGATOR
References: