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Recruiting NCT06127342

Exercise and Emotional Learning in Posttraumatic Stress Disorder

No phase Interventional PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moderate Intensity Exercise, Low Intensity Exercise.
Who it may be relevant to
Registry conditions: PTSD. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in participant subjective emotional ratings [Time frame: 24 hours]
  • Change in Heart Rate [Time frame: 24 hours]
  • Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response [Time frame: 48 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Kentucky — Lexington
  • University of Texas — Austin

Identifiers

NCT: NCT06127342 · 90369 · R61MH132722

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗