PTSDNCT06127342
Exercise and Emotional Learning in Posttraumatic Stress Disorder
A study testing Moderate Intensity Exercise and Low Intensity Exercise in people with PTSD, run by Christal L Badour at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- PTSD
- What is being tested?
- Moderate Intensity Exercise and Low Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with PTSD related to interpersonal violence
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Texas
Austin, Texas, 78712
Josh Cisler, PhD, 512-495-5162, josh.cisler@austin.utexas
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Thomas G Adams, PhD, tom.adams@uky.edu
About this study
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.
Read the 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.
- Conditions
- PTSD
- Being tested
- Moderate Intensity Exercise, Low Intensity Exercise
- Keywords
- Interpersonal Violence, Exercise
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity ExerciseBehavioural
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 ExerciseBehavioural
Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Exercise | Experimental | 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. Receives: Behavioral: Moderate Intensity Exercise |
| Low Intensity Exercise | Active comparator | 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. Receives: Behavioral: Low Intensity Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Change in Heart Rate
Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system
Measured: 24 hours
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response
Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start13 May 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christal L Badour
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Christal L Badour, University of Kentucky
- Investigators
- Thomas G Adams, Jr., PhD, Principal investigator, University of KentuckyChristal Badour, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127342
- Sponsor's protocol ID
- 90369
- Other IDs
- R61MH132722
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, clinical, psychophysiological, and MRI data will be acquired from adults with PTSD related to interpersonal violence (IPV). All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the National Institute of Mental Health (NIMH) Data Archive (NDA) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NIMH requires data measured from human subjects to be shared using the NDA.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Emotional Learning in Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06127342
- Acronym / sponsor ID
- 90369
- Conditions
- PTSD
- Keywords
- Interpersonal Violence, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christal L BadourUniversity, hospital or other
- Collaborators
- University of Texas at Austin, National Institute of Mental Health (NIMH)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Exercise | Experimental | Behavioral: Moderate Intensity ExerciseVisit 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. |
| Low Intensity Exercise | Active comparator | Behavioral: Low Intensity ExerciseVisit 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults with PTSD related to interpersonal violence
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Intensity ExerciseParticipants 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. | Behavioural | Moderate Intensity Exercise |
| Low Intensity ExerciseParticipants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes. | Behavioural | Low Intensity Exercise |
Primary outcome
Change in participant subjective emotional ratings
Time frame: 24 hours
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.
Change in Heart Rate
Time frame: 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
Time frame: 48 hours
Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Demographic, clinical, psychophysiological, and MRI data will be acquired from adults with PTSD related to interpersonal violence (IPV). All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the National Institute of Mental Health (NIMH) Data Archive (NDA) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NIMH requires data measured from human subjects to be shared using the NDA.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas G Adams, Jr., PhD principal investigator
University of Kentucky
Christal Badour, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Exercise and Low Intensity Exercise in people with PTSD, run by Christal L Badour at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christal G Badour, PhD (859-323-3817, christal.badour@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant subjective emotional ratings (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.