PTSD - Post Traumatic Stress DisorderBEE for PTSDNCT07080606
Brief Exposure and Exercise for PTSD.
A study testing Brief exposure therapy and exercise in people with PTSD - Post Traumatic Stress Disorder, run by Troy Hubert at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if 8 sessions of brief exposure and exercise therapy works to treat Post Traumatic Stress Disorder (PTSD) in adults. This study will also learn if participants think brief exposure and exercise therapy is a good and doable treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Brief exposure therapy and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Provide informed consent and are willing to participate in therapy sessions twice weekly, which include moderate-intensity aerobic exercise.
- Participants must be adults aged 18-64 meeting the criteria for PTSD within the past month, who are not currently receiving treatment from other psychotherapy or are on unstable psychiatric medication (i.e., less than four weeks of psychiatric medication).
- Participants should be able to engage in 25 minutes of moderate-intensity aerobic exercise (i.e., 70-75% of max heart rate).
- Participants must be able to speak and read English fluently to participate in the current study.
Who cannot join
- Participants who endorse health condition(s) that would prevent moderate exercise.
- Participants who endorse (i.e., "yes") any items on the Physical Activity Readiness Questionnaire (PARQ) that is not controlled or managed.
- Participants with any injuries to the lower extremities that may hinder riding an exercise bicycle.
- Psychiatric exclusion criteria include recent (within the past three months) severe use disorder(s), high risk for suicide (i.e., plan, intent, or recent attempt), mania, or psychotic symptoms unrelated to PTSD symptoms.
- Participants currently seeking or undergoing any other trauma-focused psychotherapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Exposure and Exercise Therapy for Post Traumatic Stress Disorder (PTSD)
The goal of this clinical trial is to learn if 8 sessions of brief exposure and exercise therapy works to treat Post Traumatic Stress Disorder (PTSD) in adults. This study will also learn if participants think brief exposure and exercise therapy is a good and doable treatment. and The main questions it aims to answer are:
- Do participants find brief exposure and exercise an acceptable and feasible means of treatment for PTSD?
- Does brief exposure and exercise decreases of the severity of PTSD symptoms?
Participants will:
- Complete weekly questionnaires for 10-14 weeks.
- Attend 8 twice weekly exposure therapy and exercise sessions for 4 weeks.
Read the detailed description
A community sample (n=6) of adults with PTSD will receive eight sessions of standardized brief exposure therapy with six sessions of imaginal exposures and aerobic exercise. This clinical trial will be the first study demonstrate the effectiveness of an exposure-only therapy and exercise treatment by isolating and targeting safety learning using imaginal exposures. This approach will address gaps in the literature by demonstrating treatment effectiveness, mechanistic engagement, and patients' perceptions of a brief imaginal exposure treatment combined with aerobic exercise. Addressing these gaps through a preliminary clinical trial that establishes feasibility and treatment effectiveness is a necessary first step before exerting substantial time and money on a large-scale clinical trial.
Aligned with an experimental therapeutics approach, the proposed study will take advantage of single-case experimental design (SCED) to explore changes in PTSD symptom severity and exposure therapy mechanisms (i.e., belief change, experiential avoidance, and emotional intensity) within each participant. SCEDs are parsimonious research designs that are ideal for investigating mechanisms and the effectiveness of interventions. SCEDs use each subject as their own control, resulting in high internal validity and the ability to examine effect sizes across subjects.
Upon referral to the study, participants will complete a brief battery of self-report questionnaires to screen for eligibility. Likely eligible participants, determined by the prescreening, will be given a link to schedule an intake with PI or other graduate student research personnel to complete informed consent and assessments to evaluate inclusion/exclusion criteria. Eligible participants will then be randomized to either a 3, 4 or 5 week baseline period, where participants will complete weekly self-report questionnaires to assess PTSD symptoms and exposure therapy mechanisms. Participants fill out a questionnaire battery before, during, and after treatment resulting in a total of 10-14 weeks of self-report assessments. After the baseline assessment phase, participants will complete the first session of PE, which focuses on psychoeducation and treatment planning, six sessions of imaginal exposures and exercise, and a final PE session discussing relapse prevention and future directions. During the six imaginal exposure sessions (sessions 2-7), participants will complete 20 minutes of imaginal exposure to traumatic memories, 10 minutes of emotional processing, and then 20 minutes of moderate-intensity exercise (i.e., 70-75% of MHR) on a stationary bike with 3 minutes of warmup and 2 minutes of cool-down. Proximal measures for exposure mechanisms will be assessed during treatment sessions (e.g., subjective units of distress) to align with distal measures of exposure therapy, which are assessed in the weekly self-report batteries. Following completion of the treatment, participants will be asked to provide satisfaction ratings on the treatment.
PTSD symptom severity will be assessed weekly to investigate treatment efficacy (Aim 1). Acceptability will be evaluated using a self report patient satisfaction questionnaires (Aim 2). Adherence to the treatment protocol will be used to characterize feasibility (Aim 3).
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Brief exposure therapy and exercise
- Keywords
- PTSD, Exercise, Exposure Therapy
- Medical subject headings
- Combat Disorders, 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.
Brief exposure therapy and exerciseBehavioural
Also called Imaginal Exposure
Treatment provided in this study includes an open label brief imaginal exposure therapy for Post Traumatic Stress Disorder (PTSD) and moderate intensity aerobic exercise (i.e., 70-75% max heart rate). Participants all receive 30 minutes of psychotherapy and 25 minutes of exercise.
| Study group | Role | What they receive |
|---|---|---|
| Brief exposure therapy and exercise 3 week | Experimental | Participants are randomized into the 3 week baseline condition before receiving the exposure therapy and exercise intervention. Receives: Behavioral: Brief exposure therapy and exercise |
| Brief exposure therapy and exercise 5 week | Experimental | Participants are randomized into the 5 week baseline condition before receiving the exposure therapy and exercise intervention. Receives: Behavioral: Brief exposure therapy and exercise |
| Brief exposure therapy and exercise 4 week | Experimental | Participants are randomized into the 4 week baseline condition before receiving the exposure therapy and exercise intervention. Receives: Behavioral: Brief exposure therapy and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report questionnaire used to assess PTSD symptom severity. Each of the 20 PCL-5 items corresponds to symptoms of PTSD in the DSM-5. Items are rated on a Likert scale from 0 (not at all) to 4 (extremely) based upon how bothered participants are by each symptom. Items on the PCL-5 are summed, resulting in a total score of PTSD symptom severity from 0-80. Scores >30 indicate probable PTSD.
Measured: Up to 15 weeks.
Patient Satisfaction Questionnaire Scores
Acceptability will be assessed using a patient satisfaction questionnaire. The 5 Items on the patient satisfaction questionnaire are rated on a 4 likert scale with higher scores on the indicating better perceptions of treatment. Total satisfaction of treatment can be obtained by averaging scores across the 5 items.
Measured: Once at end of treatment (up to 9 weeks).
Feasibility of the intervention
Feasibility will be analyzed by examining adherence to the treatment protocol checklist. An average score of 80% treatment adherence for all participants will be used as a threshold to define the feasibility of this intervention.
Measured: 4 weeks of treatment following the 3-to 5-week baseline.
Secondary outcomes (3)
Changes in Brief Experiential Avoidance Questionnaire
The brief experiential avoidance questionnaire (BEAQ) is a 15-item questionnaire that assesses avoidance of unwanted internal experiences, such as uncomfortable emotions, thoughts, memories, or sensations. The BEAQ has a range of 15-90, with high scores indicating more experiential avoidance.
Measured: Up to 15 weeks
Changes in the posttraumatic cognitions inventory-9 (PTCI-9)
The PTCI-9 is a 9-item self-report that assesses posttraumatic cognitions following traumatic experiences. Items on the PTCI-9 are scored on a likert scale from 0 (Strongly Disagree) to 7 (Strongly Agree) and are averaged for a total score ranging from 0-7. Higher scores indicate higher levels of post-traumatic cognitions.
Measured: Up to 15 weeks.
Changes in the positive and negative valence affect schedule (PANAS)
The negative affect subscale of the PANAS will be anchored to participants' Criterion A (i.e., index) trauma and used to assess for negative affect related to participants' PTSD over the past week. The negative affect subscale is a 10-item self-report measure rated on a Likert scale from 1 (Very slightly or not at all) to 5 (Extremely), with summed scores ranging from 10 to 50. Higher scores indicate higher levels of negative emotions and affect.
Measured: Up to 15 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Jun 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies 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
- Single group
- Model description
- Acceptability and Feasibility using a Single Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Troy Hubert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Troy Hubert, University of Kentucky
- Investigators
- Jessica Burris, Ph.D., Study director, University of KentuckyShannon Sauer-Zavala, Ph.D., Study director, University of KentuckyTroy J.J. Hubert, M.S., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080606
- Sponsor's protocol ID
- 101765
- Acronym
- BEE for PTSD
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for participants will be shared. This includes data used for primary analysis, a data dictionary defining all variables, a data analytic plan, and R code used for analysis. All IPD will be hosted on OSF and Github.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Exposure and Exercise Therapy for Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT07080606
- Acronym / sponsor ID
- BEE for PTSD / 101765
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, Exercise, Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Troy HubertUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 23 Jul 2025 (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 learn if 8 sessions of brief exposure and exercise therapy works to treat Post Traumatic Stress Disorder (PTSD) in adults. This study will also learn if participants think brief exposure and exercise therapy is a good and doable treatment. and The main questions it aims to answer are:
- Do participants find brief exposure and exercise an acceptable and feasible means of treatment for PTSD?
- Does brief exposure and exercise decreases of the severity of PTSD symptoms?
Participants will:
- Complete weekly questionnaires for 10-14 weeks.
- Attend 8 twice weekly exposure therapy and exercise sessions for 4 weeks.
Detailed description
A community sample (n=6) of adults with PTSD will receive eight sessions of standardized brief exposure therapy with six sessions of imaginal exposures and aerobic exercise. This clinical trial will be the first study demonstrate the effectiveness of an exposure-only therapy and exercise treatment by isolating and targeting safety learning using imaginal exposures. This approach will address gaps in the literature by demonstrating treatment effectiveness, mechanistic engagement, and patients' perceptions of a brief imaginal exposure treatment combined with aerobic exercise. Addressing these gaps through a preliminary clinical trial that establishes feasibility and treatment effectiveness is a necessary first step before exerting substantial time and money on a large-scale clinical trial.
Aligned with an experimental therapeutics approach, the proposed study will take advantage of single-case experimental design (SCED) to explore changes in PTSD symptom severity and exposure therapy mechanisms (i.e., belief change, experiential avoidance, and emotional intensity) within each participant. SCEDs are parsimonious research designs that are ideal for investigating mechanisms and the effectiveness of interventions. SCEDs use each subject as their own control, resulting in high internal validity and the ability to examine effect sizes across subjects.
Upon referral to the study, participants will complete a brief battery of self-report questionnaires to screen for eligibility. Likely eligible participants, determined by the prescreening, will be given a link to schedule an intake with PI or other graduate student research personnel to complete informed consent and assessments to evaluate inclusion/exclusion criteria. Eligible participants will then be randomized to either a 3, 4 or 5 week baseline period, where participants will complete weekly self-report questionnaires to assess PTSD symptoms and exposure therapy mechanisms. Participants fill out a questionnaire battery before, during, and after treatment resulting in a total of 10-14 weeks of self-report assessments. After the baseline assessment phase, participants will complete the first session of PE, which focuses on psychoeducation and treatment planning, six sessions of imaginal exposures and exercise, and a final PE session discussing relapse prevention and future directions. During the six imaginal exposure sessions (sessions 2-7), participants will complete 20 minutes of imaginal exposure to traumatic memories, 10 minutes of emotional processing, and then 20 minutes of moderate-intensity exercise (i.e., 70-75% of MHR) on a stationary bike with 3 minutes of warmup and 2 minutes of cool-down. Proximal measures for exposure mechanisms will be assessed during treatment sessions (e.g., subjective units of distress) to align with distal measures of exposure therapy, which are assessed in the weekly self-report batteries. Following completion of the treatment, participants will be asked to provide satisfaction ratings on the treatment.
PTSD symptom severity will be assessed weekly to investigate treatment efficacy (Aim 1). Acceptability will be evaluated using a self report patient satisfaction questionnaires (Aim 2). Adherence to the treatment protocol will be used to characterize feasibility (Aim 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Acceptability and Feasibility using a Single Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Brief exposure therapy and exercise 3 week | Experimental | Behavioral: Brief exposure therapy and exerciseParticipants are randomized into the 3 week baseline condition before receiving the exposure therapy and exercise intervention. |
| Brief exposure therapy and exercise 5 week | Experimental | Behavioral: Brief exposure therapy and exerciseParticipants are randomized into the 5 week baseline condition before receiving the exposure therapy and exercise intervention. |
| Brief exposure therapy and exercise 4 week | Experimental | Behavioral: Brief exposure therapy and exerciseParticipants are randomized into the 4 week baseline condition before receiving the exposure therapy and exercise intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provide informed consent and are willing to participate in therapy sessions twice weekly, which include moderate-intensity aerobic exercise.
- Participants must be adults aged 18-64 meeting the criteria for PTSD within the past month, who are not currently receiving treatment from other psychotherapy or are on unstable psychiatric medication (i.e., less than four weeks of psychiatric medication).
- Participants should be able to engage in 25 minutes of moderate-intensity aerobic exercise (i.e., 70-75% of max heart rate).
- Participants must be able to speak and read English fluently to participate in the current study.
Key exclusion criteria (5 listed)
- Participants who endorse health condition(s) that would prevent moderate exercise.
- Participants who endorse (i.e., "yes") any items on the Physical Activity Readiness Questionnaire (PARQ) that is not controlled or managed.
- Participants with any injuries to the lower extremities that may hinder riding an exercise bicycle.
- Psychiatric exclusion criteria include recent (within the past three months) severe use disorder(s), high risk for suicide (i.e., plan, intent, or recent attempt), mania, or psychotic symptoms unrelated to PTSD symptoms.
- Participants currently seeking or undergoing any other trauma-focused psychotherapy treatment.
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 |
|---|---|---|
| Brief exposure therapy and exerciseAlso: Imaginal ExposureTreatment provided in this study includes an open label brief imaginal exposure therapy for Post Traumatic Stress Disorder (PTSD) and moderate intensity aerobic exercise (i.e., 70-75% max heart rate). Participants all receive 30 minutes of psychotherapy and 25 minutes of exercise. | Behavioural | Brief exposure therapy and exercise 3 week, Brief exposure therapy and exercise 4 week, Brief exposure therapy and exercise 5 week |
Primary outcome
Change in PTSD Checklist for DSM-5 (PCL-5)
Time frame: Up to 15 weeks.
The PCL-5 is a 20-item self-report questionnaire used to assess PTSD symptom severity. Each of the 20 PCL-5 items corresponds to symptoms of PTSD in the DSM-5. Items are rated on a Likert scale from 0 (not at all) to 4 (extremely) based upon how bothered participants are by each symptom. Items on the PCL-5 are summed, resulting in a total score of PTSD symptom severity from 0-80. Scores >30 indicate probable PTSD.
Patient Satisfaction Questionnaire Scores
Time frame: Once at end of treatment (up to 9 weeks).
Acceptability will be assessed using a patient satisfaction questionnaire. The 5 Items on the patient satisfaction questionnaire are rated on a 4 likert scale with higher scores on the indicating better perceptions of treatment. Total satisfaction of treatment can be obtained by averaging scores across the 5 items.
Feasibility of the intervention
Time frame: 4 weeks of treatment following the 3-to 5-week baseline.
Feasibility will be analyzed by examining adherence to the treatment protocol checklist. An average score of 80% treatment adherence for all participants will be used as a threshold to define the feasibility of this intervention.
3 secondary outcomes
Changes in Brief Experiential Avoidance Questionnaire
Time frame: Up to 15 weeks
Changes in the posttraumatic cognitions inventory-9 (PTCI-9)
Time frame: Up to 15 weeks.
Changes in the positive and negative valence affect schedule (PANAS)
Time frame: Up to 15 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- A Github repository hosting data, analytic plan, and analytic R code.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data for participants will be shared. This includes data used for primary analysis, a data dictionary defining all variables, a data analytic plan, and R code used for analysis. All IPD will be hosted on OSF and Github.
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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. This study is not recruiting at the moment.
Jessica Burris, Ph.D. study director
University of Kentucky
Shannon Sauer-Zavala, Ph.D. study director
University of Kentucky
Troy J.J. Hubert, M.S. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief exposure therapy and exercise in people with PTSD - Post Traumatic Stress Disorder, run by Troy Hubert at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Checklist for DSM-5 (PCL-5) (time frame: Up to 15 weeks.). 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 8 Apr 2026.