Exposure Therapy + Exercise for Post-Traumatic Stress Disorder

(BEE for PTSD Trial)

Overseen By Troy JJ Hubert, M.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Troy Hubert

Must not be taking: Unstable psychiatric medication

Disqualifiers: Severe use disorder, Suicide risk, Mania, Psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining exposure therapy and exercise can reduce symptoms of Post-Traumatic Stress Disorder (PTSD) in adults. Participants will attend sessions twice a week for four weeks, engaging in therapy and moderate aerobic exercise. The trial also seeks to determine if participants find this approach manageable and worthwhile. It is recruiting adults with PTSD who are not currently in other therapy and can handle moderate exercise. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative PTSD treatment research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not be on unstable psychiatric medication (less than four weeks of use). It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that this therapy is safe for treating PTSD?

Research has shown that both exposure therapy and exercise have been studied separately for their effects on Post-Traumatic Stress Disorder (PTSD). Adding exercise to exposure therapy might enhance the treatment's effectiveness. For instance, a small study found that performing aerobic exercise before exposure therapy could reduce PTSD symptoms more effectively.

Regarding safety, exposure therapy is a common and generally well-tolerated treatment for PTSD. It involves facing fears in a safe setting, which can be challenging but is usually safe with professional guidance. Exercise is also typically safe and offers many health benefits. No specific reports of serious problems have emerged when combining these two methods. However, it is important to follow professional advice and communicate any concerns during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining brief exposure therapy with exercise for treating PTSD because it brings a fresh approach to managing the condition. Unlike standard treatments like medication or lengthy therapy sessions, this method could potentially speed up recovery by integrating physical activity, which is known to help reduce anxiety and improve mood. Additionally, the combination of brief exposure therapy and exercise is designed to be completed in just 3 to 5 weeks, providing a quicker path to relief. This could be especially beneficial for those seeking effective treatment without committing to long-term therapy.

What evidence suggests that brief exposure therapy and exercise might be an effective treatment for PTSD?

Research shows that combining exposure therapy with exercise may help treat PTSD (Post-Traumatic Stress Disorder). This trial will evaluate different durations of this combined approach. Studies have found that adding physical activity to trauma-focused treatments can enhance their effectiveness. One study discovered that PTSD symptoms decreased significantly with this combined approach compared to the starting levels. Another study suggested that short aerobic exercise could enhance the benefits of exposure therapy, helping to reduce PTSD symptoms. While exposure therapy alone works for some people, adding exercise might offer extra benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica Burris, Ph.D.

Principal Investigator

University of Kentucky

Shannon Sauer-Zavala, Ph.D.

Principal Investigator

University of Kentucky

Troy J.J. Hubert, M.S.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

Adults aged 18-64 with recent PTSD not currently in psychotherapy or on stable meds for less than four weeks. Must consent to twice-weekly sessions, be able to do moderate exercise, and speak/read English fluently.

Inclusion Criteria

I can do 25 minutes of exercise like brisk walking without much difficulty.

I can speak and read English fluently.

I agree to join therapy sessions twice a week that involve moderate exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline

Participants are randomized into a 3, 4, or 5 week baseline period to complete weekly self-report questionnaires assessing PTSD symptoms and exposure therapy mechanisms

3-5 weeks

Weekly self-report questionnaires

Treatment

Participants attend 8 sessions of brief exposure and exercise therapy, including imaginal exposures and aerobic exercise

4 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction ratings and PTSD symptom assessments

4-6 weeks

Weekly self-report questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Brief Exposure Therapy and Exercise

Trial Overview The trial tests if brief exposure therapy combined with exercise over eight sessions can treat PTSD. It checks the treatment's acceptability and effectiveness at reducing symptom severity through weekly questionnaires for up to 14 weeks.

How Is the Trial Designed?

Group I: Brief exposure therapy and exercise 5 week Experimental Treatment 1 Intervention

Participants are randomized into the 5 week baseline condition before receiving the exposure therapy and exercise intervention.

Group II: Brief exposure therapy and exercise 4 week Experimental Treatment 1 Intervention

Participants are randomized into the 4 week baseline condition before receiving the exposure therapy and exercise intervention.

Group III: Brief exposure therapy and exercise 3 week Experimental Treatment 1 Intervention

Participants are randomized into the 3 week baseline condition before receiving the exposure therapy and exercise intervention.

Who Is Running the Clinical Trial?

Troy Hubert

Lead Sponsor

Citations

1. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1215250/full

Adding physical activity to intensive trauma-focused ... This randomized controlled trial examined the effectiveness of physical activity added to an intensive trauma-focused treatment (TFT) for post-traumatic stress ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034887/

To Expose or Not to Expose: A Comprehensive Perspective ... But effectiveness and implementation data show that a large proportion of patients who undergo exposure therapy retain their PTSD diagnosis, and implementation ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1077722925000458

Inhibitory Retrieval-Based Exposure Therapy for Patients ... Results showed that PTSD symptoms significantly decreased over treatment compared to baseline (b = −0.22, p < .001). Clinically meaningful ...

4. thelancet.com thelancet.com/journals/lanpsy/article/piis2215-0366(22)00368-6/abstract

Augmenting trauma-focused psychotherapy for post ... We aimed to investigate the effects of brief aerobic exercise on the efficacy of exposure therapy in reducing the severity of PTSD.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2787933

Effect of Written Exposure Therapy vs Cognitive Processing ... Written exposure therapy was found to be noninferior to cognitive processing therapy. Dropout rates for written exposure therapy were significantly lower.

6. trialx.com trialx.com/clinical-trials/listings/321019/brief-exposure-and-exercise-for-ptsd/

Brief Exposure and Exercise for 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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02649127

The Role of Exercise in the Treatment of PTSD Symptoms The most effective treatment for PTSD is exposure therapy where, under the supervision of a trained therapist, individuals are exposed to prolonged and repeated ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2215036622003686

Augmenting trauma-focused psychotherapy for post ... Only one small pilot study has indicated that brief aerobic exercise before exposure therapy led to greater reductions in PTSD severity after treatment relative ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4464974/

Exercise Augmentation of Exposure Therapy for PTSD As reviewed, exercise may have the potential to enhance outcome in general and aid those individuals for whom a regular exposure therapy regimen falls short in ...

10. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1645660.pdf

Written Exposure Therapy for Posttraumatic Stress Symptoms ... We evaluated the efficacy of WET + CRP plus treatment as usual. (TAU; referred to as WET + CRP hereafter) compared with TAU alone in reducing suicide risk and ...