Brief Prolonged Exposure Therapy for Post-Traumatic Stress Disorder

Recruiting at 2 trial locations

Overseen By Jessica Rostockyj, M.S

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Police custody, Non-English, Cognitive impairment, Suicidal, Psychosis

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a short therapy can help prevent post-traumatic stress disorder (PTSD) after an injury. Participants will receive either Brief Prolonged Exposure Therapy, a type of focused counseling, or the usual care provided at trauma centers. The goal is to determine if the brief therapy sessions effectively reduce PTSD symptoms and other related issues. Individuals admitted to certain trauma centers who are not in police custody, are fluent in English, and do not have severe mental health issues are invited to participate. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance PTSD prevention strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Brief Prolonged Exposure Therapy is safe for treating PTSD?

Research has shown that Prolonged Exposure (PE) therapy is a proven treatment for PTSD, with studies indicating that 65% to 80% of people respond well to it. Many people find it helpful. PE therapy is considered safe and is commonly used for PTSD.

The treatment in this trial, Brief Prolonged Exposure Therapy, is a shorter version of PE therapy. Although specific safety data for this brief version is not available, it is based on the original PE therapy, suggesting it is likely to be well-tolerated. The shorter duration might even make it easier for some people to manage.

Overall, existing research on PE therapy supports its safety, suggesting that the brief version should be safe too. Participants can feel more comfortable knowing the treatment has a strong safety background. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Brief Prolonged Exposure Therapy for PTSD because it offers a quicker and more focused approach compared to traditional therapies. Unlike other treatments like Cognitive Behavioral Therapy (CBT) or Eye Movement Desensitization and Reprocessing (EMDR), which can take months, this therapy involves just three 60-minute sessions. This condensed format targets trauma-related memories and helps patients process them more efficiently, potentially speeding up recovery and making therapy more accessible for those with busy schedules. By integrating this method with standard treatments, it could enhance overall effectiveness and improve patient outcomes more rapidly.

What evidence suggests that Brief Prolonged Exposure Therapy might be an effective treatment for PTSD?

Research has shown that Brief Prolonged Exposure Therapy (BPE), which participants in this trial may receive, can effectively reduce PTSD symptoms. One study found that BPE significantly lowered PTSD, depression, and anxiety symptoms from the beginning of treatment and maintained these improvements three months later. Another study found that exposure therapy, like BPE, was more effective than counseling for improving PTSD symptoms and overall well-being. These findings suggest BPE is a promising option for those looking to manage PTSD symptoms effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

Ann Marie Warren, PhD

Principal Investigator

Baylor Scott & White Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals admitted to specific Level I Trauma Centers after an injury, who may be at risk of developing PTSD. It's not open to those with certain conditions that could interfere with the study or their recovery.

Inclusion Criteria

You were admitted to one of these specific hospitals for trauma care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Brief Prolonged Exposure Therapy, consisting of three 60-minute sessions

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for PTSD symptoms and other health outcomes at 1, 3, and 6 months from baseline

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brief Prolonged Exposure Therapy

Trial Overview Researchers are testing a short therapy called Brief Prolonged Exposure Therapy against the usual treatment methods to see if it can prevent PTSD following traumatic injuries.

How Is the Trial Designed?

Group I: Brief Prolonged Exposure Experimental Treatment 1 Intervention

Participants in the experimental group will receive Brief Prolonged Exposure Therapy. In addition to the standard clinical treatment received by all patients at BUMC, BSWMC Temple and FH/MCW (treatment as usual), participants randomized to the intervention condition will also receive three 60-minute sessions of Brief PE. Participants in the BPE group will complete a screener and then questionnaires/interviews at 1, 2, and 6 months from Baseline.

Group II: Treatment as Usual Placebo Group 1 Intervention

Participants in the Treatment as Usual group (TAU) will not receive the Brief PE therapy, but the standard clinical treatment received by all patients admitted to BUMC, BSWMC Temple or FH/MCW trauma centers. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months from Baseline.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Froedtert Hospital

Collaborator

Trials

10

Recruited

10,700+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9006570/

The efficacy and acceptability of exposure therapy for ... This meta-analysis found that ET showed superiority in terms of efficacy at post-treatment/follow-up and depressive symptoms improvement in treating PTSD in ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2808302

Written Exposure Therapy vs Prolonged ... Conclusions and Relevance In this study, WET was noninferior to PE in PTSD symptom change and was associated with significantly less attrition.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/15346501211017989

Preliminary Effectiveness of Brief Prolonged Exposure ... Overall, brief PE reduced symptoms of PTSD, depression, and anxiety from baseline to post-intervention, and at 3-month follow-up. A downward trend in symptoms ...

4. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1633606.pdf

Prolonged exposure therapy for the treatment of ... The results showed that. PE was superior to counseling for improvement in PTSD symptoms, depression, and functioning, with gains main- tained up ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721715/

Treatment of Posttraumatic Stress Disorder with Prolonged ... In a pilot study, PE-PC showed significant and large reductions in PTSD from pre- to post-treatment that were maintained at six-month follow-up (Cigrang et al., ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160482/

Enhancing Prolonged Exposure therapy for PTSD using ... Prolonged Exposure (PE) therapy is one of the most effective treatments for PTSD, with response rates ranging from 65 to 80% [[9], [10], [11]].

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK79056/

A meta-analytic review of prolonged exposure for ... - NCBI Prolonged exposure therapy was highly effective in treating post-traumatic stress disorder and significantly more effective than inactive (waiting list) and ...

8. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - PTSD: National Center for ... Results revealed significant reductions in PTSD symptom severity in both PE plus placebo and PE plus sertraline. In an RCT of 916 veterans randomized to PE or ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00057629

Prolonged Exposure Therapy for Post Traumatic Stress ... This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S245186542100065X

Comparing written exposure therapy to Prolonged ... In an ongoing randomized controlled trial (RCT) we are investigating whether WET is non-inferior in treating PTSD compared with the more time intensive PE.