Prolonged Exposure Therapy for Post-Traumatic Stress Disorder

Overseen By Vladimir Ivkovic, Phd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Boston Healthcare System

Disqualifiers: Psychotic disorders, Untreated bipolar, TBI, Neurological problems, Substance use, others

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

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how Prolonged Exposure Therapy (PE) helps treat Post-Traumatic Stress Disorder (PTSD). Researchers will track changes in brain activity, body responses, and personal feelings before, during, and after the therapy. The goal is to identify what makes PE effective and to support future research funding. Veterans diagnosed with PTSD who are interested in starting PE might be a good fit for this study.

As an unphased trial, this study offers veterans the opportunity to contribute to groundbreaking research that could enhance PTSD treatment strategies.

Will I have to stop taking my current medications?

If you are taking psychotropic medication, you can participate as long as your medication has been stable for 2 months before joining the study and stays stable during the trial.

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

Research has shown that Prolonged Exposure Therapy (PE) is a safe and well-accepted treatment for posttraumatic stress disorder (PTSD). Studies have found that PE effectively reduces PTSD symptoms. For instance, a large study with 916 veterans demonstrated significant symptom improvement after receiving PE therapy.

PE is often recommended as a first choice for treating PTSD. The therapy typically involves about 10 sessions where patients gradually confront trauma-related memories, feelings, and situations. This process helps them manage and lessen the distress these memories cause.

There are no major reports of negative effects from PE, making it a safe option for most people. However, as with any therapy, individual experiences can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prolonged Exposure Therapy for PTSD is unique because it directly confronts traumatic memories in a structured way, which helps individuals process and reduce their distress over time. Unlike other standard treatments for PTSD, such as medication or general talk therapy, Prolonged Exposure Therapy involves repeatedly revisiting traumatic events in a safe setting to gradually lessen the emotional impact. Researchers are excited about this approach because it empowers patients to face their fears head-on, potentially leading to more sustainable recovery and resilience.

What evidence suggests that Prolonged Exposure Therapy is effective for PTSD?

Studies have shown that prolonged exposure therapy effectively treats post-traumatic stress disorder (PTSD). Research indicates that people undergoing this therapy often experience a significant reduction in PTSD symptoms. In one study, 46% to 60% of participants showed substantial improvement. Another study found that prolonged exposure therapy was more effective than remaining on a waiting list. Overall, evidence supports that this therapy reduces PTSD symptoms and aids recovery. Participants in this trial will receive a full course of prolonged exposure therapy to further evaluate its effectiveness. ^{2 3 6 7 8}

Who Is on the Research Team?

Suzanne Pineles

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

This trial is for veterans diagnosed with PTSD who are interested in starting Prolonged Exposure therapy. Participants must meet the DSM-5 criteria for PTSD, confirmed by a specific diagnostic tool (CAPS-5).

Inclusion Criteria

I have been diagnosed with PTSD according to DSM-5.

Veteran

I am interested in starting PE treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Prolonged Exposure therapy for PTSD over 10 sessions, with psychophysiological and neural measures recorded

10 weeks

10 visits (in-person)

Mid-treatment Assessment

Multimodal assessment batteries administered to evaluate treatment progress

1 week

1 visit (in-person)

Post-treatment Assessment

Final assessment of treatment efficacy using multimodal assessment batteries

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Exposure Therapy for Posttraumatic Stress Disorder

Trial Overview The study tests how certain markers like brain activity, body responses, and personal feelings change before, during, and after Prolonged Exposure therapy for PTSD over a standard course of 10 sessions.

How Is the Trial Designed?

Group I: Prolonged Exposure Therapy for Posttraumatic Stress Disorder Experimental Treatment 1 Intervention

15 participants who meet study inclusion/exclusion criteria will be individually administered a full course of PE during 10, 60 minute-sessions, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment (post session 5), post-treatment, and a 1-month follow-up.

Who Is Running the Clinical Trial?

VA Boston Healthcare System

Lead Sponsor

Trials

73

Recruited

971,000+

National Center for PTSD

Collaborator

Trials

13

Recruited

1,200+

Published Research Related to This Trial

A needs assessment across eight military treatment facilities identified consistent organizational barriers to implementing prolonged exposure therapy for PTSD, including time constraints, provider issues, patient education challenges, and scheduling difficulties.

The study provides tailored potential solutions for each identified barrier, aiming to enhance the use of this effective therapy within the military health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Potential Solutions to Implementing Evidence-Based PTSD Treatment in Military Treatment Facilities. McLean, CP., Cook, J., Riggs, DS., et al.[2022]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

Prolonged exposure therapy (PE) is recognized as the most scientifically validated treatment for post-traumatic stress disorder (PTSD), outperforming various pharmacological and psychotherapeutic options.

The therapy includes both imaginal and in vivo exposure techniques, and the paper discusses its effectiveness and dissemination specifically in Japan, highlighting its importance in treating chronic PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. Asukai, N.[2018]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

Veterans with a service-connected disability for a mental health condition experienced smaller treatment gains from prolonged exposure therapy (PE) compared to those without such a connection, indicating that this factor may hinder treatment effectiveness.

Veterans treated by certified PE therapists showed significantly larger treatment gains than those treated by noncertified therapists, highlighting the importance of therapist qualifications in improving PTSD treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of service-connected disability and therapist experience on outcomes from prolonged exposure therapy with veterans. Goodson, JT., Helstrom, AW., Marino, EJ., et al.[2018]

In a study of 31 combat veterans with PTSD undergoing prolonged exposure therapy, 9 out of 24 completers achieved complete remission from PTSD, indicating the therapy's potential efficacy.

The study found that successful remission from PTSD was associated with decreased activation in the left anterior insula during negative image anticipation and increased connectivity with other brain regions, suggesting that effective treatment may involve better regulation of anticipatory anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. Simmons, AN., Norman, SB., Spadoni, AD., et al.[2021]

A training workshop on prolonged exposure (PE) therapy for PTSD significantly improved the self-efficacy and outcome expectations of 45 psychologists, leading to increased use of PE techniques in their practice.

The study highlights the importance of combining training with intensive consultation to enhance the delivery of evidence-based PTSD treatments, suggesting that such approaches could help more emergency service patients receive effective care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training plus intensive consultation improves uptake and outcome expectations of prolonged exposure therapy among practitioners treating emergency service personnel with post-traumatic stress disorder. Wade, D., Terhaag, S., Putica, A., et al.[2021]

Prolonged Exposure (PE) therapy was found to be feasible and well-accepted among Japanese patients with PTSD, with 10 out of 12 participants completing the treatment over 9 to 15 sessions.

Participants showed significant reductions in PTSD and depression symptoms from before treatment to after, with these improvements maintained at 3- and 6-month follow-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on prolonged exposure of Japanese patients with posttraumatic stress disorder due to mixed traumatic events. Asukai, N., Saito, A., Tsuruta, N., et al.[2022]

Citations

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

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

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2215036623003735/pdf

The efficacy of psychological interventions for adult post ... This meta-analysis reports strong evidence for the notion that psychological interventions are highly effective in treating not just patients with PTSD caused ...

4. 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.

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05656-9

12-month follow-up of intensive outpatient treatment for PTSD ... The treatment response rates showed that 46–60% of patients achieved recovery with respect to PTSD symptoms, and that 44–48% no longer met ...

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 efficacious, evidence-based treatments for posttraumatic stress disorder (PTSD).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00057629

Prolonged Exposure Therapy for Post Traumatic Stress ... Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment ...

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

Prolonged exposure therapy for the treatment of ... Prolonged exposure therapy (PE) is a well-established first-line treatment for posttraumatic stress disorder (PTSD) that is based on emotional ...