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

Trial Summary

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 data supports the effectiveness of the treatment Prolonged Exposure Therapy for Post-Traumatic Stress Disorder?

Research shows that Prolonged Exposure Therapy helps reduce PTSD symptoms and depression in various groups, including veterans and low-income women, even when delivered by community therapists. A study also found that Japanese patients experienced significant symptom reduction, suggesting the treatment's effectiveness across different cultures. ^{1 2 3 4 5}

Is prolonged exposure therapy safe for humans?

The research articles do not specifically address the safety of prolonged exposure therapy, but they do indicate it is a well-established treatment for PTSD, suggesting it is generally considered safe when used appropriately. ^{3 5 6 7 8}

How is prolonged exposure therapy different from other PTSD treatments?

Prolonged exposure therapy is unique because it focuses on helping patients confront and process their traumatic memories through two main techniques: imaginal exposure (reliving the trauma in a safe environment) and in vivo exposure (facing real-life situations that are reminders of the trauma). This approach is considered a first-line, evidence-based treatment for PTSD, but it is underutilized due to barriers in healthcare systems. ^{3 6 7 9 10}

What is the purpose of this trial?

The primary objective of this research is to collect pilot data that demonstrates that proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure therapy (PE) for posttraumatic stress disorder (PTSD). The aims of the study are to: (1) examine theoretically informed mechanisms as pre-treatment predictors of PE treatment efficacy, (2) characterize how neural, psychophysiological, and subjective markers measured before, during, and after treatment change over the course of PE, and (3) examine proposed mechanisms of change as measures of PE treatment efficacy. This is a longitudinal study of predictors of exposure therapy efficacy that will be conducted within the context of a standard 10 session PE treatment trial, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment, post-treatment, and at 1-month follow-up. This data will be used to support a future NIMH and/or VA grant submission.

Research Team

Suzanne Pineles

Principal Investigator

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

Eligibility Criteria

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.

I am interested in starting PE treatment.

Veteran

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of service-connected disability and therapist experience on outcomes from prolonged exposure therapy with veterans. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Barriers and Potential Solutions to Implementing Evidence-Based PTSD Treatment in Military Treatment Facilities. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot study on prolonged exposure of Japanese patients with posttraumatic stress disorder due to mixed traumatic events. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treating low-income and minority women with posttraumatic stress disorder: a pilot study comparing prolonged exposure and treatment as usual conducted by community therapists. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for post-traumatic stress disorder: a review of evidence and dissemination. [2022]

8. United States 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. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Neurosubstrates of remission following prolonged exposure therapy in veterans with posttraumatic stress disorder. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

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