Prolonged Exposure Therapy for Post-Traumatic Stress Disorder

Overseen By Kelly Peck, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Vermont

Must be taking: Methadone, Buprenorphine

Disqualifiers: Male, Unstable bipolar, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of methadone or buprenorphine for more than 14 days before the study, and if you're taking psychotropic medications, they must also be stable for more than 14 days before joining.

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

Research shows that Prolonged Exposure Therapy is an effective treatment for PTSD, especially in veterans and military personnel. Studies indicate that it helps reduce PTSD symptoms and is considered a first-line treatment for this condition. ^{1 2 3 4 5}

How is Prolonged Exposure Therapy different from other PTSD treatments?

Prolonged Exposure Therapy is unique because it focuses on helping patients confront their trauma memories directly through two techniques: imaginal exposure (repeatedly revisiting the traumatic memory in a safe environment) and in vivo exposure (gradually facing real-life situations that are reminders of the trauma). This approach is different from other treatments that might not involve such direct confrontation with trauma. ^{1 2 4 5 6}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients who are already receiving treatment for opioid use disorder. The main question it aims to answer is: Does PE+ decrease PTSD symptoms? All participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning. Participants will: * Receive individual PE+ therapy for 1 hour weekly for 12 weeks. * Receive financial incentives for attending each PE+ session. * Attend assessment visits every 4 weeks for the 12 weeks of the trial. * Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.

Eligibility Criteria

This trial is for pregnant individuals who are undergoing treatment for opioid use disorder and also have PTSD. They must be willing to attend weekly therapy sessions for 12 weeks and allow access to their medical records post-delivery.

Inclusion Criteria

Gestational age ≤ 25 weeks

I am female.

I am older than 18 years.

Exclusion Criteria

I do not have a current diagnosis of PTSD.

Not receiving medication for opioid use disorder

Gestational age > 25 weeks

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual PE+ therapy for 1 hour weekly for 12 weeks and financial incentives for attending each session

12 weeks

12 visits (in-person)

Assessment

Participants attend assessment visits every 4 weeks during the treatment phase

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of labor and delivery information

4 weeks

Treatment Details

Interventions

• Prolonged Exposure Therapy

Trial Overview The study tests whether prolonged exposure therapy, combined with financial incentives for attendance, can reduce PTSD symptoms in the participants over the course of the trial.

Participant Groups

Group I: Prolonged exposure therapy + incentives for therapy session attendance Experimental Treatment 1 Intervention

Prolonged Exposure Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

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]

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 (PE) therapy was found to be effective in reducing PTSD and depression symptoms in a small group of 10 Veterans with mild to moderate traumatic brain injury (TBI) and chronic PTSD, showing large effect sizes from pre- to posttreatment.

The therapy was safely adapted for Veterans with cognitive impairments, indicating that PE can be a viable treatment option for this population, with significant symptom improvements observed after 8 to 18 sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary examination of prolonged exposure therapy with Iraq and Afghanistan veterans with a diagnosis of posttraumatic stress disorder and mild to moderate traumatic brain injury. Wolf, GK., Strom, TQ., Kehle, SM., 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. 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]

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

A preliminary examination of prolonged exposure therapy with Iraq and Afghanistan veterans with a diagnosis of posttraumatic stress disorder and mild to moderate traumatic brain injury. [2022]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Japan pubmed.ncbi.nlm.nih.gov

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