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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a therapy called prolonged exposure plus incentives (PE+) can reduce symptoms of post-traumatic stress disorder (PTSD) in pregnant women. Participants will attend weekly one-hour therapy sessions for 12 weeks and receive small rewards for attending. The goal is to determine if their PTSD symptoms improve during the trial. Women who are up to 25 weeks pregnant and have been diagnosed with PTSD may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could enhance PTSD treatments for pregnant women.

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 prior data suggests that prolonged exposure therapy is safe for pregnant patients with PTSD?

Research has shown that prolonged exposure therapy is a well-accepted treatment for post-traumatic stress disorder (PTSD). Studies have found that it significantly reduces PTSD symptoms in many people, with success rates between 65% and 80%. Most individuals experience fewer PTSD symptoms after this therapy.

No reports of serious safety concerns have emerged with prolonged exposure therapy. It is often compared to other treatments and consistently shows strong results without major side effects. This therapy has been widely studied and used safely for treating PTSD in different groups, including veterans.

In this trial, participants will receive prolonged exposure therapy with added incentives to encourage attendance. Although this trial focuses on pregnant patients, existing studies support the treatment's safety and effectiveness for the general population. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Prolonged Exposure Therapy is unique because it directly confronts traumatic memories and cues in a controlled way, helping individuals gradually reduce their fear and anxiety associated with those memories. Unlike traditional talk therapy or medication, which might manage symptoms more generally, this therapy specifically aims to break the cycle of avoidance and fear through repeated, structured exposure. Researchers are excited about this approach because it has the potential to provide lasting relief by addressing the root cause of PTSD symptoms rather than just alleviating them temporarily.

What evidence suggests that prolonged exposure therapy might be an effective treatment for PTSD in pregnant patients?

Research has shown that Prolonged Exposure (PE) therapy effectively treats PTSD. Studies have found that individuals receiving PE therapy experience a significant reduction in PTSD symptoms. Comparisons with those on waiting lists reveal that this therapy is more effective than receiving no treatment. Success rates for PE therapy are impressive, with 65% to 80% of individuals seeing improvements in their PTSD symptoms. Participants in this trial will receive Prolonged Exposure therapy along with incentives for attending therapy sessions. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

I am female.

Exclusion Criteria

I do not have a current diagnosis of PTSD.

Gestational age > 25 weeks

Not receiving medication for opioid use disorder

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1.

ptsd.va.gov

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

Prolonged Exposure for PTSD - National Center for PTSD

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 ...

2.

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 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865422000576

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]]. A key component ...

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/s12888-022-03867-6

The efficacy and acceptability of exposure therapy for the ...

ET showed superiority in efficacy at post-treatment/follow-up and depressive symptoms improvement in children and adolescents with PTSD.

6.

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 ...

7.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2788220

Comparison of Prolonged Exposure vs Cognitive ...

Prolonged exposure was more effective than cognitive processing therapy for reducing PTSD symptoms, but the difference between treatments did ...