Prolonged Exposure Therapy for PTSD and Substance Use Disorder

(PREVAIL Trial)

Recruiting at 3 trial locations

Overseen By Sonya Norman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Veterans Medical Research Foundation

Disqualifiers: Severe cognitive impairment, Suicidal intent, Psychotic symptoms

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: 4

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if more frequent Prolonged Exposure Therapy benefits veterans with PTSD and substance use disorder more than the usual weekly sessions. Researchers seek to assess whether frequent sessions can reduce PTSD symptoms and aid in substance use management. Participants will receive therapy either once a week or several times a week to compare outcomes. Veterans who have served since September 2001, are in intensive outpatient substance use treatment, and have struggled with substance use on most days recently may be well-suited for this study. As an unphased trial, this study offers veterans a unique opportunity to contribute to understanding and improving treatment options for PTSD and substance use disorders.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Prolonged Exposure Therapy is safe for veterans with PTSD and substance use disorder?

Research has shown that Prolonged Exposure Therapy (PE) is generally a well-tolerated treatment for PTSD (post-traumatic stress disorder). Studies indicate that PE can reduce PTSD symptoms without increasing substance use, even in individuals with both PTSD and substance use disorders.

For instance, research found that using PE for those with PTSD and substance use issues did not lead to increased substance use. Another study showed that alcohol use did not cause more participants to drop out or experience worse outcomes when PE was used.

These findings suggest that PE is safe for individuals dealing with both PTSD and substance use issues. The therapy does not appear to harm participants or worsen their conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Prolonged Exposure (PE) Therapy for PTSD and Substance Use Disorder because it offers a new approach in treating these challenging conditions. Traditional treatments often focus on either PTSD or substance use independently, but PE Therapy aims to address both simultaneously, potentially improving outcomes for patients with dual diagnoses. The trial is exploring two formats: Weekly PE, which offers a structured, steady approach, and Massed PE, delivering sessions multiple times a week for faster results. This flexibility in delivery could allow for more personalized treatment plans, catering to the specific needs and schedules of patients.

What evidence suggests that this trial's treatments could be effective for PTSD and substance use disorder?

This trial will compare two formats of Prolonged Exposure Therapy for PTSD and Substance Use Disorder: Weekly PE and Massed PE. Studies have shown that Prolonged Exposure Therapy can significantly reduce PTSD symptoms. Research indicates that this therapy helps individuals confront and process their traumatic memories, leading to fewer PTSD symptoms. One study found that many patients who underwent Prolonged Exposure Therapy no longer exhibited signs of PTSD. Additionally, when combined with treatment for substance use disorders, Prolonged Exposure has effectively reduced both PTSD symptoms and substance use. This suggests that the therapy could benefit those dealing with both PTSD and substance use issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Shannon Kehle-Forbes, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for veterans with PTSD and substance use disorder who are currently in intensive outpatient treatment. Participants will be asked to complete Prolonged Exposure Therapy, which requires attending either weekly sessions or multiple sessions per week.

Inclusion Criteria

Report substance use at least 20 of the last 90 days

Meet DSM-5 criteria for PTSD

Are able to give informed consent

Exclusion Criteria

I have significant memory or thinking problems.

I do not have thoughts of harming myself or others that need immediate attention.

Current unstable psychotic or manic symptoms not attributable to SUD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Prolonged Exposure Therapy in either a massed format (multiple sessions per week) or weekly sessions for PTSD and substance use disorder

12 weeks

Multiple sessions per week or weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Assessments at 4-, 16-, 28-, and 40-weeks post-first therapy session

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Exposure Therapy

Trial Overview The study is testing the effectiveness of Prolonged Exposure Therapy for PTSD when conducted in a massed format (multiple sessions weekly) compared to the standard once-a-week session schedule among veterans undergoing substance use treatment.

How Is the Trial Designed?

Group I: Massed PE Experimental Treatment 1 Intervention

Prolonged Exposure delivered in a massed format - sessions multiple times per week

Group II: Weekly PE Active Control 1 Intervention

Prolonged Exposure delivered with weekly sessions

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?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Recruited

5,100+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

Published Research Related to This Trial

Prolonged exposure therapy (PE) is recognized as a first-line treatment for posttraumatic stress disorder (PTSD), focusing on imaginal exposure to help patients process traumatic memories.

The article discusses the efficacy and safety of PE, as well as adaptations made for specific populations, such as Hispanics, and highlights challenges in implementing this therapy widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Emotional processing theory and prolonged exposure therapy for posttraumatic stress disorder]. Kichic, R., D'Alessio, N.[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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6488423/

Concurrent Treatment of Substance Use Disorders and ... This study evaluated the efficacy of an integrated treatment that incorporates PE (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged ...

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

Prolonged Exposure for PTSD - PTSD: National Center for ... For example, one study found Concurrent Treatment for PTSD and Substance Use Disorder Using Prolonged Exposure (COPE) to be more effective in reducing PTSD ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836418

Advancing Integrated Treatment for Posttraumatic Stress ... Both groups showed significant within-group reductions in PTSD symptoms over time. Importantly, RRFT, similar to integrated treatment, did not ...

4. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624014327

A novel prolonged exposure therapy protocol for improving ... PE+ yielded high rates of PTSD diagnostic remission (83 %). •. PE was not associated with an increase in non-prescribed opioid or other drug use ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6223130/

Concurrent Treatment of PTSD and Substance Use ... Concurrent Treatment of PTSD and SUDs using Prolonged Exposure has been shown to reduce PTSD symptom severity without increasing substance use in an Australian ...

7. researchgate.net researchgate.net/profile/Carmen-Mclean-2/publication/380033370_State_of_the_Science_Prolonged_exposure_therapy_for_the_treatment_of_posttraumatic_stress_disorder/links/6639471b06ea3d0b742ca985/State-of-the-Science-Prolonged-exposure-therapy-for-the-treatment-of-posttraumatic-stress-disorder.pdf

State of the Science: Prolonged exposure therapy for the ... In a trial with U.S. civilians with mixed trauma–related PTSD. (N = 200), alcohol use did not predict dropout, adherence, or clinical outcomes ...