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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are: * Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms? * Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.

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 data supports the effectiveness of the treatment Prolonged Exposure Therapy for PTSD and Substance Use Disorder?

Prolonged Exposure Therapy (PE) has been shown to be effective in treating PTSD, especially among veterans and emergency service personnel. Studies indicate that while not all patients benefit, many do see improvements, and the therapy is more effective when therapists receive proper training and support. ^{1 2 3 4 5}

How is Prolonged Exposure Therapy different from other treatments for PTSD and Substance Use Disorder?

Prolonged Exposure Therapy is unique because it combines PTSD treatment with substance use treatment, allowing individuals to address both issues simultaneously. It involves repeated, controlled exposure to trauma-related memories and situations, helping patients process emotions and reduce symptoms, which is not typically part of standard substance use treatments. ^{4 6 7 8 9}

Research Team

Shannon Kehle-Forbes, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. 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]

2. 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]

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. 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]

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

Maintenance and Reach of Exposure Psychotherapy for Posttraumatic Stress Disorder 18 Months After Training. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Concurrent treatment of substance use disorders and PTSD using prolonged exposure: A randomized clinical trial in military veterans. [2020]

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

Prolonged Exposure Therapy for PTSD among Individuals in a Residential Substance Use Treatment Program: A Case Series. [2021]

8. Argentina pubmed.ncbi.nlm.nih.gov

[Emotional processing theory and prolonged exposure therapy for posttraumatic stress disorder]. [2018]

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

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