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Stress Disorders, Post-TraumaticPREVAILNCT06296186

Massed Prolonged Exposure for PTSD in Substance Use Treatment

A study testing Prolonged Exposure Therapy in people with Stress Disorders, Post-Traumatic and Substance Use Disorders, run by Veterans Medical Research Foundation at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prolonged Exposure Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
6 sitesUnited States
Study dates
1 Sep 2024to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veterans
  • age 18+
  • who have served since September 2001
  • who are enrolled in a SUD IOP at a participating VA
  • meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone not sufficient for inclusion)
  • meet DSM-5 criteria for PTSD
  • report substance use at least 20 of the last 90 days
  • are able to give informed consent.

Who cannot join

  • severe cognitive impairment
  • current suicidal or homicidal intent requiring immediate treatment
  • current unstable psychotic or manic symptoms not attributable to SUD

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sonya Norman, PhD contact

858-518-8266

snorman@ucsd.edu

Kaitlyn Panza, PhD contact

858-552-8585

kaitlyn.panza@va.gov

6 sites in 1 country

United States6 sites, 6 recruiting
  • VA Atlanta Healthcare System

    Atlanta, Georgia, 30033

    Kristin Lamp, PhD, kristen.lamp@va.gov

    Recruiting
  • Hines VA Healthcare System

    Chicago, Illinois, 60141

    Jonathan Bayer, PhD, jonathan.bayer2@va.gov

    Recruiting
  • Cleveland VA

    Cleveland, Ohio, 44106

    Vanessa Facemire, PhD, 216-791-3800, vanessa.facemire@va.gov

    Recruiting
  • New Orleans VA Medical Center

    New Orleans, Louisiana, 70119

    Chelsea Ennis, chelsea.ennis@va.gov

    Recruiting
  • VA San Diego Healthcare System

    San Diego, California, 92161

    Sonya Norman, PhD, 8585188266, sonya.norman@va.gov

    Recruiting
  • VA Tampa Healthcare System

    Tampa, Florida, 33612

    Brittany Davis, PhD, 813-972-2000, brittany.davis@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment (MPE)

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.
Read the detailed description

Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD, and delivering these treatments concurrent to SUD programming is recommended by the VA/DoD Clinical Practice Guidelines. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly). M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in military and Veteran populations. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M- PE delivery in of SUD intensive outpatient programming (IOP) in improving PTSD and other mental health outcomes and reducing dropout as compared to weekly PE delivery (W-PE) is the necessary next step in this critical research.

The primary goal of this project is to determine if a promising way to treat PTSD among those with SUD, M-PE, will help Veterans with their PTSD symptoms and lead to better treatment completion rates more than PE delivered weekly and if the massed format will reduce substance use comparably to weekly PE among those in intensive SUD treatment. The study will also evaluate if M-PE helps Veterans function better and feel less depressed. M-PE is a one-on-one talk therapy that is delivered over twelve sessions several times a week. The therapy is brief because of the massed format so that it can be delivered at times when lengthy interventions may not be realistic, such as military mental health clinics on bases where military personnel may be getting ready to redeploy. The research team's preliminary work with Veterans in intensive SUD treatment showed M-PE to lead to improvements in PTSD and depression symptoms with no dropout, making this larger evaluation of M-PE compared to PE delivered in the traditional longer (weekly) format a critical next step. The study will accomplish this by randomly assigning participants who are in intensive SUD treatment to receive either M-PE or W-PE. The study will have 200 Veterans who served post 9/11 go through this study and the entire study is expected to take four years to complete. The study will run the study across four VAs (San Diego, Tampa, Chicago, and Atlanta).

Being tested
Prolonged Exposure Therapy
Medical subject headings
Stress Disorders, Post-Traumatic, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged Exposure TherapyBehavioural

    Exposure therapy for PTSD

Study groups in NCT06296186
Study groupRoleWhat they receive
Massed PEExperimentalProlonged Exposure delivered in a massed format - sessions multiple times per week
Receives: Behavioral: Prolonged Exposure Therapy
Weekly PEActive comparatorProlonged Exposure delivered with weekly sessions
Receives: Behavioral: Prolonged Exposure Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

    Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity

    Measured: At 4-, 16-, 28-, and 40-weeks post-first therapy session

  2. Time Line Follow back (TLFB)

    Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use

    Measured: At 4-, 16-, 28-, and 40-weeks post-first therapy session

  3. Psychotherapy Completion Rates

    Percent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy

    Measured: 16 weeks

Secondary outcomes (3)
  1. Patient Health Questionnaire-9 (PHQ-9)

    Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity

    Measured: At 4-, 16-, 28-, and 40-weeks post-first therapy session

  2. Brief Psychosocial Functioning Inventory (B-IPF)

    Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment

    Measured: At 4-, 16-, 28-, and 40-weeks post-first therapy session

  3. Client Satisfaction Questionnaire-8 (CSQ-8)

    Measures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start1 Sep 2024
  3. Primary completionJul 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06296186
Sponsor's protocol ID
HT94252310669
Acronym
PREVAIL
Status last verified
Aug 2026
First submitted
15 Feb 2024
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share data with Strong Star Repository.

Questions about this trial

What is this clinical trial studying?

A study testing Prolonged Exposure Therapy in people with Stress Disorders, Post-Traumatic and Substance Use Disorders, run by Veterans Medical Research Foundation at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sonya Norman, PhD (858-518-8266, snorman@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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