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.
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
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Substance Use Disorders
- What is being tested?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- 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.
6 sites in 1 country
United States6 sites, 6 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Massed PE | Experimental | Prolonged Exposure delivered in a massed format - sessions multiple times per week Receives: Behavioral: Prolonged Exposure Therapy |
| Weekly PE | Active comparator | Prolonged 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.
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
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
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)
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
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
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.
- First posted6 Mar 2024
- Study start1 Sep 2024
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Center for Veterans Research and Education
- Responsible party
- Sponsor
- Investigators
- Shannon Kehle-Forbes, PhD, Principal investigator, University of Minnesota
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment (MPE)
- ClinicalTrials.gov ID
- NCT06296186
- Acronym / sponsor ID
- PREVAIL / HT94252310669
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- University of Minnesota, Center for Veterans Research and Education
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massed PE | Experimental | Behavioral: Prolonged Exposure TherapyProlonged Exposure delivered in a massed format - sessions multiple times per week |
| Weekly PE | Active comparator | Behavioral: Prolonged Exposure TherapyProlonged Exposure delivered with weekly sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- severe cognitive impairment
- current suicidal or homicidal intent requiring immediate treatment
- current unstable psychotic or manic symptoms not attributable to SUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyExposure therapy for PTSD | Behavioural | Massed PE, Weekly PE |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Time Line Follow back (TLFB)
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use
Psychotherapy Completion Rates
Time frame: 16 weeks
Percent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy
3 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Brief Psychosocial Functioning Inventory (B-IPF)
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. Will share data with Strong Star Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Kehle-Forbes, PhD principal investigator
University of Minnesota
6 sites in 1 country: see every site and its status.
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.