Skip to content

Massed Prolonged Exposure for PTSD in Substance Use Treatment

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06296186
Acronym
PREVAIL
Enrollment
200
Registered
2024-03-06
Start date
2024-09-01
Completion date
2028-08-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic, Substance Use Disorders

Brief 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. 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).

Interventions

BEHAVIORALProlonged Exposure Therapy

Exposure therapy for PTSD

Sponsors

Veterans Medical Research Foundation
Lead SponsorOTHER
University of Minnesota
CollaboratorOTHER
Center for Veterans Research and Education
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)At 4-, 16-, 28-, and 40-weeks post-first therapy sessionMeasures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Time Line Follow back (TLFB)At 4-, 16-, 28-, and 40-weeks post-first therapy sessionMeasures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use
Psychotherapy Completion Rates16 weeksPercent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy

Secondary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)At 4-, 16-, 28-, and 40-weeks post-first therapy sessionDepression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Brief Psychosocial Functioning Inventory (B-IPF)At 4-, 16-, 28-, and 40-weeks post-first therapy sessionMeasures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Client Satisfaction Questionnaire-8 (CSQ-8)16 weeksMeasures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment

Countries

United States

Contacts

CONTACTSonya Norman, PhD
snorman@ucsd.edu858-518-8266
CONTACTKaitlyn Panza, PhD
kaitlyn.panza@va.gov858-552-8585
PRINCIPAL_INVESTIGATORShannon Kehle-Forbes, PhD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026