Massed Prolonged Exposure for PTSD in Substance Use Treatment (PREVAIL)

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Disorders, Post-Traumatic; Substance Use Disorders
• Intervention / Treatment: Behavioral: Prolonged Exposure Therapy

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonya Norman, PhD; Phone Number: 858-518-8266; Email: snorman@ucsd.edu
• Study Contact Backup: Name: Kaitlyn Panza, PhD; Phone Number: 858-552-8585; Email: kaitlyn.panza@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • Recruiting
      • VA San Diego Healthcare System
      • Contact: Sonya Norman, PhD; Phone Number: 8585188266; Email: sonya.norman@va.gov
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • VA Tampa Healthcare System
      • Contact: Brittany Davis, PhD; Phone Number: 813-972-2000; Email: brittany.davis@va.gov
  • Georgia
    • Atlanta, Georgia, United States, 30033
      • Recruiting
      • VA Atlanta Healthcare System
      • Contact: Kristin Lamp, PhD; Email: kristen.lamp@va.gov
  • Illinois
    • Chicago, Illinois, United States, 60141
      • Recruiting
      • Hines VA Healthcare System
      • Contact: Jonathan Bayer, PhD; Email: jonathan.bayer2@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massed PE; Prolonged Exposure delivered in a massed format - sessions multiple times per week	Behavioral: Prolonged Exposure Therapy; Exposure therapy for PTSD
Active Comparator: Weekly PE; Prolonged Exposure delivered with weekly sessions	Behavioral: Prolonged Exposure Therapy; Exposure therapy for PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity	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	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	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity	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	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	16 weeks

Collaborators and Investigators

• Sponsor: Veterans Medical Research Foundation
• Collaborators: University of Minnesota; Center for Veterans Research and Education
• Investigators: Principal Investigator: Shannon Kehle-Forbes, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HT94252310669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share data with Strong Star Repository.
• IPD Sharing Time Frame: After study completion.
• IPD Sharing Access Criteria: Request to StrongStar Repository that Strong Star must approve.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No