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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06296186
Recruitment Status : Not yet recruiting
First Posted : March 6, 2024
Last Update Posted : March 6, 2024
Sponsor:
Collaborators:
University of Minnesota
Center for Veterans Research and Education
Information provided by (Responsible Party):
Veterans Medical Research Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Substance Use Disorders Behavioral: Prolonged Exposure Therapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment (MPE)
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : August 2027
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session ]
    Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity

  2. Brief Psychosocial Functioning Inventory (B-IPF) [ Time Frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session ]
    Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment

  3. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: 16 weeks ]
    Measures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06296186


Contacts
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Contact: Sonya Norman, PhD 858-518-8266 snorman@ucsd.edu
Contact: Kaitlyn Panza, PhD 858-552-8585 kaitlyn.panza@va.gov

Locations
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United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Contact: Sonya Norman, PhD    858-518-8266    sonya.norman@va.gov   
United States, Florida
VA Tampa Healthcare System
Tampa, Florida, United States, 33612
Contact: Brittany Davis, PhD    813-972-2000    brittany.davis@va.gov   
United States, Georgia
VA Atlanta Healthcare System
Atlanta, Georgia, United States, 30033
Contact: Kristin Lamp, PhD       kristen.lamp@va.gov   
United States, Illinois
Hines VA Healthcare System
Chicago, Illinois, United States, 60141
Contact: Jonathan Bayer, PhD       jonathan.bayer2@va.gov   
Sponsors and Collaborators
Veterans Medical Research Foundation
University of Minnesota
Center for Veterans Research and Education
Investigators
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Principal Investigator: Shannon Kehle-Forbes, PhD University of Minnesota
More Information
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Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT06296186    
Other Study ID Numbers: HT94252310669
First Posted: March 6, 2024    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will share data with Strong Star Repository.
Supporting Materials: Study Protocol
Time Frame: After study completion.
Access Criteria: Request to StrongStar Repository that Strong Star must approve.
URL: https://www.strongstar.org/research/strongstar/strong-star-repository

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
 Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders