Recruiting

Massed Prolonged Exposure

Sponsor:

Veterans Medical Research Foundation

Code:

NCT06296186

Conditions

Stress Disorders, Post-Traumatic

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged Exposure Therapy

Study Details

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.

Conditions

Stress Disorders, Post-Traumatic

Substance Use Disorders

Study ID

NCT06296186

Start date

Sep 1, 2024

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Massed PE

Prolonged Exposure delivered in a massed format - sessions multiple times per week

active comparator: Weekly PE

Prolonged Exposure delivered with weekly sessions

Interventions

Prolonged Exposure Therapy

Exposure therapy for PTSD

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 ]
  • Time Line Follow back (TLFB) [ Time Frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session ]
  • Psychotherapy Completion Rates [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Sonya Norman, PhD

858-518-8266snorman@ucsd.edu

Kaitlyn Panza, PhD

858-552-8585kaitlyn.panza@va.gov

Locations

VA San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Sonya Norman, PhD

8585188266sonya.norman@va.gov

VA Tampa Healthcare System

Recruiting

Tampa, Florida, United States, 33612

Contacts

Brittany Davis, PhD

813-972-2000brittany.davis@va.gov

VA Atlanta Healthcare System

Recruiting

Atlanta, Georgia, United States, 30033

Contacts

Kristin Lamp, PhD

kristen.lamp@va.gov

Hines VA Healthcare System

Recruiting

Chicago, Illinois, United States, 60141

Contacts

Jonathan Bayer, PhD

jonathan.bayer2@va.gov

New Orleans VA Medical Center

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Chelsea Ennis

chelsea.ennis@va.gov

Cleveland VA

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Vanessa Facemire, PhD

216-791-3800vanessa.facemire@va.gov

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2026-08-27.