NCT06296186

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Sep 2024Aug 2027

First Submitted

Initial submission to the registry

February 15, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

February 15, 2024

Last Update Submit

April 16, 2025

Conditions

Stress Disorders, Post-TraumaticSubstance Use Disorders

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9)

    At 4-, 16-, 28-, and 40-weeks post-first therapy session

  • Brief Psychosocial Functioning Inventory (B-IPF)

    At 4-, 16-, 28-, and 40-weeks post-first therapy session

  • Client Satisfaction Questionnaire-8 (CSQ-8)

    16 weeks

Study Arms (2)

Massed PE

EXPERIMENTAL

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

Behavioral: Prolonged Exposure Therapy

Weekly PE

ACTIVE COMPARATOR

Prolonged Exposure delivered with weekly sessions

Behavioral: Prolonged Exposure Therapy

Interventions

Prolonged Exposure TherapyBEHAVIORAL

Exposure therapy for PTSD

Massed PEWeekly PE

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 PTSD
  • report substance use at least 20 of the last 90 days
  • are able to give informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA San Diego Healthcare System

San Diego, California, 92161, United States

RECRUITING

VA Tampa Healthcare System

Tampa, Florida, 33612, United States

RECRUITING

VA Atlanta Healthcare System

Atlanta, Georgia, 30033, United States

RECRUITING

Hines VA Healthcare System

Chicago, Illinois, 60141, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Shannon Kehle-Forbes, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonya Norman, PhD

CONTACT

858-518-8266snorman@ucsd.edu

Kaitlyn Panza, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 6, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Will share data with Strong Star Repository.

Shared Documents
STUDY PROTOCOL
Time Frame
After study completion.
Access Criteria
Request to StrongStar Repository that Strong Star must approve.
More information

Locations

US(4)