Evaluating Evidenced Based Options for PTSD Treatment

Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders

This study will look at:

How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.

The goal is to improve personalized care by:

Identifying factors that might predict how someone will respond to a second treatment.

Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner.

The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.

Study Overview

• Status: Recruiting
• Conditions: PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy; Behavioral: Prolonged Exposure; Behavioral: Skills Training for Affective and Interpersonal Regulation

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Held, PhD; Phone Number: 312-942-1423; Email: philip_held@rush.edu
• Study Contact Backup: Name: Sarah Pridgen, MA; Phone Number: 312-563-0577; Email: sarah_pridgen@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Held; Phone Number: 312-942-1442; Email: philip_held@rush.edu
      • Contact: Pridgen; Email: sarah_pridgen@rush.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Are 18 years or older
• Are fluent in English
• Have experienced a Criterion A traumatic event during their lifetime
• Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
• Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)
• Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the course of the study

Exclusion Criteria:

• The index traumatic event occurred in the past month
• They are currently suicidal or homicidal (i.e., current plan and imminent intent)
• They have unmanaged psychosis or mania
• They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment
• They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)
• They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in treatment
• They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
• They have an active substance use disorder (within the past three months) that would require immediate medical observation if substance was abruptly discontinued
• They are involved with current legal actions related to their index trauma
• They have a visual or auditory impairment that would prevent them from fully participating in study activities
• They, at the time of consent, appear to have extenuating life circumstances (i.e., unstable housing, no internet access, etc.) which, in the judgement of the study team, could affect the ability to deliver interventions with fidelity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Initial Course of Cognitive Processing Therapy; All participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy.	Behavioral: Cognitive Processing Therapy; Cognitive Processing Therapy is a first-line intervention for the treatment of PTSD that focuses on changing unhelpful patterns of thinking.; Other Names: CPT
Active Comparator: Subsequent Treatment; At one-week follow up after initial Cognitive Processing Therapy, participants whose scores are 28 or above on the PTSD Checklist for DSM-5 will be offered a subsequent course of treatment.	Behavioral: Cognitive Processing Therapy; Cognitive Processing Therapy is a first-line intervention for the treatment of PTSD that focuses on changing unhelpful patterns of thinking.; Other Names: CPT; Behavioral: Prolonged Exposure; Prolonged Exposure is an evidence-based treatment for PTSD that helps to reduce the intensity of distress by gradually exposing participants to trauma-related memories, feelings, and situations in real life.; Other Names: PE; Behavioral: Skills Training for Affective and Interpersonal Regulation; Skills Training for Affective and Interpersonal Regulation (STAIR) is a evidence-based treatment geared towards helping regulate emotional and interpersonal needs of those with PTSD.; Other Names: STAIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5)	A self-report measure of PTSD symptom severity	Baseline to 6 month follow up
Clinician Administered PTSD Scale for DSM-5	A clinician-rated assessment of PTSD	Baseline to 6 mont follow up

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ptsd treatment
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Combat Disorders; 2-cyclohexylidenhydrazo-4-phenyl-thiazole
• Other Study ID Numbers: 23091403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No