Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06733376

Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders

Led by Rush University Medical Center · Updated on 2025-10-22

400

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to improve treatment options for people with PTSD who did not respond to their first therapy. It evaluates how practical it is to offer another round of proven therapy and compares different therapy options for those who did not improve initially. The goal is to better personalize care by identifying factors that predict treatment response and creating a simple tool to identify non-responders early, helping patients start alternative treatments sooner. All participants begin with 10 sessions of Cognitive Processing Therapy, a behavioral treatment focused on changing unhelpful thinking patterns. One week after completing this therapy, participants with higher PTSD symptom scores will be offered an additional course of treatment, which may include more sessions of Cognitive Processing Therapy, Prolonged Exposure therapy, or Skills Training for Affective and Interpersonal Regulation (STAIR). These therapies are also behavioral treatments aimed at reducing distress and improving emotional regulation. Participants will be involved in therapy sessions and will complete self-report and clinician assessments at multiple points during the study. The main outcomes measured include changes in PTSD symptoms from baseline to six months using the PTSD Checklist for DSM-5 and the Clinician Administered PTSD Scale for DSM-5. Researchers will monitor participants' progress and symptom changes to evaluate the effectiveness of these therapy options and improve personalized PTSD care. The study is scheduled to continue until June 2030.

CONDITIONS

Brief Title

Evaluating Evidenced Based Options for PTSD Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 2 weeks
  • Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the study
Not Eligible

You will not qualify if you...

  • The index traumatic event occurred in the past month
  • Currently suicidal or homicidal with a plan and imminent intent
  • Have unmanaged psychosis or mania
  • Not on a stable dose of psychotropic medication for at least one month at baseline
  • Completed or currently engaged in evidence-based cognitive behavioral PTSD treatment in the past three months
  • Have intellectual disability or significant cognitive impairment preventing treatment engagement
  • Have serious or unstable medical illness likely requiring hospitalization within a year
  • Active substance use disorder within past three months requiring medical observation if stopped
  • Involved with current legal actions related to index trauma
  • Visual or auditory impairments preventing full participation
  • Extenuating life circumstances affecting intervention delivery (e.g., unstable housing, no internet)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Initial Course of Cognitive Processing Therapy

Duration - 2 weeks

Participants receive 10 sessions of Cognitive Processing Therapy over approximately 2 weeks to address PTSD symptoms.

10 therapy sessions

Subsequent Treatment

Duration - Varies based on treatment course

Participants with significant PTSD symptoms one week after the initial therapy are offered an additional course of treatment, which may include Prolonged Exposure or Skills Training for Affective and Interpersonal Regulation.

Follow-up visit 1 week after initial therapy; additional sessions depending on treatment

Trial Site Locations

Total: 1 location

1

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

P

Philip Held, PhD

S

Sarah Pridgen, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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