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Evaluating Evidenced Based Options for PTSD Treatment
NCT06733376 · Rush University Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
About this study
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.
Eligibility criteria
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 design
Enrollment target: 400 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-06
Estimated completion: 2030-06-01
Last updated: 2025-10-22
Interventions
Behavioral: Cognitive Processing TherapyBehavioral: Prolonged ExposureBehavioral: Skills Training for Affective and Interpersonal Regulation
Primary outcomes
- • PTSD Checklist for DSM-5 (PCL-5) (Baseline to 6 month follow up)
- • Clinician Administered PTSD Scale for DSM-5 (Baseline to 6 mont follow up)
Sponsor
Rush University Medical Center · other
Contacts & investigators
ContactPhilip Held, PhD · contact · philip_held@rush.edu · 312-942-1423
ContactSarah Pridgen, MA · contact · sarah_pridgen@rush.edu · 312-563-0577
All locations (1)
Rush University Medical CenterRecruiting
Chicago, Illinois, United States