Evaluating Evidenced Based Options for PTSD Treatment
Key facts
- Who runs it
- Rush University Medical Center
- Where
- Chicago, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 6 Oct 2025
- Expected to end
- 1 Jun 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cognitive Processing Therapy
- Prolonged Exposure
- Skills Training for Affective and Interpersonal Regulation
- Record updated
- 28 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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 have a visual or auditory impairment that would prevent them from fully participating in study activities
- 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 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 are involved with current legal actions related to their index trauma
- 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
Where in United States
- Rush University Medical CenterChicago, United StatesContact: HeldTaking people
About the trial
What the trial wants to find out
This study will look at:
Read full original descriptionShow less
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.
The 2 groups in the trial
- Initial Course of Cognitive Processing TherapyOther group
All participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy.
Treatment: Cognitive Processing Therapy
- Subsequent TreatmentExisting treatment, for comparison
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.
Treatment: Cognitive Processing Therapy, Prolonged Exposure, and Skills Training for Affective and Interpersonal Regulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
- Publications
- Evaluating evidence based options for initial PTSD treatment non-response: A randomized controlled trial protocol.Contemporary clinical trials communications, 2026
- Record updated
- 28 October 2026