Trying proven PTSD therapies again or switching approaches when the first treatment doesn't work
Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
NA · Rush University Medical Center · NCT06733376
This study will test whether offering a second round of proven therapies or switching to a different therapy helps adults with PTSD who did not get better after their first treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06733376 on ClinicalTrials.gov |
What this trial studies
Adults with clinician-confirmed PTSD receive an initial course of evidence-based therapy delivered as 10 sessions over two weeks; people who do not respond may be offered an additional 10 sessions of Cognitive Processing Therapy (CPT), Prolonged Exposure (PE), or Skills Training for Affective and Interpersonal Regulation (STAIR). The study collects self-report measures and clinician-rated assessments at multiple timepoints to track symptoms and treatment response. Researchers will look for clinical, demographic, or symptom-pattern factors that predict who is unlikely to respond to the first treatment and use those factors to create a simple tool to identify probable non-responders earlier. The approach is intended to improve follow-up care by matching patients to the therapy most likely to help them when the first approach fails.
Who should consider this trial
Good fit: Adults (18+) with a CAPS-5–confirmed PTSD diagnosis who speak English, can attend an intensive 10-session treatment over two weeks, and are willing to complete repeated self-report and clinician assessments are ideal candidates.
Not a fit: People with a traumatic event within the past month, current suicidal or homicidal intent, unmanaged psychosis or mania, or unstable psychotropic medication are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could help people with PTSD get to a more effective treatment faster by identifying who needs a different approach and guiding which second-line therapy to try.
How similar studies have performed: CPT, PE, and STAIR are each supported by prior trials for PTSD, but systematic trials of planned second-line switching and simple early prediction tools are much less common.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Philip Held, PhD
- Email: philip_held@rush.edu
- Phone: 312-942-1423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PTSD - Post Traumatic Stress Disorder, ptsd treatment