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Evaluating Evidenced Based Options for PTSD Treatment

Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06733376
Enrollment
400
Registered
2024-12-13
Start date
2025-10-06
Completion date
2030-06-01
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

ptsd treatment

Brief summary

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.

Interventions

BEHAVIORALCognitive Processing Therapy

Cognitive Processing Therapy is a first-line intervention for the treatment of PTSD that focuses on changing unhelpful patterns of thinking.

BEHAVIORALProlonged 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.

BEHAVIORALSkills 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.

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for DSM-5 (PCL-5)Baseline to 6 month follow upA self-report measure of PTSD symptom severity
Clinician Administered PTSD Scale for DSM-5Baseline to 6 mont follow upA clinician-rated assessment of PTSD

Countries

United States

Contacts

Primary ContactPhilip Held, PhD
philip_held@rush.edu312-942-1423
Backup ContactSarah Pridgen, MA
sarah_pridgen@rush.edu312-563-0577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026