Recruiting

PTSD Treatment

Sponsor:

Rush University Medical Center

Code:

NCT06733376

Conditions

PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Processing Therapy

Prolonged Exposure

Skills Training for Affective and Interpersonal Regulation

Study Details

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.

Conditions

PTSD - Post Traumatic Stress Disorder

Study ID

NCT06733376

Start date

Oct 6, 2025

Status verified date

Oct, 2025

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Initial Course of Cognitive Processing Therapy

All participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy.

active comparator: Subsequent Treatment

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.

Interventions

Cognitive Processing Therapy

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

Prolonged 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.

Skills 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.

Primary outcome measure

  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline to 6 month follow up ]
  • Clinician Administered PTSD Scale for DSM-5 [ Time Frame: Baseline to 6 mont follow up ]

Central Contacts and Locations

Central contacts

Philip Held, PhD

312-942-1423philip_held@rush.edu

Sarah Pridgen, MA

312-563-0577sarah_pridgen@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Held

312-942-1442philip_held@rush.edu

Pridgen

sarah_pridgen@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • ptsd treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-10-22.