Evaluating Evidenced Based Options for PTSD Treatment

NCT06733376 | Recruiting

• 1 other identifier: 23091403
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

ptsd treatment

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  A self-report measure of PTSD symptom severity

  Baseline to 6 month follow up

• Clinician Administered PTSD Scale for DSM-5

  A clinician-rated assessment of PTSD

  Baseline to 6 mont follow up

Study Arms (2)

Initial Course of Cognitive Processing Therapy

OTHER

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

Behavioral: Cognitive Processing Therapy

Subsequent Treatment

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy; Behavioral: Prolonged Exposure; Behavioral: Skills Training for Affective and Interpersonal Regulation

Interventions

Cognitive Processing Therapy BEHAVIORAL

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

Also known as: CPT

Initial Course of Cognitive Processing Therapy; Subsequent Treatment

Prolonged Exposure BEHAVIORAL

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.

Also known as: PE

Subsequent Treatment

Skills Training for Affective and Interpersonal Regulation BEHAVIORAL

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.

Also known as: STAIR

Subsequent Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Combat Disorders

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Philip Held, PhD

CONTACT

312-942-1423; philip_held@rush.edu

Sarah Pridgen, MA

CONTACT

312-563-0577; sarah_pridgen@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)