Evaluating Evidenced Based Options for PTSD Treatment

NCT ID: NCT06733376

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2030-06-01

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Initial Course of Cognitive Processing Therapy

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

Group Type: OTHER

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

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

Prolonged Exposure

Intervention Type: 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.

Skills Training for Affective and Interpersonal Regulation

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CPT; PE; STAIR

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Philip Held

Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Philip Held, PhD

Role: CONTACT

philip_held@rush.edu

312-942-1423

Sarah Pridgen, MA

Role: CONTACT

sarah_pridgen@rush.edu

312-563-0577

Facility Contacts

Held

Role: primary

philip_held@rush.edu

312-942-1442

Pridgen

Role: backup

sarah_pridgen@rush.edu

Other Identifiers

23091403

Identifier Type: -

Identifier Source: org_study_id