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RecruitingNCT06733376Updated Oct 22, 2025

Evaluating Evidenced Based Options for PTSD Treatment

An interventional study of Cognitive Processing Therapy and Prolonged Exposure in PTSD - Post Traumatic Stress Disorder, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-22.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • PTSD - Post Traumatic Stress Disorder

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Keywords

  • ptsd treatment
03

In context

Combat Disorders

135 studies on the registry are indexed under Combat Disorders; 70 are open to participants now.

This study's planned enrollment of 400 is above the median of 76 across 113 interventional studies indexed under Combat Disorders.

Browse Combat Disorders studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Other
    Initial Course of Cognitive Processing Therapy

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

    Behavioral: 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.

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

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.

    Also known as: CPT

  • 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.

    Also known as: PE

  • 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.

    Also known as: STAIR

06

What researchers measure

Primary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5)

    A self-report measure of PTSD symptom severity

    Time frame: Baseline to 6 month follow up

  2. Clinician Administered PTSD Scale for DSM-5

    A clinician-rated assessment of PTSD

    Time frame: Baseline to 6 mont follow up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06733376
Lead sponsor
Rush University Medical Center
Responsible party
Philip Held (Research Director, Rush University Medical Center) — Principal investigator
First posted
Dec 13, 2024
Start date
Oct 6, 2025
Primary completion
Jun 1, 2029 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Oct 22, 2025

Study contacts

Philip Held, PhD
Contact
philip_held@rush.edu
312-942-1423
Sarah Pridgen, MA
Contact
sarah_pridgen@rush.edu
312-563-0577

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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