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Recruiting

NCT Number: NCT06733376

Evaluating Evidenced Based Options for PTSD Treatment

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CPT

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.

Other names: PE

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.

Other names: STAIR

Primary outcomes

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

    Time frame: Baseline to 6 month follow up

    A self-report measure of PTSD symptom severity

  2. Clinician Administered PTSD Scale for DSM-5

    Time frame: Baseline to 6 mont follow up

    A clinician-rated assessment of PTSD

Study contacts

Contact information is provided by the study sponsor or research team.

Philip Held, PhD

CONTACT

[email protected]

312-942-1423

Sarah Pridgen, MA

CONTACT

[email protected]

312-563-0577

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Dec 13, 2024
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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