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Recruiting NCT06733376

Evaluating Evidenced Based Options for PTSD Treatment

No phase Interventional PTSD - Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Processing Therapy, Prolonged Exposure, Skills Training for Affective and Interpersonal Regulation.
Who it may be relevant to
Registry conditions: PTSD - Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT06733376 · 23091403

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗