Clinical trial NCT06733376: Evaluating Evidenced Based Options for PTSD Treatment
Official title: Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD - Post Traumatic Stress Disorder
Keywords: ptsd treatment
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline to 6 month follow up
measure: Clinician Administered PTSD Scale for DSM-5
timeFrame: Baseline to 6 mont follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: