Evaluating Evidenced Based Options for PTSD Treatment

Rush

Status: Enrolling

Conditions: PTSD - Post Traumatic Stress Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06733376

23091403

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Initial Course of Cognitive Processing Therapy

Other group

Description:

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

Treatment:

Behavioral: Cognitive Processing Therapy

Subsequent Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Prolonged Exposure

Behavioral: Cognitive Processing Therapy

Behavioral: Skills Training for Affective and Interpersonal Regulation