Evaluating Evidenced Based Options for PTSD Treatment

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06733376
Status
Recruiting

Conditions

  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Oct 2025
Primary completion
Jun 1, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Initial Course of Cognitive Processing Therapy
    All participants will start in Arm 1 where they receive 10-sessions of 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.

Primary Outcome Measure

PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline to 6 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Held
312-942-1442

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