Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Initial Course of Cognitive Processing Therapy
All participants will start in Arm 1 where they receive 10-sessions of Cognitive Processing Therapy.
  • 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.
    Other names:
    • CPT
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.
  • 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.
    Other names:
    • CPT
  • 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.
    Other names:
    • PE
  • 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.
    Other names:
    • STAIR

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Rush University Medical Center

Study Contact

Philip Held, PhD
312-942-1423
philip_held@rush.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.