Exploring Mechanisms of Massed Cognitive Processing Therapy

Exploring Mechanisms of Massed Cognitive Processing Therapy: A Randomized Controlled Trial

The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Specifically, this study is designed to 1) examine changes in PTSD symptoms during and following the respective intervention, and 2) explore possible psychological treatment mechanisms, including cognitive control, inhibition, self-efficacy, and memory, and 3) examine possible moderators of treatment success (e.g. neuropsychological factors).

Study Overview

• Status: Active, not recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Cognitive Processing Therapy; Behavioral: Relaxation Training

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Denter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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
• Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend either 10 therapy sessions over the course of one week (5 days) or are interested and able to complete 5 relaxation training sessions over the course of one week (5 days)
• Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
• Reside in the state of Illinois during the course of treatment

Exclusion Criteria:

1. The traumatic event occurred in the past month
2. They are currently suicidal or homicidal (i.e., plan and intent)
3. They have unmanaged psychosis or mania
4. They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment
5. They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
6. They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT
7. They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
8. They have an active substance use disorder (within the past 3 months) that would require immediate medical observation if substance use was discontinued (i.e., potential lethality)
9. They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
10. They have a visual or auditory impairment that would prevent them from fully participating in study activities
11. Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Processing Therapy (CPT)	Behavioral: Cognitive Processing Therapy; An evidence-based treatment for posttraumatic stress disorder (PTSD)
Active Comparator: Relaxation Training (RT)	Behavioral: Relaxation Training; Guided relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Administered PTSD Scale for DSM	Clinician-Administered Assessment of PTSD	Through study completion, an average of 8 months
PTSD Checklist for DSM-5 Criteria	Self Report Measure for PTSD	Through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): September 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Therapeutics; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Relaxation Therapy
• Other Study ID Numbers: 21082701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No