Exploring Mechanisms of Massed Cognitive Processing Therapy

NCT05265039 | Active Not Recruiting

• 1 other identifier: 21082701
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

PTSD

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cognitive Processing Therapy (CPT)

EXPERIMENTAL

Behavioral: Cognitive Processing Therapy

Relaxation Training (RT)

ACTIVE COMPARATOR

Behavioral: Relaxation Training

Interventions

Cognitive Processing Therapy BEHAVIORAL

An evidence-based treatment for posttraumatic stress disorder (PTSD)

Cognitive Processing Therapy (CPT)

Relaxation Training BEHAVIORAL

Guided relaxation

Relaxation Training (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The traumatic event occurred in the past month
• They are currently suicidal or homicidal (i.e., plan and intent)
• They have unmanaged psychosis or mania
• They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment
• 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
• They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT
• 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 3 months) that would require immediate medical observation if substance use was discontinued (i.e., potential lethality)
• They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
• They have a visual or auditory impairment that would prevent them from fully participating in study activities
• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Denter

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 3, 2022
• Study Start: April 26, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)