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Active, Not Recruiting

NCT Number: NCT05265039

Exploring Mechanisms of Massed Cognitive Processing Therapy

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Denter

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

cognitive processing therapy

Behavioral

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

Relaxation Training

Behavioral

Guided relaxation

Primary outcomes

  1. Clinician-Administered PTSD Scale for DSM

    Time frame: Through study completion, an average of 8 months

    Clinician-Administered Assessment of PTSD

  2. PTSD Checklist for DSM-5 Criteria

    Time frame: Through study completion, an average of 8 months

    Self Report Measure for PTSD

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 3, 2022
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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