Exploring Mechanisms of Massed Cognitive Processing Therapy

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265039
• Other study ID #: 21082701
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Cognitive Processing Therapy
An evidence-based treatment for posttraumatic stress disorder (PTSD)
• Relaxation Training
Guided relaxation

Locations

Country	Name	City	State
United States	Rush University Medical Denter	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale for DSM	Clinician-Administered Assessment of PTSD	Through study completion, an average of 8 months
Primary	PTSD Checklist for DSM-5 Criteria	Self Report Measure for PTSD	Through study completion, an average of 8 months