Clinical trial NCT05265039: Exploring Mechanisms of Massed Cognitive Processing Therapy
Official title: Exploring Mechanisms of Massed Cognitive Processing Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PTSD
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM
timeFrame: Through study completion, an average of 8 months
measure: PTSD Checklist for DSM-5 Criteria
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Denter
state: Illinois
Study officials:
References: