fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD
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|ClinicalTrials.gov Identifier: NCT03998501|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2019
Last Update Posted : April 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Cognitive Behavioral Therapy with Mindfulness Class||Not Applicable|
Our ultimate research goal is to develop and validate a preventive strategy for PTSD. We aim to 1) demonstrate neurophysiological evidence (using fMRI) of preventive CBTm classes for PTSD, and 2) validate the utility of the proposed imaging-based biomarker for PTSD-related resiliency. Emerging evidence suggests that a program such as CBTm classes could promote resiliency to PTSD in healthy individuals at high risk for trauma exposure. Further, our preliminary brain imaging data analysis suggests that we can quantitate the brain connectivity pattern that may reflect resilience to PTSD. We thus hypothesize that CBTm will increase the PTSD resilience-related brain connectivity pattern expression.
In this novel pilot imaging study, we will recruit 40 PSP without PTSD or other mental disorder from 120 participants participating in our larger clinical trial. Twenty will be from each arm (CBTm and wait-list). The effect of CBTm on fMRI-based measures will be compared between arms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||20 participants will receive 5-week CBTm intervention. The other 20 participants will be waitlisted, but they will undergo the same assessment at the same time. Assessment including MRI will be done before and after 5-week intervention and 3 months after.|
|Masking:||None (Open Label)|
|Official Title:||Do Cognitive Behavioral Therapy Skills Classes Increase a Resiliency-related Brain Connectivity Pattern to Posttraumatic Stress Disorder?|
|Actual Study Start Date :||September 1, 2019|
|Actual Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2023|
Behavioral: Cognitive Behavioral Therapy with Mindfulness Class
The CBTm classes are five, 90-minute sessions focused on strategies to reduce symptoms of anxiety and depression.
No Intervention: Waitlisted
Waitlisted (will receive 5-week CBTm 3 months after).
- PTSD resilience-related brain connectivity pattern scores [ Time Frame: 1 hour ]fMRI-based graph theory pattern that was highly expressed in trauma-exposed control compared to PTSD and normal control. This method has not been published yet. The higher score are considered to be a better outcome (more resilience). It is a z-scored to the normal control dataset.
- Posttraumatic Checklist-5 [ Time Frame: 1 month ]Symptoms of PTSD
- Connor-Davidson Resilience Scale [ Time Frame: 1 month ]measure of resilience
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998501
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R3E 0J9|