- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998501
fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD
Do Cognitive Behavioral Therapy Skills Classes Increase a Resiliency-related Brain Connectivity Pattern to Posttraumatic Stress Disorder?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0J9
- University of Manitoba
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be enrolled in our on-going parallel study - "Cognitive Behaviour Therapy with Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial"
Exclusion Criteria:
- if they have received psychological or medication treatment for a mental disorder in the past 6 months or if they score above the clinical cutoff on the following self-report symptom measures: Posttraumatic Checklist-5 (PCL-5) score >37; Patient Health Questionnaire-9 (PHQ-9) score (depression) >10, Generalized Anxiety Disorder-7 (GAD-7) score >7, and the presence of suicidal ideation in the past six months. Individuals falling below these cutoff scores will receive further diagnostic assessment by a supervised PhD graduate student in Clinical Psychology. Those meeting criteria for PTSD or other mental disorder in the past 12 months as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) or the Mini International Neuropsychiatric Interview (MINI v.7.0.2) will also be excluded. Finally, we will exclude individuals with any contraindication to MRI (e.g., claustrophobia and metal implants).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
5-week CBTm
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour
|
Connor-Davidson Resilience Scale
Time Frame: 1 month
|
measure of resilience
|
1 month
|
Posttraumatic Checklist-5
Time Frame: 1 month
|
Symptoms of PTSD
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS22895
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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