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Trial record 2 of 4 for:    PTSD | Winnipeg, Canada

fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD

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ClinicalTrials.gov Identifier: NCT03998501
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
University of Regina
Information provided by (Responsible Party):
Ji Hyun Ko, PhD, University of Manitoba

Brief Summary:
A substantial proportion of public safety personnel (PSP) develop service-related posttraumatic stress disorder (PTSD). PTSD is associated with a range of negative outcomes and its exact underlying neurophysiological mechanism is still not well understood. Cognitive behavioral therapy (CBT) is commonly prescribed to treat PTSD, and recent studies suggest that it may be effective in preventing the condition. We have developed a 5-session class focused on teaching introductory CBT skills to prevent and manage psychological distress, and we are currently in the process of launching a clinical trial to demonstrate its effectiveness in preventing PTSD and related conditions in PSP. In the proposed adjunctive study to this trial, we will quantitate the brain connectivity signature that is specific to the PTSD-resilience, and examine whether the classes increase this resilience-related brain mechanism.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Cognitive Behavioral Therapy with Mindfulness Class Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
5-week CBTm
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).



Primary Outcome Measures :
  1. 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.

  2. Posttraumatic Checklist-5 [ Time Frame: 1 month ]
    Symptoms of PTSD

  3. Connor-Davidson Resilience Scale [ Time Frame: 1 month ]
    measure of resilience



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

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


Locations
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Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0J9
Contact: Ji Hyun Ko, PhD    204-318-2566    ji.ko@umanitoba.ca   
Sponsors and Collaborators
University of Manitoba
University of Regina
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Responsible Party: Ji Hyun Ko, PhD, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT03998501    
Other Study ID Numbers: HS22895
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders