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

NCT03998501 | Completed

• 1 other identifier: HS22895
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (3)

• PTSD resilience-related brain connectivity pattern scores

  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

  measure of resilience

  1 month

• Posttraumatic Checklist-5

  Symptoms of PTSD

  1 month

Study Arms (2)

Active

EXPERIMENTAL

5-week CBTm

Behavioral: Cognitive Behavioral Therapy with Mindfulness Class

Waitlisted

NO INTERVENTION

Waitlisted (will receive 5-week CBTm 3 months after).

Interventions

Cognitive Behavioral Therapy with Mindfulness Class BEHAVIORAL

The CBTm classes are five, 90-minute sessions focused on strategies to reduce symptoms of anxiety and depression.

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be enrolled in our on-going parallel study - "Cognitive Behaviour Therapy with Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial"

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Manitoba: lead
• University of Regina: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0J9, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: September 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)