Stress Disorders, Post-TraumaticNCT03998501
fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD
A study testing Cognitive Behavioral Therapy with Mindfulness Class in people with Stress Disorders, Post-Traumatic, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Cognitive Behavioral Therapy with Mindfulness Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be enrolled in our on-going parallel study - "Cognitive Behaviour Therapy with Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial"
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Cognitive Behavioral Therapy Skills Classes Increase a Resiliency-related Brain Connectivity Pattern to Posttraumatic Stress Disorder?
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Cognitive Behavioral Therapy with Mindfulness Class
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy with Mindfulness ClassBehavioural
The CBTm classes are five, 90-minute sessions focused on strategies to reduce symptoms of anxiety and depression.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 5-week CBTm Receives: Behavioral: Cognitive Behavioral Therapy with Mindfulness Class |
| Waitlisted | No intervention | Waitlisted (will receive 5-week CBTm 3 months after). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Connor-Davidson Resilience Scale
measure of resilience
Measured: 1 month
Posttraumatic Checklist-5
Symptoms of PTSD
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regina
- Responsible party
- Principal investigator, Ji Hyun Ko, PhD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998501
- Sponsor's protocol ID
- HS22895
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Cognitive Behavioral Therapy Skills Classes Increase a Resiliency-related Brain Connectivity Pattern to Posttraumatic Stress Disorder?
- ClinicalTrials.gov ID
- NCT03998501
- Acronym / sponsor ID
- HS22895
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Regina
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Cognitive Behavioral Therapy with Mindfulness Class5-week CBTm |
| Waitlisted | No intervention | –Waitlisted (will receive 5-week CBTm 3 months after). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be enrolled in our on-going parallel study - "Cognitive Behaviour Therapy with Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial"
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy with Mindfulness ClassThe CBTm classes are five, 90-minute sessions focused on strategies to reduce symptoms of anxiety and depression. | Behavioural | Active |
Primary outcome
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.
Connor-Davidson Resilience Scale
Time frame: 1 month
measure of resilience
Posttraumatic Checklist-5
Time frame: 1 month
Symptoms of PTSD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy with Mindfulness Class in people with Stress Disorders, Post-Traumatic, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD resilience-related brain connectivity pattern scores (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.