Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD)

NCT ID: NCT06354361

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Goal Management Training (GMT) is a program designed to help improve cognitive functioning. For this study, researchers have worked closely with the developers of this program to create a modified version called Trauma-Informed Goal Management Training (TI-GMT), that is more sensitive to the needs of public safety personnel (PSP) diagnosed with Post-Traumatic Stress Disorder (PTSD).

The goal of this clinical trial is to find out how effective this modified, Trauma-Informed Goal Management Training program is for public safety personnel diagnosed with Post-Traumatic Stress Disorder, in comparison to the standard Goal Management Training program.

The main questions it aims to answer are:

1. Does Trauma-Informed Goal Management Training result in better neuropsychological functioning and greater reductions in the severity of PTSD symptoms when compared to standard Goal Management Training?
2. Does Trauma-Informed Goal Management Training result in self-reported improvements in cognitive functioning and the overall ability to function (including intent to return to work, and/or intent to stay at work, reductions in disability status, etc.) when compared to standard Goal Management Training?
3. Does Trauma-Informed Goal Management Training continue to benefit individuals three months after treatment?

Participants will:

* complete three separate assessments before starting the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* participate in a nine-week group treatment program (one day a week for two hours)
* complete three separate assessments after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires
* complete three separate assessments three months after completing the treatment - a clinical interview to evaluate symptoms, a cognitive assessment, and completing a set of questionnaires

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Traumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomised into two groups.

One group will receive nine sessions of Trauma-Informed Goal Management Training, and the other group will receive nine sessions of standard Goal Management Training.

Each group session will be 2 hours long, and offered virtually (using Zoom for Healthcare).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trauma-Informed GMT (TI-GMT; offered online)

Participants randomly assigned to the TI-GMT condition will be asked to attend nine weekly, 2-hour virtual group sessions of TI-GMT via Zoom for Healthcare, a PHIPA-compliant video conferencing platform. Each group will consist of 1 or 2 facilitators and up to 10 participants.

Group Type EXPERIMENTAL

Trauma-Informed Goal Management Training (TI-GMT)

Intervention Type BEHAVIORAL

Trauma Informed-Goal Management Training (TI-GMT) is a modified version of Goal Management Training (GMT), a cognitive remediation program that emphasises mindfulness and practice in planning and completing goal-oriented behaviours. TI-GMT enhances the standard GMT protocol with the addition of several trauma-informed adaptations and content that is sensitive and specific to public safety personnel with PTSD.

Participants are trained to interrupt ongoing disruptive behaviours through the resumption of executive control to help define goal hierarchies and monitor goal achievement. Mindfulness meditation helps develop attentional control and the skill of bringing one's mind to the present. Real-life examples are incorporated to illustrate goal attainment failures and successes, and participants practice solving complex, real-life tasks in sessions.

Sessions include instructional material, interactive tasks, discussion of real-life deficits, and homework/practice activities.

Standard GMT (GMT; offered online)

Participants randomly assigned to the GMT condition will be asked to attend nine weekly, 2-hour virtual group sessions of GMT via Zoom for Healthcare, a PHIPA-compliant video conferencing platform. Each group will consist of 1 or 2 facilitators and up to 10 participants.

Group Type ACTIVE_COMPARATOR

Goal Management Training (GMT)

Intervention Type BEHAVIORAL

Goal Management Training (GMT) is a cognitive remediation program that emphasises mindfulness and practice in planning and completing goal-oriented behaviours.

Participants are trained to interrupt ongoing disruptive behaviours through the resumption of executive control to help define goal hierarchies and monitor goal achievement. Mindfulness meditation helps develop attentional control and the skill of bringing one's mind to the present. Real-life examples are incorporated to illustrate goal attainment failures and successes, and participants practice solving complex, real-life tasks in sessions.

Sessions include instructional material, interactive tasks, discussion of real-life deficits, and homework/practice activities.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trauma-Informed Goal Management Training (TI-GMT)

Trauma Informed-Goal Management Training (TI-GMT) is a modified version of Goal Management Training (GMT), a cognitive remediation program that emphasises mindfulness and practice in planning and completing goal-oriented behaviours. TI-GMT enhances the standard GMT protocol with the addition of several trauma-informed adaptations and content that is sensitive and specific to public safety personnel with PTSD.

Participants are trained to interrupt ongoing disruptive behaviours through the resumption of executive control to help define goal hierarchies and monitor goal achievement. Mindfulness meditation helps develop attentional control and the skill of bringing one's mind to the present. Real-life examples are incorporated to illustrate goal attainment failures and successes, and participants practice solving complex, real-life tasks in sessions.

Sessions include instructional material, interactive tasks, discussion of real-life deficits, and homework/practice activities.

Intervention Type BEHAVIORAL

Goal Management Training (GMT)

Goal Management Training (GMT) is a cognitive remediation program that emphasises mindfulness and practice in planning and completing goal-oriented behaviours.

Participants are trained to interrupt ongoing disruptive behaviours through the resumption of executive control to help define goal hierarchies and monitor goal achievement. Mindfulness meditation helps develop attentional control and the skill of bringing one's mind to the present. Real-life examples are incorporated to illustrate goal attainment failures and successes, and participants practice solving complex, real-life tasks in sessions.

Sessions include instructional material, interactive tasks, discussion of real-life deficits, and homework/practice activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* be fluent in English
* reside in Ontario
* be public safety personnel (e.g. police officer, corrections officer, probation or parole officer, firefighter, search and rescue, paramedic, nurse, dispatcher)
* be able to provide written informed consent
* meet criteria on the PTSD Checklist for DSM-5 (PCL-5) for a provisional diagnosis of PTSD (cut-off score of \>30), administered during screening
* be able to attend regular online, 2-hour sessions once a week for 9 weeks, and be willing to complete the pre- and post- treatment assessments
* have access to a smart phone, tablet, or computer with a working microphone and camera, and have reliable and consistent internet

Exclusion Criteria

* daily or almost daily use of benzodiazepines
* daily or almost daily use of narcotics
* diagnosed with alcohol use disorder OR substance use disorder in the past 12 months
* meet criteria on the Mini-International Neuropsychiatric Interview (M.I.N.I.) for diagnosis of alcohol use disorder OR substance use disorder
* history of moderate-to-severe brain injury and/or loss of consciousness with prolonged effects that interfere with daily functioning at school, work, or family unit
* history of neurological disorder(s) that may impact ability to participate in the study
* diagnosis of psychotic disorder(s) or bipolar disorder(s)
* diagnosis of neurodevelopmental disorder(s) that may impact ability to participate in the study
* other conditions/impairments/considerations that may interfere with completion of study tasks
* previous participation in Goal Management Training
* receiving treatment with anti-cholinergic medication, anti-psychotic medication, or psychostimulants
* had electroconvulsive therapy (ECT) within the past year
* currently engaged in a trauma-specific intervention that may impact the findings of the current study such as Eye Movement Desensitization and Reprocessing (EMDR), Cognitive Processing Therapy (CPT), Prolonged Exposure (PE), etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Workplace Safety and Insurance Board

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margaret McKinnon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaret McKinnon, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mina Pichtikova, MA

Role: CONTACT

4169929496

Christina Chrysler, BA (Hons)

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

Boyd JE, O'Connor C, Protopopescu A, Jetly R, Rhind SG, Lanius RA, McKinnon MC. An Open-Label Feasibility Trial Examining the Effectiveness of a Cognitive Training Program, Goal Management Training, in Individuals With Posttraumatic Stress Disorder. Chronic Stress (Thousand Oaks). 2019 Apr 18;3:2470547019841599. doi: 10.1177/2470547019841599. eCollection 2019 Jan-Dec.

Reference Type BACKGROUND
PMID: 32440592 (View on PubMed)

Protopopescu A, O'Connor C, Cameron D, Boyd JE, Lanius RA, McKinnon MC. A Pilot Randomized Controlled Trial of Goal Management Training in Canadian Military Members, Veterans, and Public Safety Personnel Experiencing Post-Traumatic Stress Symptoms. Brain Sci. 2022 Mar 12;12(3):377. doi: 10.3390/brainsci12030377.

Reference Type BACKGROUND
PMID: 35326333 (View on PubMed)

Boyd JE, Sanger BD, Cameron DH, Protopopescu A, McCabe RE, O'Connor C, Lanius RA, McKinnon MC. A Pilot Study Assessing the Effects of Goal Management Training on Cognitive Functions among Individuals with Major Depressive Disorder and the Effect of Post-Traumatic Symptoms on Response to Intervention. Brain Sci. 2022 Jun 30;12(7):864. doi: 10.3390/brainsci12070864.

Reference Type BACKGROUND
PMID: 35884671 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17440

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Training for PTSD
NCT03316196 COMPLETED NA