Clinical trial NCT06354361: Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD)
Official title: A Randomized Control Trial Examining the Efficacy of a Novel, Trauma-informed Approach to Cognitive Remediation (Goal Management Training) in Public Safety Personnel With Post-traumatic Stress Disorder (PTSD) and Co-morbid Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Goal Management Training (GMT)
Trauma-Informed Goal Management Training (TI-GMT)
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Workplace Safety and Insurance Board
First posted: 2024-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria - participants must:

* 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.

Primary outcomes:
measure: Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('CAPS-5') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
Secondary outcomes:
measure: Demographic Information
timeFrame: Collected at baseline only
measure: Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline
timeFrame: Administered at baseline only
measure: Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline
timeFrame: Administered at baseline only
measure: Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline
timeFrame: Administered at baseline only
measure: Change from baseline in scores on the Mini International Neuropsychiatric Interview 7.0.2 ('M.I.N.I.') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the California Verbal Learning Test (CVLT-3) at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on selected neuropsychological assessment measures of Visuospatial and Visuoconstructive Ability and Sensorimotor integration at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in score on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('PCL-5') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel ('MIA-PSP') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the Return to work Obstacles and Coping Efficacy - Common Mental Disorders ('ROSES-CMD') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
measure: Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up
timeFrame: Baseline, post-intervention at 9 weeks, and 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Margaret McKinnon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.