protocolSection identificationModule nctId: NCT06354361, orgStudyIdInfo id: 17440, briefTitle: Trauma-Informed Goal Management Training for Public Safety Personnel (PSP) With Post-traumatic Stress Disorder (PTSD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Workplace Safety and Insurance Board, descriptionModule briefSummary: 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, conditionsModule conditions: Post-Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Trauma-Informed Goal Management Training (TI-GMT), interventions name: Goal Management Training (GMT), outcomesModule primaryOutcomes 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, primaryOutcomes measure: Change from baseline in scores on the Sustained Attention Response Task ('SART') subtest of the Creyos Battery at post-intervention and follow-up, secondaryOutcomes measure: Demographic Information, secondaryOutcomes measure: Scores on the Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders-5th Edition ('LEC-5') at baseline, secondaryOutcomes measure: Scores on the Childhood Trauma Questionnaire ('CTQ') at baseline, secondaryOutcomes measure: Scores on the Advanced Clinical Solutions ('ACS') Test of Premorbid Functioning ('TOPF') at baseline, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Executive functioning, Processing speed and Attention at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Declarative memory at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Intellectual functioning at post-intervention and follow-up, secondaryOutcomes 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, secondaryOutcomes 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, secondaryOutcomes measure: Change from baseline in scores on selected neuropsychological assessment measures of Visual and Visuospatial Working Memory at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Depression and Anxiety Stress Scale ('DASS-21') at post-intervention and follow-up, secondaryOutcomes 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, secondaryOutcomes measure: Change from baseline in score on the Multiscale Dissociation Inventory ('MDI') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Difficulties in Emotion Regulation Scale ('DERS') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the twenty-item Toronto Alexithymia Scale ('TAS-20') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in score on the Moral Injury Assessment for Public Safety Personnel ('MIA-PSP') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Cognitive Failures Questionnaire 2.0 ('CFQ 2.0') at post-intervention and follow-up, secondaryOutcomes 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, secondaryOutcomes measure: Change from baseline in scores on the World Health Organization's Disability Assessment Schedule ('WHODAS 2.0') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Lam Employment Absence and Productivity Scale ('LEAPS') at post-intervention and follow-up, secondaryOutcomes measure: Change from baseline in scores on the Survey of Perceived Organizational Support ('SPOS') at post-intervention and follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False