protocolSection identificationModule nctId: NCT06298279, orgStudyIdInfo id: 2023-436, briefTitle: Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Regina, class: OTHER, collaborators name: Government of Canada, descriptionModule briefSummary: This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources., conditionsModule conditions: Depression, conditions: Anxiety, conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Factor 1: Tunneled or Personalized Course Delivery Factor 2: Standard or Enhanced Social Learning Resources Participants will be randomly assigned to one of four treatment conditions (tunneled delivery of ICBT with standard resources, tunneled delivery of ICBT with enhanced social learning resources, personalized delivery ICBT with standard resources, personalized delivery of ICBT with enhanced social learning resources), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Participants cannot be blinded to condition because ICBT (like other psychotherapies) cannot be both provided to and concealed from a participant. However, the difference between the four conditions (i.e., presence or absence of social learning resources, tunneled versus personalized course navigation) will be concealed from all participants. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not applicable., enrollmentInfo count: 164, type: ESTIMATED, armsInterventionsModule interventions name: Tunneled Delivery, interventions name: Personalized Delivery, interventions name: Standard Resources, interventions name: Enhanced Social Learning Resources, interventions name: Transdiagnostic Self-Guided ICBT, outcomesModule primaryOutcomes measure: Generalized Anxiety Disorder 7-item (GAD-7), primaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), primaryOutcomes measure: PTSD Checklist for the DSM-5 (PCL-5), primaryOutcomes measure: Engagement, secondaryOutcomes measure: Work and Social Adjustment Scale (WSAS), secondaryOutcomes measure: Brief Resilience Scale (BRS), secondaryOutcomes measure: Healthcare Use Questionnaire, secondaryOutcomes measure: Case Story Questionnaire, secondaryOutcomes measure: Treatment Satisfaction Questionnaire, secondaryOutcomes measure: Digital Behavior Change Interventions Engagement Scale (DCBI), otherOutcomes measure: Post-treatment Semi-structured interview, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Psychology, University of Regina, city: Regina, state: Saskatchewan, zip: S4S 0A2, country: Canada, contacts name: Heather D Hadjistavropoulos, PhD, role: CONTACT, phone: 306-585-5133, email: heather.hadjistavropoulos@uregina.ca, contacts name: Caeleigh A Landry, MSc, role: CONTACT, phone: 306-337-2473, email: caeleigh.landry@uregina.ca, contacts name: Heather D Hadjistavropoulos, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.45008, lon: -104.6178, hasResults: False