Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel

NCT06298279 | Recruiting

• 1 other identifier: 2023-436
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (4)

• Generalized Anxiety Disorder 7-item (GAD-7)

  Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome)

  Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)

• Patient Health Questionnaire-9 (PHQ-9)

  Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome)

  Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)

• PTSD Checklist for the DSM-5 (PCL-5)

  Change in total PCL-5 score which can range from 0 to 80. Higher scores indicate greater posttraumatic stress symptoms (worse outcome)

  Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)

• Engagement

  Internal portal recordings of participant how many lessons participants accessed, how many additional resources were accessed, and the dates of access. Greater course access is indicative of greater engagement within the course.

  From date of enrollment to 26 weeks (post-treatment)

Secondary Outcomes (6)

• Work and Social Adjustment Scale (WSAS)

  Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)

• Brief Resilience Scale (BRS)

  Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)

• Healthcare Use Questionnaire

  Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)

• Case Story Questionnaire

  8-weeks (post-treatment)

• Treatment Satisfaction Questionnaire

  8-weeks (post-treatment)

Other Outcomes (1)

• Post-treatment Semi-structured interview

  8-10 weeks (post-treatment)

Study Arms (4)

Tunneled Delivery/Standard Resources

EXPERIMENTAL

In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the standard resources will be presented with resources that are typically presented in PSPNET courses. This includes lesson slides case stories, do-it yourself guides, and frequently asked questions pages.

Behavioral: Tunneled Delivery; Behavioral: Standard Resources; Behavioral: Transdiagnostic Self-Guided ICBT

Tunneled Delivery/Enhanced Social Learning Resources

EXPERIMENTAL

In this arm, participants will be guided through the Self-Guided PSP Wellbeing Course in a predetermined order and using predetermined timing. Future lessons will "unlock" as previous lessons are completed. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course.

Behavioral: Tunneled Delivery; Behavioral: Enhanced Social Learning Resources; Behavioral: Transdiagnostic Self-Guided ICBT

Personalized Delivery/Standard Resources

EXPERIMENTAL

In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the standard resources will be presented with resources that are typically presented in the course. This includes lesson slides, case stories, do-it yourself guides, and frequently asked questions pages.

Behavioral: Personalized Delivery; Behavioral: Standard Resources; Behavioral: Transdiagnostic Self-Guided ICBT

Personalized Delivery/Enhanced Social Learning Resources

EXPERIMENTAL

In this arm, participants will be able to navigate through the course modules in whichever order and at whatever pace they like. Participants will not have to complete one lesson in order to gain access to the following lesson. Participants receiving the enhanced social learning resources will receive the same resources offered in the standard conditions (i.e., lesson slides, case stories, do-it-yourself guides, and frequently asked questions pages) and will also receive additional resources. Additional resources will include homework records to accompany the case stories, de-identified quotations from previous clients for each lesson, and a motivational video encouraging them to engage with the course.

Behavioral: Personalized Delivery; Behavioral: Enhanced Social Learning Resources; Behavioral: Transdiagnostic Self-Guided ICBT

Interventions

Tunneled Delivery BEHAVIORAL

Participants will be offered a pre-determined pathway to completing the 8-week course

Tunneled Delivery/Enhanced Social Learning Resources; Tunneled Delivery/Standard Resources

Personalized Delivery BEHAVIORAL

Participants will be able to complete course modules at their own pace and in the order that most interests them.

Personalized Delivery/Enhanced Social Learning Resources; Personalized Delivery/Standard Resources

Standard Resources BEHAVIORAL

Participants will receive the resources as typically included in the Self-Guided PSP Wellbeing Course.

Personalized Delivery/Standard Resources; Tunneled Delivery/Standard Resources

Enhanced Social Learning Resources BEHAVIORAL

Participants will receive additional intervention content.

Personalized Delivery/Enhanced Social Learning Resources; Tunneled Delivery/Enhanced Social Learning Resources

Transdiagnostic Self-Guided ICBT BEHAVIORAL

An ICBT course that is completed without the guidance of a therapist.

Personalized Delivery/Enhanced Social Learning Resources; Personalized Delivery/Standard Resources; Tunneled Delivery/Enhanced Social Learning Resources; Tunneled Delivery/Standard Resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Current or former public safety personnel (or public safety personnel trainee)
• Residing in Canada at time of enrollment
• Has regular access to the internet
• Confirms intent to participate in study

You may not qualify if:

• Not 18 years of age or older
• Not a current or former public safety personnel (or public safety personnel trainee)
• Not residing in Canada at time of enrollment
• Does not have regular access to the internet

Sponsors & Collaborators

• University of Regina: lead
• Government of Canada: collaborator

Study Sites (1)

Department of Psychology, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Heather D Hadjistavropoulos, PhD

CONTACT

(306)585-5133; heather.hadjistavropoulos@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 7, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)