A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Regina
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- Patient Health Questionnaire-9 (PHQ-9)
Study Overview
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.
Detailed Description
Background---- Public Safety Personnel (PSP) are at an increased risk of developing mental disorders. PSP also face many barriers to accessing mental health services (e.g., stigma, location, time). The PSP Wellbeing Course is a transdiagnostic internet-delivered cognitive behaviour therapy (ICBT) course that has been specifically tailored to PSP. The effectiveness of the therapist-guided course and a self-guided course have both been supported. Consistent with the larger literature on self-guided ICBT, engagement with and outcomes of the self-guided PSP Wellbeing Course could be strengthened. Persuasive design describes using technology to influence human behaviour. The current study is designed to assess the impact of different timing options (i.e., tunneled vs. personalized) and increased social learning (i.e., standard versus enhanced social learning) on user experience, adherence, and outcomes in ICBT.
Methods--- Participants will be recruited via posts on the PSPNET social media platforms (i.e., Twitter and Facebook) and emails distributed by PSP organizations. Members of the PSPNET team will also reach out to contacts within PSP organizations to ask them to tell their colleagues about the proposed research. All interested participants will be directed to the study website (www.pspnet.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), information about depression and other mental health issues, and background information (e.g., medical history, mental health history, symptoms).
After completing the questionnaires, participant responses will be reviewed by PSP staff for eligibility. Clients who are eligible will be randomized into one of four conditions. Participants who do not meet criteria, but are over the age of 18, will not be randomized and will instead be enrolled into the "treatment-as-usual" version of the course, which consists of a tunneled delivery and standard resources. Ineligible participants' data will not be included in analyses. Individuals under the age of 18 will not be eligible for any services.The two factors in the trial are:
Factor 1: Tunneled course delivery or personalized course delivery
Factor 2: Standard or enhanced social learning resources.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Tunneled Delivery/Standard Resources
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.
Intervention: Tunneled Delivery (Behavioral)
Tunneled Delivery/Standard Resources
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.
Intervention: Standard Resources (Behavioral)
Tunneled Delivery/Standard Resources
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.
Intervention: Transdiagnostic Self-Guided ICBT (Behavioral)
Tunneled Delivery/Enhanced Social Learning Resources
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.
Intervention: Tunneled Delivery (Behavioral)
Tunneled Delivery/Enhanced Social Learning Resources
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.
Intervention: Enhanced Social Learning Resources (Behavioral)
Tunneled Delivery/Enhanced Social Learning Resources
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.
Intervention: Transdiagnostic Self-Guided ICBT (Behavioral)
Personalized Delivery/Standard Resources
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.
Intervention: Personalized Delivery (Behavioral)
Personalized Delivery/Standard Resources
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.
Intervention: Standard Resources (Behavioral)
Personalized Delivery/Standard Resources
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.
Intervention: Transdiagnostic Self-Guided ICBT (Behavioral)
Personalized Delivery/Enhanced Social Learning Resources
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.
Intervention: Personalized Delivery (Behavioral)
Personalized Delivery/Enhanced Social Learning Resources
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.
Intervention: Enhanced Social Learning Resources (Behavioral)
Personalized Delivery/Enhanced Social Learning Resources
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.
Intervention: Transdiagnostic Self-Guided ICBT (Behavioral)
Outcomes
Primary Outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome)
PTSD Checklist for the DSM-5 (PCL-5)
Time Frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total PCL-5 score which can range from 0 to 80. Higher scores indicate greater posttraumatic stress symptoms (worse outcome)
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome)
Engagement
Time Frame: From date of enrollment to 26 weeks (post-treatment)
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.
Secondary Outcomes
- Brief Resilience Scale (BRS)(Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment))
- Digital Behavior Change Interventions Engagement Scale (DCBI)(8-weeks (post-treatment))
- Healthcare Use Questionnaire(Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment))
- Work and Social Adjustment Scale (WSAS)(Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment))
- Case Story Questionnaire(8-weeks (post-treatment))
- Treatment Satisfaction Questionnaire(8-weeks (post-treatment))