Clinical trial NCT06298279: Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel
Official title: A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Stress Disorders, Post-Traumatic
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Government of Canada
First posted: 2024-03-07
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

As this is a factorial trial with two factors, each client will be randomized to one of four conditions:

Condition 1: Tunneled Delivery and Standard Resources Condition 2: Tunneled Delivery and Enhanced Social Learning Resources Condition 3: Personalized Delivery and Standard Resources Condition 4: Personalized Delivery and Enhanced Social Learning Resources

Randomization will occur within 2 business-days of completion of the screening questionnaires.

All participants will receive the Self-Guided PSP Wellbeing Course, a transdiagnostic internet intervention. The program is an adaptation of a previous Australian course, the Wellbeing Course. The course involved 5 lessons that are typically completed over an 8 week period, though participants will have access to the course materials for up to 26 weeks. The content is focused on cognitive behavior therapy and relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills). All participants are presented with worksheets at the end of each lesson that contain exercises that facilitate skill acquisition. Participants will be sent automatic emails reminding them to stay engaged with the lessons and to complete questionnaires. Participants will complete questionnaires at screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment).

Eligibility criteria: 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

Primary outcomes:
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
measure: PTSD Checklist for the DSM-5 (PCL-5)
timeFrame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
measure: Engagement
timeFrame: From date of enrollment to 26 weeks (post-treatment)
Secondary outcomes:
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
measure: Brief Resilience Scale (BRS)
timeFrame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
measure: Healthcare Use Questionnaire
timeFrame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
measure: Case Story Questionnaire
timeFrame: 8-weeks (post-treatment)
measure: Treatment Satisfaction Questionnaire
timeFrame: 8-weeks (post-treatment)
measure: Digital Behavior Change Interventions Engagement Scale (DCBI)
timeFrame: 8-weeks (post-treatment)
Other outcomes:
measure: Post-treatment Semi-structured interview
timeFrame: 8-10 weeks (post-treatment)
Locations:
city: Regina
country: Canada
facility: Department of Psychology, University of Regina
state: Saskatchewan
Study officials:
References: