Department of Psychology, University of Regina
Regina, Saskatchewan, S4S 0A2, Canada
Location status: Recruiting
NCT Number: NCT06298279
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Regina, Saskatchewan, S4S 0A2, Canada
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be offered a pre-determined pathway to completing the 8-week course
Participants will be able to complete course modules at their own pace and in the order that most interests them.
Participants will receive the resources as typically included in the Self-Guided PSP Wellbeing Course.
Participants will receive additional intervention content.
An ICBT course that is completed without the guidance of a therapist.
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)
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)
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)
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.
Time frame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total WSAS score which can range from 0 to 40. Higher scores indicate greater levels of distress related to functional impairment (worse outcome)
Time frame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Change in total BRS score which can range from 0 to 30. Higher scores indicate greater resilience (better outcome)
Time frame: Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)
Bespoke questionnaire regarding access to healthcare resources
Time frame: 8-weeks (post-treatment)
Bespoke questionnaire inquiring about participants' experiences with the case stories. Participants receiving enhanced social learning resources will be asked additional questions about the enhanced social learning resources.
Time frame: 8-weeks (post-treatment)
Bespoke 7-item questionnaire assessing participants' treatment satisfaction.
Time frame: 8-weeks (post-treatment)
The DBCI is a questionnaire where participants are asked to rate their feelings of engagement with online interventions, which can range from 0-56. Higher scores are indicative of more positive feelings about engagement.
Time frame: 8-10 weeks (post-treatment)
A semi-structured interview developed to assess for clients experiences within the course.
Interested in participating?
Request InfoUniversity of Regina
Other
A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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