Health TrialsbyHealthPanel

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

ConditionsDepressionAnxietyStress Disorders, Post-Traumatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Tunneled Delivery

    Behavioral

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

  • Personalized Delivery

    Behavioral

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

  • Standard Resources

    Behavioral

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

  • Enhanced Social Learning Resources

    Behavioral

    Participants will receive additional intervention content.

  • Transdiagnostic Self-Guided ICBT

    Behavioral

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

Treatment groups

164 Participants
are divided into 4 treatment groups
Group A: Tunneled Delivery/Standard ResourcesExperimental treatment 3 interventions
Group B: Tunneled Delivery/Enhanced Social Learning ResourcesExperimental treatment 3 interventions
Group C: Personalized Delivery/Standard ResourcesExperimental treatment 3 interventions
Group D: Personalized Delivery/Enhanced Social Learning ResourcesExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
2

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)

Time frame
Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)
3

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)

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

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.

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

Secondary outcomes

1

Work and Social Adjustment Scale (WSAS)

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)
2

Brief Resilience Scale (BRS)

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)
3

Healthcare Use Questionnaire

Bespoke questionnaire regarding access to healthcare resources

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

Case Story Questionnaire

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)

Other outcomes

1

Post-treatment Semi-structured interview

A semi-structured interview developed to assess for clients experiences within the course.

Time frame
8-10 weeks (post-treatment)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Regina

Lead sponsor

Government of Canada

Collaborator

Source ClinicalTrials.gov
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