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DepressionNCT06298279

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

A study testing Tunneled Delivery, Personalized Delivery and Standard Resources in people with Depression and Anxiety, run by University of Regina at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Tunneled Delivery, Personalized Delivery and Standard Resources
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteCanada
Study dates
12 Mar 2024to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heather D Hadjistavropoulos, PhD contact

(306)585-5133

heather.hadjistavropoulos@uregina.ca

Canada1 site, 1 recruiting
  • Department of Psychology, University of Regina

    Regina, Saskatchewan, S4S 0A2

    Heather D Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca

    Caeleigh A Landry, MSc, 306-337-2473, caeleigh.landry@uregina.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Randomized Factorial Trial of Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel: Examining the Impact of Content Delivery Method

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.

Read the 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).

Being tested
Tunneled Delivery, Personalized Delivery, Standard Resources, Enhanced Social Learning Resources, Transdiagnostic Self-Guided ICBT
Medical subject headings
Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tunneled DeliveryBehavioural

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

  • Personalized DeliveryBehavioural

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

  • Standard ResourcesBehavioural

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

  • Enhanced Social Learning ResourcesBehavioural

    Participants will receive additional intervention content.

  • Transdiagnostic Self-Guided ICBTBehavioural

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

Study groups in NCT06298279
Study groupRoleWhat they receive
Tunneled Delivery/Standard ResourcesExperimentalIn 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.
Receives: Behavioral: Tunneled Delivery; Behavioral: Standard Resources; Behavioral: Transdiagnostic Self-Guided ICBT
Tunneled Delivery/Enhanced Social Learning ResourcesExperimentalIn 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.
Receives: Behavioral: Tunneled Delivery; Behavioral: Enhanced Social Learning Resources; Behavioral: Transdiagnostic Self-Guided ICBT
Personalized Delivery/Standard ResourcesExperimentalIn 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.
Receives: Behavioral: Personalized Delivery; Behavioral: Standard Resources; Behavioral: Transdiagnostic Self-Guided ICBT
Personalized Delivery/Enhanced Social Learning ResourcesExperimentalIn 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.
Receives: Behavioral: Personalized Delivery; Behavioral: Enhanced Social Learning Resources; Behavioral: Transdiagnostic Self-Guided ICBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: 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)

    Measured: 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.

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

Secondary outcomes (6)
  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)

    Measured: 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)

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

  3. Healthcare Use Questionnaire

    Bespoke questionnaire regarding access to healthcare resources

    Measured: 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.

    Measured: 8-weeks (post-treatment)

  5. Treatment Satisfaction Questionnaire

    Bespoke 7-item questionnaire assessing participants' treatment satisfaction.

    Measured: 8-weeks (post-treatment)

  6. Digital Behavior Change Interventions Engagement Scale (DCBI)

    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.

    Measured: 8-weeks (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start12 Mar 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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)
Masking
None (open label)
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06298279
Sponsor's protocol ID
2023-436
Status last verified
Apr 2026
First submitted
14 Feb 2024
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tunneled Delivery, Personalized Delivery and Standard Resources in people with Depression and Anxiety, run by University of Regina at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heather D Hadjistavropoulos, PhD ((306)585-5133, heather.hadjistavropoulos@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generalized Anxiety Disorder 7-item (GAD-7) (time frame: Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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