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

NCT ID: NCT06298279

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-04-30

Brief Summary

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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

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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).

Conditions

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Depression Anxiety Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Tunneled Delivery

Intervention Type BEHAVIORAL

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

Standard Resources

Intervention Type BEHAVIORAL

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

Transdiagnostic Self-Guided ICBT

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Tunneled Delivery

Intervention Type BEHAVIORAL

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

Enhanced Social Learning Resources

Intervention Type BEHAVIORAL

Participants will receive additional intervention content.

Transdiagnostic Self-Guided ICBT

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Personalized Delivery

Intervention Type BEHAVIORAL

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

Standard Resources

Intervention Type BEHAVIORAL

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

Transdiagnostic Self-Guided ICBT

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Personalized Delivery

Intervention Type BEHAVIORAL

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

Enhanced Social Learning Resources

Intervention Type BEHAVIORAL

Participants will receive additional intervention content.

Transdiagnostic Self-Guided ICBT

Intervention Type BEHAVIORAL

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

Interventions

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Tunneled Delivery

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

Intervention Type BEHAVIORAL

Personalized Delivery

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

Intervention Type BEHAVIORAL

Standard Resources

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

Intervention Type BEHAVIORAL

Enhanced Social Learning Resources

Participants will receive additional intervention content.

Intervention Type BEHAVIORAL

Transdiagnostic Self-Guided ICBT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government of Canada

OTHER_GOV

Sponsor Role collaborator

University of Regina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Psychology, University of Regina

Regina, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather D Hadjistavropoulos, PhD

Role: CONTACT

(306)585-5133

Facility Contacts

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Heather D Hadjistavropoulos, PhD

Role: primary

306-585-5133

Caeleigh A Landry, MSc

Role: backup

306-337-2473

Other Identifiers

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2023-436

Identifier Type: -

Identifier Source: org_study_id

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