## Protocol Section
### Identification Module
**NCT ID:** NCT06298279

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2023-436
#### Organization
**Class:** OTHER
**Full Name:** University of Regina
### Status Module
#### Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-07

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-04

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-12

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-03-07
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-14
**Study First Submit QC Date:** 2024-03-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Government of Canada

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Regina

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Depression

- Anxiety

- Stress Disorders, Post-Traumatic

### Design Module

#### Design Info

**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)

##### Masking Info

**Masking:** NONE

**Masking Description:** 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.

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 164

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Tunneled Delivery

- Behavioral: Standard Resources

- Behavioral: Transdiagnostic Self-Guided ICBT

**Label:** Tunneled Delivery/Standard Resources

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Tunneled Delivery

- Behavioral: Enhanced Social Learning Resources

- Behavioral: Transdiagnostic Self-Guided ICBT

**Label:** Tunneled Delivery/Enhanced Social Learning Resources

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Behavioral: Personalized Delivery

- Behavioral: Standard Resources

- Behavioral: Transdiagnostic Self-Guided ICBT

**Label:** Personalized Delivery/Standard Resources

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Behavioral: Personalized Delivery

- Behavioral: Enhanced Social Learning Resources

- Behavioral: Transdiagnostic Self-Guided ICBT

**Label:** Personalized Delivery/Enhanced Social Learning Resources

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tunneled Delivery/Enhanced Social Learning Resources

- Tunneled Delivery/Standard Resources

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

**Name:** Tunneled Delivery

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Personalized Delivery/Enhanced Social Learning Resources

- Personalized Delivery/Standard Resources

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

**Name:** Personalized Delivery

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Personalized Delivery/Standard Resources

- Tunneled Delivery/Standard Resources

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

**Name:** Standard Resources

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- Personalized Delivery/Enhanced Social Learning Resources

- Tunneled Delivery/Enhanced Social Learning Resources

**Description:** Participants will receive additional intervention content.

**Name:** Enhanced Social Learning Resources

**Type:** BEHAVIORAL

#### Intervention 5

**Arm Group Labels:**

- Personalized Delivery/Enhanced Social Learning Resources

- Personalized Delivery/Standard Resources

- Tunneled Delivery/Enhanced Social Learning Resources

- Tunneled Delivery/Standard Resources

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

**Name:** Transdiagnostic Self-Guided ICBT

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

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

**Measure:** Post-treatment Semi-structured interview

**Time Frame:** 8-10 weeks (post-treatment)

#### Primary Outcomes

**Description:** Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome)

**Measure:** Generalized Anxiety Disorder 7-item (GAD-7)

**Time Frame:** Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)

**Description:** Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome)

**Measure:** Patient Health Questionnaire-9 (PHQ-9)

**Time Frame:** Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)

**Description:** Change in total PCL-5 score which can range from 0 to 80. Higher scores indicate greater posttraumatic stress symptoms (worse outcome)

**Measure:** PTSD Checklist for the DSM-5 (PCL-5)

**Time Frame:** Screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment)

**Description:** 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.

**Measure:** Engagement

**Time Frame:** From date of enrollment to 26 weeks (post-treatment)

#### Secondary Outcomes

**Description:** 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)

**Measure:** Work and Social Adjustment Scale (WSAS)

**Time Frame:** Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)

**Description:** Change in total BRS score which can range from 0 to 30. Higher scores indicate greater resilience (better outcome)

**Measure:** Brief Resilience Scale (BRS)

**Time Frame:** Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)

**Description:** Bespoke questionnaire regarding access to healthcare resources

**Measure:** Healthcare Use Questionnaire

**Time Frame:** Screening, 8 weeks (post-treatment), and 20 weeks (post-treatment)

**Description:** 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.

**Measure:** Case Story Questionnaire

**Time Frame:** 8-weeks (post-treatment)

**Description:** Bespoke 7-item questionnaire assessing participants' treatment satisfaction.

**Measure:** Treatment Satisfaction Questionnaire

**Time Frame:** 8-weeks (post-treatment)

**Description:** 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.

**Measure:** Digital Behavior Change Interventions Engagement Scale (DCBI)

**Time Frame:** 8-weeks (post-treatment)

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** heather.hadjistavropoulos@uregina.ca

**Name:** Heather D Hadjistavropoulos, PhD

**Phone:** (306)585-5133

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Regina

**Contacts:**

***Contact 1:***

- **Email:** heather.hadjistavropoulos@uregina.ca

- **Name:** Heather D Hadjistavropoulos, PhD

- **Phone:** 306-585-5133

- **Role:** CONTACT

***Contact 2:***

- **Email:** caeleigh.landry@uregina.ca

- **Name:** Caeleigh A Landry, MSc

- **Phone:** 306-337-2473

- **Role:** CONTACT

***Contact 3:***

- **Name:** Heather D Hadjistavropoulos, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Canada

**Facility:** Department of Psychology, University of Regina

**State:** Saskatchewan

**Zip:** S4S 0A2

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Stress Disorders, Post-Traumatic

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-24
