Exploring the Role of Online Discussion Forums in Internet-Delivered Therapy for Canadian Public Safety Personnel

NCT05145582 | Completed

• 1 other identifier: 2021-130
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet-delivered cognitive behavioural therapy tailored specifically for public safety personnel both with and without a built-in online discussion forum.

Conditions

Depression; Anxiety; Stress Disorders, Post-Traumatic

Keywords

Internet-Based Intervention; Cognitive Behavioral Therapy; Telemedicine

Outcome Measures

Primary Outcomes (3)

• Change in Depression

  Patient Health Questionnaire-9. The Patient Health Questionnaire-9 (PHQ-9) is a commonly used measure of depression that includes an item to measure suicidality (Kroenke et al., 2001). It has demonstrated excellent psychometric properties in many studies (e.g., Cameron et al., 2008; Kroenke et al., 2001, 2010). Its nine items are rated on a four-point Likert scale from 0 (not at all) to 3 (nearly every day) for a total score ranging from 0 to 27. Traditionally, a score of 10 or greater has been considered indicative of a likely diagnosis of major depressive disorder on the PHQ-9 (Manea et al., 2012). A change in score of six points has been identified as a reliable change index (National Collaborating Centre for Mental Health, 2019).

  Baseline, 8 weeks, 20 weeks

• Change in Anxiety

  Generalized Anxiety Disorder-7. The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item measure of generalized anxiety symptoms. Like the PHQ-9, its items are rated on a four-point Likert scale from 0 (not at all) to 3 (nearly every day). Possible total scores range from 0 to 21. Research shows that the GAD-7 has strong psychometric properties, and a score of 10 or greater can be used to indicate a likely diagnosis of generalized anxiety disorder (Kroenke et al., 2010; Spitzer et al., 2006). Following the precedent of other ICBT researchers, a change in score of five points or more will be considered clinically significant (Titov et al., 2017).

  Baseline, 8 weeks, 20 weeks

• Change in Posttraumatic Stress

  PTSD Checklist for DSM-5. The PTSD Checklist for DSM-5 (PCL-5) is a common measure of PTSD that was updated following the release of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; (American Psychiatric Association, 2013; Blevins et al., 2015; Weathers et al., 2013). It includes 20 items that are rated on a five-point Likert scale from 0 (not at all) to 4 (extremely), for a total score between 0 and 80. Several research groups have suggested that a score of 33 or greater indicates a likely diagnosis of PTSD (Bovin et al., 2016; Wortmann et al., 2016). A change in score of 10 points or more is considered a reliable change on the PCL-5 (Byllesby et al., 2019). At baseline (but not at later timepoints), the investigators will administer a version of the PCL-5 that includes five additional questions about the nature of the potentially psychologically traumatic event that a respondent experienced (Weathers et al., 2013).

  Baseline, 8 weeks, 20 weeks

Secondary Outcomes (7)

• Change in Functional Impairment

  Baseline, 8 weeks, 20 weeks

• Change in Resilience

  Baseline, 8 weeks, 20 weeks

• Change in Wellbeing and Flourishing

  Baseline, 8 weeks, 20 weeks

• Change in Healthcare Use

  Baseline, 8 weeks, 20 weeks

• Treatment Satisfaction

  8 weeks

Study Arms (2)

Unguided, Transdiagnostic ICBT Tailored for PSP

EXPERIMENTAL

An 8-week, unguided, transdiagnostic ICBT program tailored specifically for public safety personnel and designed to treat depression, anxiety, and PTSD.

Behavioral: The Self-Guided PSP Wellbeing Course

Unguided, Transdiagnostic ICBT Tailored for PSP + Online Discussion Forum

EXPERIMENTAL

An 8-week, unguided, transdiagnostic ICBT program tailored specifically for public safety personnel and designed to treat depression, anxiety, and PTSD plus a built-in online discussion forum.

Behavioral: The Self-Guided PSP Wellbeing Course; Behavioral: Online Discussion Forum

Interventions

The Self-Guided PSP Wellbeing Course BEHAVIORAL

An unguided version of a transdiagnostic ICBT program that has shown promising initial outcomes in prior research (https://doi.org/10.2196/27610).

Unguided, Transdiagnostic ICBT Tailored for PSP; Unguided, Transdiagnostic ICBT Tailored for PSP + Online Discussion Forum

Online Discussion Forum BEHAVIORAL

An online discussion forum designed to provide an opportunity for participants to support one another in their use of the ICBT program.

Unguided, Transdiagnostic ICBT Tailored for PSP + Online Discussion Forum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regina: lead
• Government of Canada: collaborator

Study Sites (2)

Department of Psychology and Collaborative Centre for Justice and Safety

Regina, Saskatchewan, S4S 0A2, Canada

Location

University of Regina

Regina, Saskatchewan, S4S0A2, Canada

Location

Related Publications (1)

• McCall HC, Hadjistavropoulos HD. Impact of an Online Discussion Forum on Self-Guided Internet-Delivered Cognitive Behavioral Therapy for Public Safety Personnel: Randomized Trial. J Med Internet Res. 2024 Aug 14;26:e59699. doi: 10.2196/59699.

  PMID: 39141899 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Hugh C McCall, MA

  University of Regina

  PRINCIPAL INVESTIGATOR

• Heather D Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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 two conditions (i.e., presence or absence of an online discussion forum) will be concealed from all participants. Because only participants assigned to the ICBT + Peer Support Forum condition will have access to the Peer Support Forum, it will not be possible to mask the forum moderator to those participants' condition. Because outcomes will be assessed via self-report questionnaire measures, outcomes assessor masking is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two treatment conditions (unguided ICBT only or unguided ICBT + online discussion forum)

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 6, 2021
• Study Start: December 1, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)