ClinicalTrials.gg
RecruitingNCT04127032Updated Jun 18, 2026

Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel

An interventional study of PSP Wellbeing Course in Depression, Anxiety and Psychological Trauma, sponsored by University of Regina. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by University of Regina · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Depression by University of Regina — 12 open to participants now, 12 under way, none of them phase 3. Depression · University of Regina.

Planned enrollment
9th of 31
250 · median 158
Started
2019
with 4 others
No phase
29 of 33
12 open now
Primary completion
2028-03
later than 8 of 11 live
Registered
11th of 33
by date

Among the 33 studies in Depression by University of Regina, this one is the 9th largest by planned enrollment of the 31 interventional ones that give a count, is one of 5 that started in 2019, is one of 29 with no phase, reaches primary completion later than 8 of the 11 other live ones, and was the 11th registered.

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

Browse Depression studies →

Open to participants now

12 of the 33 studies in Depression by University of Regina are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This study evaluates a transdiagnostic Internet-delivered cognitive behavioural therapy (ICBT) recently tailored for Canadian public safety personnel (PSP) reporting symptoms of depression, anxiety, or posttraumatic stress. Outcomes of interest include engagement with the intervention, changes in symptoms and functioning, and strengths and limitations of implementing ICBT with Canadian PSP.

Read the detailed description

Background:

Public Safety Personnel (PSP) is a term that broadly encompasses personnel who ensure the safety and security of Canadians across jurisdictions, including, but not necessarily limited to, public safety communications officials (e.g., call centre operators/dispatchers), correctional employees, firefighters, paramedics, border services personnel, operational and intelligence personnel, search and rescue personnel, and police officers. As a function of their vocations, PSP are frequently exposed to traumatic events (e.g., threatened or actual physical assaults, sexual violence, fires, and explosions) and are at risk of post-traumatic stress injuries. Results from a recent survey with a large Canadian PSP sample showed 44.5% screened positive for one or more mental health disorders, which is much higher than the 10.1% diagnostic rate among the Canadian general public. For many Canadian PSP access to in-person evidence-based care is impeded for several reasons, including preference to self-manage symptoms, geographic barriers (e.g., difficulty accessing care while deployed to remote locations), logistical barriers (e.g., shift work limits access to standard service hours), stigma (e.g., perceptions of being evaluated negatively for having mental health concerns), growing waiting-lists, and limited resources (e.g., insufficient access to mental health care coverage).

Transdiagnostic Internet-delivered cognitive behaviour therapy (ICBT) represents a convenient method for PSP to access care for mental health concerns, such as depression, anxiety, and post-traumatic stress. In transdiagnostic ICBT, clients receive access to standardized lessons that provide the same information and skills as traditional face-to-face CBT. Divergent mental health symptoms are targeted within transdiagnostic ICBT by educating clients in strategies that apply to multiple conditions (e.g., cognitive restructuring, graded exposure); this helps to ensure multiple concerns are addressed in an efficient manner. This is important given high rates of mental health comorbidity. In addition to weekly lessons, clients are encouraged to complete homework assignments to facilitate learning. Research shows that transdiagnostic ICBT is effective at reducing symptoms of anxiety, depression and trauma and there is also evidence that the findings of research trials translate into routine clinic settings. Most commonly, ICBT is delivered with brief once weekly e-therapist assistance (\~20 minutes) via the telephone or secure email over \~8 weeks. There are also encouraging research results that clients can benefit with lower levels of support, such as when treatment is largely self-directed but with automated reminder emails, e-therapist monitoring and optional e-therapist support as needed by clients.

Research purpose:

The purpose of the current research project is to explore outcomes of a transdiagnostic ICBT course that is specifically tailored for PSP (e.g., case examples are relevant to PSP), referred to as the PSP Wellbeing Course. Of particular interest in this study are: 1) the usage of the PSP Wellbeing Course among PSP who are informed about the PSP Wellbeing Course (e.g., # enrolling, completion rates, use of e-therapist support); 2) outcomes of the PSP Wellbeing Course with respect to diverse outcome measures (e.g., depression, anxiety, trauma, functioning) measured at 8, and 26 week follow-up; and 3) strengths and challenges of the PSP Wellbeing Course when offered to Canadian PSP. In order to take part, PSP will first complete an online questionnaire and telephone screening to assess whether they meet the following inclusion criteria: 1) 18 years of age or older; 2) resident of the Canadian provinces of Saskatchewan, Quebec, Nova Scotia, New Brunswick, Prince Edward Island or Ontario; 3) not endorsing high suicide risk or recent suicide attempts in the past year; 4) able to access and comfortable using computers and the internet; 5) not seeking help primarily for alcohol and or drugs, bipolar disorder, or psychotic symptoms; and 6) willing to provide an emergency contact unless the participant does not have a physician and the clinician assesses the need for an emergency contact as low during the telephone screening. The PSP Wellbeing Course will be delivered by trained providers with graduate training in psychology or social work or graduate students under supervision. Of note, the program was first offered in Saskatchewan and later translated to French and offered to PSP who reside in Quebec as well (update: recruitment in Quebec began on September 23, 2020). The program was also expanded to PSP in Nova Scotia, New Brunswick, and Prince Edward Island in February 2022, as well as to PSP in Ontario in March 2023. Of note, a purely self-guided version of the PSP Wellbeing Course (i.e., without therapist guidance) was made available to PSP anywhere in Canada in English on December 1st, 2021 and in French on November 19th, 2022. The primary research questions to be answered include:

  1. ENGAGEMENT: How many PSP will enroll in and complete the PSP Wellbeing Course? What will be the uptake of optional e-therapist support, versus 1x week or 2x week e-therapist support? What will be the length of support selected (8 week-16 week)?
  2. OUTCOMES: What will be the impact of the PSP Wellbeing Course on symptom improvement and functioning at 8, 26, and 52 weeks post-enrollment? What factors will predict outcomes (e.g., symptom severity, demographics, engagement)? Please note: as of December 2024, we are exploring the impact of the PSP Wellbeing Course on symptom improvement and functioning at 8, and 26 weeks post-enrollment. The impact of this course at weeks 8, 26, and 52 was previously explored and has been published
  3. IMPLEMENTATION: What are stakeholder experiences, positive and negative, with the PSP Wellbeing Course? What are the suggested improvements to ICBT to meet the needs of PSP?

Significance:

This project will provide information that will inform future use of ICBT to assist PSP with common mental health concerns. Data will be extracted and analyzed on a quarterly basis in order to provide a preliminary evaluation of engagement, outcomes and implementation experiences and determine if adjustments to ICBT are required. Once adjustments are completed or deemed unnecessary, data will be extracted and analyzed biannually.

03

Conditions studied

  • Depression, Anxiety
  • Psychological Trauma

Keywords

  • Internet
  • Cognitive Behavioral Therapy
  • Telemedicine
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age or older
  • residing in a Canadian province or territory in which PSPNET is able to offer services
  • endorsing symptoms of anxiety, depression, or post-traumatic stress
  • able to access a computer and internet service
  • willing to provide a physician as emergency contact unless the participant does not have a physician and the clinician conducting the telephone screening assesses the need for an emergency contact to be low.

Exclusion criteria

Exclusion Criteria:

  • high suicide risk
  • suicide attempt or hospitalization in the last year
  • primary problems with psychosis, alcohol or drug problems, mania
  • currently receiving regular psychological treatment for anxiety or depression
  • not present in Canada during treatment
  • concerns about ICBT
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Tailored ICBT for PSP

    Therapist-guided, Internet-delivered cognitive behavioral therapy tailored specifically for Canadian public safety personnel.

    Behavioral: PSP Wellbeing Course

Interventions

  • BehavioralPSP Wellbeing Course

    A tailored ICBT intervention will be delivered to public safety personnel who report symptoms of depression, anxiety, or posttraumatic stress. Clients will choose whether they prefer weekly therapist support, twice-weekly support, or monitored optional support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their access to therapist support by an additional 8 weeks (i.e., up to 16 weeks in total).

06

What researchers measure

Primary outcomes

  1. Change in depression

    Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27. Note: this measure is only administered at weeks 9 through 16 for clients who are still engaged in treatment at those timepoints.

    Time frame: screening and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  2. Change in anxiety

    Generalized Anxiety Disorder - 7 Item (GAD-7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21. Note: this measure is only administered at weeks 9 through 16 for clients who are still engaged in treatment at those timepoints.

    Time frame: screening and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, 14, 15, 16, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  3. Change in posttraumatic stress

    PTSD Checklist for DSM-5 (PCL-5). Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  4. Change in posttraumatic stress

    Abbreviated PTSD Checklist - Civilian Version (PCL-C). Higher total scores indicate greater severity of posttraumatic stress. Scores range from 5 to 30. Note: this measure is only administered at weeks 9 through 16 for clients who are still engaged in treatment at those timepoints.

    Time frame: 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 and 16 weeks

Secondary outcomes

  1. Change in panic symptoms

    Panic Disorder Severity Scale-Self Report (PDSS-SR), 2-item version. Higher total scores indicate greater severity of panic symptoms. Scores range from 0 to 8. Note: this measure replaced the full PDSS-SR on October 6, 2023.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  2. Change in social anxiety

    Mini-Social Phobia Inventory (Mini-SPIN): Higher total scores indicate greater severity of social anxiety, with scores ranging from 0 to 12. In the English version of the course, the Mini-SPIN replaced the 6-item Social Interaction Anxiety Scale (SIAS-6) and the 6-item Social Phobia Scale (SPS-6) on October 6th, 2023. In the French version of the course, it replaced the Social Interaction Phobia Scale (SIPS) on March 20th, 2024.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  3. Change in anger

    Dimensions of Anger Reactions (DAR-5) scale. Higher total scores indicate greater severity of anger problems. Scores range from 0 to 20.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  4. Change in sleep problems

    Insomnia Severity Index (ISI). Higher total scores indicate greater severity of sleep problems. Scores range from 0 to 28. Note: this measure was added on December 3, 2020.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  5. Other sleep problems

    SLEEP-50 Questionnaire. This questionnaire consists of 50 items spanning 9 subscales. However, instead of administering and scoring the entire questionnaire, we are administering only 21 items for descriptive purposes. Note: this measure was added on December 3, 2020.

    Time frame: screening

  6. Alcohol use

    Alcohol Use Disorders Identification Test (AUDIT). Higher scores indicate greater alcohol consumption and alcohol-related problems. Scores ranger from 0 to 40.

    Time frame: screening

  7. Drug use

    Drug Use Disorders Identification Test-C (DUDIT-C). Higher scores indicate greater drug use and drug-related problems. Scores ranger from 0 to 16. Note: this measure replaced the full DUDIT in December 2024.

    Time frame: screening

  8. Change in functioning

    Work and Social Adjustment Scale (WSAS). Higher total scores indicate a greater degree of impairment. Total scores range from 0 to 40. Note: this measure is only administered at 12 weeks for clients who are still engaged in treatment at this timepoint. Note: this measure replaced the Sheehan Disability Scale (SDS).

    Time frame: screening and 4, 8, 12, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  9. Change in resiliency

    Brief Resiliency Scale (BRS). Higher total scores indicate greater resiliency. Total scores represent mean scores across the six items of the scale and range from 0 to 5. Note: this measure was added on December 3, 2020.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  10. Change in use of health services

    Health Service Use Questionnaire is a bespoke questionnaire that assesses the use of health services for mental health problems.

    Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  11. Treatment satisfaction

    Treatment Satisfaction Questionnaire. A bespoke questionnaire consisting of 32 items with varying response formats measuring treatment satisfaction and perceived treatment credibility. Items are not designed to be combined into a unitary measure.

    Time frame: week 8

  12. Working alliance

    Working Alliance Inventory - Short Revised (WAI-SR). Higher scores indicate greater working alliance. Scores in three distinct domains of working alliance each range from 4 to 20.

    Time frame: week 8

  13. Lifetime Traumatic Events History

    Life Events Checklist for DSM-5 (LEC-5). A checklist of common traumatic events used to establish the nature of the traumatic events a respondent has experienced. This questionnaire is not intended to be scored.

    Time frame: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  14. Worst Traumatic Event

    Worst Traumatic Event Questionnaire. A checklist of common traumatic events used to establish the nature of the single worst traumatic event a respondent has experienced. This questionnaire is not intended to be scored.

    Time frame: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  15. Engagement and Homework Compliance

    Homework Reflection. A bespoke questionnaire consisting of 8 items with varying response formats, designed to measure engagement with treatment tasks and help alert therapists to any challenges clients face. Items are not designed to be combined into a unitary measure. Note: this measure is only administered at 9, 10, 11, and 12 weeks for clients who are still engaged in treatment at those timepoints.

    Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks

  16. Change in Moral Injury

    Moral Injury Outcome Scale - Abbreviated Winter Campaign version. High total scores indicate greater levels of current moral injury. Scores range from 0 - 56. Note: this measure was added in December 2024

    Time frame: screening, 8 and 26 weeks.

07

Study locations

1 of 1 sites recruiting
  • Department of Psychology and Canadian Institute for Public Safety Research and Treatment
    Regina, Saskatchewan S4S 0A2, Canada
    Recruiting
08

References and documents

Publications

  • Price JA, McCall HC, Demyen SA, Spencer SM, Katz BM, Clairmont AP, Hadjistavropoulos HD. Optimization of Internet-Delivered Cognitive Behavioral Therapy for Canadian Leaders Within Public Safety: Qualitative Study. J Med Internet Res. 2025 Apr 17;27:e72321. doi: 10.2196/72321. PubMed 40245389 ↗
  • Price JA, Gregory J, McCall HC, Landry CA, Beahm JD, Hadjistavropoulos HD. Client Perspectives of Case Stories in Internet-Delivered Cognitive Behavioral Therapy for Public Safety Personnel: Mixed Methods Study. JMIR Form Res. 2024 Oct 25;8:e64454. doi: 10.2196/64454. PubMed 39453705 ↗
  • Hadjistavropoulos HD, McCall HC, Thiessen DL, Huang Z, Carleton RN, Dear BF, Titov N. Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study. J Med Internet Res. 2021 May 5;23(5):e27610. doi: 10.2196/27610. PubMed 33949959 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for Mar 2028, 99 months after the start.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 99 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2019
First posted
Oct 15, 2019
StartActual
Dec 1, 2019
Primary completionEst.
Mar 31, 2028
CompletionEst.
Mar 31, 2028
Last update
Jun 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04127032
Lead sponsor
University of Regina
Collaborators
Government of Canada
Responsible party
Sponsor
First posted
Oct 15, 2019
Start date
Dec 1, 2019
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Jun 18, 2026

Study contacts

Heather D Hadjistavropoulos, PhD
Contact
heather.hadjistavropoulos@uregina.ca
306-585-5133
Heather D Hadjistavropoulos, PhD
principal investigator · University of Regina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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