Depression, AnxietyNCT04127032
Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel
A study testing PSP Wellbeing Course in people with Depression, Anxiety and Psychological Trauma, run by University of Regina at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Psychological Trauma
- What is being tested?
- PSP Wellbeing Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to 31 Mar 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Department of Psychology and Canadian Institute for Public Safety Research and Treatment
Regina, Saskatchewan, S4S 0A2
Heather D Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca
Heather D Hadjistavropoulos, PhD
About this study
Official title: Internet-Delivered Cognitive Behaviour Therapy (ICBT) for Public Safety Personnel (PSP): Examination of Engagement, Outcomes, Strengths and Challenges
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:
- 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)?
- 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
- 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.
- Conditions
- Depression, Anxiety, Psychological Trauma
- Being tested
- PSP Wellbeing Course
- Keywords
- Internet, Cognitive Behavioral Therapy, Telemedicine
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSP Wellbeing CourseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Tailored ICBT for PSP | Experimental | Therapist-guided, Internet-delivered cognitive behavioral therapy tailored specifically for Canadian public safety personnel. Receives: Behavioral: PSP Wellbeing Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 and 16 weeks
Secondary outcomes (16)
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening
Alcohol use
Alcohol Use Disorders Identification Test (AUDIT). Higher scores indicate greater alcohol consumption and alcohol-related problems. Scores ranger from 0 to 40.
Measured: screening
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.
Measured: screening
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).
Measured: screening and 4, 8, 12, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: week 8
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.
Measured: week 8
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.
Measured: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
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.
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks
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
Measured: screening, 8 and 26 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Dec 2019
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Canada
- Responsible party
- Sponsor
- Investigators
- Heather D Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127032
- Sponsor's protocol ID
- 2019-157
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 40245389Price 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 39453705Hadjistavropoulos 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Delivered Cognitive Behaviour Therapy (ICBT) for Public Safety Personnel (PSP): Examination of Engagement, Outcomes, Strengths and Challenges
- ClinicalTrials.gov ID
- NCT04127032
- Acronym / sponsor ID
- 2019-157
- Conditions
- Depression, Anxiety, Psychological Trauma
- Keywords
- Internet, Cognitive Behavioral Therapy, Telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Government of Canada
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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)?
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored ICBT for PSP | Experimental | Behavioral: PSP Wellbeing CourseTherapist-guided, Internet-delivered cognitive behavioral therapy tailored specifically for Canadian public safety personnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSP Wellbeing CourseA 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). | Behavioural | Tailored ICBT for PSP |
Primary outcome
Change in depression
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).
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.
Change in anxiety
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).
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.
Change in posttraumatic stress
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
PTSD Checklist for DSM-5 (PCL-5). Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.
Change in posttraumatic stress
Time frame: 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 and 16 weeks
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.
16 secondary outcomes
Change in panic symptoms
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Change in social anxiety
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Change in anger
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Change in sleep problems
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Other sleep problems
Time frame: screening
Alcohol use
Time frame: screening
Drug use
Time frame: screening
Change in functioning
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).
Change in resiliency
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Change in use of health services
Time frame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Treatment satisfaction
Time frame: week 8
Working alliance
Time frame: week 8
Lifetime Traumatic Events History
Time frame: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Worst Traumatic Event
Time frame: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
Engagement and Homework Compliance
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks
Change in Moral Injury
Time frame: screening, 8 and 26 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 40245389Price 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.
- Derived from this study: PubMed 39453705Price 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.
- Derived from this study: PubMed 33949959Hadjistavropoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather D Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSP Wellbeing Course in people with Depression, Anxiety and Psychological Trauma, 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 6 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 18 Jun 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?
Change in depression (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).). 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?
On the ClinicalTrials.gov record for NCT04127032, which also lists 3 linked publications.
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 18 Jun 2026.