ClinicalTrials.gg
RecruitingNCT07021183Updated Sep 4, 2026

The PSP Sleep Course: An Online Sleep Intervention for Public Safety Personnel With Self-reported Sleep Difficulties.

An interventional study of Sleep Course in Insomnia, sponsored by University of Regina. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

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

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the PSP Sleep Course, adapted for public safety personnel (PSP) experiencing sleep difficulties. The study seeks to replicate prior results from an Australian version of the Sleep Course assessing its effectiveness and acceptability when offered to Canadian PSP.

Read the detailed description

Background:

Public safety personnel (PSP) refer to individuals who ensure the safety and security of their citizens (e.g., border services officers, correctional workers, firefighters, paramedics, police). These occupations often require long and irregular hours (e.g., shift work) which can negatively impact daily functioning and work performance. PSP also experience increased exposure to potentially psychologically traumatic events (PPTEs) which can increase risk for mental health challenges (e.g., anxiety, depression, posttraumatic stress). These occupational stressors can also lead to sleep disturbance among PSP. Contributing factors to PSP sleep difficulties include long work hours, varying shift work, high stress, and exposure to PPTEs. Some evidence suggests that certain sectors are more susceptible to sleep difficulties, with correctional workers, paramedics, and Royal Canadian Mounted Police (RCMP) experiencing more difficulties than firefighters and police officers.

To improve access to effective psychological treatment, internet-delivered cognitive behavioural therapy (ICBT) has emerged as a structured online alternative to face-to-face cognitive behavioural therapy (CBT) in which treatment materials are delivered periodically over several months. The approach can be offered with or without therapist support. Research supports the effectiveness of ICBT for conditions like depression, anxiety, alcohol misuse, and insomnia with outcomes comparable to face-to-face therapy. Moreover, there is evidence that PSP benefit from transdiagnostic and PTSD-specific ICBT but to date there are no studies exploring Internet-delivered cognitive behaviour therapy for insomnia (ICBTi) among PSP.

Individuals who experience sleep disturbances are more likely to report increased physical (e.g., illness, poor health, pain) and mental challenges (e.g., anxiety, depression), as well as decreased work performance, daily functioning, and quality of life. PSP similarly experience these effects of sleep disturbances.

ICBTi is an evidence-based treatment for insomnia and sleep difficulties. Studying this among PSP is important as access to specialized psychological services, such as CBTi, is often limited, even though CBTi is a well-established treatment, and generally preferred over medication. ICBTi offers a promising approach for expanding access to evidence-based treatment for insomnia. The current study aims to explore the extent to which this ICBTi program, called the Sleep Course will be used by PSP, found to be acceptable and effective. Findings will shape long-term practices of working with PSP, contribute to a broader understanding of how ICBTi can address insomnia in PSP, and address the personal and societal impacts of untreated insomnia.

Research purpose:

The purpose of this research project is to offer and evaluate an ICBTi program called the PSP Sleep Course - offered in self- or therapist-guided options. The PSP Sleep Course is an intervention targeting sleep concerns. It comprises of 4 online lessons that provide: 1) psychoeducation on sleep (week 1); 2) information on sleep restriction and stimulus control strategies (week 2); 3) information on thought monitoring and challenging and worry time (week 4); and 4) behavioural strategies including activity scheduling and wind down and up routines (week 6).

To take part in the PSP Sleep Courses, all prospective participants will undergo online screening to assesses a variety of demographic and clinical characteristics pre-treatment to ensure eligibility and collect baseline information. Eligible participants who are interested in the self-guided version of the Course will be immediately enrolled into the Course. Eligible participants who are interested in the therapist-guided version of the Course will then complete a telephone screen with a PSPNET registered therapist to ensure eligibility and answer questions before Course enrollment. Those who do not meet initial inclusion criteria will be given the option of scheduling a phone interview with a clinician to further discuss their eligibility.

Lessons will be released gradually in a standardized order over 7 weeks with regular automatic emails and messages informing clients about upcoming lessons. Supplementary resources can be accessed at any time but are recommended as follows: Lesson 1 Myth-busting; Lesson 2 Shift Work, Diet, Medication \& Exercise; Lesson 3 Relaxation and Nightmares; and Lesson 4 Maintaining Progress. 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). Each of the 4 lessons offer Do-It-Yourself Exercises that facilitate skill acquisition for all clients.

Participants in the therapist-guided version of the PSP Sleep Course can email their assigned therapist at any time for 7 weeks, with the possibility of extending care up to 12 weeks. Participants who request support will be contacted by their therapist by secure emails on their designated check-in dates. Therapists will offer support and encouragement related to the PSP Sleep Course content and answer any client questions. Therapists will also contact clients by phone if therapists are concerned about client safety, if clients have not logged in to the PSP Sleep Course, or if clients request a phone call instead of email.

The primary research questions to be answered are:

  1. What will be the uptake and completion of the PSP Sleep Courses?
  2. What are the baseline demographic and clinical characteristics of participants in the PSP Sleep Courses?
  3. How acceptable is the PSP Sleep Courses as assessed via participants' ratings and feedback?
  4. Will the PSP Sleep Courses result in significant reductions on sleep-related and secondary measures?

Significance:

The data collected will shape long-term practices within PSPNET, which provides ICBT to PSP, and has potential to significantly enhance service delivery. The research will also provide valuable insights for other online clinics regarding the potential of offering ICBTi to PSP. By exploring the program's use, client characteristics, acceptability, and effectiveness, this study will contribute to a broader understanding of how ICBTi can be offered to PSP ultimately improving access to evidence-based treatment for insomnia.

02

Conditions studied

  • Insomnia

Keywords

  • Digital Mental Health Interventions
  • Insomnia
  • Sleep Difficulties
  • Depression
  • Anxiety
  • Public Safety Personnel
  • ICBT
  • Posttraumatic Stress
  • First Responders
  • Internet-Delivered Cognitive Behavioural Therapy
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 60 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

University of Regina is the lead sponsor of 58 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • Canada resident
  • Trainee, staff, or retired public safety personnel (PSP)
  • Willingness to learn information and skills to manage sleep difficulties
  • Have internet access
  • Consent to the PSP Sleep Course

Exclusion criteria

Exclusion Criteria:

  • Current severe medical or psychiatric disorder (e.g. current and recent mania or psychosis, recent hospitalization for mental health concerns, actively suicidal, medical condition client thinks will interfere with treatment, severe substance use)
  • Unable to read and understand English. (All content is provided in English and staff is English speaking; pending findings of the research PSPNET will explore translating the course into French)
05

Study design

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

Study arms

  • Experimental
    ICBT for insomnia

    Therapist-guided, self-guided, internet-delivered cognitive behavioral therapy (ICBT), insomnia, sleep difficulties, public safety personnel, first responders

    Behavioral: Sleep Course

Interventions

  • BehavioralSleep Course

    The Sleep Course was previously developed and evaluated in Australia and has since been tailored to Canadian public safety personnel. The PSP Sleep Course is 7 weeks (4 lessons) and is available in self- or therapist-guided versions. Therapist-guided participants can access optional therapist support via secure online messages or phone calls (up to twice a week). Both versions are accessible for up to 6 months.

06

What researchers measure

Primary outcomes

  1. Insomnia

    Insomnia Severity Index (ISI) includes 7 items rated on a 0 to 5 scale. Total scores range from 0 to 28. Higher total scores indicate greater severity of insomnia symptoms over the past two weeks. Scores of ≥ 10 indicate probable insomnia.

    Time frame: Screening, week 7 (post-treatment), and week 12 (follow-up).

Secondary outcomes

  1. Sleep Quality

    Sleep Quality Scale (SQS) includes 1-item with total scores ranging from 0-10. Higher scores indicate better overall sleep quality for over the past week. No clinical cut-off score.

    Time frame: Screening, start of each lesson (days 0, 7, 21, and 35), week 7 (post-treatment), and week 12 (follow-up).

  2. Sleep-Related Impairment

    The PROMIS Sleep Related Impairment Short Form (SRI-SF) includes 8 items rated between 0 (not at all) to 4 (very much). Total scores range from 8-40 with higher scores indicating greater sleep related impairment. No clinical cut-off score.

    Time frame: Screening, week 7 (post-treatment), and week 12 (follow up).

  3. Sleep Attitudes and Beliefs

    Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) includes 16 items rated on a 0 to 10-point scale. Total scores range from 0 to 160 with higher scores indicating greater dysfunctional beliefs about sleep. Scores ≥ 4.3 probable level of dysfunctional beliefs associated with clinical insomnia.

    Time frame: Screening, week 7 (post-treatment), week 12 (follow-up).

  4. Depression

    Patient Health Questionnaire (PHQ-9) includes 9 items rated between 0 to 3. Total scores range from 0 to 27 with higher total scores indicating greater severity of depression. Score of ≥10 indicate probable Major Depressive Disorder.

    Time frame: Screening, week 7 (post-treatment), and week 12 (follow-up).

  5. Anxiety

    Generalized Anxiety Disorder (GAD-7) includes 7 items rated between 0 to 3. Total scores range from 0 to 21 with higher total scores indicating greater severity of anxiety. Scores of ≥10 indicates probable Generalized Anxiety Disorder.

    Time frame: Screening, week 7 (post-treatment), and week 12 (follow-up).

  6. Posttraumatic Stress

    Abbreviated PTSD Checklist - Civilian Version (PCL-C) includes 6 items rated between 0 (not at all) and 4 (extremely). Total scores range from 0 to 24 with higher total scores indicating greater severity of posttraumatic stress. Scores of ≥ 8 indicate probable Posttraumatic Stress Disorder.

    Time frame: Screening, week 7 (post-treatment), and week 12 (follow-up).

  7. Lesson Reflections

    Lesson Reflection Questionnaire is a bespoke survey that includes 5 items to understandable if participants completed the assigned lesson and their perceptions/feedback. This survey is used for clinicians to monitor treatment. No overall score is created.

    Time frame: At the end of each lesson (days 0, 7, 21, and 35).

  8. Treatment Satisfaction

    Treatment Satisfaction Questionnaire is a bespoke survey consisting of 18 items with varying response formats measuring treatment satisfaction. Items are not combined into a unitary measure. Higher scores indicate greater treatment satisfaction.

    Time frame: Week 3 (2 questions only) and week 7 (post-treatment).

  9. Number of Materials Accessed

    The system collects information on the number of lessons completed and number of additional resources accessed.

    Time frame: Collects engagement from time of consent to week 12 (follow-up).

  10. Number of Contacts with Therapist

    The system collects information on the number of emails and/or phone calls sent to and received from the assigned therapist.

    Time frame: Collects engagement from time of consent to week 12 (follow-up).

  11. Background Information

    Background Information Questionnaire is a bespoke survey that collects sample characteristics at screening for descriptive purposes. No scores are calculated.

    Time frame: Screening

  12. Sleep and Treatment History

    Sleep and treatment history questions will be administered at screening for descriptive purposes. No scores are calculated based on these questions.

    Time frame: Screening

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 Mar 2025 (actual). Primary completion is estimated for Mar 2028, 36 months after the start.

Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 36 months is above that.

Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

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

Registered
Mar 31, 2025
First posted
Jun 13, 2025
StartActual
Mar 6, 2025
Primary completionEst.
Mar 31, 2028
CompletionEst.
Mar 31, 2028
Last update
Sep 4, 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 Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07021183
Lead sponsor
University of Regina
Collaborators
Government of Canada
Responsible party
Sponsor
First posted
Jun 13, 2025
Start date
Mar 6, 2025
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 4, 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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