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InsomniaNCT07021183

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

A study testing Sleep Course in people with Insomnia, run by University of Regina at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Insomnia
What is being tested?
Sleep Course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
6 Mar 2025to 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heather D Hadjistavropoulos, PhD contact

306-585-5133

heather.hadjistavropoulos@uregina.ca

Canada1 site, 1 recruiting
  • University of Regina

    Regina, Saskatchewan, S4S 0A2

    Heather D Hadjistavropoulos, PhD, heather.hadjistavropoulos@uregina.ca

    Heather D Hadjistavropoulos, PhD

    Recruiting

Other trials in Canada

About this study

Official title: Uptake, Acceptability, and Effectiveness of Internet-Delivered Cognitive Behavioural Therapy for Public Safety Personnel With Self-Reported Sleep Difficulties

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.

Conditions
Insomnia
Being tested
Sleep Course
Keywords
Digital Mental Health Interventions, Insomnia, Sleep Difficulties, Depression, Anxiety, Public Safety Personnel, ICBT, Posttraumatic Stress, First Responders, Internet-Delivered Cognitive Behavioural Therapy
Medical subject headings
Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep CourseBehavioural

    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.

Study groups in NCT07021183
Study groupRoleWhat they receive
ICBT for insomniaExperimentalTherapist-guided, self-guided, internet-delivered cognitive behavioral therapy (ICBT), insomnia, sleep difficulties, public safety personnel, first responders
Receives: Behavioral: Sleep Course

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start6 Mar 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021183
Sponsor's protocol ID
1088
Status last verified
Sep 2026
First submitted
31 Mar 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Course in people with Insomnia, 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 6 inclusion and 2 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 4 Sep 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?

Insomnia (time frame: Screening, week 7 (post-treatment), and week 12 (follow-up).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Sep 2026.

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