Clinical trial NCT07021183: The Public Safety Personnel (PSP) Sleep Course: An Online Sleep Intervention for PSP.
Official title: Uptake, Acceptability, and Effectiveness of Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel With Self-Reported Sleep Difficulties
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Internet
Internet-Delivered CBT
Digital Mental Health Interventions
Insomnia
Sleep Difficulties
Depression
Anxiety
Public Safety Personnel
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Government of Canada
First posted: 2025-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the 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 PSP.

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) more difficulties than firefighters and police officers.

To improve access to effective psychological treatment, internet-delivered cognitive behaviour therapy (ICBT) has emerged as a structured online alternative to face-to-face cognitive behaviour 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 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.

Internet-delivered cognitive behaviour therapy for insomnia (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, the Sleep Course, for PSP. Key objectives are to examine: 1) the uptake and completion rates of the Sleep Course among PSP, 2) the baseline demographic and clinical characteristics of PSP enrolled in the program, 3) clients' acceptability ratings and feedback, 4) reductions in sleep-related measures, and 5) reductions in secondary measures.

To take part in this study, PSP will undergo a two-stage intake process: First, interested individuals will complete an online screening questionnaire that assesses a variety of clinical characteristics pre-treatment. Second, participants who meet initial inclusion criteria will be enrolled in the program and matched with a clinician. 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.

All clients will receive the same Sleep Course, which was developed at Macquarie University, Australia. The Sleep Course is an intervention targeting sleep concerns. It comprises 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). Lessons will be released gradually in a standardized order over 6 weeks with regular automatic emails 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 offers Do-It-Yourself Exercises that facilitate skill acquisition for all clients.

Once enrolled in the Sleep Course, clients will be able to email their assigned therapist at any time for 8 weeks, with the possibility of extending care up to 12 weeks. Should they request support clients will be contacted by their therapist by secure emails on their designated check-in dates. Therapists will offer support and encouragement related to the 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 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 Sleep Course among PSP?
2. What are the baseline demographic and clinical characteristics of PSP who are enrolled in the Sleep Course?
3. How acceptable is the Sleep Course as assessed via participants' ratings and feedback?
4. Will the Sleep Course result in significant reductions on sleep-related and secondary measures?

Significance:

The data collected will shape long-term practices within our unit that 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of older
* Current or former paid or volunteer PSP
* Living in a province in Canada where we offer the PSP Sleep Couse for the treatment period
* Willingness to learn information and skills to self-manage sleep difficulties
* Have internet access
* Consent to Sleep Course, online therapy as provided by PSPNET, and associated research

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 we will explore translating the course into French)

Primary outcomes:
measure: Change in insomnia
timeFrame: Screening, week 7 (post-treatment), and 3-month follow-up
Secondary outcomes:
measure: Change in Sleep Quality
timeFrame: Screening, start of lesson 1 (day 0), start of lesson 2 (day 7), start of lesson 3 (day 21), start of lesson 4 (day 35), and week 7 (post-treatment), and 3-month follow-up
measure: Change in Sleep-Related Impairment
timeFrame: Screening, week 7 (post-treatment), and 3 month follow up
measure: Change in attitudes and beliefs about sleep
timeFrame: Screening, week 7 (post-treatment) and 3-month follow-up
measure: Change in depression
timeFrame: Screening, week 7 (post-treatment) and 3-month follow-up
measure: Change in anxiety
timeFrame: Screening, week 7 (post treatment) and 3-month follow-up
measure: Change in posttraumatic stress
timeFrame: Screening, week 7 (post treatment) and 3-month follow-up
measure: Lesson reflection
timeFrame: At the end of Lesson 1 (day 0), Lesson 2 (day 7), Lesson 3 (day 21), and Lesson 4 (day 35).
measure: Evaluation of treatment
timeFrame: Week 7 (post-treatment)
measure: Number of Materials Accessed
timeFrame: Collects engagement from time of consent to 3-month follow-up
measure: Number of Contacts with Therapist
timeFrame: Collects engagement from time of consent to 3-month follow-up.
measure: Demographics
timeFrame: Screening
measure: Sleep history & treatment history
timeFrame: Screening
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: