University of Regina
Regina, Saskatchewan, S4S 0A2, Canada
Location status: Recruiting
Location contact
Heather D Hadjistavropoulos, PhD
CONTACT
Heather D Hadjistavropoulos, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07021183
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Regina, Saskatchewan, S4S 0A2, Canada
Location status: Recruiting
Heather D Hadjistavropoulos, PhD
CONTACT
Heather D Hadjistavropoulos, PhD
PRINCIPAL_INVESTIGATOR
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Screening, week 7 (post-treatment), and week 12 (follow-up).
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, start of each lesson (days 0, 7, 21, and 35), week 7 (post-treatment), and week 12 (follow-up).
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, week 7 (post-treatment), and week 12 (follow up).
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), week 12 (follow-up).
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), and week 12 (follow-up).
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).
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).
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: At the end of each lesson (days 0, 7, 21, and 35).
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: Week 3 (2 questions only) and week 7 (post-treatment).
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: Collects engagement from time of consent to week 12 (follow-up).
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).
The system collects information on the number of emails and/or phone calls sent to and received from the assigned therapist.
Time frame: Screening
Background Information Questionnaire is a bespoke survey that collects sample characteristics at screening for descriptive purposes. No scores are calculated.
Time frame: Screening
Sleep and treatment history questions will be administered at screening for descriptive purposes. No scores are calculated based on these questions.
Contact information is provided by the study sponsor or research team.
University of Regina
Other
Uptake, Acceptability, and Effectiveness of Internet-Delivered Cognitive Behavioural Therapy for Public Safety Personnel With Self-Reported Sleep Difficulties
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