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 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.
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 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 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). 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 offer 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. Clients 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 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:
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 previously developed and evaluated in Australia has been tailored to PSP and will be delivered to clients meeting participation criteria. The Sleep Course has been slightly adapted for PSP by including relevant statistics and literature pertaining to sleep disturbance in PSP. The Sleep Course has four lessons and includes optional therapist support for up to 8 - 12 weeks. Clients who request support will be contacted by their therapist by secure emails on their designated check-in dates. The therapist also reviews client progress in the course and emails clients on a designated check in date. Sometimes the therapist will call the client. Phone calls are typically made if a client is not logging in or if the therapist feels that a phone call would be a helpful way to provide support.
Time frame: Screening, week 7 (post-treatment), and 3-month follow-up
Insomnia Severity Index (ISI). Includes 7 items rated on a 0 to 5 scale. Higher total scores indicate greater severity of insomnia symptoms over the past two weeks. Scores range from 0 to 28.
Time frame: 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
Sleep Quality Scale (SQS) is a 1-item survey with total scores ranging from 0-10. Higher scores indicate better overall sleep quality for over the past week.
Time frame: Screening, week 7 (post-treatment), and 3 month follow up
The PROMIS Sleep Related Impairment Short Form (SRI-SF) scale assesses the impact of sleep disturbances on daytime functioning. There are 8 items, which are related to cognitive, emotional, and social functioning. Responses range from 0 (not at all) to 4 (very much) with total scores ranging from 8-40.
Time frame: Screening, week 7 (post-treatment) and 3-month follow-up
Dysfunctional Beliefs and Attitudes about Sleep- 16 item (DBAS-16) with items rated on a 0 to 10-point scale. Scores range from 0 to 160 with higher scores indicating greater dysfunctional beliefs about sleep.
Time frame: Screening, week 7 (post-treatment) and 3-month follow-up
Patient Health Questionnaire - 9 Item (PHQ-9). Includes 9 items rated 0 to 3. Higher total scores indicate greater severity of depression. Scores range from 0 to 27. Clinical cutoff of ≥10 indicate clinically significant depression.
Time frame: Screening, week 7 (post treatment) and 3-month follow-up
Generalized Anxiety Disorder - 7 Item (GAD-7). Includes 7 items rated 0 to 3. Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21. Clinical cutoff of ≥10 indicates clinically significant anxiety.
Time frame: Screening, week 7 (post treatment) and 3-month follow-up
Abbreviated PTSD Checklist - Civilian Version (PCL-C). Six items. Higher total scores indicate greater severity of posttraumatic stress. Scores range from 5 to 30.
Time frame: At the end of Lesson 1 (day 0), Lesson 2 (day 7), Lesson 3 (day 21), and Lesson 4 (day 35).
Lesson reflection questionnaire - A bespoke 5-item survey that inquires about how understandable and helpful the lesson was, client successes or challenges over the previous week, and suggestions for improvement. This survey is used for clinicians to monitor treatment. No overall score is created.
Time frame: Week 7 (post-treatment)
Treatment Satisfaction Survey. A bespoke questionnaire 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 3-month 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 3-month 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
Demographic questions will be collected 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 Behaviour Therapy for Public Safety Personnel With Self-Reported Sleep Difficulties
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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