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临床试验/NCT07021183
NCT07021183招募中不适用

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

University of Regina1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Change in insomnia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

ICBT for insomnia

Experimental

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

干预措施: Sleep Course (Behavioral)

结局指标

主要结局

Change in insomnia

时间窗: 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.

Insomnia

时间窗: 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.

次要结局

  • Evaluation of treatment(Week 7 (post-treatment))
  • Number of Contacts with Therapist(Collects engagement from time of consent to 3-month follow-up.)
  • Change in Sleep Quality(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)
  • Change in Sleep-Related Impairment(Screening, week 7 (post-treatment), and 3 month follow up)
  • Change in attitudes and beliefs about sleep(Screening, week 7 (post-treatment) and 3-month follow-up)
  • Change in depression(Screening, week 7 (post-treatment) and 3-month follow-up)
  • Change in anxiety(Screening, week 7 (post treatment) and 3-month follow-up)
  • Change in posttraumatic stress(Screening, week 7 (post treatment) and 3-month follow-up)
  • Lesson reflection(At the end of Lesson 1 (day 0), Lesson 2 (day 7), Lesson 3 (day 21), and Lesson 4 (day 35).)
  • Number of Materials Accessed(Collects engagement from time of consent to 3-month follow-up)
  • Demographics(Screening)
  • Sleep history & treatment history(Screening)
  • Sleep Quality(Screening, start of each lesson (days 0, 7, 21, and 35), week 7 (post-treatment), and week 12 (follow-up).)
  • Sleep-Related Impairment(Screening, week 7 (post-treatment), and week 12 (follow up).)
  • Sleep Attitudes and Beliefs(Screening, week 7 (post-treatment), week 12 (follow-up).)
  • Depression(Screening, week 7 (post-treatment), and week 12 (follow-up).)
  • Anxiety(Screening, week 7 (post-treatment), and week 12 (follow-up).)
  • Posttraumatic Stress(Screening, week 7 (post-treatment), and week 12 (follow-up).)
  • Lesson Reflections(At the end of each lesson (days 0, 7, 21, and 35).)
  • Treatment Satisfaction(Week 3 (2 questions only) and week 7 (post-treatment).)
  • Number of Materials Accessed(Collects engagement from time of consent to week 12 (follow-up).)
  • Number of Contacts with Therapist(Collects engagement from time of consent to week 12 (follow-up).)
  • Background Information(Screening)
  • Sleep and Treatment History(Screening)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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