Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)

Last updated: December 5, 2024
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Anxiety Disorders

Insomnia

Treatment

Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)

Clinical Study ID

NCT05816304
20-5619
  • All Genders

Study Summary

The COVID-19 pandemic has resulted in increased workload and concerns about personal and family safety for frontline healthcare workers (HCWs), which can lead to decreased well-being and worsening mental health. Sleep disruption is particularly prevalent among HCWs providing frontline COVID-19 care. It can have direct consequences on their cognitive and emotional functioning, as well as on patient safety. Cognitive Behavioral Therapy for insomnia (CBTi) is a first-line treatment for insomnia. It has been shown to improve sleep health and wellbeing in the general population. However, there are significant barriers to delivering CBTi to frontline HCWs, including limited availability of trained sleep therapists and high costs. To address this, a Canada-wide randomized controlled trial is developed to determine the effectiveness of a digital CBTi program on the sleep health, mental health, wellness, and overall quality of life of frontline HCWs caring for COVID-19 patients. This study may provide an easily accessible and scalable sleep health intervention that can be included as part of a national and global response to the COVID-19 pandemic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Health care workers with probable insomnia disorder, as indicated by a score of 16or lower on the Sleep Condition Indicator (SCI),

  • Self-identify as being involved in frontline management of patients;

  • Access to a mobile phone or a computer with Internet access.

Exclusion

Exclusion Criteria:

  • Participants requiring urgent CBT treatment as per their health care provider,

  • Participants received CBT in the past 3 months

  • Participants participating in other psychological treatments and/or drug trialsduring the study;

  • Self-reported additional sleep related disorders: sleep apnea or restless legssyndrome;

  • Significant other significant medical or psychiatric conditions e.g. lifethreatening (e.g. cancer), neurological conditions (e.g. epilepsy); severedepression , active suicide intent.

Study Design

Total Participants: 366
Treatment Group(s): 1
Primary Treatment: Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)
Phase:
Study Start date:
June 16, 2023
Estimated Completion Date:
April 30, 2025

Study Description

Sleep disruption is prevalent in frontline healthcare workers (HCWs), of which more than 30% are physicians and nurses. The ongoing COVID-19 crisis has caused decreasing well-being and worsening mental health. Frontline HCWs involved in the management of patients with COVID-19 are nearly 3 times more likely to experience insomnia than anxiety or depression. It can have direct consequences on cognitive and emotional functioning and well-being, which impacts the safety of the patients. Insomnia is a health problem that may be appropriately treated with a less resource-intensive solution. Hypnotics can be considered for short-term use for severe insomnia but it is not free of psychological and/or physical dependence, tolerance, substance misuse, and sleepiness. Therefore, non-pharmacological sleep therapies such as CBTi may be advantageous for improving sleep health, HCW wellness, and in preventing burnout.

Cognitive Behavioral Therapy for insomnia (CBTi) is currently a first-line therapy for adults with sleep disorders including insomnia and other sleep health disruptions. The principles and specific elements of CBTi include stimulus control, sleep hygiene, relaxation therapy, cognitive re-appraisal, and sleep restriction techniques. Delivering CBTi to frontline HCWs is associated with significant barriers including the limited availability of trained sleep therapists and the high cost of receiving face-to-face treatment. Digital CBTi can be easily accessed while maintaining physical distancing, and is less resource intensive than traditional CBTi, while providing symptom self-management and ongoing coach-tailored feedback. Recently, digital CBTi (Sleepio™, Big Health Ltd., London, UK) was made available free of charge to over 1 million frontline COVID-19 HCWs in the United Kingdom's National Health Service for the duration of the COVID-19 pandemic. Indeed, CBTi has already been shown to be effective for patients with insomnia in the general population, but it has not been evaluated amongst HCWs during a pandemic. We propose a national RCT amongst frontline HCWs taking care of patients during the COVID19 era to determine the effect of a digital CBTi program (SleepioTM) on their sleep health, mental health, wellness domains, and overall HRQL.

Connect with a study center

  • Toronto Western Hospital

    Toronto, Ontario
    Canada

    Site Not Available

  • Toronto Western Hospital - UHN

    Toronto, Ontario M5T 2S8
    Canada

    Active - Recruiting

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