Viewing Study NCT05816304



Ignite Creation Date: 2024-05-06 @ 6:52 PM
Last Modification Date: 2024-10-26 @ 2:56 PM
Study NCT ID: NCT05816304
Status: RECRUITING
Last Update Posted: 2023-05-19
First Post: 2023-03-30

Brief Title: Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers The HCW-CBTi Study
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Evaluating the Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers The HCW-CBTi Study a 2-arm Pragmatic Prospective Parallel Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HCW-CBTi
Brief 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
Detailed 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 andor 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 Kingdoms 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None