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Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)
NCT05816304 · University Health Network, Toronto
In plain English
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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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Health care workers with probable insomnia disorder, as indicated by a score of 16 or 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 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 trials during the study;
* Self-reported additional sleep related disorders: sleep apnea or restless legs syndrome;
* Significant other significant medical or psychiatric conditions e.g. life threatening (e.g. cancer), neurological conditions (e.g. epilepsy); severe depression , active suicide intent.
Study design
Enrollment target: 366 participants
Allocation: randomized
Masking: single
Age groups: child, adult, older_adult
Timeline
Starts: 2023-06-16
Estimated completion: 2025-04-30
Last updated: 2024-12-11
Interventions
Behavioral: Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)
Primary outcomes
- • Assessing changes in the nature and severity of insomnia: (12 weeks)
Sponsor
University Health Network, Toronto · other
Contacts & investigators
ContactMandeep Singh, MBBS, FRCPC · contact · mandeep.singh@uhn.ca · 416-603-5118
ContactAbdel Basit Al Hawwari, MSN, RN · contact · abdelbasit.alhawwari@uhn.ca · 4166035800
InvestigatorMandeep Singh, MD, FRCPC · principal_investigator, Associate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN
All locations (2)
Toronto Western Hospital - UHNRecruiting
Toronto, Ontario, Canada
Toronto Western HospitalEnrolling By Invitation
Toronto, Ontario, Canada