Clinical trial NCT05816304: Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Post Traumatic Stress Disorder
Anxiety Disorders
Depression
Keywords: Insomnia,
sleep health,
Cognitive Behavioral Therapy
Digital Cognitive Behavioral Therapy
Health Care Workers
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, pragmatic prospective, parallel, multi-center, randomized controlled trial (RCT)
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Assessing changes in the nature and severity of insomnia:
timeFrame: 12 weeks
Secondary outcomes:
measure: Sleep Condition Indicator
timeFrame: 12 weeks
measure: Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Disturbance
timeFrame: 12 weeks
measure: Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Related Impairment
timeFrame: 12 weeks
measure: Generalized Anxiety Disorder (GAD) 7
timeFrame: 12 weeks
measure: Warwick Edinburgh Mental Wellbeing Scale(WEMWBS )
timeFrame: 12 weeks
measure: Work And Social Adjustment Scale (WSAS)
timeFrame: 12 weeks
measure: Impact of Event Scale
timeFrame: 12 weeks
measure: Work Productivity and Activity Impairment Questionnaire
timeFrame: 12 weeks
measure: Maslach Burnout Inventory - Human Service Survey
timeFrame: 12 weeks
measure: Patient Global Impression Scale
timeFrame: 12 weeks
measure: Therapy Evaluation Questionnaire
timeFrame: 12 weeks
measure: Acceptability E-scale
timeFrame: 12 weeks
measure: Sleep Health Disruption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital - UHN
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Associate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN
name: Mandeep Singh, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: