Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention arm Digital CBTi will be offered using the SleepioTM website and supporting Sleepio™ app (Big Health Ltd., London, UK) via 6 sessions training program (spanning 6 to 12 weeks), lasting an average of 20 minutes each, unlocked weekly. The participant will receive the Sleepio intervention as soon as they become assigned. |
Behavioral: Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)
Digital CBTi is a computer-based cognitive behavioral therapy that provides strategies to improve sleep and daytime function (concentration, productivity) and decreases symptoms of sleep-related attributions, night-time thought content in individuals with insomnia. It is easily accessible with any internet-connected device, eg, computer, tabs, and smartphones.
Other Names:
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| No Intervention: Attention Control arm Participants in the control group will have access to online the sleep diary and sleep education material for 12 weeks, without the CBTi intervention by the Sleepio™ app (Big Health Ltd., London, UK). They will start the digital cognitive behavioral therapy for insomnia (dCBTi) intervention 12 weeks after the initial enrollment. |
Outcome Measures
Primary Outcome Measures
- Assessing changes in the nature and severity of insomnia: [12 weeks]
Change in score on the Insomnia Severity Index (ISI ) from baseline to 12 weeks. ISI is a 7-item self-report questionnaire that assesses insomnia's nature, severity, and impact.
Secondary Outcome Measures
- Sleep Condition Indicator [12 weeks]
It is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. The SCI is valid, reliable, and sensitive to change.
- Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Disturbance [12 weeks]
The PROMIS Sleep Disturbance is an eight-item scale that assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.
- Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Related Impairment [12 weeks]
The PROMIS Sleep-Related impairment is an eight-item scale that focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.
- Generalized Anxiety Disorder (GAD) 7 [12 weeks]
The GAD-7 is a valid and efficient tool for screening and assessing the severity of generalized anxiety disorder (GAD) in clinical practice and research.
- Warwick Edinburgh Mental Wellbeing Scale [12 weeks]
14 items to measure feeling and functional aspect of mental wellbeing
- Work And Social Adjustment Scale [12 weeks]
5 items to measure functional impairment attributed to a given disorder.
- Impact of Event Scale [12 weeks]
22 items to measure current subjective distress due to traumatic life event.
- Work Productivity and Activity Impairment Questionnaire [12 weeks]
It consists of 6 items to measure impairments in works.
- Maslach Burnout Inventory - Human Service Survey [12 weeks]
22 items to measure burnout in medical professionals
- Patient Global Impression Scale [12 weeks]
1 item a participant's impression of change from the start to the end of the study
- Therapy Evaluation Questionnaire [12 weeks]
5 items to evaluate the therapy
- Acceptability E-scale [12 weeks]
6 items to evaluate the feasibility of SleepioTM app
- Sleep Health Disruption [12 weeks]
Sleep efficiency, total sleep time, total wake time, bed time and rise time collected from the sleep diary embedded in SleepioTM app
Eligibility Criteria
Criteria
Inclusion Criteria:
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Health care workers (physicians and nurses) with probable insomnia disorder, as indicated by a score of 16 or lower on the Sleep Condition Indicator (SCI),
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Self-identify as being involved in frontline management of patients;
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English speaking
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Access to a mobile phone or a computer with Internet access.
Exclusion Criteria:
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Participants requiring urgent CBT treatment as per their health care provider,
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Participants received CBT in the past 3 months
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Participants participating in other psychological treatments and/or drug trials during the study;
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Self-reported additional sleep related disorders: sleep apnea or restless legs syndrome;
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Significant other significant medical or psychiatric conditions:
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life threatening (e.g. cancer),
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neurological conditions (e.g. epilepsy);
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severe depression
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active suicide intent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toronto Western Hospital | Toronto | Ontario | Canada |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Mandeep Singh, MD, FRCPC, Associate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-5619