Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Cognitive Behavioral Therapy for Insomnia (dCBTi).
- Who it may be relevant to
- Registry conditions: Insomnia, Post Traumatic Stress Disorder, Anxiety Disorders, Depression. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Assessing changes in the nature and severity of insomnia: [Time frame: 12 weeks]
Secondary outcome measures (12)
- Sleep Condition Indicator [Time frame: 12 weeks]
- Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Disturbance [Time frame: 12 weeks]
- Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Related Impairment [Time frame: 12 weeks]
- Generalized Anxiety Disorder (GAD) 7 [Time frame: 12 weeks]
- Warwick Edinburgh Mental Wellbeing Scale(WEMWBS ) [Time frame: 12 weeks]
- Work And Social Adjustment Scale (WSAS) [Time frame: 12 weeks]
- Impact of Event Scale [Time frame: 12 weeks]
- Work Productivity and Activity Impairment Questionnaire [Time frame: 12 weeks]
- Maslach Burnout Inventory - Human Service Survey [Time frame: 12 weeks]
- Patient Global Impression Scale [Time frame: 12 weeks]
- Therapy Evaluation Questionnaire [Time frame: 12 weeks]
- Acceptability E-scale [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Toronto Western Hospital - UHN — Toronto
- Toronto Western Hospital — Toronto
Identifiers
NCT: NCT05816304 · 20-5619