Digital CBT for Insomnia in Healthcare Workers
(HCW-CBTi Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byMandeep Singh, MD, FRCPC
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Sleep apnea, Restless legs, Cancer, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are participating in other psychological treatments or drug trials, you would not be eligible for this study.
What data supports the effectiveness of the treatment Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)?
Research shows that digital cognitive behavioral therapy for insomnia (dCBTi) is effective in improving sleep quality and reducing insomnia severity. It has been found to be as effective as traditional therapy and helps improve overall health and psychological well-being.
12345Is digital CBT for insomnia safe for humans?
The research does not specifically mention safety concerns, suggesting that digital CBT for insomnia is generally considered safe for humans.
12456How is digital CBT for insomnia different from other treatments?
Digital CBT for insomnia is unique because it is delivered through digital platforms like smartphone apps, making it more accessible and scalable compared to traditional in-person therapy. It focuses on changing thoughts and behaviors related to sleep, which can improve sleep quality and daytime functioning without the need for medication.
12457Eligibility Criteria
This trial is for frontline healthcare workers experiencing insomnia, with a score of 16 or lower on the Sleep Condition Indicator. They must be actively involved in patient care during the COVID-19 pandemic and have access to a mobile phone or computer with internet. Those with urgent CBT needs, recent CBT treatment, additional sleep disorders like apnea or restless legs syndrome, severe medical/psychiatric conditions, or participating in other treatments/drug trials are excluded.Inclusion Criteria
Self-identify as being involved in frontline management of patients
Access to a mobile phone or a computer with Internet access
Health care workers with probable insomnia disorder, as indicated by a score of 16 or lower on the Sleep Condition Indicator (SCI)
Exclusion Criteria
I do not have any life-threatening conditions, severe neurological issues, or severe mental health problems.
My doctor says I urgently need cognitive behavioral therapy.
I have undergone cognitive behavioral therapy in the last 3 months.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants in the intervention arm receive digital CBTi via the Sleepio app over 6 to 12 weeks, while the control group accesses sleep diary and education material for 12 weeks.
12 weeks
Follow-up
Participants are monitored for changes in sleep health, mental health, and overall quality of life after the treatment phase.
12 weeks
Participant Groups
The study tests if digital Cognitive Behavioral Therapy for Insomnia (dCBTi) can improve sleep health, mental well-being, and quality of life among healthcare workers caring for COVID-19 patients. It's a Canada-wide randomized controlled trial comparing dCBTi's effectiveness against usual care practices.
2Treatment groups
Active Control
Group I: Attention Control armActive Control1 Intervention
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.
Group II: Intervention armActive Control1 Intervention
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.
Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) is already approved in Canada, United States, European Union for the following indications:
🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:
- Insomnia
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for Insomnia for:
- Insomnia
🇪🇺 Approved in European Union as Cognitive Behavioral Therapy for Insomnia for:
- Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto Western Hospital - UHNToronto, Canada
Toronto Western HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life.
Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]Digital cognitive behavior therapy for insomnia (dCBT-I) is an effective treatment in alleviating insomnia. This study examined the effect of dCBT-I for improving sleep quality in patients with insomnia complaints from a clinical population in a real-world setting.
Factors influencing the effectiveness of digital cognitive behavioural therapy for chronic insomnia in clinical practice. [2023]Digital cognitive behavioural therapy for chronic insomnia (D-CBT-I) has been shown to be as efficacious as traditional CBT-I. However, not all patients achieve insomnia remission after treatment. We explored the factors influencing the effectiveness of D-CBT-I in a clinical practice. A total of 414 Asian chronic insomniacs were studied during a 6 week D-CBT-I intervention. All patients were assessed at baseline and posttreatment and were determined to be remitters or non-remitters, responders or non-responders by posttreatment criteria; Insomnia Severity Index (ISI
The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]Digital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.
Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]Although digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many randomized clinical trials and is recommended as a first-line treatment option, few studies have systematically examined its effectiveness, engagement, durability, and adaptability in clinical settings.
Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]Digital cognitive behavioural therapy (dCBT) is an effective treatment for chronic insomnia and also improves well-being and quality of life (QoL). We assessed whether these benefits are sustained and if the effects of dCBT extend to the use of sleep medication and healthcare. In total 1,711 adults (48.0 ± 13.8 years, 77.6% female) with complaints of chronic insomnia participated in a previously published randomized controlled trial (ISRCTN 60530898) comparing dCBT (n = 853) with sleep hygiene education (SHE, n = 858). At weeks 0, 4, 8, 24, 36 and 48, we assessed functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale); psychological well-being (Warwick-Edinburgh Mental Well-being Scale) and sleep-related QoL (Glasgow Sleep Impact Index), prescribed and non-prescribed sleep medication use, and healthcare utilization. At week 25, those who received SHE at baseline were offered dCBT. dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p
Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.