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Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)

NCT ID: NCT05816304

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Insomnia Post Traumatic Stress Disorder Anxiety Disorders Depression

Keywords

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Insomnia, sleep health, Cognitive Behavioral Therapy Digital Cognitive Behavioral Therapy Health Care Workers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm, pragmatic prospective, parallel, multi-center, randomized controlled trial (RCT)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be randomized and allocated to either the intervention or attention control arm of the trial. Randomization will be centrally controlled, and allocation will be concealed using a secure, web-based randomization using the Research Electronic Data Capture (REDCap) platform.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Sleepio

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mandeep Singh, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN

Locations

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Toronto Western Hospital - UHN

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status ENROLLING_BY_INVITATION

Countries

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Canada

Central Contacts

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Mandeep Singh, MBBS, FRCPC

Role: CONTACT

Phone: 416-603-5118

Email: [email protected]

Abdel Basit Al Hawwari, MSN, RN

Role: CONTACT

Phone: 4166035800

Email: [email protected]

Facility Contacts

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Mandeep Singh, MBBS, FRCPC

Role: primary

Abdel Basit Al Hawwari

Role: backup

Other Identifiers

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20-5619

Identifier Type: -

Identifier Source: org_study_id