- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816304
Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study) (HCW-CBTi)
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mandeep Singh, MBBS, FRCPC
- Phone Number: 416-603-5118
- Email: mandeep.singh@uhn.ca
Study Contact Backup
- Name: Nayeemur Rahman, MBBS, PhD
- Phone Number: 3959 416-603-5800
- Email: sleapprogram@uhn.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada
- Toronto Western Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing changes in the nature and severity of insomnia:
Time Frame: 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. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. The score can be classified in the following way: the total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe). |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Condition Indicator
Time Frame: 12 weeks
|
It is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. Each item was scored on a 5-point scale (0-4), with lower scores, in the 0-2 range, reflecting putative threshold criteria for insomnia disorder. The possible total score ranges from 0 to 32, with higher values than 16 indicative of better sleep. The SCI is valid, reliable, and sensitive to change. |
12 weeks
|
Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Disturbance
Time Frame: 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.
Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
The raw scores on the 8 items should be summed to obtain a total raw score.
|
12 weeks
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Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Related Impairment
Time Frame: 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.
Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
The raw scores on the 8 items should be summed to obtain a total raw score.
|
12 weeks
|
Generalized Anxiety Disorder (GAD) 7
Time Frame: 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. Screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder; The following cut-offs correlate with the level of anxiety severity:
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12 weeks
|
Warwick Edinburgh Mental Wellbeing Scale(WEMWBS )
Time Frame: 12 weeks
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14 items to measure feeling and functional aspects of mental well-being.
The WEMWBS is scored by summing the scores for each of the 14 items, which are scored from 1 to 5. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score.
Scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
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12 weeks
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Work And Social Adjustment Scale (WSAS)
Time Frame: 12 weeks
|
5 items to measure functional impairment attributed to a given disorder.5
items can be scored from 0 to 8. A score of all Items will be summed up.
WSAS score >20 reflects severe or worse psychopathology., 10 to 20 reflects significant functional impairment but less severe clinical symptomatology and <10 appears to signify subclinical disorders populations.
|
12 weeks
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Impact of Event Scale
Time Frame: 12 weeks
|
22 items to measure current subjective distress due to traumatic life events.
The Impact of Event Scale has a scoring range of 0 to 88and a score above 24 is meaningful.
A score of 24 or more will have partial PTSD or at least some of the symptoms.
A score of 33 and above is a probable diagnosis of PTSD.
A score of 37 or more is high enough to suppress the immune system's functioning.
|
12 weeks
|
Work Productivity and Activity Impairment Questionnaire
Time Frame: 12 weeks
|
It consists of 6 items to measure impairments in works.
The sum of specific health problem impairment and impairment due to other health reasons is equal to impairment due to all health reasons.
WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.
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12 weeks
|
Maslach Burnout Inventory - Human Service Survey
Time Frame: 12 weeks
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22 items to measure burnout in medical professionals. Responses are scored on a six-point Likert scale, ranging from 0 = never to 6 = every day, for each subscale, and tabulated into three tiers (low, moderate, or high). Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions. Based on the reference ranges provided with the MBI-HSS: for EE, low (0-16), moderate (17-26), and high (≥27); for DP, low (0-6), moderate (7-12) and high (≥13), and finally, for PA, low (≤31), moderate (32-38) and high (≥39). Burnout was defined by the updated Maslach-recommended criteria of "high EE and high DP" or "high EE and low PA" |
12 weeks
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Patient Global Impression Scale
Time Frame: 12 weeks
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PGIC is a 7-point scale depicting a patient's rating of overall improvement.
Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
PGIC is commonly used to evaluate the overall improvement or change in symptoms following treatment and is an important indicator of significant change in treatments of chronic pain.
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12 weeks
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Therapy Evaluation Questionnaire
Time Frame: 12 weeks
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5 items can be scored from 1 to 7. The higher score signifies the greater Depth, Smoothness, and Positivity, of therapy.
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12 weeks
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Acceptability E-scale
Time Frame: 12 weeks
|
Acceptability E-scale has strong psychometric properties and can be useful in assessing the acceptability and usability of computerized health-related programs.
The score was rated on five Likert-type scale responses; 1-strongly disagree; 2disagree; 3-not sure; 4-agree; 5-strongly agree.
A score of 40 or above indicates that program iss feasible for the use.
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12 weeks
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Sleep Health Disruption
Time Frame: 12 weeks
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Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Mandeep Singh, MD, FRCPC, Associate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-5619
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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