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Behavioral Intervention
Digital CBT for Insomnia in Healthcare Workers (HCW-CBTi Trial)
N/A
Waitlist Available
Led By Mandeep Singh, MD, FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
HCW-CBTi Trial Summary
This trial will study if digital CBTi can help frontline healthcare workers (HCWs) caring for COVID-19 patients get better sleep, mental health, wellness, and quality of life.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since dCBTi is a non-pharmaceutical therapy involving behavioral changes and education through digital means, it typically does not have direct physical side effects like medication might. However, participants may experience frustration or stress if they find adapting new sleeping habits challenging.
HCW-CBTi Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessing changes in the nature and severity of insomnia
Secondary outcome measures
Acceptability E-scale
Generalized Anxiety Disorder (GAD) 7
Impact of Event Scale
+10 moreHCW-CBTi Trial Design
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.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,478 Previous Clinical Trials
485,034 Total Patients Enrolled
3 Trials studying Anxiety Disorders
69 Patients Enrolled for Anxiety Disorders
Mandeep Singh, MD, FRCPCPrincipal InvestigatorAssociate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have sleep apnea or restless legs syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control arm
- Group 2: Intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there presently an opportunity to join this investigation?
"The trial details listed on clinicaltrials.gov indicate that this medical study, which was initially published on May 1st 2023, is no longer recruiting patients. Nonetheless, there are 2716 other studies currently open to potential participants."
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