Digital CBT for Insomnia in Healthcare Workers (HCW-CBTi Trial)

N/A

Recruiting

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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessing changes in the nature and severity of insomnia

Secondary study objectives

Acceptability E-scale

Generalized Anxiety Disorder (GAD) 7

Impact of Event Scale

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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