Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia

What this study is about

Insomnia is defined as the inability to fall asleep or stay asleep at night and it is one of the most prevalent sleep disorders that can have deleterious impacts on health and this population's quality of life. Currently, both pharmaceutical interventions (trazodone) and cognitive behavioral therapy (CBTi) are widely used to treat patients with insomnia. Although CBTi has been efficacious in many patients, multitude of barriers for receiving treatment such as its limited availability of therapists, high costs and long wait times challenge its ability in sufficiently meeting the population's health needs and demands. To improve the delivery of CBT, electronically delivered CBTi (e-CBTi) has been developed as an accessible and effective alternative intervention for improving sleep outcomes in patients with insomnia. While evidence suggest that e-CBTi is effective when compared to placebos/waitlist control, evidence comparing guided e-CBTi to pharmaceutical interventions is still insufficient and needs further exploration.

Who can join (things the study team will check)

✅ You may be able to join if…

• At least 18 years of age at the start of the study
• Non-organic insomnia
• Difficulty initiating, and/or maintaining sleep for ≥ 30 minutes and
• Use of sleep-promoting medication at least three nights per week for at least 3 months
• Ability to speak and read English
• Consistent and reliable access to the internet.

🚫 You may not be able to join if…

• Presence of another untreated sleep disorder
• Alcohol or substance use disorder
• Ongoing CBT
• Non-assessed or untreated clinically significant somatic or mental symptoms or illnesses
• Other sleep disorders that could explain current insomnia symptoms or interfere with or be worsened by e-CBTi
• Pregnancy

Where this trial is running

• Queen's University, Kingston, Ontario, Canada

Who to contact

Nazanin Alavi, MD FRCPC · 6135443310 · nazanin.alavi@queensu.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05125146.