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

ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Nazanin Alavi

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • e-CBTi
  • Trazodone

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr. Nazanin Alavi

Lead sponsor

Queen's University

Sponsor institution

Online PsychoTherapy Clinic

Collaborator