Clinical Trial

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

Recruiting
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Record status
This record was last updated October 18, 2024 (before its estimated May 21, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-11-08; most recent amendment 2024-10-16.
Trial Details
NCT Number NCT05125146
Lead Sponsor Dr. Nazanin Alavi
Collaborators: Online PsychoTherapy Clinic
Conditions Insomnia
Enrollment 60 participants
Start Date 2021-11-01
Primary Completion 2025-05-21 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-18