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

Condition(s) studied

Investigational drug(s) / intervention(s)

e-CBTi: See arm/group description

Trazodone: See arm/group edescription

Study 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.

Eligibility

Primary outcome measure(s)

• Insomnia Severity Index (ISI) - Change in Symptoms (Quantitative) — Baseline (week 0), mid-point (week 3-4), post-treatment (week 7)
  Measures insomnia symptom severity; 7 questions; answer range from 0-4, 0 being best, 4 being worst

Trial sites (1)

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