Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05125146

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

Led by Dr. Nazanin Alavi · Updated on 2024-10-18

60

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

D

Dr. Nazanin Alavi

Lead Sponsor

O

Online PsychoTherapy Clinic

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age at the start of the study
  • Diagnosed with non-organic insomnia
  • Difficulty initiating or maintaining sleep for 30 minutes or more
  • 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
Not Eligible

You will not qualify if you...

  • Presence of another untreated sleep disorder
  • Alcohol or substance use disorder
  • Ongoing cognitive-behavioral therapy
  • Untreated or unassessed significant somatic or mental symptoms or illnesses
  • Other sleep disorders that could explain insomnia symptoms or interfere with or be worsened by e-CBTi
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Queen's University

Kingston, Ontario, Canada, K7L5G2

Actively Recruiting

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Research Team

N

Nazanin Alavi, MD FRCPC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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