Investigating the Effectiveness of Electronically Delivered Cognitive Behavioural Therapy (e-CBTi) Compared to Pharmaceutical Interventions in the Treatment of Insomnia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Queen's University
RECRUITING
Kingston
Contact Information
Primary
Nazanin Alavi, MD FRCPC
nazanin.alavi@queensu.ca
6135443310
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 60
Treatments
Active_comparator: Pharmacotherapy
Trazodone is the treatment of choice for insomnia and participants allocated to the pharmaceutical intervention group will be prescribed trazodone as a regular treatment for the duration of the study. Participants on trazodone will also visit the psychiatrist every month to ensure their wellbeing is protected, the quality of the data is maintained, the conduct of the trial is in compliance with the approved protocol, and other regulatory requirements. Trazodone is the routine practice for insomnia and is covered through most patients' healthcare. However, if the patient does not have coverage for trazodone, they will be provided financial compensation to offset the cost.
Experimental: e-CBTi
The e-CBTi modules will involve guiding participants to develop constructive and balanced strategies that would help to handle sleep problems. The e-CBTi program is based on the idea that insomnia is caused by thoughts and behaviours that can be changed. The modules aim to adjust negative thinking so patients can think about and adapt to the events that are happening to them, allowing them to adjust their behaviour and thoughts to be more realistic. Continuing, the modules are designed to help patients with insomnia deal with inaccurate thoughts about sleep and negative sleep behaviours, change their lifestyle practices that negatively affect their sleep, and improve relaxation skills to improve healthy sleep patterns. More specifically, the focus of the program is on addressing and exploring the concept of sleep, sleep habits, sleep hygiene, bedtime worries, negative thoughts, and thought examination.
Related Therapeutic Areas
Sponsors
Collaborators: Online PsychoTherapy Clinic
Leads: Dr. Nazanin Alavi

This content was sourced from clinicaltrials.gov