Investigating the Effectiveness of e-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia
Insomnia
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Mental health, Psychotherapy, Cognitive behavioral therapy, Online, Internet, Mental health care, Pharmacotherapy, Pharmaceutical
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Other sleep disorders that could explain current insomnia symptoms or interfere with or be worsened by e-CBTi
- Pregnancy
Sites / Locations
- Queen's UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Pharmacotherapy
e-CBTi
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.
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.