Comparing online cognitive behavioral therapy to medication for insomnia treatment
Investigating the Effectiveness of Electronically Delivered Cognitive Behavioural Therapy (e-CBTi) Compared to Pharmaceutical Interventions in the Treatment of Insomnia
This study is testing whether online therapy for insomnia works better than a sleep medication called trazodone for people struggling with sleep issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT05125146 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of electronically delivered cognitive behavioral therapy for insomnia (e-CBTi) compared to the pharmaceutical intervention trazodone in treating patients with insomnia. It aims to recruit 60 participants diagnosed with non-organic insomnia, who will undergo an initial psychiatric assessment to confirm eligibility. Participants will receive either e-CBTi or trazodone, with the goal of improving sleep outcomes and addressing barriers to traditional CBT treatment. The study seeks to provide evidence on the comparative effectiveness of these two treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with non-organic insomnia who have difficulty initiating or maintaining sleep and have been using sleep-promoting medication regularly.
Not a fit: Patients with untreated sleep disorders, substance use disorders, or those currently undergoing cognitive-behavioral therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for patients suffering from insomnia.
How similar studies have performed: While evidence suggests that e-CBTi is effective compared to placebos, this study is novel in comparing it directly to pharmaceutical interventions like trazodone.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kingston, Ontario
- Queen's University — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Nazanin Alavi, MD FRCPC — Queen's University
- Study coordinator: Nazanin Alavi, MD FRCPC
- Email: nazanin.alavi@queensu.ca
- Phone: 6135443310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.