60 Participants Needed

e-CBTi vs Trazodone for Insomnia

NA
Overseen ByNazanin Alavi, MD FRCPC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dr. Nazanin Alavi
Must be taking: Sleep-promoting medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves comparing e-CBTi to trazodone, you might be required to continue using sleep-promoting medication if you are already doing so.

Is digital CBT-I safe for treating insomnia?

Digital CBT-I is considered a safe treatment for insomnia, as it avoids the adverse effects often associated with medication and has been shown to improve sleep quality and well-being.12345

How does the treatment e-CBTi differ from other treatments for insomnia?

e-CBTi (digital cognitive behavioral therapy for insomnia) is unique because it is delivered online, making it more accessible and scalable compared to traditional face-to-face therapy. Unlike trazodone, a medication that alters brain activity during sleep, e-CBTi focuses on changing sleep-related behaviors and thoughts, which can also help with related issues like depression and anxiety.36789

What data supports the effectiveness of the treatment e-CBTi for insomnia?

Research shows that digital cognitive behavioral therapy for insomnia (dCBT-I) is effective in treating insomnia, improving sleep quality, and enhancing overall well-being and quality of life. Studies also suggest that adding personalized telephone sessions to dCBT-I can provide additional benefits for those with chronic insomnia.5791011

Who Is on the Research Team?

NA

Nazanin Alavi, MD FRCPC

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adults with non-organic insomnia who struggle to fall or stay asleep for at least 30 minutes. Participants must have internet access, use sleep meds thrice a week for 3 months, and understand English. It's not for pregnant individuals, those with untreated sleep disorders or substance abuse issues, current CBT patients, or people with significant untreated health problems.

Inclusion Criteria

Ability to speak and read English
Consistent and reliable access to the internet
I have been diagnosed with insomnia not caused by a physical condition.
See 2 more

Exclusion Criteria

Pregnancy
Alcohol or substance use disorder
I have an untreated sleep disorder.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants are randomly assigned to either e-CBTi or trazodone treatment for 7 weeks

7 weeks
Weekly online sessions for e-CBTi group; Monthly in-person visits for trazodone group

Follow-up

Participants are monitored for changes in sleep quality and insomnia severity after treatment

4 weeks
2 visits (in-person)

Open-label extension (optional)

Participants in the trazodone group may opt into the e-CBTi program after the 7-week study period

Optional

What Are the Treatments Tested in This Trial?

Interventions

  • e-CBTi
  • Trazodone
Trial Overview The study compares e-CBTi—an online cognitive behavioral therapy—and Trazodone—a medication—to see which is more effective in treating insomnia. The goal is to determine if e-CBTi can be an accessible alternative to traditional treatments.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: e-CBTiExperimental Treatment1 Intervention
Group II: PharmacotherapyActive Control1 Intervention

e-CBTi is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Somryst for:
🇪🇺
Approved in European Union as Digital CBT-I for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Nazanin Alavi

Lead Sponsor

Trials
14
Recruited
1,100+

Dr. Nazanin Alavi

Lead Sponsor

Trials
14
Recruited
1,100+

Queen's University

Lead Sponsor

Trials
382
Recruited
122,000+

Online PsychoTherapy Clinic

Collaborator

Trials
9
Recruited
710+

Published Research Related to This Trial

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.
The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.
Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial.Espie, CA., Emsley, R., Kyle, SD., et al.[2023]
Integrating personalized telephone sessions with digital cognitive behavior therapy for insomnia (TD-CBTI) significantly improved treatment outcomes, leading to a 167% increase in the odds of achieving remission from insomnia compared to standard D-CBTI alone.
Patients receiving TD-CBTI also had a 352% higher likelihood of successfully reducing their sleep medication use, highlighting the added clinical benefits of personalized support in managing chronic insomnia.
The beneficial effects of integrating a personalized telephone-delivered component into digital cognitive behavioral therapy for insomnia in a large, hospital-based population.Ren, R., Zhang, Y., Shi, Y., et al.[2023]
In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.
The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.
The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT.Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

Citations

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]
The beneficial effects of integrating a personalized telephone-delivered component into digital cognitive behavioral therapy for insomnia in a large, hospital-based population. [2023]
The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]
Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]
Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]
Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. [2021]
Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. [2021]
Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. [2023]
Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]
Effect of trazodone versus cognitive-behavioural treatment on high- and slow-frequency activity during non-rapid eye movement sleep in chronic insomnia: A pilot, randomized clinical trial. [2022]
Secondary psychiatric care patients' experiences of internet CBT for insomnia - a qualitative study. [2022]
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