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e-CBTi vs Trazodone for Insomnia

N/A

Recruiting

Led By Nazanin Alavi, MD FRCPC

Research Sponsored by Dr. Nazanin Alavi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, 1, 2, 3, 4, 5, 6, 7

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is comparing the effects of a common sleep medication (trazodone) to a cognitive behavioral therapy (CBTi) delivered electronically (e-CBTi) in patients with insomnia.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

e-CBTi may cause minimal side effects as it's a therapeutic intervention without drugs. Trazodone can lead to drowsiness, dizziness, constipation, blurred vision and sometimes more serious effects like irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, 1, 2, 3, 4, 5, 6, 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, 1, 2, 3, 4, 5, 6, 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, 1, 2, 3, 4, 5, 6, 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI) - Change in Symptoms (Quantitative)

Secondary study objectives

Behavioural Interactions- Change in Engagement

Sleep Diary - Change in Sleep Quality

Sleep Diary - Change in Sleep quality

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: e-CBTiExperimental Treatment1 Intervention

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.

Group II: PharmacotherapyActive Control1 Intervention

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.

Do I qualify?Apply below to find out