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Compares treatment options for Insomnia
Official title Investigating the Effectiveness of E-CBTi Compared to Pharmaceutical Interventions in Treating Insomnia
ClinicalTrials.gov ID: NCT05125146
What this study is testing
What is Trazodone?
Trazodone is an investigational medicine, given as an once-weekly, being studied as a potential treatment for insomnia.
Also referred to as Control.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.