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e-CBTi 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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Index (ISI) - Change in Symptoms (Quantitative)
Secondary outcome measures
Behavioural Interactions- Change in Engagement
Sleep Diary - Change in Sleep Quality
Sleep Diary - Change in Sleep quality
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.
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Who is running the clinical trial?
Dr. Nazanin AlaviLead Sponsor
12 Previous Clinical Trials
1,056 Total Patients Enrolled
Queen's UniversityLead Sponsor
366 Previous Clinical Trials
121,677 Total Patients Enrolled
Online PsychoTherapy ClinicOTHER
8 Previous Clinical Trials
641 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment capacity for this research project?
"Affirmative. The information on clinicaltrials.gov indicates that this experiment is presently recruiting participants, with a total of 60 needed from one site since it was first posted in November 1st 2021 and last updated on the 17th."
Answered by AI
What other explorations have taken place regarding the efficacy of e-CBTi?
"Currently, 6 trials are underway for e-CBTi with two of them in their final phase. 55 sites worldwide are conducting these clinical studies, including a few located in Los Angeles, California."
Answered by AI
What ailments typically benefit from e-CBTi treatment?
"Electronic Cognitive-Behavioural Therapy Intervention (e-CBTi) has been shown to mitigate the effects of pain, as well as managing symptoms associated with schizophrenia, eating disorders, and Alzheimer's disease."
Answered by AI
Is this research endeavor currently accepting new participants?
"As per the information hosted on clinicaltrials.gov, this trial is ongoing and actively seeking participants. It was first announced on November 1st 2021, with the last alterations to its details occurring 16th of that same month."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Queen's University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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