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In-person CBTi for Sleep Disorders (CBTi Trial)
CBTi Trial Summary
This trial is testing whether CBTi can help improve sleep, circadian rhythms, biomarkers, cognitive performance, and MRI scans in adults aged 50-65.
CBTi Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCBTi Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CBTi Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with Insomnia Disorder according to the DSM-5 criteria.You are currently receiving therapy for insomnia using a specific type of therapy called Cognitive Behavioral Therapy (CBT).You have sleep problems like trouble sleeping, being overly sleepy, or having a disrupted sleep schedule. We want to make sure the treatment we're testing is safe and effective for people with these issues, but we haven't checked that yet.You are currently at risk for suicide and need immediate help.You have normal hearing, with or without the use of hearing aids.You are afraid of needles or small spaces, like those in an MRI machine.
- Group 1: In-person CBTi
- Group 2: Telehealth CBTi
- Group 3: Internet CBTi
- Group 4: Waitlist Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still available openings for volunteers to participate in this clinical trial?
"Affirmative. Per the information on clinicaltrials.gov, this research is currently recruiting participants. It was first posted to the website in October 2021 and has since been updated in February 2022. A total of 100 patients from a single location are required for this experiment."
Is eligibility for this trial restricted to individuals over twenty years of age?
"Eligibility for this clinical study necessitates that participants are aged between 50 and 65 years old."
What criteria must be fulfilled to join this research study?
"For this clinical trial, 100 subjects aged 50-65 who have been diagnosed with Insomnia Disorder are being recruited. Furthermore they must be able to demonstrate normal hearing and cognitive abilities, possess a computer capable of video calls, read/speak English fluently and remain in the area for 6 months post initial assessment. Additionally participants will need to adhere to an Internet connection speed suitable for teletherapy or digital Cognitive Behavioral Therapy (CBT). They also cannot start any external treatment plans pertaining to sleep during their participation in the study"
How many participants are signing up for the experimental program?
"Affirmative. According to the clinicaltrials.gov portal, this trial is currently recruiting participants who meet its requirements. It was first posted on October 21st 2021 and updated most recently on February 4th 2022, with an aim of enrolling 100 patients at 1 site."
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