Internet CBTi for Sleep Disorders

The University of Arizona, Tucson, AZ
Sleep DisordersInternet Cognitive Behavioral Therapy for Insomnia - Behavioral
Eligibility
50 - 65
All Sexes

Study Summary

This trial is testing whether CBTi can help improve sleep, circadian rhythms, biomarkers, cognitive performance, and MRI scans in adults aged 50-65.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 week Post-treatment

12 week Post-treatment
Circadian Rhythm
Diary-assessed Sleep
Evaluation of episodic memory
Evaluation of executive functioning
Inflammatory Health
Magnetic resonance imaging (MRI)
12-week Post-treatment
Insomnia Severity Index

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Internet CBTi
1 of 4
Waitlist Control
1 of 4
In-person CBTi
1 of 4
Telehealth CBTi
1 of 4

Active Control

100 Total Participants · 4 Treatment Groups

Primary Treatment: Internet CBTi · No Placebo Group · N/A

Internet CBTi
Behavioral
ActiveComparator Group · 1 Intervention: Internet Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Waitlist ControlNoIntervention Group · 1 Intervention: Waitlist Control · Intervention Types:
In-person CBTi
Behavioral
ActiveComparator Group · 1 Intervention: In-Person Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Telehealth CBTi
Behavioral
ActiveComparator Group · 1 Intervention: Telehealth Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 week post-treatment

Who is running the clinical trial?

University of ArizonaLead Sponsor
475 Previous Clinical Trials
142,730 Total Patients Enrolled
Daniel J Taylor, Ph.D.Principal InvestigatorThe University of Arizona
2 Previous Clinical Trials
281 Total Patients Enrolled

Eligibility Criteria

Age 50 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have trouble falling asleep or staying asleep regularly, and this problem meets the official criteria for Insomnia Disorder as defined by the DSM-5.
You are between the ages of 50 and 65.
You have normal hearing, with or without the use of hearing aids.
You have a fast and reliable internet connection that allows you to use video platforms like Zoom Health for teletherapy.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.