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Behavioral Intervention

In-person CBTi for Sleep Disorders (CBTi Trial)

N/A
Recruiting
Led By Daniel J Taylor, Ph.D.
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal hearing with or without hearing aids
Meets DSM-5 Criteria for Insomnia Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week post-treatment
Awards & highlights

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 below
Select...
You have normal hearing, with or without the use of hearing aids.
Select...
You have been diagnosed with Insomnia Disorder according to the DSM-5 criteria.

CBTi Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week post-treatment for reporting.

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
Secondary outcome measures
Diary-assessed Sleep
Other outcome measures
Circadian Rhythm
Evaluation of episodic memory
Evaluation of executive functioning
+2 more

CBTi Trial Design

4Treatment groups
Active Control
Group I: In-person CBTiActive Control1 Intervention
CBTi of variable treatment length will be administered by trained study staff in-person.
Group II: Telehealth CBTiActive Control1 Intervention
CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.
Group III: Internet CBTiActive Control1 Intervention
Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).
Group IV: Waitlist ControlActive Control1 Intervention
Treatment will be postponed by 12 weeks.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
511 Previous Clinical Trials
148,188 Total Patients Enrolled
Daniel J Taylor, Ph.D.Principal InvestigatorThe University of Arizona
2 Previous Clinical Trials
281 Total Patients Enrolled

Media Library

In-Person Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05226585 — N/A
Sleep Disorders Research Study Groups: In-person CBTi, Telehealth CBTi, Internet CBTi, Waitlist Control
Sleep Disorders Clinical Trial 2023: In-Person Cognitive Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05226585 — N/A
In-Person Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226585 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~29 spots leftby Mar 2025