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Behavioral Intervention

Telehealth 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

Be older than 18 years old

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.

Who is the study for?

Adults aged 50-65 with insomnia, normal cognitive status (MoCA scores ≥24), and access to a computer with video/audio for teletherapy are eligible. They must plan to stay local for 6 months, speak English, have normal hearing, and not start new sleep treatments during the study. Excluded if they have high sleep efficiency (>85%), serious mental health issues, untreated sleep disorders like apnea, current CBTi treatment or circadian rhythm disorders.Check my eligibility

What is being tested?

The trial is testing how Cognitive Behavioral Therapy for Insomnia (CBTi) works when delivered in-person, via telehealth or internet platforms. It measures changes in participants' sleep quality, circadian rhythms, biomarkers of health and stress levels before and after therapy using questionnaires and MRI scans.See study design

What are the potential side effects?

Since this trial involves behavioral therapy rather than medication there are no direct side effects as one might expect from drugs; however participants may experience discomfort from blood draws or claustrophobia in MRI machines.

CBTi Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 week post-treatment

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: Telehealth CBTiActive Control1 Intervention

CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.

Group II: In-person CBTiActive Control1 Intervention

CBTi of variable treatment length will be administered by trained study staff in-person.

Group III: Waitlist ControlActive Control1 Intervention

Treatment will be postponed by 12 weeks.

Group IV: Internet CBTiActive Control1 Intervention

Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

516 Previous Clinical Trials

148,371 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: Telehealth CBTi, In-person CBTi, Waitlist Control, Internet CBTi

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

Recent research and studies

clinicaltrials.govStudy

Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)

2021. "Mechanisms of Change in Cognitive Behavioral Therapy for Insomnia (CBTi)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226585.

All > Sleep Disorders > Insomnia