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Behavioral Intervention

Cognitive Behavioral Therapy 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
No Placebo-Only Group

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.
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.
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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index
Secondary study objectives
Diary-assessed Sleep
Other study objectives
Circadian Rhythm
Evaluation of episodic memory
Evaluation of executive functioning
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,576 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
~24 spots leftby Dec 2025
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