Cognitive Behavioral Therapy for Sleep Disorders
(CBTi Trial)

Recruiting in Palo Alto (17 mi)

Overseen byDaniel J Taylor, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arizona

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to investigate the mechanisms of change in Cognitive Behavioral Therapy for insomnia (CBTi) in a sample of adults aged 50-65. This study aims to evaluate the pre-post treatment change in sleep, circadian rhythms, biomarkers, cognitive performance, and structural and functional magnetic resonance imaging scans (MRI).

Eligibility Criteria

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.

Inclusion Criteria

MoCA scores ≥24 will be deemed normal cognitive status and considered eligible for study participation and/or assessed by the ability to comprehend the baseline screening questionnaires

Possession of a computer with video and audio capabilities

Indication that the individual plans to be in the area for the 6 months following the first baseline assessment

+6 more

Exclusion Criteria

Sleep efficiency > 85%, assessed by the sleep diary

Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed by structured interview (M.I.N.I.)

Failure to follow protocol (e.g., consistent "no show" for appointments, answering questionnaires dishonestly, refusal to complete more than 2 assessments [e.g., fMRI and Neuropsych])

+8 more

Participant Groups

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.

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).