Cognitive Behavioral Therapy for Sleep Disorders

(CBTi Trial)

Overseen By Ethan Olson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Circadian disorders, Sleep apnea, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

93 Participants Needed

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).

Research Team

Daniel J Taylor, Ph.D.

Principal Investigator

The University of Arizona

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

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])

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3-4 weeks

Multiple visits (online and in-person)

Baseline Assessment

Participants complete online demographic information, sleep diaries, and undergo a diagnostic in-home sleep study with various assessments

3 weeks

Multiple visits (online and in-person)

Treatment Phase I

Participants receive up to 12 weeks of insomnia treatment or are placed on a waitlist

12 weeks

Variable visits (in-person, telehealth, or internet)

12-Week Post-treatment

Participants complete online sleep diaries, actigraphy, and repeat baseline assessments

2 weeks

Multiple visits (online and in-person)

Treatment Phase II (WLC)

Treatment starts for participants who were on the waitlist

Variable

3-Month Follow-Up

Participants complete online self-report questionnaires

1 week

Online

Treatment Details

Interventions

• In-Person Cognitive Behavioral Therapy for Insomnia
• Internet Cognitive Behavioral Therapy for Insomnia
• Telehealth Cognitive Behavioral Therapy for Insomnia

Trial Overview 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.

Participant Groups

Group I: Telehealth CBTi Active Control 1 Intervention

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

Group II: In-person CBTi Active Control 1 Intervention

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

Group III: Waitlist Control Active Control 1 Intervention

Treatment will be postponed by 12 weeks.

Group IV: Internet CBTi Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+