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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cognitive Behavioral Therapy for Insomnia (CBTi) can improve sleep, body clocks, and brain function in adults aged 50-65. Participants will receive CBTi through in-person sessions, online platforms, or telehealth, with progress monitored through various assessments, including brain scans. The trial suits those who have struggled with insomnia, have normal hearing, and can access a computer with internet for therapy sessions. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance insomnia treatments for many.

What prior data suggests that Cognitive Behavioral Therapy for insomnia is safe?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTi) is generally safe and effective in various formats. For in-person CBTi, studies have found it as effective as sleep medication but without the side effects. Sleep often improves over time, with a lower risk of insomnia returning.

For online CBTi, evidence supports its safety but notes some possible downsides, such as feeling tired and less motivated. Despite these, it effectively enhances sleep quality and duration.

Telehealth CBTi is also considered safe. One study found no major safety issues, with many participants finding it helpful. Overall, CBTi—whether in-person, online, or through telehealth—offers a safe alternative to medication for treating insomnia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for insomnia because they offer more flexible approaches to Cognitive Behavioral Therapy for Insomnia (CBTi). Traditional CBTi typically requires in-person sessions, but these treatments explore different delivery methods. Telehealth CBTi allows patients to receive therapy via secure video calls, making it accessible from home. Internet CBTi is self-paced and utilizes a platform called Sleep Healthy Using The Internet (SHUTi), giving users the freedom to engage with the therapy at their convenience. These options could make effective insomnia treatment more accessible, especially for those with busy schedules or limited access to in-person therapy.

What evidence suggests that this trial's treatments could be effective for insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTi) helps improve sleep. In this trial, participants may receive one of several CBTi methods. In-person CBTi greatly reduces insomnia symptoms. Studies have also shown that online CBTi improves sleep quality and sleep efficiency. Telehealth CBTi, another option in this trial, enhances sleep quality, reduces tiredness, and increases confidence in sleeping well, with participants adhering to the treatment plan. Overall, all these CBTi methods effectively address insomnia, offering flexibility based on individual needs and preferences. ^{3 6 7 8 9}

Who Is on the Research Team?

Daniel J Taylor, Ph.D.

Principal Investigator

The University of Arizona

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39186370/

Efficacy of eHealth Versus In-Person Cognitive Behavioral ... Conclusions: eCBTI and ipCBTI were found to be statistically significantly equivalent for treating insomnia for most examined outcomes, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40982264/

Cognitive Behavioral Therapy for Insomnia in People With ... CBT-I was associated with significantly improved outcomes for insomnia severity (g = 0.98; 95% CI, 0.81-1.16) and moderate effect sizes ...

3. nature.com nature.com/articles/s41598-023-28853-0

Comparative efficacy of onsite, digital, and other settings ... The primary aim of the study was to compare the efficacy of available CBT-I settings on insomnia severity.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000594

Effects of cognitive behavioral therapy for insomnia (CBT-I) ... The effects of cognitive behavioral therapy for insomnia (CBT-I) have consistently been shown to improve insomnia symptoms and other health-related outcomes.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079220301556

Reporting of adverse events in cognitive behavioural ... Cognitive behavioural therapy (CBTI) is the first line treatment for insomnia but studies have reported potential negative effects during acute implementation.

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6460

Computerized Cognitive Behavioral Therapy for Insomnia in a ... Study Impact: The significant improvements in reported sleep suggest that implementing cb-CBT-I treatment in a community mental health center would be a simple, ...

9. academic.oup.com academic.oup.com/sleep/article/41/6/zsy069/4956251

Impact of cognitive behavioral therapy for insomnia disorder ... CBTi was an effective treatment for insomnia and comorbid symptoms including daytime fatigue, general mental health, nicotine, and caffeine use.