Cognitive Behavioral Therapy for Sleep Disorders
(CBTi Trial)
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.
Will I have to stop taking my current medications?
The trial requires that you do not start any new behavioral health or medication treatments for sleep issues during the study, but it does not specify if you need to stop your current medications.
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.12345Why 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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete online demographic information, sleep diaries, and undergo a diagnostic in-home sleep study with various assessments
Treatment Phase I
Participants receive up to 12 weeks of insomnia treatment or are placed on a waitlist
12-Week Post-treatment
Participants complete online sleep diaries, actigraphy, and repeat baseline assessments
Treatment Phase II (WLC)
Treatment starts for participants who were on the waitlist
3-Month Follow-Up
Participants complete online self-report questionnaires
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?
4
Treatment groups
Active Control
CBTi of variable treatment length will be administered by trained study staff via HIPAA-compliant tele-video conference.
CBTi of variable treatment length will be administered by trained study staff in-person.
Treatment will be postponed by 12 weeks.
Self-paced CBTi of variable treatment length will be administered via Sleep Healthy Using The Internet (SHUTi).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
Citations
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, ...
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 ...
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.
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.
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 ...
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 ...
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.
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, ...
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.
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