Cognitive Behavioral Therapy for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how an online program called Sleep Healthy Using The Internet (SHUTi) can improve sleep and depression symptoms in people with insomnia through Cognitive Behavioral Therapy for Insomnia. The researchers aim to understand the role of one of the brain's glutamate receptors (mGluR5) in this process. Suitable candidates for this trial have moderate to severe depression, experience long delays in falling asleep, and are not currently taking antidepressants. Participants should not have other sleep disorders like sleep apnea or be undergoing major lifestyle changes such as shift work. As a Phase 4 trial, this research explores how an already FDA-approved and proven effective treatment can benefit more patients.
Will I have to stop taking my current medications?
If you are currently taking effective antidepressants or medications known to affect glutamate, you will need to stop them to participate in this trial. The protocol does not specify a washout period, but these medications are part of the exclusion criteria.
What is the safety track record for Cognitive Behavioral Therapy for Insomnia?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and manageable. Studies indicate that it works as well as sleep medication but without the usual side effects. Participants often experience lasting improvements, with sleep continuing to improve over time.
Some may feel slightly tired or sleepy during the day initially, but this usually subsides. Occasionally, individuals report feeling very tired or less motivated, though this is less common. Overall, CBT-I is considered effective and has long-lasting positive effects, especially since it focuses on changing behavior rather than using medication.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered through the online program, SHUTi, because it offers a unique, accessible approach to treating insomnia. Unlike traditional in-person therapy sessions, SHUTi allows users to engage with CBT-I techniques online, providing flexibility and convenience. This digital format can help overcome common barriers to treatment like scheduling conflicts and geographical limitations, making it easier for more people to access effective insomnia care.
What is the effectiveness track record for Cognitive Behavioral Therapy for Insomnia?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial will receive, effectively treats sleep problems. Studies indicate that CBT-I significantly reduces insomnia severity, with one study showing a strong improvement in sleep issues. Additionally, online versions of CBT-I have effectively helped people with long-term insomnia, particularly older adults. A review of multiple studies confirmed that internet-based CBT-I enhances sleep quality and efficiency. These findings emphasize CBT-I's success in helping people with insomnia achieve better sleep.46789
Are You a Good Fit for This Trial?
This trial is for individuals with Major Depressive Disorder, Insomnia, or Depression. It's designed to understand how a specific glutamate receptor (mGluR5) affects the success of Cognitive Behavioral Therapy for Insomnia (CBT-I).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I) through an online program, SHUTi, for 8 weeks
Assessment
Participants undergo polysomnography and PET imaging to assess sleep latency and mGluR5 density before and after CBT-I
Follow-up
Participants are monitored for changes in sleep latency and mGluR5 density after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy for Insomnia
- PET Scan with [11C]ABP688
Trial Overview
Participants will undergo PET scans using [11C]ABP688 to study mGluR5 activity and receive CBT-I sessions. The goal is to see if changes in mGluR5 are linked to improvements in sleep and mood.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stony Brook University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Citations
Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer
Finally, one study showed that CBT-I could even be effective in treating insomnia among “real world” patients (i.e., those with comorbid medical and behavioral ...
A randomized controlled trial of a digital cognitive ...
The findings of this study offer compelling evidence for the efficacy of tailored, digital CBT-I to treat chronic insomnia among older adults.
main outcomes of a randomized dismantling trial
A greater reduction in dysfunctional beliefs about sleep (DBAS) from baseline is associated with greater insomnia symptom improvement after ...
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 ...
Internet-delivered Cognitive Behavioral Therapy for Insomnia
A meta-analysis by Robert Zachariae et al. confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, ...
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 ...
a focus on components of cognitive behavioral therapy for ...
It is a safe therapy with lasting effects and only transient initial side effects such as daytime drowsiness or fatigue [8]. Despite its ...
Negative effects of cognitive behavioral therapy for insomnia
Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation). Psychometrically ...
Voice-Activated Cognitive Behavioral Therapy for Insomnia
This randomized clinical trial of an in-home, voice-activated CBT-I program among breast cancer survivors found that the intervention improved insomnia ...
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