Cognitive Behavioral Therapy for Insomnia

Overseen By Christine DeLorenzo, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Stony Brook University

Must not be taking: Antidepressants, Glutamate affecting

Disqualifiers: Psychosis, Drug dependence, Sleep apnea, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

42 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{4 6 7 8 9}

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

I am in good health with no major medical issues.

Uniform range of sleep latencies up to 128 minutes

I understand and can agree to the study's procedures and risks.

Exclusion Criteria

PET or MRI contraindications, including pregnancy or currently breastfeeding

I am currently on antidepressants that work for me.

Lifetime history of psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I) through an online program, SHUTi, for 8 weeks

8 weeks

Online program access

Assessment

Participants undergo polysomnography and PET imaging to assess sleep latency and mGluR5 density before and after CBT-I

8 weeks

1-2 nights in Sleep Lab for polysomnography, PET imaging sessions

Follow-up

Participants are monitored for changes in sleep latency and mGluR5 density after treatment

4 weeks

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?

Group I: Cognitive Behavioral Therapy for Insomnia Treatment Arm Experimental Treatment 2 Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002474/

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 ...

2. nature.com nature.com/articles/s41746-025-01847-0

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.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11756

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 ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2839294

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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

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, ...

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. kosinmedj.org kosinmedj.org/journal/view.php?number=1311

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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725001133

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 ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823907

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 ...