Cognitive Behavioral Therapy for Insomnia

(RESET Trial)

IV
Overseen ByIvan Vargas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep and reduce stress-related issues. The researchers aim to understand how changes in cortisol (a stress hormone) and stress response affect sleep quality. Participants will receive either 4 weeks or 10 weeks of CBT-I to assess how different treatment durations impact sleep. Individuals with chronic insomnia who typically sleep less than six hours per night might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding how CBT-I can enhance sleep and alleviate stress.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any sleep medications or medications that affect sleep or cortisol levels to participate in this trial.

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

Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is safe and easy to manage. Research indicates that CBT-I can be as effective as sleep medication, but without side effects. This makes it a preferred first choice for treating insomnia. Those who have tried CBT-I not only sleep better but also experience fewer recurrences of insomnia. Overall, CBT-I is a safe option for individuals dealing with long-term sleep issues.12345

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) because it offers a non-drug approach to treating insomnia, unlike traditional options like sleep medications. CBT-I works by addressing the underlying behaviors and thoughts that contribute to sleep problems, potentially leading to long-lasting improvements in sleep quality. Additionally, the trial is exploring different lengths of therapy, with a 4-week and a 10-week option, to determine the most effective duration for patients. This personalized approach could make CBT-I a more flexible and sustainable option for those struggling with insomnia.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia is effective for improving sleep and related outcomes?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively reduces insomnia symptoms. In one study, all groups receiving CBT-I experienced a significant reduction in symptoms. Another study found that CBT-I increased total sleep time by 8 minutes and improved sleep efficiency by 10%. The results of CBT-I are comparable to those of sleep medication but without the side effects. Long-term benefits have been observed, with positive effects lasting up to ten years, and many participants no longer meeting the criteria for insomnia. This trial will compare two different durations of CBT-I: a 4-week program and a 10-week program. Overall, CBT-I is considered a top treatment for chronic insomnia due to its proven effectiveness.14678

Are You a Good Fit for This Trial?

This trial is for individuals with chronic insomnia, specifically those who either sleep less than 6 hours or at least 6 hours per night. Participants must be willing to undergo in-lab assessments, provide saliva and hair samples, wear an actigraphy watch, and complete online diaries. People with other sleep disorders besides insomnia are not eligible.

Inclusion Criteria

Speaks English
Meets DSM-5 criteria for Insomnia Disorder, determined through initial screener than verified during brief clinical interview (at intake)
I am 18 years old or older.

Exclusion Criteria

Excessive alcohol/substance use or AUD/SUD
Pregnant or nursing women
I have a sleep disorder that is not insomnia.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Participants complete an in-lab assessment, online survey, stress task, and provide samples for cortisol measurement. They are sent home with a sleep test and actigraphy watch.

4 weeks
1 visit (in-person), daily online diaries

Treatment

Participants receive either 4 or 10 weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). Sleep patterns and insomnia symptoms are monitored via diaries.

4-10 weeks
1 visit (in-person), daily online diaries

Follow-up

Participants are monitored for safety and effectiveness after treatment. The follow-up visit replicates initial lab procedures.

3 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy for Insomnia
Trial Overview The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I) improves sleep by affecting stress hormones like cortisol. It compares the effects of a short (4-week) versus longer (10-week) therapy program on people with different durations of nightly sleep.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: 4-Week CBT-IExperimental Treatment1 Intervention
Group II: 10-Week CBT-IExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials
36
Recruited
60,000+

Citations

Cognitive-Behavioral Therapy for Insomnia: An Effective ...Total sleep time improved by 8 minutes, and sleep efficiency improved by 10%. CBT-i produces results that are equivalent to sleep medication, with no side ...
main outcomes of a randomized dismantling trialAll groups exhibited insomnia symptom reduction at posttreatment (CT: d = −2.53, P < .001; BT: d = −2.39, P < .001; CBT: d = −2.90, P < .001) ...
Network meta-analysis examining efficacy of components ...The current results suggest that sleep restriction therapy and stimulus control therapy are the most effective components of CBT-I.
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 ...
Very long-term outcome of cognitive behavioral therapy for ...Positive effects of CBT were still present after ten years. Insomnia severity remained low, and two-thirds of participants no longer fulfilled criteria for an ...
Effectiveness of group-delivered cognitive behavioural ...Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line therapy for insomnia [10] due to its safety, efficacy and long-lasting outcomes ...
The efficacy of cognitive behavioral therapy for insomnia in ...At follow-up time point, a statistically significant improvement in insomnia (SMD = −0.79; 95% CI -1.42 to −0.17; p = 0.01) was observed following CBT-I.
a focus on components of cognitive behavioral therapy for ...A 2024 component network meta-analysis found SCT to be potentially beneficial for insomnia treatment (iOR, 1.43; 95% CI, 1.00–2.05) and is ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security