Digital Cognitive Behavioral Therapy for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if digital cognitive behavioral therapy (delivered through digital platforms) combined with a plan to reduce medication is more effective than reducing medication alone for people with insomnia. Many individuals with insomnia rely on sleep medications, which can pose risks over time. The trial seeks participants who have used sleep medications like benzodiazepines for over six months and wish to reduce their usage. The goal is to assess whether digital therapy can aid in reducing medication use and improving sleep. This could lead to better, more accessible treatment options for those struggling with insomnia. As a Phase 4 trial, the research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial focuses on reducing or eliminating the use of hypnotic medications for insomnia, so you may need to taper off these medications as part of the study. However, the protocol does not specify if you must stop other medications, but it does exclude those using certain medications for other conditions.
What is the safety track record for these treatments?
Research has shown that Digital Cognitive Behavioral Therapy for Insomnia (dCBTI) is generally safe and easy to manage. Studies have found that dCBTI effectively reduces insomnia symptoms without causing significant side effects. For instance, a large study with 4,052 patients found that dCBTI improved sleep more effectively than medication and did not report any major negative effects.
In this trial, dCBTI is used alongside a structured plan to gradually reduce sleep medication, helping to safely decrease reliance on these drugs. Since this trial is in its later stages, sufficient evidence supports the safety of these methods.
Overall, both dCBTI and the gradual reduction of medication aim to improve sleep without the risks associated with long-term medication use, such as falls or memory problems. This makes them promising options for managing insomnia.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about digital cognitive behavioral therapy (dCBTI) for insomnia because it offers a unique, tech-savvy approach to treatment. Unlike traditional methods that often rely on medications, dCBTI uses an online platform to help retrain the brain's sleep patterns through cognitive and behavioral techniques. This method not only aims to address the root causes of insomnia but also provides the convenience of accessing therapy from home. Additionally, when combined with structured medication tapering, it offers an innovative way to potentially reduce reliance on sleep medications, which can have side effects. Overall, this approach could transform how we manage insomnia, making effective treatment more accessible and personalized.
What evidence suggests that this trial's treatments could be effective for insomnia?
Research has shown that digital cognitive behavioral therapy for insomnia (dCBTI), which participants in this trial may receive, can greatly improve sleep. One study found that 60% of people using dCBTI experienced significant improvement in their insomnia, compared to only 16% with other treatments. Another study found that dCBTI was more effective than medication after six months, improving sleep quality and significantly reducing insomnia symptoms. These results suggest that dCBTI could be a strong option for managing insomnia, especially for those looking to reduce sleep medications. Meanwhile, another treatment arm in this trial involves structured medication tapering alone, which will be assessed for its effectiveness in managing insomnia.46789
Are You a Good Fit for This Trial?
This trial is for adults with insomnia who've been using sleep meds (benzodiazepine or non-benzodiazepine) regularly for over 6 months and want to cut down. They must meet the DSM-5 criteria for insomnia disorder and be willing to consent to participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either digital cognitive behavioral therapy combined with structured medication tapering or structured medication tapering alone
Follow-up
Participants are monitored for insomnia remission and hypnotic discontinuation rates
What Are the Treatments Tested in This Trial?
Interventions
- Digital Cognitive Behavioral Therapy
- Structured Medication Tapering
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Jewish Health
Lead Sponsor