Digital Cognitive Behavioral Therapy for Insomnia
Trial Summary
What is the purpose of this trial?
Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments. While evidence-based approaches like physician-supervised medication tapering exist, they're not widely available in primary care. Most primary care providers are willing to explore non-drug treatments like cognitive behavioral therapy for insomnia (CBTI), but accessing such treatments can be challenging outside of specialized sleep centers. This gap between research and practice underscores the need for cost-effective interventions to manage insomnia and help patients reduce their reliance on hypnotics in primary care. In response to this need, the project aims to conduct a large randomized trial comparing a combined digital CBT (dCBTI) and medication tapering intervention with medication tapering alone. We'll recruit 430 patients reliant on hypnotics from 8-10 primary care clinics affiliated with the University of Colorado Medical School. The main goal is to assess the effectiveness of dCBTI+SMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms. Additionally, we'll evaluate factors affecting the adoption and implementation of these interventions at the patient, provider, and system levels. This information will inform future implementation strategies to disseminate effective treatments in primary care. Furthermore, we'll gather data to identify which patients benefit most from dCBTI+SMT. Overall, this study will provide valuable insights into the feasibility, clinical utility, and acceptability of these interventions in managing insomnia and reducing reliance on hypnotic medications in primary care. Ultimately, this project represents a crucial first step toward making accessible and cost-effective strategies available to improve the quality of life for millions of chronic users of sleep aids.
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 data supports the effectiveness of the treatment Digital Cognitive Behavioral Therapy for Insomnia?
Research shows that digital cognitive behavioral therapy for insomnia (dCBT-I) is effective in improving sleep quality and reducing insomnia severity. It has been found to be as effective as traditional therapy and helps improve overall quality of life by addressing the daytime consequences of poor sleep.12345
Is digital cognitive behavioral therapy for insomnia safe for humans?
How is digital cognitive behavioral therapy for insomnia different from other treatments?
Digital cognitive behavioral therapy for insomnia (dCBT-I) is unique because it is delivered through digital platforms, making it more accessible and scalable compared to traditional in-person therapy. It focuses on changing thoughts and behaviors related to sleep, and unlike medication, it addresses the root causes of insomnia without the risk of side effects.12468
Eligibility Criteria
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
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
Treatment Details
Interventions
- Digital Cognitive Behavioral Therapy
- Structured Medication Tapering
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Jewish Health
Lead Sponsor