Enhancing Hypnotic Medication Discontinuation in Primary Care Through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy
National Jewish Health
Summary
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.
Description
Treatment-seeking insomnia sufferers most often present in primary care where their first and usually only treatment is a prescription hypnotic medication. More than 65% of individuals prescribed hypnotics use them for more than a year, and more than 30% remain on them for more than five years. Such agents may be useful for acute insomnia and certain cases with chronic sleep difficulties, but prolonged hypnotic use can lead to dependency and increased morbidity (e.g., falls, cognitive/driving impairments). Reducing or discontinuing hypnotics after prolonged use is a challenging task for both p…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications; * a desire to decrease/eliminate hypnotic use; * a history of insomnia that meets DSM-560 criteria for insomnia disorder; and * willingness to provide written informed consent to participate. Exclusion Criteria: * a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder; * presence of an unstable, untreated, or terminal major medical or psychiatric disorder; * alcohol or drug abuse within the…
Interventions
- BehavioralDigital Cognitive Behavioral Therapy
Adaptive cloud-based software delivering cognitive behavioral therapy tailored to the needs of the individual patient.
- BehavioralStructured Medication Tapering
A structured tapering of hypnotic (or other) medication to promote successful discontinuation by patients seeking to discontinue use.
Location
- National Jewish HealthDenver, Colorado