Enhancing Hypnotic Medication Discontinuation in Primary Care

Conditions

• Hypnotic Dependence
• Insomnia

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Digital Cognitive Behavioral Therapy — BEHAVIORAL
  Adaptive cloud-based software delivering cognitive behavioral therapy tailored to the needs of the individual patient.
• Structured Medication Tapering — BEHAVIORAL
  A structured tapering of hypnotic (or other) medication to promote successful discontinuation by patients seeking to discontinue use.

Study Details

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.

Key Dates

Start date

Jan 1, 2025

Status verified

Jan 2025

Primary completion

Jun 30, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

430 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Digital cognitive behavioral therapy combined with structured medication tapering
  dCBTI delivered in tandem with SMT during intervention phase.
• Experimental: Structured medication tapering alone
  Structured medication tapering delivered alone with general sleep hygiene information.

Primary Outcome Measure

Hypnotic discontinuation rates [ Time Frame: Post-treatment at weeks 22 and 49 of participation ]

Central Contacts

• RJ Johnson, MA
  303-398-1058
  [email protected]

Locations (1)

Find similar trials in Denver, CO

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