Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-15
Brief Title:
Enhancing Hypnotic Medication Discontinuation in Primary Care
Sponsor:
National Jewish Health
Organization:
National Jewish Health
Study Overview
Official Title:
Enhancing Hypnotic Medication Discontinuation in Primary Care Through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 theyre 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 Well 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 dCBTISMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms
Additionally well 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 well gather data to identify which patients benefit most from dCBTISMT 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
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 Well 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 dCBTISMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms
Additionally well 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 well gather data to identify which patients benefit most from dCBTISMT 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
Detailed 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 eg falls cognitivedriving impairments Reducing or discontinuing hypnotics after prolonged use is a challenging task for both prescribing physicians and the patients who use them Although evidenced-based physician-supervised medication tapering SMT protocols have shown efficacy such interventions have yet to be disseminated widely in primary care Most primary care providers PCPs are willing to refer their insomnia patients to alternative evidence-based non-drug treatments such as cognitive behavioral insomnia therapy CBTI but such treatment is often difficult to access outside of specialty sleep centers Given this gap between research and clinical practice there is a pressing need to develop and validate cost-effective interventions to facilitate the management of insomnia and hypnotic tapering in primary care This study has been carefully designed to address these issues Investigators will conduct a large randomized trial RCT to compare the combined digital CBT dCBTISMT intervention to the SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement A sample of 430 hypnotic-reliant patients drawn from 8-10 primary care clinics within a practice-based research network affiliated with the University of Colorado Medical School in Aurora Colorado will serve as study participants The main objective of the project is to compare the performance of dCBTISMT with SMT used alone for achieving hypnotic reductiondiscontinuation and insomnia symptom improvement In addition investigators will incorporate an Effectiveness-Implementation assessment into the RCT to identify patient- provider- and system-level factors that may impact adoption implementation and maintenance of the types of interventions tested Findings from the effectivenessimplementation should help design future trials of implementation strategies identified herein to promote dissemination of dCBTI and SMT interventions into primary care should these treatments prove effective in the current trial Investigators also will gather exploratory data to determine who responds best to dCBTISMT This study will provide new and useful information about the feasibility clinical utility and patient- provider- and system-level acceptability of these interventions to manage insomnia and reduceeliminate hypnotic use in primary care This project should serve as a necessary first step toward the eventual dissemination of accessible cost-effective strategies to manage a significant public health problem and improve the quality of life of millions of chronic users of controlled-substance sleep aids
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None