Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Condition: Narcolepsy; Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional

Summary: 
      The overall goal of this research is to test the effectiveness of a mindfulness-based
      intervention (MBI) for improving health-related quality of life as a complementary practice
      to standard care for narcolepsy. This study is a feasibility trial in which 60 adults with
      narcolepsy will be randomized to receive either a 4-week (brief), 8-week (standard), or
      12-week (extended) MBI. Each MBI will be delivered in small groups using a live
      videoconferencing platform and teaches mindfulness practices to help cope with narcolepsy
      symptoms. By developing a scalable mind-body intervention, this project can addresses a major
      research gap on improving psychosocial functioning in people with narcolepsy.
    

Detailed description: 
      Narcolepsy is a serious and debilitating condition involving persistent and excessive
      sleepiness that affects 1 in 2000 Americans and 3 million people worldwide. Although
      wake-promoting pharmacotherapy can reduce sleepiness there is no cure and people with
      narcolepsy experience significantly poor health-related quality of life, particularly in the
      domains of mental and social health. Therefore, the overarching goal of this research is to
      test the effectiveness of a mindfulness-based intervention (MBI) for improving health-related
      quality of life as a complementary practice to standard care for narcolepsy. The purpose of
      this study is to conduct a feasibility trial to determine the optimal parameters for adapting
      and delivering MBI to people with narcolepsy. The specific aims are to: 1) Determine the
      feasibility and acceptability of MBI delivered using videoconferencing for the purpose of
      improving psychosocial functioning in people with narcolepsy and 2) Determine the feasibility
      of recruitment and assessment methods for delivering MBI using videoconferencing. The
      feasibility trial includes 60 adults with narcolepsy who will be randomized to receive either
      a 4-week (brief), 8-week (standard), or 12-week (extended) MBI. Each MBI will be similar in
      content, which includes mindfulness practices and group discussions with adaptations for
      working with narcolepsy symptoms. All MBIs will be delivered in small groups using a live
      videoconferencing platform to enhance accessibility. If the findings of this project support
      the feasibility of further testing, the next project would be aimed at enhancing rigor and
      reproducibility (e.g., designing appropriate control, refining outcome measures and
      eligibility criteria) in preparation for a large-scale pragmatic trial. The overall
      significance of this research is to develop a scalable mind-body intervention that addresses
      a major research gap on improving psychosocial functioning in people with narcolepsy.
    

Intervention name(s): Brief MBI; Standard MBI; Extended MBI
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.; The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.; The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to receive one of there different MBI treatments: 1) Brief MBI, 4 weeks, 2) Standard MBI, 8 weeks, 3) Extended MBI, 12 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Narcolepsy; psychosocial; mindfulness; health-related quality of life; hypersomnia