Mind-Body Approach to Improve Health-Related Quality of Life for People With Narcolepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants Who Attended ≥ 80% of Sessions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18 and older (except when the age of majority for a state differs from 18, including Delaware [19 years or older], Mississippi [21 years or older], and Nebraska [19 years or older])
- •ICSD-3 criteria (8) for Narcolepsy (Type I or II)
- •Endorse current psychological distress based on a t-score ≥ 60 on the PROMIS depression or anxiety scales
- •Established standard care for narcolepsy. Patients who have not been previously diagnosed will be required to complete a clinical work-up through a sleep clinic (i.e., nocturnal PSG followed by a next-day MSLT) before participating. Standard care is managed outside of the study.
排除标准
- •Hypersomnia not of central origin (i.e., hypersomnia attributed to psychiatric disorder, medical disorder, other sleep disorder such as circadian rhythm sleep disorder, or insufficient sleep).
- •Current suicidal ideation or intent.
- •Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
- •Inability to engage in the treatment protocol due to a psychiatric (e.g., psychotic disorder) or cognitive issue.
- •Untreated moderate-to-severe sleep-related breathing disorder, defined as an apnea hypopnea index (AHI) ≥
- •Those receiving treatment for a sleep-related breathing disorder and can demonstrate adequate management (e.g., residual AHI < 5) will be allowed to participate.
- •Previous participation in a formal MBI program, such as MBSR.
- •Unstable dose of medications at the time of screening (e.g., stimulants).
- •Unable to attend intervention sessions due to accessibility (i.e., reliable internet connection) or availability (i.e., not available due to scheduling conflicts).
- •Currently living outside of the United States.
研究组 & 干预措施
Brief MBI
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
干预措施: Brief MBI (Behavioral)
Standard MBI
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
干预措施: Standard MBI (Behavioral)
Extended MBI
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
干预措施: Extended MBI (Behavioral)
结局指标
主要结局
Number of Participants Who Attended ≥ 80% of Sessions
时间窗: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Number of participants who attended greater than or equal to 80% of sessions
Number of Participants Who Practiced Meditation ≥ 4 Days Per Week
时间窗: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Number of participants who practiced meditation greater than or equal to 4 days per week
Number of Participants Who Completed Assessments
时间窗: Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing)
次要结局
- Self-Compassion Scale (SCS)(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
- Five Facet Mindfulness Questionnaire (FFMQ)(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale(Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks))
研究者
Jennifer Mundt, PhD
Assistant Professor, Department of Neurology
Northwestern University