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Randomized Controlled Trial
. 2024 Oct 11;47(10):zsae137.
doi: 10.1093/sleep/zsae137.

Development of a mindfulness-based intervention for narcolepsy: a feasibility study

Affiliations
Randomized Controlled Trial

Development of a mindfulness-based intervention for narcolepsy: a feasibility study

Jennifer M Mundt et al. Sleep. .

Abstract

Study objectives: Mindfulness-based interventions (MBI) have been shown to improve psychosocial functioning in medical populations but have not been studied in narcolepsy. This study examined the feasibility and acceptability of an MBI that was adapted for narcolepsy, including three variations in program length.

Methods: Adults with narcolepsy (N = 60) were randomized to MBI groups of varying durations: brief (4 weeks), standard (8 weeks), or extended (12 weeks). Participants completed assessments at baseline, 4, 8, and 12 weeks. To assess feasibility and acceptability, primary outcomes included attendance, meditation practice, and data completeness. Additionally, participants completed measures of mindfulness, self-compassion, mood, sleep, psychosocial functioning, and cognition. An effect size of Cohen's d ≥ 0.5 was used as the prespecified benchmark for a minimal clinically important difference (MCID).

Results: The attendance, meditation, and data completeness benchmarks were met by 71.7%, 61.7%, and 78.3% of participants, respectively. Higher proportions of the brief and extended groups met these benchmarks compared to the standard group. All groups met the MCID for mindfulness, self-compassion, self-efficacy for managing emotions, positive psychosocial impact, global mental health, and fatigue. Standard and extended groups met the MCID for anxiety and depression, and extended groups met the MCID for additional measures including social and cognitive functioning, daytime sleepiness, hypersomnia symptoms, and hypersomnia-related functioning.

Conclusions: Results suggest that the remote delivery and data collection methods are feasible to employ in future clinical trials, and it appears that the extended MBI provides the most favorable clinical impact while maintaining attendance and engagement in meditation practice.

Clinical trial registration: Awareness and Self-Compassion Enhancing Narcolepsy Treatment (ASCENT), NCT04306952, https://clinicaltrials.gov/ct2/show/NCT04306952.

Keywords: Narcolepsy; anxiety; depression; mind-body therapies; mindfulness; psychosocial functioning.

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Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
CONSORT flow diagram. Brief MBI = 4-week mindfulness-based intervention (MBI). Standard = 8-week MBI. Extended = 12-week MBI.
Figure 2.
Figure 2.
Within-group and total sample effect sizes for changes in mindfulness and clinical outcomes from baseline to posttreatment. Brief = 4-week Mindfulness-based intervention (MBI). Standard = 8-week MBI. Extended = 12-week MBI. FFMQ, Five Facet Mindfulness Questionnaire; SCS, Self-Compassion Scale; Anx = Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety. Dep = PROMIS Depression. GSE = PROMIS General Self-Efficacy. SEM Sx = PROMIS Self-Efficacy for Managing Symptoms. SEM Emot = PROMIS Self-Efficacy for Managing Emotions. SEM Soc = PROMIS Self-Efficacy for Managing Social Interactions. Partic Soc = PROMIS Ability to Participate in Social Roles and Activities. Isol = PROMIS Social Isolation. Cog Func = PROMIS Cognitive Function. Impact Neg = PROMIS Psychosocial Illness Impact—Negative. Impact Pos = PROMIS Psychosocial Illness Impact—Positive. Global Mental = PROMIS Global Mental Health. Global Physical = PROMIS Global Physical Health. Sleep Disturb = PROMIS Sleep Disturbance. Sleep Impair = PROMIS Sleep-Related Impairment. Fatigue = PROMIS Fatigue. ESS, Epworth Sleepiness Scale; HSI, Hypersomnia Severity Index; FOSQ, Functional Outcomes of Sleep Questionnaire.
Figure 3.
Figure 3.
Within-group and total sample effect sizes for changes in neurocognitive outcomes from baseline to posttreatment. Brief = 4-week Mindfulness-based intervention (MBI). Standard = 8-week MBI. Extended = 12-week MBI. PROMIS Cog Fx, Patient-Reported Outcomes Measurement Information System Cognitive Function; Trail A, Trail Making A; Trail B, Trail Making B; RBANS Immed Mem, Repeatable Battery for the Assessment of Neuropsychological Status Immediate Memory Index Score; Vis Con, Visuospatial/Constructional Index Score; Lang, Language Index Score; Atten, Attention Index Score; Delay. Mem, Delayed Memory Index Score; Stroop Word, Stoop Word; Stroop Color, Stroop Color; Stroop C-W, Stroop Color-Word; NAB Digits Fwd, Neuropsychological Assessment Battery Digits Forward Raw Score; NAB Digits Back, NAB Digits Backward Raw Score; Phon Fluen, Phonemic Fluency (total score for three trials).

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