Clinical trial NCT04306952: Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Official title: Mind-Body Approach to Improve Health-Related Quality of Life for People With Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy
Narcolepsy Without Cataplexy
Narcolepsy With Cataplexy
Keywords: Narcolepsy
psychosocial
mindfulness
health-related quality of life
hypersomnia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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 \[19 years or older\])
2. ICSD-3 criteria (8) for Narcolepsy (Type I or II)
3. Endorse current psychological distress based on a t-score ≥ 60 on the PROMIS depression or anxiety scales
4. 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.

Exclusion Criteria:

1. 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).
2. Current suicidal ideation or intent.
3. Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
4. Inability to engage in the treatment protocol due to a psychiatric (e.g., psychotic disorder) or cognitive issue.
5. Untreated moderate-to-severe sleep-related breathing disorder, defined as an apnea hypopnea index (AHI) ≥ 15. Those receiving treatment for a sleep-related breathing disorder and can demonstrate adequate management (e.g., residual AHI \< 5) will be allowed to participate.
6. Previous participation in a formal MBI program, such as MBSR.
7. Unstable dose of medications at the time of screening (e.g., stimulants).
8. Unable to attend intervention sessions due to accessibility (i.e., reliable internet connection) or availability (i.e., not available due to scheduling conflicts).
9. Currently living outside of the United States.

Primary outcomes:
measure: Number of Participants Who Attended ≥ 80% of Sessions
timeFrame: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
measure: Number of Participants Who Practiced Meditation ≥ 4 Days Per Week
timeFrame: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
measure: Number of Participants Who Completed Assessments
timeFrame: Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Secondary outcomes:
measure: Self-Compassion Scale (SCS)
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
timeFrame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Circadian and Sleep Medicine, Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jennifer Mundt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mundt JM, Zee PC, Schuiling MD, Hakenjos AJ, Victorson DE, Fox RS, Dawson SC, Rogers AE, Ong JC. Development of a mindfulness-based intervention for narcolepsy: a feasibility study. Sleep. 2024 Oct 11;47(10):zsae137. doi: 10.1093/sleep/zsae137.