N/A
N=60
Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Narcolepsy · Narcolepsy Without Cataplexy · Narcolepsy With Cataplexy
Bottom Line
View on ClinicalTrials.gov: NCT04306952 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants Who Attended ≥ 80% of Sessions — 15; 13; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief MBI (Behavioral); Standard MBI (Behavioral); Extended MBI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Attended ≥ 80% of Sessions |
15; 13; 15 | — |
| PRIMARY Number of Participants Who Practiced Meditation ≥ 4 Days Per Week |
16; 8; 13 | — |
| PRIMARY Number of Participants Who Completed Assessments |
18; 13; 16 | — |
| SECONDARY Self-Compassion Scale (SCS) |
2.66; 2.91; 2.52; 3.12; 3.58; 3.61 | — |
| SECONDARY Five Facet Mindfulness Questionnaire (FFMQ) |
115.90; 122.50; 107.00; 132.42; 144.00; 136.53 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive |
39.35; 42.07; 38.74; 42.83; 46.94; 43.85 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale |
60.94; 59.35; 62.59; 58.70; 56.52; 57.28 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale |
38.01; 40.43; 36.03; 41.17; 44.77; 42.73 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale |
62.54; 61.24; 61.69; 62.46; 56.62; 58.04 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale |
59.53; 56.11; 60.06; 57.70; 53.89; 52.73 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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) ≥ 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04306952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.