Narcolepsy Clinical Trial
— ASCENTOfficial title:
Mind-Body Approach to Improve Health-Related Quality of Life for People With Narcolepsy
Verified date | October 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 30, 2022 |
Est. primary completion date | May 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Circadian and Sleep Medicine, Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Attended = 80% of Sessions | Number of participants who attended greater than or equal to 80% of sessions | 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI) | |
Primary | Number of Participants Who Practiced Meditation = 4 Days Per Week | Number of participants who practiced meditation greater than or equal to 4 days per week | 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI) | |
Primary | Number of Participants Who Completed Assessments | Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing) | Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI) | |
Secondary | Self-Compassion Scale (SCS) | The SCS assesses the acquisition of self-compassion. It is a 26-item self report measure with three main components of self-compassion: self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification. The total score ranges from 1-5, with higher scores reflecting more self-compassion. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) | |
Secondary | Five Facet Mindfulness Questionnaire (FFMQ) | The FFMQ assesses the acquisition of mindfulness skills. It is a 39-item self-report measure that consists of five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-195, with higher scores reflecting more mindfulness. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) | |
Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive | Measures the direct positive psychosocial effect related to illness with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) | |
Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale | Measures the direct negative psychosocial effect related to illness with higher scores reflecting worse outcomes. Population mean (T-score) of 50 with a standard deviation of 10. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) | |
Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale | Measures overall physical and mental health with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) | |
Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale | Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) | |
Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale | Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10. | Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks) |
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