Awareness and Self-Compassion Enhancing Narcolepsy Treatment (ASCENT)

• ClinicalTrials.gov Identifier: NCT04306952
• Recruitment Status: Completed
• First Posted: March 13, 2020
• Last Update Posted: May 6, 2023
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Jennifer Mundt, PhD, Northwestern University

Study Description

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 reserach gap on improving psychosocial functioning in people with narcolepsy.

Condition or disease	Intervention/treatment	Phase
Narcolepsy; Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy	Behavioral: Brief MBI; Behavioral: Standard MBI; Behavioral: Extended MBI	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mind-Body Approach to Improve Health-Related Quality of Life for People With Narcolepsy
• Actual Study Start Date: June 15, 2020
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Brief MBI; The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.	Behavioral: Brief MBI; The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
Experimental: Standard MBI; The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.	Behavioral: Standard MBI; The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
Experimental: 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.	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. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).

Outcome Measures

Primary Outcome Measures :

1. Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures general self-efficacy, self-efficacy for managing emotions, self-efficacy for managing social interactions, self-efficacy for managing symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting better self-efficacy.
2. Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures ability to participate using Computer Adaptive Testing (CAT) with higher scores reflecting more ability to participate
3. Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures social isolation using Computer Adaptive Testing (CAT) with higher scores reflecting more social isolation
4. Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depression symptoms.
5. Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms.
6. Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures fatigue using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.
7. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures sleep disturbances using Computer Adaptive Testing (CAT) with higher scores reflecting more sleep disturbance.
8. Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures sleep-related impairment using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.
9. Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   Measures overall physical and mental health using Computer Adaptive Testing (CAT) with higher scores reflecting better outcomes.
10. Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
    Measures cognitive function using Computer Adaptive Testing (CAT) with higher scores reflecting better outcomes.
11. Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
    Measures the direct negative psychosocial effect related to illness using Computer Adaptive Testing (CAT) with higher scores reflecting worse outcomes.
12. Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
    Measures the direct positive psychosocial effect related to illness using Computer Adaptive Testing (CAT) with higher scores reflecting better outcomes.
13. Five Facets of Mindfulness (FFMQ) [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
    The FFMQ assesses the acquisition of mindfulness skills. It is a 39-item self-report measure that consists of five factors representing elements of mindfulnes: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
14. Self-Compassion Scale (SCS) [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
    The SCS assesses the acuisition 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.

Secondary Outcome Measures :

1. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   The FOSQ assesses the impact of sleepiness on daily behaviors and quality of life. It is comprised of 30 items divided into five subscales: activity level, vigilance, intimate and sexual relationships, general productivity, and social outcome. Items are rated from 1 to 4, with higher score reflecting better functioning.
2. Epworth Sleepiness Scale (ESS) [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   The ESS consists of eight questions rated from 0 to 3, with higher scores indicating greater likelihood of falling asleep. Total scores of 10 or greater reflect excessive daytime sleepiness.
3. NAB Digits Forward/Digits Backward Test (DS) [ Time Frame: Baseline (week 0), and post-treatment for each condition (week 4 for Brief MBI, week 8 for Standard MBI, and week 12 for Extended MBI) ]
   The DS consists of 14 trials of number sequences that get progressively longer, assessing a person's attention and working memory.
4. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline (week 0), and post-treatment for each condition (week 4 for Brief MBI, week 8 for Standard MBI, and week 12 for Extended MBI) ]
   The RBANS assesses neuropsychological change over time and covers five domains including Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
5. Trail Making Test (TMT) [ Time Frame: Baseline (week 0), and post-treatment for each condition (week 4 for Brief MBI, week 8 for Standard MBI, and week 12 for Extended MBI) ]
   The TMT is a two part test with the first part requiring participants to connect numbered circles in sequential order and the second part to connect lettered and numbered circles in an alternating fashion. This test assesses visual attention and task switching.
6. Controlled Oral Word Association Test (COWAT) [ Time Frame: Baseline (week 0), and post-treatment for each condition (week 4 for Brief MBI, week 8 for Standard MBI, and week 12 for Extended MBI) ]
   The COWAT asks participants to provide as many words that start with a given letter (F, A, or S) in one minute, and assesses verbal fluency and executive dysfunction.
7. Stroop Color and Word Test (SCWT) [ Time Frame: Baseline (week 0), and post-treatment for each condition (week 4 for Brief MBI, week 8 for Standard MBI, and week 12 for Extended MBI) ]
   The Stroop test consists of three tables outlining a set of tasks. It assesses the ability to inhibit cognitive interference.
8. Wrist Actigraphy [ Time Frame: One week at Baseline (week 0) and one week at post-treatment for each condition (week 4 for Brief MBI, week 8 for Standard MBI, and week 12 for Extended MBI) ]
   Actigraphy is an objective measure that will assess measured sleep/wake patterns for one week.
9. Hypersomnia Severity Index (HSI) [ Time Frame: Change from Baseline (A1=week 0) to each assessment point (A2=week 4, A3=week 8, A4=week 12) ]
   The HSI consists of nine questions rated from 0 to 5, with higher scores indicating greater severity of hypersomnia.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Center for Circadian and Sleep Medicine, Northwestern University

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

More Information

• Responsible Party: Jennifer Mundt, PhD, Assistant Professor, Department of Neurology, Northwestern University
• ClinicalTrials.gov Identifier: NCT04306952
• Other Study ID Numbers: STU00209890
• First Posted: March 13, 2020
• Last Update Posted: May 6, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Mundt, PhD, Northwestern University:

Narcolepsy; psychosocial; mindfulness; health-related quality of life; hypersomnia

Additional relevant MeSH terms:

Narcolepsy; Cataplexy; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders