Awareness and Self-Compassion Enhancing Narcolepsy Treatment

Mind-Body Approach to Improve Health-Related Quality of Life for People With Narcolepsy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04306952

Acronym

ASCENT

Enrollment

Registered

2020-03-13

Start date

2020-06-15

Completion date

2022-06-30

Last updated

2024-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy

Keywords

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

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.

Interventions

BEHAVIORALBrief 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.

BEHAVIORALStandard 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.

BEHAVIORALExtended 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Attended ≥ 80% of Sessions	4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)	Number of participants who attended greater than or equal to 80% of sessions
Number of Participants Who Practiced Meditation ≥ 4 Days Per Week	4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)	Number of participants who practiced meditation greater than or equal to 4 days per week
Number of Participants Who Completed Assessments	Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)	Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing)

Secondary

Measure	Time frame	Description
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	Measures overall physical and mental health with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Self-Compassion Scale (SCS)	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	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.
Five Facet Mindfulness Questionnaire (FFMQ)	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	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.
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive	Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Brief MBI The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. 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.	20
Standard MBI The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. 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.	20
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 hoursin between the bi-weekly group sessions and one all day meditation retreat. 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).	20
Total	60

Baseline characteristics

Characteristic	Brief MBI	Standard MBI	Extended MBI	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	2 Participants	3 Participants
Age, Categorical Between 18 and 65 years	20 Participants	19 Participants	18 Participants	57 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	2 Participants	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants	18 Participants	18 Participants	54 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Patient-Reported Outcomes Measurement Information System Depression	59.53 T-Score STANDARD_DEVIATION 4.76	56.11 T-Score STANDARD_DEVIATION 4.81	60.06 T-Score STANDARD_DEVIATION 6.25	58.57 T-Score STANDARD_DEVIATION 5.52
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	2 Participants	3 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	18 Participants	20 Participants	17 Participants	55 Participants
Sex/Gender, Customized Female	16 Participants	17 Participants	20 Participants	53 Participants
Sex/Gender, Customized Male	3 Participants	2 Participants	0 Participants	5 Participants
Sex/Gender, Customized Non-binary	1 Participants	1 Participants	0 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20	0 / 20
other Total, other adverse events	7 / 20	5 / 20	1 / 20
serious Total, serious adverse events	0 / 20	1 / 20	0 / 20

Outcome results

Primary

Number of Participants Who Attended ≥ 80% of Sessions

Number of participants who attended greater than or equal to 80% of sessions

Time frame: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Brief MBI	Number of Participants Who Attended ≥ 80% of Sessions	15 Participants
Standard MBI	Number of Participants Who Attended ≥ 80% of Sessions	13 Participants
Extended MBI	Number of Participants Who Attended ≥ 80% of Sessions	15 Participants

Primary

Number of Participants Who Completed Assessments

Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing)

Time frame: Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Brief MBI	Number of Participants Who Completed Assessments	18 Participants
Standard MBI	Number of Participants Who Completed Assessments	13 Participants
Extended MBI	Number of Participants Who Completed Assessments	16 Participants

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

Time frame: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Brief MBI	Number of Participants Who Practiced Meditation ≥ 4 Days Per Week	16 Participants
Standard MBI	Number of Participants Who Practiced Meditation ≥ 4 Days Per Week	8 Participants
Extended MBI	Number of Participants Who Practiced Meditation ≥ 4 Days Per Week	13 Participants

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.

Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)