Awareness and Self-Compassion Enhancing Narcolepsy Treatment (ASCENT)

Northwestern University

Status: Completed

Conditions: Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy; Narcolepsy

Treatments: Behavioral: Extended MBI; Behavioral: Brief MBI; Behavioral: Standard MBI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04306952

STU00209890

R34AT009551 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Brief MBI

Experimental group

Description:

The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.

Treatment:

Behavioral: Brief MBI

Standard MBI

Experimental group

Description:

The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.

Treatment:

Behavioral: Standard MBI

Extended MBI

Experimental group

Description:

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.

Treatment:

Behavioral: Extended MBI