Awareness and Self-Compassion Enhancing Narcolepsy Treatment

NCT04306952 | Completed Results DMC

• 2 other identifiers: STU00209890R34AT009551
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy; Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (7)

• Self-Compassion Scale (SCS)

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

• Five Facet Mindfulness Questionnaire (FFMQ)

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

• 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)

• 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)

• 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)

Study Arms (3)

Brief MBI

EXPERIMENTAL

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

Behavioral: Brief MBI

Standard MBI

EXPERIMENTAL

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

Behavioral: Standard MBI

Extended MBI

EXPERIMENTAL

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

Interventions

Brief MBI BEHAVIORAL

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.

Brief MBI

Standard MBI BEHAVIORAL

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.

Standard MBI

Extended MBI BEHAVIORAL

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).

Extended MBI

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Center for Circadian and Sleep Medicine, Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Mundt JM, Zee PC, Schuiling MD, Hakenjos AJ, Victorson DE, Fox RS, Dawson SC, Rogers AE, Ong JC. Development of a mindfulness-based intervention for narcolepsy: a feasibility study. Sleep. 2024 Oct 11;47(10):zsae137. doi: 10.1093/sleep/zsae137.

  PMID: 38895897 RESULT

MeSH Terms

Conditions

Narcolepsy; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Jennifer Mundt PhD
• Organization: Northwestern University

jennifer.mundt@nm.org

312-503-2846

Study Officials

• Jennifer Mundt, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurology

Model Details: 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

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 13, 2020
• Study Start: June 15, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 20, 2024
• Results First Posted: November 1, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)