Evidence map›Paper›PMID 37434109›Full record

Trial reportBMC neurology2023

A pilot, randomized, placebo-controlled study of mindfulness meditation in treating insomnia in multiple sclerosis.

Joseph B Guarnaccia, Valentine Y Njike, Anne Dutton, Rockiy G Ayettey, Judith A Treu, Beth P Comerford, Rajita Sinha

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03949296 (A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03949296 nacompletednot on this map

A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

TypeinterventionalSponsorGriffin HospitalRan2017 to 2019Enrolled49ConditionsInsomnia Chronic, Multiple SclerosisArmsMindfulness Intervention, Sleep Hygiene
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Joseph B GuarnacciaMultiple Sclerosis Treatment Center, Griffin Hospital, 350 Seymour Ave., Suite 1C, Derby, Connecticut, 06418, USA. cthealthcarealliance@gmail.com.
Valentine Y NjikeYale-Griffin Prevention Research Center, Griffin Hospital, 130 Division St., Derby, Connecticut, 06418, USA.
Anne DuttonDepartment of Psychiatry, Yale Stress Center, Yale University, New Haven, Connecticut, 06510, USA.
Rockiy G AyetteyYale-Griffin Prevention Research Center, Griffin Hospital, 130 Division St., Derby, Connecticut, 06418, USA.
Judith A TreuYale-Griffin Prevention Research Center, Griffin Hospital, 130 Division St., Derby, Connecticut, 06418, USA.
Beth P ComerfordYale-Griffin Prevention Research Center, Griffin Hospital, 130 Division St., Derby, Connecticut, 06418, USA.
Rajita SinhaDepartment of Psychiatry, Yale Stress Center, Yale University, New Haven, Connecticut, 06510, USA.
Griffin Hospital · USYale University · USYale Griffin Prevention Research Center · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

objectiveMindfulness is an established approach to reduce distress and stress reactivity by improving awareness and tolerability of thoughts and emotions. This study compares mindfulness training to sleep hygiene in persons with multiple sclerosis (PWMS) who report chronic insomnia, examining sleep efficiency (SE), self-reported sleep quality and quality of life.

methodsFifty-three PWMS were randomized (1:1) in a single-blinded, parallel group design to ten, two-hour weekly sessions of Mindfulness Based Stress Intervention for Insomnia (MBSI-I) over a span of ten weeks or a single, one hour sleep hygiene (SH) session over one day. The primary outcome measure was SE, measured by the Fitbit™ Charge 2 wrist device, at 10 and 16 weeks from the start of study interventions. Self-report outcomes included the Pittsburg Sleep Quality Rating Scale (PSQI), Insomnia Severity Index (ISI) and the Multiple Sclerosis Quality of Life Inventory (MSQLI). Nineteen participants in the MBSI-I group and 24 in the SH group completed the primary study. Subsequently, ten participants in the original SH group participated in the 10-week MSBI-I course and their data was added to the MBSI-I cohort (eMSBI-I).

resultsWhile neither SE nor the PSQI showed significant differences between MBSI-I, eMBSI-I and SH groups, ISI improved in both the MSBI-I and eMBSI-I vs SH at 10 weeks (p = 0.0014 and p = 0.0275) but not 16 weeks. However, pre and post assessments within the MBSI-I and eMBSI-I cohorts did show significant improvement in the PSQI and ISI at 10 and 16 weeks, while SH was significant in the ISI only at 16 weeks. Several quality of life measurements, including fatigue, mental health and cognitive function favored the mindfulness cohorts.

conclusionThis pilot study demonstrates beneficial effects of MBSR on insomnia, sleep quality and quality of life in PWMS.

trial registrationNCT03949296. 14 May 2019.

Indexed as

MeditationMindfulnessMultiple SclerosisSleep Initiation and Maintenance DisordersHumansPilot ProjectsQuality of LifeFatigueInsomniaMindfulnessMultiple SclerosisSleep HygieneSleep Quality

Identifiers

PMID37434109
PMCPMC10334613
OpenAlexW4383906993

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.