Internet delivered, non-inferiority, two-arm, assessor-blinded intervention comparing mindfulness-based stress reduction and cognitive-behavioral treatment for insomnia: a protocol study for a randomized controlled trial for nursing staff with insomnia.
Yaling Li, Nabi Nazari, Masoud Sadeghi
Trials December 16, 2022 DOI: 10.1186/s13063-022-06986-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Peer reviewed |
|---|---|
| Population | Clinical nurses with insomnia |
| Intervention | Internet-delivered mindfulness-based stress reduction (iMBSR) |
| Measures | Insomnia Severity Index |
| Topics | Meditation |
| Keywords | Cbt-i Covid-19 Insomnia Internet Sleep disorders Treatment |
| Key findings | Proposes that internet-delivered mindfulness-based stress reduction (iMBSR) will be non-inferior to internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) in reducing insomnia severity among clinical nurses with insomnia, with sleep quality measured by the Insomnia Severity Index as the primary outcome. |
Abstract
Insomnia and poor sleep quality are highly prevalent conditions related to coronavirus disease 2019 (COVID-19) complications among clinical nurses. Although cognitive behavioral therapy for insomnia (CBT-I) is a first-line treatment, CBT-I suffers from several major drawbacks. This study investigates whether the application of the internet-delivered mindfulness-based stress reduction (iMBSR) intervention will produce effects that are non-inferior to the internet-delivered CBT-I (iCBT-I) intervention in reducing the severity of insomnia in clinical nurses with insomnia at the end of the study. This study protocol presents an internet-delivered, parallel-groups, assessor-blinded, two-arm, non-inferiority randomized controlled trial. The primary outcome is sleep quality, assessed by the Insomnia Severity Index. Secondary outcomes include depression, dysfunctional beliefs, five facets of mindfulness, and client satisfaction. It is expected that this study may address several gaps in the literature. The non-inferiority study design is a novel approach to evaluating whether a standardized, complementary treatment (i.e., MBSR) is as practical as a gold standard treatment rather than its potential benefits. This approach may lead to expanded evidence-based practice and improve patient access to effective treatments. Trial registration number: ISRCTN36198096 . Registered on 24th May 2022.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 13
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- Mindfulness Meditation and Improvement in Sleep Quality and Daytime Impairment Among Older Adults With Sleep Disturbances JAMA Internal Medicine February 16, 2015
- Mindfulness, self-compassion and wellbeing Personality and Individual Differences 2021
- Effects of mindfulness meditation interventions on depression in older adults: A meta-analysis Aging & Mental Health July 15, 2020
- A Systematic Review and Meta-Analysis of Workplace Mindfulness Training Randomized Controlled Trials Journal of Occupational Health Psychology February 1, 2019
and 8 more in the library