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.
Study Goal
The researchers aimed to determine whether internet-delivered mindfulness-based stress reduction (iMBSR) is non-inferior to internet-delivered cognitive behavioral therapy for insomnia (iCBT-I) in reducing insomnia severity among clinical nurses.
Results Summary
The study protocol suggests that iMBSR may be as practical as iCBT-I for improving sleep quality, with secondary outcomes including reduced depression, dysfunctional beliefs, and enhanced mindfulness facets. Final results are pending, but the non-inferiority design indicates potential comparable efficacy.
Population
Clinical nurses with insomnia
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
internet-delivered mindfulness-based stress reduction (iMBSR) intervention | decrease | severity of insomnia | clinical nurses with insomnia | non-inferior | produce effects that are non-inferior to the internet-delivered CBT-I (iCBT-I) intervention in reducing the severity of insomnia | #1 |
internet-delivered mindfulness-based stress reduction (iMBSR) intervention | no change | practicality | - | - | is as practical as a gold standard treatment | #2 |
BACKGROUND: 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. METHODS: 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. CONCLUSION: 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: Trial registration number: ISRCTN36198096 . Registered on 24th May 2022.