JMIR Publications

ABSTRACT

Background:

Recently published guidelines by the National Institute for Health and Care Excellence (NICE) have recommended both mindfulness-based and stress-reduction approaches as effective preventative mental wellbeing interventions for healthcare and other public sector staff at risk of poor mental health.

Objective:

This trial aims to assess the effectiveness of an increasingly implemented Mindfulness-Based Cognitive Therapy-for Life (MBCT-L) intervention versus a routinely available Stress-Reduction Psychoeducation (SRP) intervention in reducing perceived stress and improving other mental health and work-related outcomes in national healthcare and other public sector service employees.

Methods:

The trial is a multi-site, single-blind, parallel-group, two-arm superiority Randomised Controlled Trial (RCT). Recruitment, interventions and assessments will be conducted remotely, via online digital platforms. We will recruit 260 healthcare and other public sector staff in 26 intervention groups across the UK to be delivered through existing integrated care or wellbeing hub services or other human resource staff wellbeing channels affiliated with the participating National Health Service (NHS) Trusts. Participants will be randomly allocated in a 1:1 ratio to either the MBCT-L or SRP. Primary and secondary outcomes will be collected at 6, 12 and 20 weeks following randomisation. The primary outcome will be change on the Perceived Stress Scale-14 (PSS-14) from baseline to 20 weeks post randomisation. Demographic, intervention-related and health economic data will also be collected. Adverse events will be recorded. Data analysis will involve multilevel modelling and will be conducted on an intention-to-treat basis. A sub-study will involve online semi-structured interviews post 20 weeks randomisation with a sub-sample of participants (n=30). Transcribed data will be subjected to thematic analysis for eliciting qualitative outcomes on perceived wellbeing and work-related changes post intervention, and drivers and barriers to intervention uptake and acceptability.

Results:

Recruitment of participants commenced on August 29th, 2023. The target recruitment of 260 participants was reached 30th April 2024. Follow up outcome data collection was completed 30th September 2024 and data analysis is underway. Thirty qualitative interviews have been conducted.

Conclusions:

Findings will be made publicly available and will inform future refinements in intervention suitability and implementation for public care staff wellbeing. Clinical Trial: ISRCTN18049845