Mindfulness-Based cognitive therapy for Life (MBCT-L) versus stress reduction psychoeducation (SRP) for the improvement of mental well-being in health care and other public sector staff : protocol for the well at work randomized controlled trial

Abstract

BACKGROUND: Mindfulness-based and stress reduction interventions have been recommended by the National Institute for Health and Care Excellence guidelines in England and Wales as effective preventive mental well-being interventions for health care and other public sector staff at risk of poor mental health. OBJECTIVE: This trial aims to assess the effectiveness of the 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 health care and other public sector service employees. METHODS: The trial is a multisite, single-blind, parallel-group, 2-arm superiority randomized controlled trial. Recruitment, interventions, and assessments will be conducted remotely via online platforms. We will recruit 260 health care and other public sector staff into 26 intervention groups across the United Kingdom, with the intervention delivered through human resource staff well-being provision channels affiliated with participating National Health Service trusts. Participants will be randomly allocated in a 1:1 ratio to either MBCT-L or SRP. Primary and secondary outcomes will be collected at 6, 12, and 20 weeks after randomization. The primary outcome will be the change in scores on the Perceived Stress Scale-14 from baseline to 20 weeks after randomization. Demographic, intervention-related, and health economic data will also be collected. Secondary outcomes will involve assessments of well-being, mental health state, and work-related engagement and performance. Adverse events will be recorded. Data analysis will involve multilevel modeling, and it will be conducted on an intention-to-treat basis. A substudy will involve online semistructured interviews after 20 weeks of randomization with a subsample of participants (n=30, 12%). Transcribed data will be subjected to thematic analysis to elicit qualitative outcomes on perceived well-being and work-related changes after intervention as well as drivers and barriers to intervention uptake and acceptability. RESULTS: Recruitment of participants commenced on August 29, 2023. The target recruitment of 260 participants was reached on April 30, 2024. Follow-up outcome data collection was completed on September 30, 2024, and data analysis is underway. A total of 30 qualitative interviews have been conducted. CONCLUSIONS: Findings will inform future recommendations on intervention suitability and implementation for public care staff well-being. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN18049845; https://www.isrctn.com/ISRCTN18049845. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67695.