Research paperBrief mindfulness-based stress management program for a better mental state in working populations - Happy Nurse Project: A randomized controlled trial✰✰
Introduction
Previous systematic reviews have shown that mindfulness-based psychotherapy is efficacious for several types of health problems, including not only mental disturbances such as anxiety (Chen et al., 2012, Goyal et al., 2014) and depression (Fjorback et al., 2011, Goyal et al., 2014), but also physical complaints like pain (Anheyer et al., 2017, Goyal et al., 2014). According to a recent systematic review and meta-analyses of individual patient data (Kuyken et al., 2016), mindfulness-based therapy appeared to prevent relapse of major depression when compared with active treatment options including antidepressants.
Among working populations, hospital nurses represent one of the most highly stressed professions. The prevalence of depressive symptoms above a clinical cut-off among hospital-employed nurses is 18% in the U.S. (Letvak et al., 2012). Nurses with depression are not only likely to suffer personally, but their illness may also have an impact on the quality of care for patients through an increase in presenteeism. Less-experienced junior nurses need support from senior colleagues and may require interventions to strengthen resilience to alleviate their psychological distress.
When considering working populations vulnerable to depression, pharmacological treatments cannot be relied upon because they are not useful as a preventive intervention due to their adverse side effects. As mindfulness-based therapy was developed by modifying Buddhism meditation (Samuel, 2015), it has been considered acceptable and possibly effective in preventing common mental disorders, including depression and anxiety. In a recent overview that focused on the prevention of mental disorders including depression, anxiety, and first-episode psychosis, mindfulness-based interventions were recognized as promising areas for further development (Mendelson and Eaton, 2018). A meta-analysis of randomized controlled trials (RCTs) comparing mindfulness-based stress reduction programs and control conditions showed an effect size of 0.48 in healthy adults (Khoury et al., 2015). Moreover, a recent systematic review that focused on mindfulness-based psychotherapy for nurses reported that mindfulness significantly improved nurses’ mental health (Guillaumie et al., 2017). This review collected data on the efficacy of mindfulness interventions from single-arm pre-post design studies as well as RCTs. However, RCTs in the review only included studies enrolling under 50 participants (Kim et al., 2013, Mackenzie et al., 2006), which might have led to a large degree of random errors, or only nursing students were recruited but not nurses (Johansson, 1991, Kanji et al., 2006). Mindfulness-based interventions were conducted by trained instructors in these studies. Trained instructors are generally regarded as the best treatment providers; however, applying the results from these trials to people in the real world could be problematic because trained instructors are not always accessible. To increase real world applicability, a psychosocial intervention conducted by trained lay people showing the effectiveness of mindfulness-based interventions is required.
Based on these facts, a conclusive RCT is needed to further examine if mindfulness-based interventions could help working populations, especially hospital nurses, to maintain a healthy mental state. The present study aimed to examine the effects of a brief mindfulness-based stress management program provided by senior nurses in their workplace.
Section snippets
Trial design
The present study is a part of a factorial-design RCT with a 52-week follow-up including outcome assessments at baseline, and weeks 13, 26 and 52, aimed at investigating the efficacy of both a brief mindfulness-based stress management program and the effects of omega-3 polyunsaturated fatty acids (PUFAs) (Watanabe et al., 2015). These interventions were terminated within 13 weeks from the registration of participants. The study focuses on the comparison between a brief mindfulness-based stress
Enrollment and baseline characteristics of participants
Between June 11, 2014 and August 27, 2015, 83 nurses were assessed for eligibility, of which 80 were enrolled and randomized to the mindfulness-based stress management program (n = 40) or the psychological leaflet (n = 40) groups. We did not find any clinically important differences between these two groups (Table 1).
Attrition, adherence and study integrity
Concerning the primary outcomes at 26 weeks, we obtained data from 37 participants (92.5%) for the brief mindfulness-based stress management program and 40 (100%) for the
Discussion
To our knowledge, this is the first study to investigate the effectiveness of a mindfulness-based stress management program administered by trained senior hospital nurses for junior nurses, who are thought to be vulnerable to mental conditions including depression and anxiety disorders. However, no significant differences between the program and leaflet groups were observed not only in terms of our primary outcome but also in all the other secondary outcomes. Adherence of participants to the
Limitations
The present study is not without methodological limitations. First, we did not manage to recruit the number of participants we initially set out, as defined by a power analysis in the protocol, probably because nurses in hospitals might think participating in the present study would be burdensome or stigmatizing. However, our post-hoc analyses showed that the effect size (Cohen's d) (Cohen, 1988) of the primary outcome for study completers was −0.15, with 95% CIs from −0.60 to 0.30. Thus, even
Conclusion
Comparing the leaflet containing psychoeducation information about dealing with stress with the brief mindfulness-based stress management program provided by trained peers, this last treatment did not lead to additional benefits concerning mental state and self-evaluated work efficiency in work populations. We do not recommend this form of psychosocial intervention for people within the general population who are willing to maintain their mental health.
Role of the funding source
This study was funded by Intramural Research Grant(25-8) for Neurological and Psychiatric Disorders of National Center of Neurology and Psychiatry, Japan. The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Contributors
Norio Watanabe - Participated in the conception and design of the study, recruited participants, collected data, performed the analysis and wrote the manuscript.
Masaru Horikoshi - Participated in the conception and design of the study.
Issei Shinmei - Participated in the conception and design of the study.
Yuki Oe - Participated in the conception and design of the study.
Tomomi Narisawa - Participated in the conception and design of the study, recruited participants, and collected data.
Mie Kumachi
Acknowledgment of assistance
We thank all the collaborators (Miyuki Makino, CP, RN at National Center of Neurology and Psychiatry, and Masato Usuki, MD, PhD at National Disaster Medical Center), technical assistant staff (Shizuko Takebe at University of Toyama), and the administrative staff (Mayuko Yamano at National Center of Neurology and Psychiatry). We also thank Shinako Ushijima, RN at National Center of Neurology and Psychiatry Hospital, Keiko Osada, RN and Masami Harasawa, RN at National Disaster Medical Center,
Potential conflicts of interests
The authors have no conflicts of interests to declare, that may be affected by the publication of the manuscript.
Dr Watanabe has received research funds from the Japanese Ministry of Health Labor and Welfare, The Japanese Ministry of Education, Science, and Technologyand National Center of Neurology and Psychiatry, Intramural Research Grantfor Neurological and Psychiatric Disorders. He has also received royalties from Sogensha and Akatsuki.
Dr Kumachi has received research funds from Japan
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Institution at which the work was performed: National Center of Neurology and Psychiatry, Japan; Kyoto University, Japan; University of Toyama, Japan
✰✰Trial registration ClinicalTrials.gov: NCT02151162 (registered on May 27, 2014) https://clinicaltrials.gov/ct2/show/NCT02151162