scholarly journals A study protocol for a cluster randomised controlled trial on mindfulness-based stress reduction: Studying effects of mindfulness-based stress reduction and an additional organisational health intervention on mental health and work-related perceptions of teachers in Dutch secondary vocational schools

2019 ◽  
Author(s):  
Math Janssen ◽  
Yvonne Heerkens ◽  
Beatrice van der Heijden ◽  
Hubert Korzilius ◽  
Pascale Peters ◽  
...  
Keyword(s):  
Mental Health ◽  
Stress Reduction ◽  
Work Performance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Health Intervention ◽  
Vocational Schools ◽  
Work Related ◽  
Mindfulness Based Stress Reduction

Abstract Background: Dutch teachers in secondary vocational schools suffer from stress and burnout complaints that can cause considerable problems at work. This paper presents a study design that can be used to evaluate the short- and long-term effectiveness of Mindfulness-Based Stress Reduction (MBSR), being a person-focused intervention, both within and without the context of an additional organisational health intervention. Methods: The proposed study comprises a cluster randomised controlled trial that will be conducted in at least three secondary vocational schools, for which teachers will[HBvd(1] be recruited from three types of courses: Care, Technology, and Economy. The allocation of the intervention programme to the participating schools will be randomised. The teachers from each school will be assigned to either Intervention Group 1 (IG 1), Intervention Group 2 (IG 2), or the Waiting List Group (WG). IG 1 will receive MBSR training and IG 2 will receive MBSR training combined with an additional organisational health intervention. WG, that is the control group, will receive MBSR training one year later. The primary outcome variable of the proposed study is mindfulness, which will be measured with the Dutch version of the Five Facet Mindfulness Questionnaire (FFMQ-NL). In the conceptual model, the effects of teachers’ mindfulness resulting from the intervention programmes (MBSR training and MBSR training combined with an additional organisational health intervention) will be related to salient (secondary outcome) variables: mental health outcomes (e.g., burnout, work engagement), work performance, work-related perceptions (job demands and job resources), and personal competencies (e.g., occupational self-efficacy). Data will be collected before (T0) and immediately after the MBSR training (T1), and three (T2) and nine months (T3) after the training. The power analysis revealed a required sample size of 66 teachers (22 for each group). Discussion: The proposed study aims to provide insight into: (1) the short- and long-term effects of MBSR on teachers’ mental health, (2) the possible enhancing effects of the additional organisational health intervention, and (3) the teachers’ experiences with the interventions (working mechanisms, steps in the mindfulness change process). Strengths of this study design are the use of both positive and negative outcomes, the wide range of outcomes, both outcome and process measures, longitudinal data, mixed methods, and an integral approach. Although the proposed study protocol may not address all weaknesses of current studies (e.g., self-selection bias, self-reporting of data, the Hawthorne effect), it is innovative in many ways and can be expected to make important contributions to both the scientific and practical debate on how to beat work-related stress and occupational burnout, and on how to enhance work engagement and work performance.

scholarly journals A study protocol for a cluster randomised controlled trial on mindfulness-based stress reduction: Studying effects of mindfulness-based stress reduction and an additional organisational health intervention on mental health and work-related perceptions of teachers in Dutch secondary vocational schools

2020 ◽  
Author(s):  
Math Janssen ◽  
Yvonne Heerkens ◽  
Beatrice van der Heijden ◽  
Hubert Korzilius ◽  
Pascale Peters ◽  
...  
Keyword(s):  
Mental Health ◽  
Work Engagement ◽  
Stress Reduction ◽  
Work Performance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Intervention ◽  
Vocational Schools ◽  
Work Related ◽  
Mindfulness Based Stress Reduction

Abstract Background: Dutch teachers in secondary vocational schools suffer from stress and burnout complaints that can cause considerable problems at work. This paper presents a study design that can be used to evaluate the short- and long-term effectiveness of Mindfulness-Based Stress Reduction (MBSR), being a person-focused intervention, both within and without the context of an additional organisational health intervention. Methods: The proposed study comprises a cluster randomised controlled trial that will be conducted in at least three secondary vocational schools, for which teachers will be recruited from three types of courses: Care, Technology, and Economy. The allocation of the intervention programme to the participating schools will be randomised. The teachers from each school will be assigned to either Intervention Group 1 (IG 1), Intervention Group 2 (IG 2), or the Waiting List Group (WG). IG 1 will receive MBSR training and IG 2 will receive MBSR training combined with an additional organisational health intervention. WG, that is the control group, will receive MBSR training one year later. The primary outcome variable of the proposed study is mindfulness, which will be measured with the Dutch version of the Five Facet Mindfulness Questionnaire (FFMQ-NL). In the conceptual model, the effects of teachers’ mindfulness resulting from the intervention programmes (MBSR training and MBSR training combined with an additional organisational health intervention) will be related to salient (secondary outcome) variables: mental health outcomes (e.g., burnout, work engagement), work performance, work-related perceptions (job demands and job resources), and personal competencies (e.g., occupational self-efficacy). Data will be collected before (T0) and immediately after the MBSR training (T1), and three (T2) and nine months (T3) after the training. The power analysis revealed a required sample size of 66 teachers (22 for each group). Discussion: The proposed study aims to provide insight into: (1) the short- and long-term effects of MBSR on teachers’ mental health, (2) the possible enhancing effects of the additional organisational health intervention, and (3) the teachers’ experiences with the interventions (working mechanisms, steps in the mindfulness change process). Strengths of this study design are the use of both positive and negative outcomes, the wide range of outcomes, both outcome and process measures, longitudinal data, mixed methods, and an integral approach. Although the proposed study protocol may not address all weaknesses of current studies (e.g., self-selection bias, self-reporting of data, the Hawthorne effect), it is innovative in many ways and can be expected to make important contributions to both the scientific and practical debate on how to beat work-related stress and occupational burnout, and on how to enhance work engagement and work performance. Trial registration: The trail is registered with the Dutch Trial Register (www.trialregister.nl): NL5581 (July 2016). The first participants were randomly assigned in September 2016. Keywords: Mindfulness-Based Stress Reduction; Additional organisational health intervention; Mental health; Teachers; Longitudinal approach; Mindfulness; Burnout; Stress; Work engagement; Work performance

scholarly journals An intervention to improve teacher well-being support and training to support students in UK high schools (the WISE study): A cluster randomised controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (11) ◽  
pp. e1003847
Author(s):  
Judi Kidger ◽  
Nicholas Turner ◽  
William Hollingworth ◽  
Rhiannon Evans ◽  
Sarah Bell ◽  
...  
Keyword(s):  
Mental Health ◽  
School Environment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Median Number ◽  
Poor Mental Health ◽  
Control Group ◽  
Health And Well Being

Background Teachers are at heightened risk of poor mental health and well-being, which is likely to impact on the support they provide to students, and student outcomes. We conducted a cluster randomised controlled trial, to test whether an intervention to improve mental health support and training for high school teachers led to improved mental health and well-being for teachers and students, compared to usual practice. We also conducted a cost evaluation of the intervention. Methods and findings The intervention comprised (i) Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service. About 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement were randomly allocated to intervention (n = 12) or control group (n = 13) after collection of baseline measures. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience. The primary outcome was teacher well-being (Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment. Follow-up was at months 12 (T1) and 24 (T2). We collected process data to test the logic model underpinning the intervention, to aid interpretation of the findings. A total of 1,722 teachers were included in the primary analysis. Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference −0.90, 95% CI –2.07 to 0.27, p = 0.130). The only effect on secondary outcomes was higher teacher-reported absence among the intervention group at T2 (intervention group median number of days absent 0, control group median number of days absent 0, ratio of geometric means 1.04, 95% CI 1.00 to 1.09, p = 0.042). Process measures indicated little change in perceived mental health support, quality of relationships, and work-related stress. The average cost of the intervention was £9,103 per school. The study’s main limitations were a lack of blinding of research participants and the self-report nature of the outcome measures. Conclusions In this study, we observed no improvements to teacher or student mental health following the intervention, possibly due to a lack of impact on key drivers of poor mental health within the school environment. Future research should focus on structural and cultural changes to the school environment, which may be more effective at improving teacher and student mental health and well-being. Trial registration www.isrctn.com ISRCTN95909211.

scholarly journals The Effects of Mindfulness-Based Stress Reduction Program on the Mental Health of Family Caregivers: A Randomized Controlled Trial

2014 ◽  
Vol 83 (1) ◽  
pp. 45-53 ◽  
Author(s):  
Rebecca Jing Hou ◽  
Samuel Yeung-Shan Wong ◽  
Benjamin Hon-Kei Yip ◽  
Anchor T.F. Hung ◽  
Herman Hay-Ming Lo ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Family Caregivers ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Reduction Program ◽  
Mindfulness Based Stress Reduction

scholarly journals Mindfulness-based stress reduction adapted to pregnant women with psychosocial vulnerabilities—a protocol for a randomized feasibility study in a Danish hospital-based outpatient setting

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
S. Skovbjerg ◽  
D. Birk ◽  
S. Bruggisser ◽  
A. L. A. Wolf ◽  
L. Fjorback
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pregnant Women ◽  
Feasibility Study ◽  
Stress Reduction ◽  
Controlled Trial ◽  
University Hospital ◽  
Randomized Controlled ◽  
Mindfulness Based Stress Reduction

Abstract Background This protocol is for a feasibility study of a mindfulness-based stress reduction (MBSR) program adapted for pregnant women with psychosocial vulnerabilities. The rationale for the study is the need for a wider array of evidence-based options to address prenatal mental health care needs in pregnant women. MBSR is a promising mental health intervention but has not yet been adapted for pregnant women with the aim of addressing prenatal mental health. The purpose is thus to evaluate the feasibility, acceptability, and clinical outcomes of an adapted MBSR program, prenatal MBSR, compared to usual care to inform a randomized controlled trial. Methods/design Pregnant women (n = 60) referred to an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark, will be recruited for the study. The design is a single-center feasibility trial, with prenatal MBSR, as an add-on to usual care. The primary outcome is to assess the feasibility of a full-scale randomized controlled trial. The secondary feasibility outcome includes possible effects of the adapted MBSR program estimated by self-report questionnaires measuring stress, anxiety, depression, well-being, decentering, reflective functioning, mindfulness, and compassion. Participants will be randomized in a 1:1 ratio to prenatal MBSR or usual care. Discussion The study is part of the Good Start to Family Life study anchored at Copenhagen University Hospital, Amager and Hvidovre, Denmark. Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to reduce stress, improve mental health, and provide support in the transition to parenthood. The outcomes of the feasibility study will inform the design of a fully powered randomized controlled trial. Trial registration ClinicalTrials.gov, NCT04571190. Registered on September 30, 2020

scholarly journals Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): a protocol for a hybrid III parallel cluster randomised controlled trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Danielle Mazza ◽  
Samantha Chakraborty ◽  
Vera Camões-Costa ◽  
Justin Kenardy ◽  
Bianca Brijnath ◽  
...  
Keyword(s):  
Mental Health ◽  
General Practice ◽  
Service Use ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Work Outcomes ◽  
Work Related ◽  
Hybrid Iii ◽  
Patient Health ◽  
Randomised Controlled

Abstract Background The Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline) was published in 2019. The objective of this trial is to implement the Guideline in general practice. Trial design Implementing work-related Mental health conditions in general PRacticE is a hybrid III, parallel cluster randomised controlled trial undertaken in Australia. Its primary aim is to assess the effectiveness of a complex intervention on the implementation of the Guideline in general practice. Secondary aims are to assess patient health and work outcomes, to evaluate the cost-effectiveness of the trial, and to develop a plan for sustainability. Methods A total of 86 GP clusters will be randomly allocated either to the intervention arm, where they will receive a complex intervention comprising academic detailing, enrolment in a community of practice and resources, or to the control arm, where they will not receive the intervention. GP guideline concordance will be assessed at baseline and 9 months using virtual simulated patient scenarios. Patients who meet the eligibility criteria (>18years, employed, and receiving care from a participating GP for a suspected or confirmed work-related mental health condition) will be invited to complete surveys about their health and work participation and provide access to their health service use data. Data on health service use and work participation compensation claim data will be combined with measures of guideline concordance and patient outcomes to inform an economic evaluation. A realist evaluation will be conducted to inform the development of a plan for sustainability. Results We anticipate that GPs who receive the intervention will have higher guideline concordance than GPs in the control group. We also anticipate that higher concordance will translate to better health and return-to-work outcomes for patients, as well as cost-savings to society. Conclusions The trial builds on a body of work defining the role of GPs in compensable injury, exploring their concerns, and developing evidence-based guidelines to address them. Implementation of these guidelines has the potential to deliver improvements in GP care, patient health, and return-to-work outcomes. Trial registration ACTRN12620001163998, November 2020

scholarly journals Is there an app for that? A cluster randomised controlled trial of a mobile app–based mental health intervention

2019 ◽  
Vol 26 (3) ◽  
pp. 1538-1559 ◽  
Author(s):  
Rachel Kenny ◽  
Amanda Fitzgerald ◽  
Ricardo Segurado ◽  
Barbara Dooley
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

Demand for the use of mobile apps in mental health interventions has grown in recent years, particularly among adolescents who experience elevated levels of distress. However, there is a scarcity of evidence for the effectiveness of these tools within this population. The aim of this study was to test the effectiveness of CopeSmart, a mental health mobile app, using a multicentre cluster randomised controlled trial design. Participants were 15–18-years-olds (N = 560) recruited from 10 schools randomly assigned to an intervention or control condition. Intervention participants used the app over a 4-week period. Multi-level modelling analyses revealed no significant changes in the intervention group from pre-test to post-test, when compared to the control group, in terms of emotional distress, well-being, emotional self-awareness or coping strategies. Findings suggest that a 4-week app-based intervention may not be enough to elicit intra-personal changes in mental health outcomes in a general adolescent population.

scholarly journals Effectiveness of mindfulness-based stress reduction and attachment-based compassion therapy for the treatment of depressive, anxious and adjustment disorders in mental health settings: A randomized controlled trial

2021 ◽  
Author(s):  
Carlos Collado-Navarro ◽  
Adrian Perez-Aranda ◽  
Mayte Navarro-Gil ◽  
Yolanda López del Hoyo ◽  
Javier Garcia-Campayo ◽  
...  
Keyword(s):  
Mental Health ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Post Treatment ◽  
Adjustment Disorders ◽  
Affective Distress ◽  
Treatment As Usual ◽  
Self Compassion ◽  
Mindfulness Based Stress Reduction

Objectives: To study the effectiveness of Attachment-Based Compassion Therapy (ABCT) for reducing affective distress in a sample of outpatients with depressive, anxiety or adjustment disorders, and to explore its action mechanisms.Methods: This randomised controlled trial involved assessment time points of pre-treatment, post-treatment, and 6-months follow-up. A total of 90 patients from three mental health units in Castellón (Spain) were recruited and randomly assigned to ‘ABCT + treatment as usual (TAU)’, ‘Mindfulness-based stress reduction (MBSR) + TAU’, or ‘TAU’ alone. Affective distress, as measured by the ‘Depression, Anxiety and Stress Scales’ (DASS-21) was the main outcome; self-compassion and mindfulness were also assessed. Multilevel mixed-effects models were performed to estimate the efficacy of the programme, and path analysis were conducted to study the potential mechanistic role of mindfulness and self-compassion.Results: ABCT was not superior to MBSR in any outcome or assessment point. ABCT was superior to TAU both post-treatment (B=-13.20; 95% CI: -19.57, -6.84) and at 12-month follow-up (B=-7.20; 95% CI: -13.63, -0.76) for reducing DASS-21, and MBSR was superior to TAU both post-treatment (B=-11.51; 95% CI: -17.97, -5.05) and at 12-month follow-up (B=-8.59; 95% CI -15.09, -2.10), with large effects (d≥0.90). Changes produced in DASS-21 by ABCT were mediated by self-compassion, while changes produced by MBSR were mediated by both mindfulness and self-compassion.Conclusion: ABCT is efficacious for reducing affective distress in patients with anxiety, depressive or adjustment disorders, although its effect is not superior to MBSR’s. Self-compassion seems to be a significant mediator of the effects of ABCT.

scholarly journals The Effects of a Modified Mindfulness-Based Stress Reduction Program for Nurses: A Randomized Controlled Trial

2018 ◽  
Vol 67 (3) ◽  
pp. 111-122 ◽  
Author(s):  
Lin Lin ◽  
Guoping He ◽  
Jin Yan ◽  
Can Gu ◽  
Jianfei Xie
Keyword(s):  
Job Satisfaction ◽  
Negative Affect ◽  
Positive Affect ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mainland China ◽  
Control Groups ◽  
Mindfulness Based Stress Reduction ◽  
The Impact

The purpose of the study was to evaluate the effects of a modified mindfulness-based stress reduction (MBSR) program on the levels of stress, affect, and resilience among nurses in general hospitals in mainland China. In addition, the study attempted to determine the impact of the program on job satisfaction. A total of 110 nurses were randomly assigned to the intervention versus control groups. The intervention group participated in a modified 8-week MBSR program. All participants were evaluated with questionnaires at baseline, immediately after the intervention, and 3 months later. The intervention group showed decreases in stress and negative affect and increases in positive affect and resilience after the intervention. No improvement in job satisfaction was observed, but the trends of the data were in the hypothesized direction that job satisfaction would improve. The modified MBSR program is an effective approach for nurses to decrease stress and negative affect and improve positive affect and resilience. In addition, the program has the potential to improve job satisfaction.

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