Steps that count! A feasibility study of a pedometer-based, health-promotion intervention in an employed, South African population

Background. The emergence of the pedometer as a useful motivational aid for increasing physical activity (PA) has supported its use in PA interventions. Objectives. To examine the feasibility of a 10-week pedometer-based intervention complemented by regular motivational messages, to increase ambulatory PA; and to determine the minimum sample size required for a randomised, controlled trial (RCT). Methods. Participants, sourced by convenience sampling of employees from an academic institution, were randomly assigned to either an intervention group (IG) (n=11) or control group (CG) (n=11), following baseline health measurements and blinded pedometer wear (week 1). Participants in the IG subsequently wore an unblinded pedometer (10 weeks) to self-monitor daily steps. Individualised messages using pedometer data (IG) and general motivational messages (IG and CG) were provided bi-weekly. Blinded pedometer wear (IG and CG) and a feedback questionnaire (IG) were completed at week 12. Pedometer data were compared between the IG and CG at week 12. Results. Participants’ perceptions of the intervention supported the benefit of the pedometer as a useful motivational aid and a reminder to increase steps per day. Occupational sitting time and inability to incorporate PA into daily routine emerged as the main barrier to adherence. Steps per day increased more in the IG (mean ± standard deviation (SD) 996±1 748) than in the CG (mean±SD 97±750). Modest improvements were noted in all clinical measures (IG). Conclusion. Based on the improvement of 1 000 steps/day (IG), a minimum of 85 participants in the IG and CG, respectively, is required for a future RCT (80% power; p<0.05). We recommend a minimum of 150 participants in each group to account for loss to follow-up and to allow for subgroup analyses.

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Mindfulness-based programme for residents: study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-035025 ◽

2020 ◽

Vol 10 (3) ◽

pp. e035025

Author(s):

Vanessa Marie-Jane Aeschbach ◽

Johannes Caspar Fendel ◽

Anja Simone Göritz ◽

Stefan Schmidt

Keyword(s):

Mental Distress ◽

Medical Center ◽

Controlled Trial ◽

Intervention Group ◽

Maintenance Phase ◽

Self Report ◽

Physiological Data ◽

Control Group ◽

Daily Routine ◽

Randomised Controlled

IntroductionResidency is a stressful phase associated with high prevalence of mental distress. Besides impaired personal health, mental distress in residents has an impact on the quality of patient care and produces economic costs. Therefore, there is demand for interventions that improve resident physicians’ mental health. The aim of the present study is to examine the effects of a mindfulness-based intervention that has been tailored to residents’ needs. Specifically, mindfulness has been supplemented by a focus on the concept of Muße.Methods and analysisThis study applies a randomised controlled multimethod design. Residents assigned to the intervention group will participate in an 8-week mindfulness course followed by a 4-month maintenance phase, whereas residents assigned to the control group will read text-based information about mindfulness on a weekly basis for the duration of 8 weeks. The intervention is focussed on a transfer of learnt techniques into the daily routine and is targeted to promote residents’ self-care as well as on building empathic relationships. Participants will be assessed before, directly after the intervention, after the maintenance phase as well as at follow-up 6 months after the intervention group completes the intervention. Assessments will consist of self-report measures, physiological data, qualitative interviews, third-party reports as well as implicit and projective measures and will focus on both psychopathology and salutogenesis. The primary outcome will be burnout. Data will be analysed using linear mixed modelling.Ethics and disseminationThe study was approved by the ethics committee of the Medical Center - University of Freiburg and is funded by the German Research Foundation as part of the interdisciplinary Collaborative Research Center ‘SFB Muße 1015’. The results of this study will be published in scientific journals and disseminated through the study’s website, and conferences.Trial registration numberDRKS00014015.

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The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-210953 ◽

2017 ◽

Vol 76 (9) ◽

pp. 1603-1606 ◽

Cited By ~ 34

Author(s):

Tanja Thomsen ◽

Mette Aadahl ◽

Nina Beyer ◽

Merete Lund Hetland ◽

Katrine Løppenthin ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Sitting Time ◽

Control Group ◽

Behavioural Intervention ◽

Secondary Outcomes ◽

Randomised Controlled ◽

General Self Efficacy ◽

Motivational Counselling

ObjectivesThe aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA).MethodsIn this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist–hip ratio.Results75 patients were allocated to each group. Mean reduction in daily sitting time was −1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference −2.20 (95% CI −2.72 to −1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention.ConclusionAn individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels.Trial registration numberNCT01969604; Results.

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The COVID-OR Study: 1 year Observation of Recovery from critical illness following COVID-19 and feasibility of smartwatch assisted rehabilitation. (Preprint)

10.2196/preprints.25494 ◽

2021 ◽

Author(s):

Alex Hunter ◽

Todd Leckie ◽

Oliver Coe ◽

Benjamin Hardy ◽

Daniel Fitzpatrick ◽

...

Keyword(s):

Critical Care ◽

Critical Illness ◽

Controlled Trial ◽

Step Count ◽

Control Group ◽

Feedback Questionnaire ◽

Critical Care Admission ◽

Steps Per Day ◽

One Year ◽

Randomised Controlled

BACKGROUND As a sequelae of the COVID-19 pandemic, a large cohort of critical illness survivors have had to recover in the context of ongoing societal restrictions. OBJECTIVE To observe the recovery of survivors of critical care admission with COVID-19 using smartwatches, evaluate how these devices enabled a remote multidisciplinary team (MDT) to support patient recovery, and assess the usability of these devices. METHODS A prospective multi-centre observational trial in eight UK critical care units. 50 participants with moderate or severe lung injury as a result of confirmed COVID-19 disease were recruited at discharge from critical care and given a smartwatch (Fitbit Charge 3). Data collected included step count and daily resting heart rate (HR). A subgroup, the ‘MDT site’ (n=19), had their smartwatch data used to inform a regular MDT meeting. Devices were evaluated by use of a patient feedback questionnaire and direct feedback from the MDT. Participants that did not upload smartwatch data were excluded from analysis. RESULTS From the overall cohort, 35 (70%) participants used and uploaded data from their smartwatch during the 1 year period. 14 users uploaded data from the MDT site. The overall cohort recorded a mean increase of 4359 (±3488) steps per day in the first month following discharge, to 7914(±4146) steps at 1 year (p<0.01). HR reduced from a mean of 79 (7) beats per minute in the first month to 69 (4) at one year following discharge (p<0.01)). The MDT subgroup increased mean step count by more than the control group (176 vs 42%, p=0.04) over the 1 year. 94% of fitbit users found their smartwatch easy to use and 80% felt that the technology helped and motivated them to recover. CONCLUSIONS This is the first study to report 1-year recovery of patients who survived COVID-19 critical illness using smartwatch technology. Future work could explore the role of smartwatches as part of a randomised controlled trial to assess clinical and economic effectiveness. INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.12968/ijtr.2020.0102

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Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040108 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040108

Author(s):

Rowan W Johnson ◽

Sian A Williams ◽

Daniel F Gucciardi ◽

Natasha Bear ◽

Noula Gibson

Keyword(s):

Exercise Prescription ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Home Exercise ◽

Control Group ◽

Neurodevelopmental Disabilities ◽

Home Exercise Programme ◽

Exercise Programmes ◽

Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

BioMed Research International ◽

10.1155/2014/610591 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Charlotte Loumann Krogh ◽

Charlotte Ringsted ◽

Charles B. Kromann ◽

Maria Birkvad Rasmussen ◽

Tobias Todsen ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Global Rating ◽

Training Performance ◽

Significant Difference ◽

Training Format ◽

Peer Performance ◽

And Performance ◽

Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

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Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽

10.1093/qjmed/hcab115.005 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Hatem Hussein El-Gamal ◽

Walid El-Basuony Mohammad ◽

Ahmed Samir Mohamed Zeerban

Keyword(s):

Quality Of Life ◽

Caesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Expectant Management ◽

Control Group ◽

Randomised Controlled ◽

Caesarean Scar Defect ◽

Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

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The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

10.21203/rs.2.12594/v1 ◽

2019 ◽

Author(s):

Caroline Laker ◽

Matteo Cella ◽

Felicity Callard ◽

Til Wykes

Keyword(s):

Mental Health ◽

Controlled Trial ◽

Occupational Status ◽

Intervention Group ◽

Direct Care ◽

Care Staff ◽

Control Group ◽

Staff Perceptions ◽

Barriers To Change ◽

Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

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Effects of two types of smartphone-based stress management programmes on depressive and anxiety symptoms among hospital nurses in Vietnam: a protocol for three-arm randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-025138 ◽

2019 ◽

Vol 9 (4) ◽

pp. e025138 ◽

Cited By ~ 6

Author(s):

Kotaro Imamura ◽

Thuy Thi Thu Tran ◽

Huong Thanh Nguyen ◽

Kazuto Kuribayashi ◽

Asuka Sakuraya ◽

...

Keyword(s):

Stress Management ◽

Free Choice ◽

Controlled Trial ◽

Intervention Group ◽

Anxiety Symptoms ◽

Control Group ◽

Hospital Nurses ◽

Management Intervention ◽

Stress Management Intervention ◽

Randomised Controlled

IntroductionDue to an increasing demand for healthcare in low-income and middle-income countries in Asia, it is important to develop a strategy to manage work-related stress in healthcare settings, particularly among nurses in these countries. The purpose of this three-arm randomised controlled trial (RCT) is to examine the effects of a newly developed smartphone-based multimodule stress management programme on reducing severity of depressive and anxiety symptoms as primary outcomes at 3-month and 7-month follow-ups among hospital nurses in Vietnam.Methods and analysisThe target study population will be registered nurses working in a large general hospital (which employs approximately about 2000 nurses) in Vietnam. They will be invited to participate in this study. Participants who fulfil the eligibility criteria will be randomly allocated to the free-choice, multimodule stress management (intervention group A, n=360), the internet cognitive behavioural therapy (iCBT), that is, fixed-order stress management (intervention group B, n=360), or a treatment as usual control group (n=360). Two types (free-choice and fixed sequential order) of smartphone-based six-module stress management programmes will be developed. Participants in the intervention groups will be required to complete one of the programmes within 10 weeks after the baseline survey. The primary outcomes are depressive and anxiety symptoms, measured by using the Depression Anxiety and Stress Scales (DASS) at 3-month and 7 month follow-ups.Ethics and disseminationThe study procedures have been approved by the Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (no 11991) and the Ethical Review Board for Biomedical Research of Hanoi University of Public Health (no 346/2018/YTCC-HD3). If a significant effect of the intervention programmes will be found in the RCT, the programmes will be made available to all nurses in the hospital including the control group. If the positive effects are found in this RCT, the e-stress management programmes will be disseminated to all nurses in Vietnam.Trial registration numberUMIN000033139; Pre-results.

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