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

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.

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

Health Informatics Journal ◽

10.1177/1460458219884195 ◽

2019 ◽

Vol 26 (3) ◽

pp. 1538-1559 ◽

Cited By ~ 3

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.

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The Effects of a Mindfulness Program on Mental Health in Students at an Undergraduate Program for Teacher Education: A Randomized Controlled Trial in Real-Life

Frontiers in Psychology ◽

10.3389/fpsyg.2021.722771 ◽

2021 ◽

Vol 12 ◽

Author(s):

Lise Juul ◽

Eva Brorsen ◽

Katinka Gøtzsche ◽

Birgitte Lund Nielsen ◽

Lone Overby Fjorback

Keyword(s):

Mental Health ◽

Teacher Education ◽

Student Teachers ◽

Perceived Stress ◽

Controlled Trial ◽

Intervention Group ◽

Real Life ◽

Well Being ◽

Control Group ◽

Undergraduate Program

Background: In this study, we aimed to investigate the effects of a mindfulness program including Mindfulness-Based Stress Reduction (MBSR) on the mental health of student teachers when offered at their educational institution in a real-life context.Methods: A parallel randomized controlled trial (RCT) was conducted among self-selected student teachers at a Danish undergraduate program for teacher education in the autumns of 2019 and 2020. Participation was not recommended in case of (1) clinical depression or a diagnosis of psychosis or schizophrenia, (2) abuse of alcohol, drugs, and/or medicine. Randomization was performed by a Statistician who was blinded to the identity of the students. Data was collected using self-reported questionnaires. The primary outcome was a change in perceived stress 3 months from baseline. Secondary outcome measures were symptoms of anxiety and depression, well-being, resilience, mindfulness, and thoughts and feelings during rest. The effects were analyzed according to the intention-to-treat principle using mixed-effect linear regression models. Mediating effects of mindfulness skills on the mental health outcomes were explored using structural equation modeling.Results: The study group included 67 student teachers with 34 allocated to the intervention group (median age: 25 years; women: n = 24, 71%); and 33 students (median age: 25 years; women: n = 25, 76%) allocated to a waiting list control group. At baseline, mean Perceived Stress Scale (PSS) scores were 18.88 (SD: 5.75) in the intervention group and 17.91 (SD: 6.36) in the waiting list control group. A total of 56 students completed the questionnaire at a 3-month follow-up (28 in both the intervention- and the control group). Statistically significant effects of the intervention were found on perceived stress, symptoms of anxiety and depression, well-being, and on three of seven resting-state dimensions. No effects were found on resilience or mindfulness. Statistically significant mediated effects via resting-state dimensions were found.Conclusion The findings suggested that offering a mindfulness program at an undergraduate program for teacher education could significantly improve the mental health among self-selected students within 3 months. Results of mediation analysis supported the hypothesis that some of the effects might be explained by reduced distracting thoughts.Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT04558099].

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Mindfulness-based online intervention on mental health and quality of life among COVID-19 patients in China: an intervention design

Infectious Diseases of Poverty ◽

10.1186/s40249-021-00836-1 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Ming-Yu Si ◽

Wei-Jun Xiao ◽

Chen Pan ◽

Hao Wang ◽

Yi-Man Huang ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Physical Symptoms ◽

Psychological Status ◽

Control Group ◽

Post Traumatic Stress

Abstract Background COVID-19 can lead to increased psychological symptoms such as post-traumatic stress disorder (PTSD), depression, and anxiety among patients with COVID-19. Based on the previous mindfulness-based interventions proved to be effective, this protocol reports a design of a randomized controlled trial aiming to explore the efficacy and possible mechanism of a mindful living with challenge (MLWC) intervention developed for COVID-19 survivors in alleviating their psychological problems caused by both the disease and the pandemic. Methods In April 2021, more than 1600 eligible participants from Hubei Province of China will be assigned 1:1 to an online MLWC intervention group or a waitlist control group. All participants will be asked to complete online questionnaires at baseline, post-program, and 3-month follow-up. The differences of mental health status (e.g. PTSD) and physical symptoms including fatigue and sleeplessness between the COVID-19 survivors who receiving the online MLWC intervention and the control group will be assessed. In addition, the possible mediators and moderators of the link between the MLWC intervention and target outcomes will be evaluated by related verified scales, such as the Five Facets Mindfulness Questionnaire. Data will be analyzed based on an intention-to-treat approach, and SPSS software will be used to perform statistical analysis. Discussion The efficacy and potential mechanism of MLWC intervention in improving the quality of life and psychological status of COVID-19 survivors in China are expected to be reported. Findings from this study will shed light on a novel and feasible model in improving the psychological well-being of people during such public health emergencies. Trial registration Chinese Clinical Trial Registry (ChiCTR), ChiCTR2000037524; Registered on August 29, 2020, http://www.chictr.org.cn/showproj.aspx?proj=60034.

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Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽

10.1136/bmjopen-2020-042850 ◽

2021 ◽

Vol 11 (1) ◽

pp. e042850

Author(s):

Karin Leder ◽

John J Openshaw ◽

Pascale Allotey ◽

Ansariadi Ansariadi ◽

S Fiona Barker ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Human Health ◽

Controlled Trial ◽

Informal Settlements ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Cluster Randomised ◽

Abundance And Diversity ◽

Randomised Controlled ◽

Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

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Assessing the impact of the European resilience curriculum in preschool, early and late primary school children

School Psychology International ◽

10.1177/01430343211025075 ◽

2021 ◽

pp. 014303432110250

Author(s):

Celeste Simões ◽

Anabela C. Santos ◽

Paula Lebre ◽

João R. Daniel ◽

Cátia Branquinho ◽

...

Keyword(s):

Mental Health ◽

Intervention Group ◽

Well Being ◽

Primary School Children ◽

Control Group ◽

Physical And Mental Health ◽

Quasi Experimental ◽

Mental Health Difficulties ◽

Prosocial Behaviours ◽

The Impact

Resilience is an individual’s ability to adapt successfully to and persevere during and after significant challenges. Resilience programmes based on a socioemotional learning approach have been associated with an increase in protextive factors (e.g., prosocial competencies), improvements in physical and mental health, and a decrease in internalised and externalised symptoms. The present study aimed to evaluate the impact of the RESCUR curriculum implemented in Portuguese schools on students’ academic, behavioural, and socioemotional outcomes, based on child and teacher reports. Participants included 1,084 children (53.2% male) aged 3-15 ( M = 7.24, SD = 2.31). A quasi-experimental study compared outcomes for an experimental intervention group (AIG) with a waiting list control group (WG). The results showed the RESCUR programme decreased mental health difficulties while increasing both prosocial behaviours and well-being. In addition, academic performance increased for those in preschool after implementation. Both teachers and children consistently reported positive behavioural changes in resilience-related competencies after implementing RESCUR. Our findings contribute to the recent research on the potential of RESCUR to address key socioemotional competencies and improve relevant protextive factors. Study limitations and future recommendations are addressed.

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The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02631-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mostafa Hemamy ◽

Naseh Pahlavani ◽

Alireza Amanollahi ◽

Sheikh Mohammed Shriful Islam ◽

Jenna McVicar ◽

...

Keyword(s):

Mental Health ◽

Vitamin D ◽

Attention Deficit ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Magnesium Supplementation ◽

Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

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Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073689 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3689

Author(s):

Tzofnat Zadok-Gurman ◽

Ronit Jakobovich ◽

Eti Dvash ◽

Keren Zafrani ◽

Benjamin Rolnik ◽

...

Keyword(s):

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stressful Events ◽

Control Group ◽

Subjective Well Being ◽

Intention To Treat ◽

School Year ◽

Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

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Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

BMC Psychiatry ◽

10.1186/s12888-021-03280-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Roya Rahimi ◽

Shirin Hasanpour ◽

Mojgan. Mirghafourvand ◽

Khalil Esmaeilpour

Keyword(s):

Mental Health ◽

Confidence Interval ◽

Group Counseling ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

The Mean ◽

And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

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Efficacy of ‘Foundations’, a Digital Mental Health App to Improve Mental Well-Being, during COVID-19: A Proof-of-Principle Randomised Controlled Trial (Preprint)

10.2196/preprints.30976 ◽

2021 ◽

Author(s):

Silvina Catuara-Solarz ◽

Bartlomiej Skorulski ◽

Inaki Estella ◽

Claudia Avella-Garcia ◽

Sarah Shepherd ◽

...

Keyword(s):

Mental Health ◽

Perceived Stress ◽

Intervention Group ◽

Well Being ◽

Self Report ◽

World Health ◽

Randomised Control Trial ◽

Control Group ◽

Mental Well Being ◽

Proof Of Principle

BACKGROUND Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomised control trial that took place during the first wave of the COVID-19 pandemic in the UK. METHODS Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomised to either the intervention or control arm. Participants in the intervention arm were given access to the app, Foundations, for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10]; 7-item Generalised Anxiety Disorder scale [GAD-7]; Office of National Statistics Four Subjective Well-being Questions [ONS-4]; World Health Organisation-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and weeks 2 and 4; and, in addition, on perceived stress weekly (10-item Perceived Stress Score [PSS]). RESULTS 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety (GAD-7 score, delta from baseline to week 2 in the intervention group: -1.35 [SD 4.43]; control group: -0.23 [SD 3.24]; t134= 1.71 , P=.04), resilience (CD-RISC score, delta from baseline to week 2 in the intervention group: 1.79 [± SD 4.08]; control group: -0.31 [± SD 3.16]; t134 -3.37, P<.001), sleep (MISS score, delta from baseline to week 2 in the intervention group: -1.16 [± SD 2.67]; control group: -0.26 [± SD 2.29]; t134= 2.13, P=.01), and mental well-being (WHO-5 score, delta from baseline to week 2 in the intervention group: 1.53 [5.30]; control group: -0.23 [± SD 4.20]; t134= -2.16, P=.02) within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the results did not reach statistical significance relative to the control group (PSS score, delta from baseline to week 2 in the intervention group: -2.94 [± SD 6.84]; control group: -2.05 [± SD 5.34]; t134= 0.84, P=.20). CONCLUSIONS This study provides proof-of-principle that the digital mental health app, Foundations, can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. It therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.

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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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