The impact of the Covid-19 pandemic on mental health in Danish school children in 5th to 7th grade.

AIM: We wanted to examine the impact of the Covid-19 pandemic on mental health in Danish school children in 5th to 7th grade (11 to 15 years), and whether the impact differed across age and sex. METHODS: We included 793 and 391 school children from winter 2020 and winter 2021, respectively. Mental health was measured using the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS), Strengths and Difficulties Questionnaire (SDQ), and Brief Resilience Scale (BRS). Data were analyzed by sex using linear regression models adjusting for grade (age), cohabitation, geographical region, employment status of parents, and schools as clusters. RESULTS: Girls in 5th grade and boys in 6th grade during Covid-19 had statistically significant lower well-being (SWEMWBS) compared with before Covid-19. Girls in 5th and 6th grade during Covid-19 had non-statistically significant lower scores on all subscales of SDQ compared with girls before Covid-19. Girls in 7th grade during Covid-19 had statistically significant lower total difficulty score (SDQ) and fewer conduct problems (SDQ) compared with girls before Covid-19. Boys in 5th grade during Covid-19 had statistically significant fewer conduct problems (SDQ) compared with boys before Covid-19. CONCLUSIONS: This study indicates that the Covid-19 pandemic impacted Danish school children differently across sex and grade (age). During Covid-19, mental health tended to be better among the oldest girls and worse among the youngest girls compared with girls before Covid-19. Boys in 6th grade had poorer mental well-being, and boys in 5th grade had fewer conduct problems during Covid-19 compared with before Covid-19.

Altered self-reported resting state mediates the effects of Mindfulness-Based Stress Reduction on mental health: a longitudinal path model analysis within a community-based randomized trial with 6-months follow-up.

Background: A large body of randomized controlled trials (RCTs) has shown that mindfulness-based interventions are effective for improving mental health, but research is lacking in regards to the mechanisms of change. We aimed to investigate the mediating effects of self-reported altered resting state of Mindfulness-Based Stress Reduction (MBSR) on mental health, when provided as a universal intervention in a real-life context. Methods: Autoregressive path models with three time points of measurement, and contemporaneous and constant b paths were used in an RCT. The RCT took place in all five geographical regions of Denmark and included 110 schools and 191 schoolteachers. The schools were randomized 1:1 in each geographical region to intervention or a wait-list control group. The intervention was the standardized MBSR. Data were collected at baseline and after 3 and 6 months. The outcomes were perceived stress, measured by Cohen's Perceived Stress Scale (PSS), symptoms of anxiety and depression, measured by Hopkins Symptom Check List-5 (SCL-5), and well-being measured by WHO-5 Well-being Index (WHO-5). The mediator was resting state measured by the Amsterdam Resting State Questionnaire (ARSQ). Results: Statistically significant mediated effects of altered ARSQ-subscales scores for Discontinuity of Mind, Planning, and Comfort were found for the MBSR effect on all outcomes; PSS, SCL-5 and WHO-5. Furthermore, statistically significant mediated effects of altered sleepiness subscale score of the effects on PSS and SCL-5 of MBSR were found. No statistically significant mediating effects of the subscales Theory of Mind, Self and Somatic Awareness for the MBSR intervention effect were found. Conclusion: The results support that the MBSR program can alter self-reported resting state, towards less mind wandering and more comfort, measured by the ARSQ, and that this may explain some of the mechanisms regarding the effectiveness of MBSR on mental health at 6 months, when provided as a universal intervention. The study provides insight into an active ingredient of how MBSR may improve mental health and well-being. It supports the suggestions that mindfulness meditation may be a sustainable way of training the mental health.Clinical trial registration:ClinicalTrials.gov, identifier NCT03886363.

The impact of an organizational-level mindfulness-based intervention on workplace social capital and psychological safety: A qualitative content analysis.

Background: Through the past decades, the mental health of the European population has been continuously declining. Social relations in various spheres of life, including workplace settings, have been shown to impact mental health. Mindfulness-based stress reduction (MBSR) has been found effective in enhancing well-being, and reducing perceived stress, and symptoms of depression and anxiety. Research into mindfulness-based interventions (MBIs) in workplace settings has shown that these interventions may positively affect workplace outcomes, such as interpersonal relations. However, research regarding the organizational impacts of MBIs is still nascent. The objective of this study was to investigate how an organizational-level mindfulness-based intervention (MBI) including a workplace-adapted MBSR programme may impact workplace social capital and psychological safety. Methods: Four small and medium-sized private companies were included in this study, representing 368 employees and managers. The intervention consisted of three steps: 1. Mandatory participation in introductory sessions on mental health and mindfulness, 2. Voluntary participation in a 10-week workplace-adapted MBSR programme, and 3. A workshop for selected employee representatives and managers on further implementation of mindfulness. Data was collected using pre and post-intervention focus group interviews. In total, 27 interviews including 76 respondents were conducted. Verbatim transcription was performed. Data was analyzed using deductive content analysis with theoretical frameworks for social capital and psychological safety. Results: The analysis resulted in three main categories: 1. Social capital (1.1. bonding social capital, 1.2. bridging social capital, 1.3. linking social capital), 2. Psychological safety, and 3. Emergent theme: The role of lockdown on the perceived organizational impact of a workplace MBI. The greatest impact was found relating to the bridging social capital, i.e., social capital between departments, and psychological safety among colleagues at the same level of employment. Conclusion: The results indicate that company participation in this organizational-level MBI including a workplace-adapted MBSR programme may positively impact social relations at work, especially the bridging social capital and psychological safety between colleagues at the same level of employment. These results may have been influenced by lockdowns due to the COVID-19 pandemic.

Mental health and sociodemographic characteristics among Icelanders, data from a cross-sectional study in Iceland.

BACKGROUND: Mental health challenges are on the rise worldwide. In Iceland, little is known about the sociodemographic factors associated with poor mental health. This study aimed to investigate symptoms of depression, anxiety, stress, and psychiatric medication for mental disorders in a nationally representative sample in Iceland and to explore its associations with sociodemographic factors. METHODS: This Icelandic cross-sectional study 'Health and Wellbeing of Icelanders' was conducted in 2017 and included 9,887 randomly chosen adults. Participants' depression, anxiety, and stress levels were measured with the Depression Anxiety and Stress scale-21(DASS-21) and the association with sociodemographic factors and prescribed psychiatric medication was assessed in a multinominal logistic regression analysis. RESULTS: The youngest age group (18 to 29 years old) had the poorest mental health. Males had a higher risk of medium and high depression scores than females, RRR 1.23 (95% CI 1.06-1.44) and RRR 1.71 (95% CI 1.25-2.33) when adjusted for sociodemographic factors (age, sex, education, marital status, financial status, living area, employment) and use of psychiatric medication. Participants with the most considerable financial difficulties had the highest risk of high scores on depression RRR 11.19 (95% CI 5.8-21.57), anxiety RRR 12.35 (95% CI 5.62-27.14) and stress RRR 11.55 (95% CI 4.75-28.04) when compared to those that do not. CONCLUSIONS: The youngest participants and those with the most extensive financial difficulties had the highest depression, anxiety, and stress scores. Males scored higher than females on depression. There was a trend towards worse mental health with lower sociodemographic status. Higher education, living with someone, and financial security were associated with better mental health. These results implicate the importance of government actions to counteract social inequalities in the Icelandic nation.

On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care.

BACKGROUND: Mental health is decreasing among young people in Denmark. Our primary aim is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in Danish upper secondary schools and schools of health and social care on students' self-reported mental well-being 6 months from baseline. Secondary aims are (1) to evaluate the effectiveness in a vulnerable subgroup as well as in the total population of students 3 and 6 months from baseline using other outcome measures on mental health and (2) to investigate the facilitators and barriers among teachers to implement mindfulness in schools. METHODS: This pragmatic cluster-randomised two-arm superiority trial includes 30 upper secondary schools, 13 schools of health and social care, 76 teachers, and approximately 1100 students aged 16 to 24 years. Our intervention is multi-level and consists of (a) a teacher training programme and (b) a mindfulness programme delivered to students. Students in control schools receive education as usual. Our primary study population is the total population of students. The primary outcome is changes in the short version of the Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). We also evaluate the effectiveness in a vulnerable subgroup (the 15% with the lowest SWEMWBS score), as well as in the total population of students 3 and 6 months from baseline using other outcome measures on mental health. Data will be analysed using repeated measurement models taking clusters into account. Facilitators and barriers among teachers to implement mindfulness in schools will be investigated through qualitative focus group interviews. DISCUSSION: The trial will estimate the effectiveness of a population-based strategy on mental health in Danish young people enrolled in education. TRIAL REGISTRATION: ClinicalTrials.gov NCT04610333 . Registered on October 10 2020.

Psychometric properties of the Short Warwick-Edinburgh Mental Well-Being Scale in a sample of Danish schoolchildren.

AIM: The aims of this this study was to examine the psychometric properties, including internal consistency and construct validity, of the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) in a sample of Danish schoolchildren aged 10-16 years. METHOD: A total of 1155 schoolchildren (54% girls) aged 10-16 years (Mage=12 years, SD=1.3) responded to an electronic questionnaire as part of the Danish SELFCARE study. To examine the internal consistency and construct validity of the SWEMWBS, we performed descriptive statistics, reliability and correlation analyses in Stata as well as confirmatory factor analysis (CFA) in Mplus. Correlations between scores on the SWEMWBS and scores on scales from the Strengths and Difficulties Questionnaire (SDQ) were calculated using Spearman's rank correlation coefficients. The analysis was conducted on the general study population and in subgroups divided by sex and class (age groups). RESULTS: CFA confirmed SWEMWBS one-dimensional factor structure, and the model fit the data well (CFI=0.984, TLI=0.97, RMSEA=0.062 and SRMR=0.021). The scale showed satisfactory internal consistency (ɑ=0.78) and composite reliability (ω=0.82). In addition, the scale was shown to have acceptable construct validity. Thus, correlations between scores on the SWEMWBS and SDQ subscales were in line with expectations. Corresponding results were found for subgroups divided by sex and class (age groups). CONCLUSIONS: Our study indicates that the Danish translation of the SWEMWBS is valid for measuring well-being among Danish schoolchildren aged 10-16 years. This construct validation study is among the first to validate the SWEMWBS in younger populations.

Mindfulness Training Changes Brain Dynamics During Depressive Rumination: A Randomized Controlled Trial.

BACKGROUND: Depression is a leading cause of disability worldwide and its prevalence is on the rise. One of the most debilitating aspects of depression is the dominance and persistence of depressive rumination, a state of mind that is linked to onset and recurrence of depression. Mindfulness meditation trains adaptive attention regulation and present-moment embodied awareness, skills that may be particularly useful during depressive mind states characterized by negative ruminative thoughts. METHODS: In a randomized controlled functional magnetic resonance imaging study (N = 80), we looked at the neurocognitive mechanisms behind mindfulness-based cognitive therapy (n = 50) for recurrent depression compared with treatment as usual (n = 30) across experimentally induced states of rest, mindfulness practice and rumination, and the relationship with dispositional psychological processes. RESULTS: Mindfulness-based cognitive therapy compared with treatment as usual led to decreased salience network connectivity to the lingual gyrus during a ruminative state, and this change in salience network connectivity mediated improvements in the ability to sustain and control attention to body sensations. CONCLUSIONS: These findings showed that a clinically effective mindfulness intervention modulates neurocognitive functioning during depressive rumination and the ability to sustain attention to the body.

The effect of mental health interventions on psychological distress for informal caregivers of people with mental illness: A systematic review and meta-analysis.

Introduction: Informal caregivers of people with a mental illness are at increased risk of developing depression, anxiety, and stress, so preventive interventions are needed. Method: The review was reported in PROSPERO (ID: CRD42018094454). The PsycINFO, PubMed, and Scopus databases were searched in June 2019. The Cochrane Risk of Bias and Jadad scale scores were used to assess study quality. Inclusion criteria were: RCTs of informal caregiver interventions regardless of the care receiver's mental illness and intervention modality. Interventions should be compared to a waitlist, treatment as usual or active control, taught in real-time by a mental health professional, include an outcome measure on psychological distress, and published in a peer-reviewed journal article in English. RCTs were excluded if the intervention was given in dyads (caregiver + care receiver), limited to the provision of respite care where the patient sample included a mix of both physical and psychological illnesses, unpublished, not peer-reviewed, study protocols, or dissertations. Results: A total of 2,148 studies were identified; of these, 44 RCT studies met the inclusion criteria, and 31 had sufficient data to conduct a meta-analysis including subgroup analysis (N = 1,899). The systematic review showed that thirty-one out of the 44 RCTs had an effect of the intervention on decreasing psychological distress. The results of the meta-analysis, which included informal caregiver interventions, compared to waitlist, treatment as usual, or active control, regardless of care-receiver mental illness or intervention modality showed a small effect of -0.32 (95% CI -0.53 to -0.11). The heterogeneity of the included studies was high (I 2 = 78). The subgroup analysis included manualized interventions lasting at least 8 weeks and the subgroup analysis that included an active control showed a small effect and low heterogeneity. Lack of active control and long-term follow-up is a limitation of most of the studies. Conclusion: The evidence supports that several interventions improve the mental health of caregivers. Manualized interventions ≥ 8 weeks with active participation are most effective. Future RCTs should improve methodology, and research should investigate which intervention modality is most effective for what kind of caregiver. Future research should clearly specify what the included intervention components are, use longer follow-up times, and conduct mediational analyses to better understand what mechanisms create the effect of an intervention. Systematic review registration: Identifier: CRD42018094454.

The effectiveness of mindfulness-based stress reduction for school teachers: a cluster-randomized controlled trial.

BACKGROUND: Teaching has been found to be one of the most stressful occupations. Hence, current interest in reducing stress and enhancing the well-being of teachers is strong. Mindfulness-based stress reduction (MBSR) is documented to be effective in reducing stress and increasing well-being. This study investigated the effectiveness of delivering MBSR to lower secondary school teachers as a part of a teacher-training programme. METHODS: This study was a nested trial within the parallel cluster-randomized controlled trial, Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE). Schools were recruited from all five geographical regions in Denmark between May 2018 and May 2019. One to three teachers from each school were allowed to participate. At baseline, 110 schools, representing 191 lower secondary school teachers, were cluster-randomized to intervention or a wait-list control group. The intervention group received MBSR during 2019 and the wait-list control group during 2020. Data were collected at baseline and after 3 and 6 months. The primary outcome was measured by Cohen's Perceived Stress Scale (PSS). Data were analyzed using a mixed-effect linear regression model and bootstrapped for cluster effects. RESULTS: At 3 months, the intervention group statistically significantly reduced their PSS score 1.7 [95% confidence interval (CI) 0.04-3.3] points more than did the wait-list control group. At 6 months, the intervention group had statistically significantly reduced their mean PSS score 2.1 (95% CI: 0.5-3.8) points more than the wait-list control group. CONCLUSION: It is possible to reduce perceived stress among lower secondary school teachers by delivering MBSR as part of a teacher-training programme.

Associations between mental health and sociodemographic characteristics among schoolchildren. A cross-sectional survey in Denmark 2019.

Aims: We aimed to investigate associations between mental health and sociodemographic characteristics among schoolchildren in Denmark. Methods: We performed a cross-sectional survey from January to October 2019 among 4th to 9th graders (N=1247) based on pilot data from a nationwide research project Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE). We assessed mental health using the five-item World Health Organization Well-Being Index and the self-report version of the Strengths and Difficulties Questionnaire. We investigated associations between mental health and sex, age in terms of grade, type of school, family setting and geographic region using regression analysis. Results: Mental health was poorer among girls in the older classes compared to girls in 4th grade, and better among boys in the older classes compared to boys in 4th grade. We found no difference in mental health among schoolchildren in municipal and private schools. Mental health was poorer among both girls and boys living alternately with their parents compared to residing with both of them. Mental health varied across geographic regions. Conclusions: We found associations between mental health and sex, age in terms of grade, family setting and geographic region.

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.

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].

Mediators for the Effect of Compassion Cultivating Training: A Longitudinal Path Analysis in a Randomized Controlled Trial Among Caregivers of People With Mental Illness.

Background: There is a paucity of research on mediators of change, within compassion training programs. The aim was to investigate the mediators, of an 8-week compassion cultivation training (CCT) program, on the effect of psychological distress on caregivers of people with a mental illness. Method: Longitudinal path models in a randomized controlled trial (RCT). One hundred ninety-two participants were assessed for eligibility, and 161 participants were included into the trial and randomized. The main outcome was psychological distress measured by the Depression, Anxiety and Stress scale at 6 months. Mediators included self-compassion (SC), mindfulness (FM), emotion regulation (ER), emotion suppression (ES), and cognitive reappraisal (CR). Baseline, post, and 3- and 6-month follow-up measurements were collected. Results: The mediated effects for CCT are as follows: depression at 6 months: SC: -1.81 (95% CI: -3.31 to -0.31); FM: -1.98 (95% CI: -3.65 to -0.33); ER: -0.14 (95% CI: -1.31 to 1.02); anxiety at 6 months: SC: -0.71 (95% CI: -1.82 to 0.40); FM: -1.24 (95% CI: -2.39 to -0.09); ER: 0.18 (95% CI: -1.04 to 1.40); stress at 6 months: SC: -1.44 (95% CI: -2.84 to -0.05); FM: -2.17 (95% CI: -3.63 to -0.71); ER: -0.27 (95% CI: -1.51 to 0.98). Conclusion: Mindfulness and self-compassion are important components in reducing psychological distress experienced by informal caregivers of people with a mental illness. Results contribute to the knowledge about the underlying mechanisms of CCT.

Pre-retirement Employees Experience Lasting Improvements in Resilience and Well-Being After Mindfulness-Based Stress Reduction.

The socio-economic benefits of interventions to prevent stress and related mental health problems are enormous. In the labor market, it is becoming desirable to keep employees for as long as possible. Since aging implies additional stressors such as increased risk of illness, and added pressure by professional tasks such as transferring knowledge, or learning new technologies, it is of particular relevance to offer stress-reduction to pre-retirement employees. Here, we report the effects of an eight-week Mindfulness-Based Stress Reduction (MBSR) intervention on mental well-being in 60-65-year-old work-active Danish employees, compared to a waiting-list control group. We observed improvements in resilience (Brief Resilience Scale) and mental well-being (WHO-5) not only at the end of the intervention, but also at the 12-month follow-up measurement that was preceded by monthly booster sessions. Interestingly, whereas well-being usually refers to experiences in the past weeks or months, we observed increasing Comfort in the MBSR-intervention group during a 5-minute eyes-closed rest session suggesting that this therapeutic effect of MBSR is measurable in how we feel even during short periods of time. We argue that MBSR is a cost-effective intervention suited for pre-retirement employees to cultivate resilience to prevent stress, feel more comfortable with themselves, maintain a healthy work-life in the last years before retirement, and, potentially, stay in their work-life a few more years than originally planned.

A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting.

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

Effect of Mindfulness-Based Stress Reduction on dehydroepiandrosterone-sulfate in adults with self-reported stress. A randomized trial.

Long-term stress can lead to long-term increased cortisol plasma levels, which increases the risk of numerous diseases. Dehydroepiandrosterone (DHEA) and its sulfated form dehydroepiandrosterone-sulfate (DHEAS), together DHEA(S), have shown to counteract some of the effects of cortisol and may be protective during stress. The program "Mindfulness-Based Stress Reduction" (MBSR) has shown to have positive effects on stress. The present study examined a possible effect of MBSR on DHEAS in plasma compared to a waiting list and a locally developed stress reduction program (LSR) in people with self-reported stress. The study was a three-armed randomized controlled trial conducted in a municipal health care center in Denmark. It included 71 participants with self-reported stress randomized to either MBSR (n = 24) or LSR (n = 23), or a waiting list (n = 24). Blood samples were collected at baseline and at 12 weeks follow-up to estimate effects of MBSR on DHEAS. The effect of MBSR on DHEAS was statistically significant compared to both the waiting list and LSR. We found a mean effect of 0.70 µmol/L (95% confidence interval [CI] = 0.18-1.22) higher DHEAS in the MBSR group compared with the waiting list group and a mean effect of 0.54 µmol/L (95% CI = 0.04-1.05) higher DHEAS in the MBSR group compared with the LSR group. Findings indicate an effect on DHEAS of the MBSR program compared to a waiting list and LSR program in people with self-reported stress. However, we consider our findings hypothesis-generating and validation by future studies is essential.

Effect of a Compassion Cultivation Training Program for Caregivers of People With Mental Illness in Denmark: A Randomized Clinical Trial.

Importance: Caregivers of people with mental illness are at increased risk of developing depression, anxiety, and stress. Objective: To investigate the effect of a compassion cultivation training (CCT) program on decreasing caregiver psychological distress. Design, Setting, and Participants: This waitlist-controlled randomized clinical trial was conducted in 2 different community settings in Denmark. Caregivers were excluded if they had a diagnosed and untreated mental illness, addiction, meditation practice, or current psychotherapeutic treatment. Enrollment occurred between May 2018 and March 2019. A repeated measurement model was used to examine the impact of the intervention. The primary analysis was based on the intention-to-treat principle. Data analysis was conducted from June 4 to July 7, 2020. Interventions: Participants were randomized 1-to-1 to an 8-week CCT course or waitlist control. Block randomization was used with 40 participants in each block. Main Outcomes and Measures: The main outcome was reduction in psychological distress, as measured by the Depression, Anxiety, Stress Scale (DASS). Baseline, postintervention, and 3- and 6-month follow-up measurements were collected. Results: Among 192 participants assessed for eligibility, 161 participants were included in the study (mean [SD] age, 52.6 [12.5] years; 142 [88.2%] women), with 79 participants randomized to the CCT intervention and 82 participants in the waitlist control group. At baseline, the mean (SD) DASS scores for the intervention vs control groups were 10.89 (8.66) vs 10.80 (8.38) for depression, 6.89 (6.48) vs 6.68 (5.33) for anxiety, and 14.96 (7.90) vs 15.77 (7.40) for stress. The CCT group experienced statistically significant improvement in the primary outcome in mean change from baseline vs the control group at postintervention (adjusted mean difference: depression, -4.16 [95% CI, -6.75 to -1.58]; P = .002; anxiety, -2.24 [95% CI, -3.99 to -0.48]; P = .01; stress, -4.20 [95% CI, -6.73 to -1.67]; P = .001), the 3-month follow-up (adjusted mean difference: depression, -3.78 [95% CI, -6.40 to -1.17]; P = .005; anxiety, -2.50 [95% CI, -4.27 to -0.73]; P = .006; stress, -3.76 [95% CI, -6.32 to -1.21]; P = .004), and the 6-month follow-up (adjusted mean difference: depression: -4.24 [95% CI, -6.97 to -1.52]; P = .002; anxiety, -2.12 [95% CI, -3.96 to -0.29]; P = .02; stress: -3.79 [95% CI, -6.44 to -1.13]; P = .005). Conclusions and Relevance: These findings suggest that CCT was superior to the waitlist control in supporting caregivers' mental health. Statistically and clinically significant reductions in psychological distress were found and sustained at the 6-month follow-up. The improvements noted in this randomized clinical trial could serve to encourage implementation of future evidence-based programs for caregivers. Trial Registration: ClinicalTrials.gov Identifier: NCT03730155.

Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE): a protocol for a cluster randomised trial testing a school teacher training programme to teach mindfulness (".b").

BACKGROUND: There is a call for sustainable, evidence-based interventions in schools to promote mental health in schoolchildren. Our primary aim of this trial is to evaluate the effectiveness in vulnerable pupils of a school teacher training programme to teach mindfulness (".b" programme) as a part of compulsory class room teaching in Danish schools on the pupils' self-reported mental health at 6-month follow-up. Our secondary aim is to evaluate the effectiveness of the school teacher training programme to teach the ".b"-programme as a part of compulsory class room teaching among the total pupil population on the pupils' self-reported mental health at 3 and 6 months after baseline. METHODS: The pragmatic cluster two-armed randomised controlled trial includes 110 municipal or private schools from all five regions in Denmark; 191 school teachers and approximately 2000 pupils at 11-15 years of age. Exclusion criteria; for schools: < 100 pupils; for pupils: parental opt out. Our intervention consists of (A) a school teacher training programme and (B) the ".b"-programme delivered as part of compulsory class room teaching in schools to pupils at the age of 11-15 years. The pupils in the control schools receive education as usual. Our primary study population is the vulnerable subgroup with a Strengths and Difficulties Questionnaire (SDQ) total difficulties score > 80% percentile at baseline (approximately 400 pupils). The primary outcome is change in the SDQ total score by the pupils. We also evaluate the effectiveness among the total pupil study population and in girls and boys, respectively and use other measures on mental health. Data will be analysed with repeated measurement models taken clusters into account. DISCUSSION: This large-scale trial will estimate the effectiveness of a population-based strategy on mental health in Danish schoolchildren. The trial evaluates the effect of a school teacher training programme, where teachers are trained in teaching the ".b" programme. The ".b" programme will be taught as a part of compulsory class room teaching. The intervention takes implementation issues into account. Effectiveness will be evaluated both in a vulnerable subgroup and among the total population. Trial registration number ClinicalTrials.gov Identifier: NCT04208113, registered December 23 2019, https://clinicaltrials.gov/ct2/show/NCT04208113 .

"I am getting something out of this, so I am going to stick with it": supporting participants' home practice in Mindfulness-Based Programmes.

BACKGROUND: The practice of mindfulness at home is a core component of standard eight-week mindfulness-based programmes (MBP). Teachers of mindfulness courses require an understanding of the factors that need to be addressed to support participants in establishing and maintaining a mindfulness practice. METHOD: Here, we present a review of seven factors that we argue are important for participants' practice of mindfulness. We use the well-established model of Behaviour Change, the COM-B model (Capability, Opportunity, Motivation and Behaviour) to organise and consider these factors. For each factor, we first present a definition and then a discussion in relation to psychological, health and Buddhist literature. We illustrate the importance of each factor with quotes from MBP participant interviews. RESULTS: We discuss participants' Capability (planning/commitment, physical space), Opportunity (social support, the relationship with the teacher) and Motivation (readiness for self-care, beliefs about practice, self-efficacy, experiencing the rewards of practice), and how these lead to the target Behaviour (mindfulness practice). CONCLUSIONS: Our understanding, as teachers and researchers, of how best to support and guide participants during MBPs is at an early stage. We draw out practical lessons around each of the seven factors for mindfulness teachers in supporting participants' home practice.

A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting.

BACKGROUND: The purpose of the present study was to conduct a pilot randomised controlled trial (RCT) to lend support to a larger effectiveness RCT comparing Mindfulness-Based Stress Reduction (MBSR), a locally-developed stress reduction intervention (LSR) and a waiting list control group in a Danish municipal health care center setting. METHODS: A three-armed parallel pilot RCT was conducted among 71 adults who contacted a Danish municipal health care center due to stress-related problems. Recruitment was made between January and April 2018 and followed usual procedures. EXCLUSION CRITERIA: 1) acute treatment-demanding clinical depression or diagnosis of psychosis or schizophrenia, 2) abuse of alcohol, drugs, medicine, 3) pregnancy. Randomisation was performed by an independent data manager using the REDCap electronic data capture tool. The primary outcome was a description of RCT feasibility (recruitment and retention rates regarding intervention participation and 12-week follow-up). Secondary outcomes were completion rates regarding questionnaire data and proposed effect-estimates of outcome measures considered to be used in the following real RCT. Type of intervention and outcome assessment were not blinded. RESULTS: We recruited 71 of 129 eligible individuals from the target population (55, 95%CI: 46-64). Forty-two (59%) were females. Median age: 44 years (1-quartile:34, 3-quartile:50). Twenty-nine (41%) had < 16 years of education. Forty-eight (68%) were employed; 30 of these 48 (63%) were on sick leave. Mean scores for perceived stress (PSS): 25.4 ± 5.3; symptoms of anxiety and depression (SCL-5): 2.9 ± 0.6, and well-being (WHO-5): 31.7 ± 8.5 indicated a need for intervention. 16/24 (67, 95%CI: 45 to 84) who were allocated to MBSR and 17/23 (74, 95%CI: 52 to 90) who were allocated to LSR participated in ≥5 sessions. The loss to follow-up at 12 weeks: MBSR: 5 (21% (95% CI: 7 to 42), LSR: 5 (22% (95% CI: 7 to 44) and waiting list: 4 (17% (95% CI: 5 to 37). This was acceptable and evenly distributed. The results indicated MBSR to be superior. CONCLUSIONS: An RCT assessing the effectiveness of stress reduction interventions in a real-life municipal health care setting is feasible among adults with a clear need for stress reduction interventions based on scores on mental health. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT03663244. Registered September 10, 2018.