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Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark.

ABSTRACT: BACKGROUND:Prolonged psychological stress is a risk factor for illness and constitutes an increasing public health challenge creating a need to develop public interventions specifically targeting stress and promoting mental health. The present randomized controlled trial evaluated health effects of a novel program: Relaxation-Response-based Mental Health Promotion (RR-MHP). METHODS:The multimodal, meditation-based course was publicly entitled "Open and Calm" (OC) because it consistently trained relaxed and receptive ("Open") attention, and consciously non-intervening ("Calm") witnessing, in two standardized formats (individual or group) over nine weeks. Seventy-two participants who complained to their general practitioner about reduced daily functioning due to prolonged stress or who responded to an online health survey on stress were randomly assigned to OC formats or treatment as usual, involving e.g., unstandardized consultations with their general practitioner. Outcomes included perceived stress, depressive symptoms, quality of life, sleep disturbances, mental health, salivary cortisol, and visual perception. Control variables comprised a genetic stress-resiliency factor (serotonergic transporter genotype; 5-HTTLPR), demographics, personality, self-reported inattentiveness, and course format. RESULTS:Intent-to-treat analyses showed significantly larger improvements in OC than in controls on all outcomes. Treatment effects on self-reported outcomes were sustained after 3 months and were not related to age, gender, education, or course format. The dropout rate was only 6 %. CONCLUSIONS:The standardized OC program reduced stress and improved mental health for a period of 3 months. Further testing of the OC program for public mental health promotion and reduction of stress-related illnesses is therefore warranted. A larger implementation is in progress. TRIAL REGISTRATION:ClinicalTrials.gov.: NCT02140307. Registered May 14 2014.

SUBMITTER: Jensen CG

PROVIDER: S-EPMC4682248 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark.

Jensen Christian G CG Lansner Jon J Petersen Anders A Vangkilde Signe A SA Ringkøbing Signe P SP Frokjaer Vibe G VG Adamsen Dea D Knudsen Gitte M GM Denninger John W JW Hasselbalch Steen G SG

BMC public health 20151216

<h4>Background</h4>Prolonged psychological stress is a risk factor for illness and constitutes an increasing public health challenge creating a need to develop public interventions specifically targeting stress and promoting mental health. The present randomized controlled trial evaluated health effects of a novel program: Relaxation-Response-based Mental Health Promotion (RR-MHP).<h4>Methods</h4>The multimodal, meditation-based course was publicly entitled "Open and Calm" (OC) because it consis ...[more]

PMID: 26673225

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Project description:Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents.To determine the effectiveness of MBSR in reducing burnout in residents.A randomized controlled trial comparing MBSR with a waitlist control group.Residents from all medical, surgical and primary care disciplines were eligible to participate. Participants were self-referred.The MBSR consisted of eight weekly 2.5-h sessions and one 6-h silent day.The primary outcome was the emotional exhaustion subscale of the Dutch version of the Maslach Burnout Inventory-Human Service Survey. Secondary outcomes included the depersonalization and reduced personal accomplishment subscales of burnout, worry, work-home interference, mindfulness skills, self-compassion, positive mental health, empathy and medical errors. Assessment took place at baseline and post-intervention approximately 3 months later.Of the 148 residents participating, 138 (93%) completed the post-intervention assessment. No significant difference in emotional exhaustion was found between the two groups. However, the MBSR group reported significantly greater improvements than the control group in personal accomplishment (p?=?0.028, d?=?0.24), worry (p?=?0.036, d?=?0.23), mindfulness skills (p?=?0.010, d?=?0.33), self-compassion (p?=?0.010, d?=?0.35) and perspective-taking (empathy) (p?=?0.025, d?=?0.33). No effects were found for the other measures. Exploratory moderation analysis showed that the intervention outcome was moderated by baseline severity of emotional exhaustion; those with greater emotional exhaustion did seem to benefit.The results of our primary outcome analysis did not support the effectiveness of MBSR for reducing emotional exhaustion in residents. However, residents with high baseline levels of emotional exhaustion did appear to benefit from MBSR. Furthermore, they demonstrated modest improvements in personal accomplishment, worry, mindfulness skills, self-compassion and perspective-taking. More research is needed to confirm these results.

Project description:Objective: The aim of this study was to evaluate an in situ stress reduction program, named PROGRESS, developed to meet the specific needs of workers in a business context and to research its impact upon non-severe psychiatric symptoms, stress, anxiety, depression, processing speed/attention and mindfulness. Methods: Participants with stress complaints were randomized into two groups: the main intervention group: group 1-G1, (n = 22); and the control group: group 2-G2, (n = 22). The protocol was divided into three distinct phases for the purpose of the study. Both groups were evaluated at time 1 (T1), before the first 8-week intervention, which only G1 received. The second evaluation was made on both groups at time 2 (T2), immediately after this first program; in order to test the program's replicability and investigate possible follow-up effects, an identical second 8-week program was offered to G2 during time 3 (T3), while G1 was simply instructed to maintain the practice they had learned without further instruction between T2 and T3. A Confirmatory factor analysis (CFA) was conducted to investigate the construct validity of PROGRESS. Results: Repeated measures MANOVA test, comparing G1 and G2, showed the effect of the intervention from T1 to T2 (p = 0.021) and from T2 to T3 (p = 0.031). Univariate analysis showed that participants from G1 improved levels of non-severe psychiatric symptoms, anxiety, depression, stress, processing speed/attention and mindfulness when compared with G2, from T1 to T2 (p < 0.05). After the participants in G2 received the intervention (T2 to T3), this group also showed improvement in the same variables (p < 0.05). At the end of their follow-up period (T2-T3) - during which they received no further support or instruction - G1 maintained the improvements gained during T1-T2. The two main components were stress (stress in the last 24-h, in the last week and last month) and mental health (non-severe psychiatric symptoms, depression, anxiety and mindfulness). Conclusion: PROGRESS, an in situ mindfulness program adapted to fit within the reality of business time constraints, was effective at replicating in more than one group the reduction of stress, depression, anxiety, non-severe psychiatric symptoms, processing speed and also the improvement of attention skills, showing sustained improvement even after 8-weeks follow-up. Clinicaltrails.gov identifier: NCT02660307. https://clinicaltrials.gov/ct2/show/NCT02660307?term=Progress&rank=6.

Project description:BackgroundMiddle-aged adults (40-65 years) report higher stress levels than most other age groups. There is a need to determine the feasibility of using a meditation app to reduce stress and improve stress-related outcomes in middle-aged adults with a focus on men, as previous meditation app-based studies have reported a low proportion of or even no male participants.ObjectiveThis study aims to (1) determine the feasibility (ie, acceptability and demand with a focus on men) of a consumer-based meditation app (Calm), to reduce stress among middle-aged adults reporting elevated stress levels, and (2) explore the preliminary effects of Calm on perceived stress, psychological outcomes (anxiety, depressive symptoms, mindfulness, and general coping), health behaviors (physical activity and eating habits), and COVID-19 perceptions.MethodsThis feasibility randomized controlled trial evaluated an app-based meditation intervention in middle-aged adults (N=83) with elevated stress levels (ie, Perceived Stress Scale score ≥15) and limited or no previous experience with meditation. Participants were randomized to the intervention group (Calm app) or a control (educational podcasts; POD) group. Participants completed self-report assessments at baseline and postintervention (week 4). Feasibility was measured as acceptability and demand using Bowen framework. Feasibility and COVID-19 perceptions data were examined using descriptive statistics, and preliminary effects were evaluated using repeated measures analysis of variance.ResultsParticipants were satisfied with Calm (27/28, 96%) and found it appropriate or useful (26/28, 93%). Most reported they would likely continue using the Calm app (18/28, 64%). More Calm users reported satisfaction, appropriateness or usefulness, and intent to continue app use than POD users. Calm users (n=33) completed a mean of 20 (SD 31.1) minutes of meditation on the days they meditated and 103 (SD 109.1) minutes of meditation per week. The average adherence rate to the prescribed meditation was 71% among Calm app users, compared to 62% among POD users. Recruitment rate of men was 35% (29/83). Of those randomized to Calm, 55% (15/29) were men, and retention among them was higher (14/15, 93%) than that among women (12/20, 60%). No significant within or between group differences were observed.ConclusionsA 4-week, app-based mindfulness meditation intervention (Calm) may be feasible for middle-aged adults and a useful stress-management tool. Calm users expressed satisfaction with the app and felt it was appropriate and useful. Significant improvements in perceived stress and psychological outcomes or stress-related health behaviors were not observed. Even though men spent less time in meditation than women did and completed fewer weekly sessions, they were more likely to adhere to the prescription. Further research is needed for improving stress and stress-related outcomes among middle-aged adults with emphasis on the effects of mindfulness meditation apps for men.Trial registrationClinicalTrials.gov NCT04272138; https://clinicaltrials.gov/ct2/show/NCT04272138.

Project description:BackgroundCollege students experience high levels of stress. Mindfulness meditation delivered via a mobile app may be an appealing, efficacious way to reduce stress in college students.ObjectiveWe aimed to test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile app-Calm-compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention's effect on health behaviors (ie, sleep disturbance, alcohol consumption [binge drinking], physical activity, and healthy eating [fruit and vegetable consumption]) and the feasibility and acceptability of the app.MethodsThis study was a randomized, wait-list, control trial with assessments at baseline, postintervention (8 weeks), and at follow-up (12 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored ≥14 points on the Perceived Stress Scale, (3) owned a smartphone, (4) were willing to download the Calm app, (5) were willing to be randomized, and (7) were able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A P value ≤.05 was considered statistically significant.ResultsA total of 88 participants were included in the analysis. The mean age (SD) was 20.41 (2.31) years for the intervention group and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between the intervention and control groups after adjustment for covariates postintervention (all P<.04). These effects persisted at follow-up (all P<.03), except for the nonreacting subscale of mindfulness (P=.08). There was a significant interaction between group and time factors in perceived stress (P=.002), mindfulness (P<.001), and self-compassion (P<.001). Bonferroni posthoc tests showed significant within-group mean differences for perceived stress in the intervention group (P<.001), while there were no significant within-group mean differences in the control group (all P>.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group×time interaction in models of sleep disturbance was found, but no significant effects were found for other health behaviors. The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future. The majority were satisfied using Calm and likely to recommend it to other college students. The intervention group participated in meditation for an average of 38 minutes/week during the intervention and 20 minutes/week during follow-up.ConclusionsCalm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college students. Our findings provide important information that can be applied to the design of future studies or mental health resources in university programs.Trial registrationClinicalTrials.gov NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810.

Project description:BackgroundThe aim of the trial was to investigate the effect of a hypnotherapeutic group program in healthy persons with increased levels of perceived stress.MethodsIn a randomized controlled multicenter trial participants with a self-assessed subjective stress level ≥ 40 mm on a visual analogue scale (0-100 mm; VAS) for the previous week and a stable state of health were randomized to either 5 weekly sessions of 120-min duration of a hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group). The primary outcome parameter was the VAS stress level for the previous week after 5 weeks. Secondary outcome parameters included the VAS stress level after 12 weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36) after 5 weeks and 12 weeks. Analysis of covariance with a significance level of 5% using the full analysis set was used for analysis; the model included treatment (fixed effect), VAS baseline value (fixed covariate), and center (random effect).ResultsA total of 95 participants were randomized; 47 (40 female, 45 ± 13.4 years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9 ± 14.3 years) were allocated to the control group. Regarding VAS stress level after 5 weeks, the adjusted VAS mean in the hypnosis group was 41.8 mm [95% confidence interval (CI): 35.2; 48.4] compared to 62.9 mm [56.2; 69.7] in the control group, and the group difference was - 21.2 mm [- 30.1; - 12.2] (P < 0.001). After 12 weeks, the stress intensity on the VAS showed a between-group difference of - 14.7 mm [- 25.1; - 4.4] (P = 0.006), and the adjusted means were 41.1 mm [33.4; 48.8] in the hypnosis group and 55.9 mm [48.4; 63.5] in the control group. Improvements were also reported for CPSS, SF-36, SWE and ADS-K after 5 and 12 weeks.ConclusionCompared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks.Trial registrationClinicalTrials.gov NCT03525093 ; date of registration: May 15, 2018.

Project description:IntroductionReducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing.Study designCluster RCT with randomization at the center level and N=160 participants.Setting/participantsLatino children aged 3-5 years and their parents were recruited from six Head Start centers in Houston TX in 2010-2012 with analyses in 2013-2014.InterventionF5K was culturally adapted for Latino preschoolers and the overall goal was to reduce TV viewing. Study staff taught F5K over 7-8 weeks during the regular Head Start day directly to intervention students. Control schools provided the usual Head Start curriculum, which did not specifically cover TV viewing.Main outcome measuresIndividual-level outcomes were measured prior to (Time 1) and immediately following (Time 2) the intervention. The primary outcome, TV viewing (minutes/day), was measured by validated 7-day TV diaries (parent-reported). Sedentary time was measured by accelerometers.ResultsPer the adjusted repeated measures linear mixed effects model for TV viewing (minutes/day), intervention children decreased from 76.2 (9.9) at Time 1 to 52.1 (10.0) at Time 2, whereas control children remained about the same from 84.2 (10.5) at Time 1 to 85.4 (10.5) at Time 2. The relative difference from Time 1 to Time 2 was -25.3 (95% CI= -45.2, -5.4) minutes for intervention versus control children (N=160, p=0.01). In a similar adjusted model, there was a relative decrease in sedentary time (minutes/day) from Time 1 to Time 2 favoring the intervention children (-9.5, 95% CI= -23.0, 4.1), although not significant at p<0.05.ConclusionsF5K reduced Latino preschoolers' TV viewing by >25 minutes daily. These findings have implications for prevention of obesity, related disorders, and health equity.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01216306.

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Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark.

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Open and Calm--a randomized controlled trial evaluating a public stress reduction program in Denmark.

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