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 (original) (raw)
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BMC Public Health, 2006
Background The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS), as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT). The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs) are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP) at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients. Methods The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrolment of patients took place after screening in the source population, that comprised 20–60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate. Discussion In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.
Journal of Environmental and Occupational Science, 2012
Objective: The aim of this study was to evaluate the effects of a group based multidisciplinary stress treatment program on reductions in symptom levels and the return to work (RTW) rate. Methods: General practitioners referred 199 patients with persistent work related stress symptoms to the project. The inclusion criteria included being employed and being on sick leave. Using a randomized wait-list control design, the participants were randomized into three groups: the intervention group (IG, 70 participants) was treated using the Stress Therapy Concept of Kalmia, which consists of an integrative approach of group psychotherapy for 2.5 hours per week and Basic Body Awareness Therapy (BBAT) with mindfulness meditation for 1.5 hours per week, which runs in a parallel process supplemented with workplace dialogue; the treatment-as-usual control group (TAUCG, 71 participants), who received 12 consultations with a psychologist; and the wait-listed control group (WLCG, 58 participants). Treatment in the IG and the TAUCG lasted 10 and 12 weeks, respectively. Results :Reductions in symptom levels (as measured by scores on the SCL92) were significantly larger in the IG (Cohen´s d= 0.73) and TAUCG compared to the WLCG. Further, the prevalence of depression declined significantly in the IG and the TAUCG compared to the WLCG. Regarding the RTW rate, 66% of the participants in the IG had returned to full time work after three months. This rate was significantly greater than the percentage in the TAUCG (36%) and the WLCG (24%). Conclusion : The stress treatment program significantly reduced symptom levels and increased the RTW rate in the IG compared to the TAUCG and the WLCG.
Trials
Background: Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management courses based on cognitive behavioural therapy (CBT) principles and mindfulness-based interventions (MBIs). However, research examining effects of these interventions on sickness absence (an objective indicator of stress) and compassion for others (an indicator of patient care) is limited, as is research on brief CBT stress-management courses (which may be more widely accessible) and on MBIs adapted for workplace settings. Methods/design: This protocol is for two randomised controlled trials with participant preference between the two trials and 1:1 allocation to intervention or wait-list within the preferred choice. The first trial is examining a one-day CBT stress-management workshop and the second trial an 8-session Mindfulness-Based Cognitive Therapy for Life (MBCT-L) course, with both trials comparing intervention to wait-list. The primary outcome for both trials is stress post-intervention with secondary outcomes being sickness absence, compassion for others, depression symptoms, anxiety symptoms, wellbeing, work-related burnout, self-compassion, presenteeism, and mindfulness (MBCT-L only). Both trials aim to recruit 234 staff working in the National Health Service in the UK.
Journal of Environmental and Occupational Science, 2014
Objective: The aim of this study was to evaluate the effects of a group based multidisciplinary stress treatment program on reductions in symptom levels and the return to work (RTW) rate. Methods: General practitioners referred 199 patients with persistent work related stress symptoms to the project. The inclusion criteria included being employed and being on sick leave. Using a randomized wait-list control design, the participants were randomized into three groups: the intervention group (IG, 70 participants) was treated using the Stress Therapy Concept of Kalmia, which consists of an integrative approach of group psychotherapy for 2.5 hours per week and Basic Body Awareness Therapy (BBAT) with mindfulness meditation for 1.5 hours per week, which runs in a parallel process supplemented with workplace dialogue; the treatment-as-usual control group (TAUCG, 71 participants), who received 12 consultations with a psychologist; and the wait-listed control group (WLCG, 58 participants). Treatment in the IG and the TAUCG lasted 10 and 12 weeks, respectively. Results :Reductions in symptom levels (as measured by scores on the SCL92) were significantly larger in the IG (Cohen´s d= 0.73) and TAUCG compared to the WLCG. Further, the prevalence of depression declined significantly in the IG and the TAUCG compared to the WLCG. Regarding the RTW rate, 66% of the participants in the IG had returned to full time work after three months. This rate was significantly greater than the percentage in the TAUCG (36%) and the WLCG (24%). Conclusion : The stress treatment program significantly reduced symptom levels and increased the RTW rate in the IG compared to the TAUCG and the WLCG.
Journal of Negative Results in BioMedicine
Background: Work-related stress is a global problem with negative implications for individuals and society. The purpose of the current study was to evaluate a stress management intervention for patients on sick leave due to work-related stress complaints using a three-armed randomized controlled design. Methods: Participants were patients referred from three municipalities to the regional Department of Occupational Medicine. Inclusion criteria were: 1) sick leave due to work-related stress complaints, 2) a diagnosis of adjustment disorder or reactions to severe stress (ICD 10 code: F43,2-F 43,9 not PTSD) or mild depressive episode (F 32.0). Through a double randomization procedure patients (n = 163) were randomized to either an intervention group (n = 58), a 'control group A' receiving a clinical examination (n = 56), or 'control group B' (n = 49) receiving no offers at the department. The intervention comprised six sessions of individual cognitive behavioral therapy and the offer of a small workplace intervention. Questionnaire data were analyzed with multivariate repeated measurements analysis. Primary outcomes assessed were perceived stress and general mental health. Secondary outcomes were sleep quality and cognitive failures. Follow-up was at four and 10 months after baseline. Results: Complaints were significantly reduced in all groups over time. No group effects were observed between the intervention group and control group A that was clinically assessed. Significant group effects were found for perceived stress and memory when comparing the intervention group to group B, but most likely not due to an intervention effect. Conclusion: Psychological complaints improved substantially over time in all groups, but there was no significant treatment effect on any outcomes when the intervention group was compared to control group A that received a clinical assessment. Trial registration: ISRCTN ISRCTN91404229. Registered 03 August 2012 (retrospectively registered).
Journal of Affective Disorders, 2010
Background: Stress-related mental health problems negatively impact quality of life and productivity. Worldwide, treatment is often sought in primary care. Our objective was to determine whether a general practitioner-based minimal intervention for workers with stressrelated sick leave (MISS) was cost-effective compared to usual care (UC). Methods: We conducted an economic evaluation from a societal perspective. Quality-adjusted life years (QALYs) and resource use were measured by the EuroQol and cost diaries, respectively. Uncertainty was estimated by 95% confidence intervals, cost-effectiveness planes and acceptability curves. Sensitivity analyses and ancillary analyses based on preplanned subgroups were performed. Results: No statistically significant differences in costs or QALYs were observed. The mean incremental cost per QALY was −€7356 and located in the southeast quadrant of the costeffectiveness plane, whereby the intervention was slightly more effective and less costly. For willingness-to-pay (λ) thresholds from €0 to €100,000, the probability of MISS being cost-effective was 0.58-0.90. For the preplanned subgroup of patients diagnosed with stress-related mental disorders, the incremental ratio was −€28,278, again in the southeast quadrant. Corresponding probabilities were 0.92 or greater. Limitations: Non-significant findings may be related to poor implementation of the MISS intervention and low power. Also, work-presenteeism and unpaid labor were not measured. Conclusions: The minimal intervention was not cost-effective compared to usual care for a heterogeneous patient population. Therefore, we do not recommend widespread implementation. However, the intervention may be cost-effective for the subgroup stress-related mental disorders. This finding should be confirmed before implementation for this subgroup is considered.
2010
Objective: To study the effects of a brief patient-stress management training on the performance of general practitioners (GPs). Methods: After training in the Minimal Intervention for Stress-related mental disorders with Sick leave (MISS), the performance of 24 GPs was compared with the usual care provided by 22 GPs. Outcome measures in this intervention were: assignment of a diagnosis, taking an activating approach and monitoring the symptoms. Results: Twenty-three GPs completed the training. Outcomes showed that the training added to a psychosocial diagnosis. Other skills (using a questionnaire to make a diagnosis, handing out information leaflets and monitoring the symptoms) were to some extent improved by the training. Conclusion: The result indicates limited adherence of GPs to the MISS. Only a few components of the training were actually applied after the training, and there is still ample room for improvement. Practice implications: More than the current 11 h of training are probably needed to change the behaviour of GPs in general. Within educational programmes more attention should be given to the implementation of new behaviour, particularly when it concerns the treatment of patients with stressrelated problems.
International Archives of Occupational and Environmental Health, 2018
Purpose Randomized controlled trials (RCTs) of interventions aimed at reducing work-related stress indicate that cognitive behavioural therapy (CBT) is more effective than other interventions. However, definitions of study populations are often unclear and there is a lack of interventions targeting both the individual and the workplace. The aim of this study was to determine whether a stress management intervention combining individual CBT and a workplace focus is superior to no treatment in the reduction of perceived stress and stress symptoms and time to lasting return to work (RTW) in a clinical sample. Methods Patients with work-related stress reactions or adjustment disorders were randomly assigned to an intervention group (n = 57, 84.2% female) or a control group (n = 80, 83.8% female). Subjects were followed via questionnaires and register data. The intervention contained individual CBT and the offer of a workplace meeting. We examined intervention effects by analysing group differences in score changes on the Perceived Stress Scale (PSS-10) and the General Health Questionnaire (GHQ-30). We also tested if intervention led to faster lasting RTW. Results Mean baseline values of PSS were 24.79 in the intervention group and 23.26 in the control group while the corresponding values for GHQ were 21.3 and 20.27, respectively. There was a significant effect of time. 10 months after baseline, both groups reported less perceived stress and improved mental health. 4 months after baseline, we found significant treatment effects for both perceived stress and mental health. The difference in mean change in PSS after 4 months was − 3.09 (− 5.47, − 0.72), while for GHQ it was − 3.91 (− 7.15, − 0.68). There were no group differences in RTW. Conclusions The intervention led to faster reductions in perceived stress and stress symptoms amongst patients with workrelated stress reactions and adjustment disorders. 6 months after the intervention ended there were no longer differences between the groups.