Dataset Information

A cluster-randomised trial evaluating an intervention for patients with stress-related mental disorders and sick leave in primary care.

ABSTRACT:

Objective

Mental health problems often affect functioning to such an extent that they result in sick leave. The worldwide reported prevalence of mental health problems in the working population is 10%-18%. In developed countries, mental health problems are one of the main grounds for receiving disability benefits. In up to 90% of cases the cause is stress-related, and health-care utilisation is mainly restricted to primary care. The aim of this study was to assess the effectiveness of our Minimal Intervention for Stress-related mental disorders with Sick leave (MISS) in primary care, which is intended to reduce sick leave and prevent chronicity of symptoms.

Design

Cluster-randomised controlled educational trial.

Setting

Primary health-care practices in the Amsterdam area, The Netherlands.

Participants

A total of 433 patients (MISS n = 227, usual care [UC] n = 206) with sick leave and self-reported elevated level of distress.

Interventions

Forty-six primary care physicians were randomised to either receive training in the MISS or to provide UC. Eligible patients were screened by mail.

Outcome measures

The primary outcome measure was duration of sick leave until lasting full return to work. The secondary outcomes were levels of self-reported distress, depression, anxiety, and somatisation.

Results

No superior effect of the MISS was found on duration of sick leave (hazard ratio 1.06, 95% confidence interval 0.87-1.29) nor on severity of self-reported symptoms.

Conclusions

We found no evidence that the MISS is more effective than UC in our study sample of distressed patients. Continuing research should focus on the potential beneficial effects of the MISS; we need to investigate which elements of the intervention might be useful and which elements should be adjusted to make the MISS effective.

SUBMITTER: Bakker IM

PROVIDER: S-EPMC1885369 | biostudies-literature | 2007 Jun

REPOSITORIES: biostudies-literature

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Publications

A cluster-randomised trial evaluating an intervention for patients with stress-related mental disorders and sick leave in primary care.

Bakker Ingrid M IM Terluin Berend B van Marwijk Harm W J HW van der Windt Daniëlle A W M DA Rijmen Frank F van Mechelen Willem W Stalman Wim A B WA

PLoS clinical trials 20070601 6

<h4>Objective</h4>Mental health problems often affect functioning to such an extent that they result in sick leave. The worldwide reported prevalence of mental health problems in the working population is 10%-18%. In developed countries, mental health problems are one of the main grounds for receiving disability benefits. In up to 90% of cases the cause is stress-related, and health-care utilisation is mainly restricted to primary care. The aim of this study was to assess the effectiveness of ou ...[more]

PMID: 17549228

Similar Datasets

Project description:ObjectivesTo evaluate the effectiveness of a brief intervention about early identification of work-related stress combined with feedback at consultation with a general practitioner (GP) on the number of self-reported sick leave days.DesignRandomised controlled trial. Prospective analyses of self-reported sick leave data collected between November 2015 and January 2017.SettingSeven primary healthcare centres in western Sweden.ParticipantsThe study included 271 employed, non-sick-listed patients aged 18-64 years seeking care for mental and/or physical health complaints. Of these, 132 patients were allocated to intervention and 139 patients to control.InterventionsThe intervention group received a brief intervention about work-related stress, including training for GPs, screening of patients' work-related stress, feedback to patients on screening results and discussion of measures at GP consultation. The control group received treatment as usual.Outcome measuresThe number of self-reported gross sick leave days and the number of self-reported net sick leave days, thereby also considering part-time sick leave.ResultsAt 6 months' follow-up, 220/271 (81%) participants were assessed, while at 12 months' follow-up, 241/271 (89%) participants were assessed. At 6-month follow-up, 59/105 (56%) in the intervention group and 61/115 (53%) in the control group reported no sick leave. At 12-month follow-up, the corresponding numbers were 61/119 (51%) and 57/122 (47%), respectively. There were no statistically significant differences between the intervention group and the control group in the median number of self-reported gross sick leave days and the median number of self-reported net sick leave days.ConclusionsThe brief intervention showed no effect on the numbers of self-reported sick leave days for patients seeking care at the primary healthcare centres. Other actions and new types of interventions need to be explored to address patients' perceiving of ill health due to work-related stress.Trial registration numberNCT02480855.

Project description:BackgroundCommon mental disorders are highly prevalent in the working population, affecting about 1 in 5 persons in the Organisation for Economic Co-operation and Development countries. About 30% of those affected have a first period of sick leave. Despite several attempts to reduce the risk of sick leave among employees with common mental disorders, there is a lack of knowledge about effective, preventive interventions which aim to reduce such risks. This protocol describes the design of a study to evaluate the effectiveness of a problem-solving intervention delivered by first-line managers to employees with common mental disorders on the prevention of sick leave during the 12-month follow-up.Methods/designThe study applies a two-armed cluster-randomized trial design of a problem-solving intervention conducted in private-sector companies. First-line managers are randomized into intervention- or control groups by computer-generated random numbers, allocation ratio 1:1. Employees are eligible if at risk for future sick leave due to common mental disorders. These are identified by self-reported psychological health measured by the General Health Questionnaire 12-item, cut-off ≥3, or a positive answer to risk of sick leave. The intervention is based on problem-solving principles. It involves the training of the first-line managers who then deliver the intervention to employees identified at risk of sick leave. First-line managers in the control group receives a lecture. Primary outcome is number of registered days of sick leave due to common mental disorders during the 12-month follow-up. Secondary outcomes are general health, psychological symptoms, work performance, work ability and psychosocial work environment. A process evaluation will examine the intervention's reach, fidelity, dose delivered, dose received, satisfaction and context. Research assistants managing the screening procedure, outcome assessors and employees are blinded to randomization and allocation.DiscussionThe study includes analyses of the intervention's effectiveness and an alongside process evaluation. Methodological strengths and limitations, for example the risk of selection bias, attrition and risk of contamination are discussed.Trial registrationClinicaltrials.gov NCT04975750 Date of registration: 08/16/2021.

Project description:BackgroundSick leave due to common mental disorders (CMDs) is a public health problem in several countries, including Sweden. Given that symptom relief does not necessarily correspond to return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care.ObjectiveThe aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs.MethodsA randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform.ResultsAt the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave.ConclusionsA person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave.Trial registrationClinicalTrials.gov NCT03404583; https://clinicaltrials.gov/ct2/show/NCT03404583.

Project description:BackgroundCommon mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders.MethodsThe study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee's return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity.DiscussionThe study is a pragmatic trial which will include analyses of the intervention's effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care.Trial registrationClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.

Project description:BACKGROUND:For a decade, experts have suggested integrating mental health care into primary care to help bridge mental health Treatment Gap. General Practitioners (GPs) are the first port-of-call for many patients with mental ill-health. In Indonesia, the WHO mhGAP is being systematically introduced to its network of 10,000 primary care clinics as an add-on mental health training for pairs of GPs and Nurses, since the end of 2015. In one of 34 provinces, there exists an integrated care model: the co-location of clinical psychologists in primary care clinics. This trial evaluates patient outcomes among those provided mental health care by GPs with those treated by clinical psychologists in primary care. METHODS:In this partially-randomised, pragmatic, two-arm cluster non-inferiority trial, 14 primary care clinics were assigned to receive the WHO mhGAP training and 14 clinics with the co-location framework were assigned to the Specialist arm. Participants (patients) were blinded to the existence of the other pathway, and outcome assessors were blinded to group assignment. All adult primary care patients who screened positive for psychiatric morbidity were eligible. GPs offered psychosocial and/or pharmacological interventions and Clinical Psychologists offered psychosocial interventions. The primary outcome was health and social functioning as measured by the HoNOS and secondary outcomes include disability measured by WHODAS 2.0, health-related quality of life measured by EQ-5D-3L, and resource use and costs evaluated from a health services perspective, at six months. RESULTS:153 patients completed the outcome assessment following GP care alongside 141 patients following Clinical Psychologists care. Outcomes of GP care were proven to be statistically not inferior to Clinical Psychologists in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Economic analyses indicate lower costs and better outcomes in the Specialist arm and suggest a 50% probability of WHO mhGAP framework being cost-effective at the Indonesian willingness to pay threshold per QALY. CONCLUSION:General Practitioners supported by nurses in primary care clinics could effectively manage mild to moderate mental health issues commonly found among primary care patients. They provide non-stigmatising mental health care within community context, helping to reduce the mental health Treatment Gap. TRIAL REGISTRATION:ClinicalTrials.gov NCT02700490.

Dataset Information

A cluster-randomised trial evaluating an intervention for patients with stress-related mental disorders and sick leave in primary care.

Objective

Design

Setting

Participants

Interventions

Outcome measures

Results

Conclusions

Publications

A cluster-randomised trial evaluating an intervention for patients with stress-related mental disorders and sick leave in primary care.

Similar Datasets

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