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

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.