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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).    Electronic supplementary material  The online version of this article (doi:10.1186/s12952-017-0078-z) contains supplementary material, which is available to authorized users.

journal of negative results in biomedicine

Work-focused cognitive behavioral intervention for psychological complaints in patients on sick leave due to work-related stress: Results from a randomized controlled trial