Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA)

Elisabeth Björk Brämberg, Kristina Holmgren, Ute Bültmann, Hanna Gyllensten, Jan Hagberg, Lars Sandman, Gunnar Bergström, Elisabeth Björk Brämberg, Kristina Holmgren, Ute Bültmann, Hanna Gyllensten, Jan Hagberg, Lars Sandman, Gunnar Bergström

Abstract

Background: Common 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.

Methods: The 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.

Discussion: The 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 registration: ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.

Keywords: Adjustment disorders; Anxiety disorders; Cluster-randomized trial; Common mental disorders; Depression; Economic evaluation; Ethical evaluation; Problem solving skills; Return to work; Sick leave.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from the regional ethical review board in Gothenburg, reference numbers 496–17 and T039–18. Informed written consent will be obtained from all participants. The written and oral information that will be given to the participants, stresses that their participation is voluntary and that they may withdraw at any time without having to give a reason.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart and overview of the trial
Fig. 2
Fig. 2
Overview of the problem solving intervention

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