The effects of a shared decision-making intervention in primary care of depression: A cluster-randomized controlled trial Andreas Loh a, * , Daniela Simon a , Celia E. Wills b , Levente Kriston a , Wilhelm Niebling c , Martin Ha ¨rter a a University Hospital of Freiburg, Department of Psychiatry and Psychotherapy, Section Clinical Epidemiology and Health Services Research, Freiburg, Germany b Michigan State University, College of Nursing, Michigan, USA c University Hospital of Freiburg, Department of Primary Care, Freiburg, Germany Received 12 January 2007; received in revised form 30 March 2007; accepted 30 March 2007 Abstract Objective: Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time. Methods: Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Su ¨dbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self- report. Depression severity and remission outcomes were assessed with the Brief PHQ-D. Results: Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups. Conclusion: A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes. Practice implications: The study results encourage the implementation of patient participation in primary care of depression. # 2007 Elsevier Ireland Ltd. All rights reserved. Keywords: Depression; Shared decision-making; Patient participation; Primary care 1. Introduction Depressive disorders are among the most common health problems seen by general practitioners. Unipolar depressive disorders are projected to be the second leading cause of the global burden of disease by the year 2030 [1]. Insufficiently treated depression is associated with a variety of adverse health, social, and occupational outcomes, resulting in substantially increased rates of morbidity, mortality, and other excess costs. Like most other Western countries, depression is prevalent in the German population (approximately 11.5% annual pre- valence [2]), and depression care continues to be in need of quality improvement. Most patients with clinically significant depression still do not receive adequate, guideline-concordant treatment [3,4], especially in the general health care sector. Patient-related barriers to treatment are important but have been under- researched in the testing of depression care quality improve- ment interventions. A high percentage of patients are reluctant to consider taking antidepressant medication; e.g., Peveler et al. www.elsevier.com/locate/pateducou Patient Education and Counseling 67 (2007) 324–332 * Corresponding author. Tel.: +49 761 2706984; fax: +49 761 2706989. E-mail address: Andreas.Loh@uniklinik-freiburg.de (A. Loh). 0738-3991/$ – see front matter # 2007 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2007.03.023