Bypass surgery with psychological and spiritual support (the By.pass study): study design and research methods.

Effects of psychological as well as spiritual interventions on outcome in cardiac surgery have mostly been studied with a focus on presurgical interventions. Systematically controlled analyses of the effects of psychological and spiritual interventions depending on the patients' preference have not been performed so far, although these studies would help to assign patients to an adequate support. The By.pass study is a bi-center, controlled trial of patients undergoing coronary bypass surgery and coronary bypass surgery combined with valve replacement surgery in 2 different German hospitals. Patients are assigned to 1 of 5 conditions, mainly according to their personal therapeutic preference: preference for psychological interventions (group 1), preference for spiritual interventions (group 2), or preference for no intervention (group 5). Patients who are open for any kind of intervention are randomly assigned either to psychological (group 3) or spiritual interventions (group 4). Six months before the start and 6 months after the end of the treatment phase, patients were assigned to the control groups. These were asked about their subjective preference (psychological, spiritual, no intervention, or no specific preference) as well but received no interventions. Patients will be enrolled from October 2006 to December 2009. The 6-month follow-up will be completed in July 2010.