This study examined whether baseline (3–14 days pre-surgery) levels of (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs moderate the effects of additional preoperative interventions before coronary artery bypass graft surgery on (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs 1 day before surgery, 1 week and 6 months after surgery. In the PSY-HEART trial, 115 patients were assessed. They were randomized into one of three groups: 1. receiving standard medical care only (SMC), additional psychological interventions: 2. aiming to optimize patients’ expectations (EXPECT), or 3. focusing on emotional support. Patients with a higher baseline level of depressive symptoms receiving a preoperative psychological intervention indicated lower depressive symptoms 6 months after surgery compared to SMC. EXPECT increased personal control and concern levels in patients with low baseline personal control/concern 1 day before surgery. Brief preoperative psychological interventions can improve psychological outcomes in heart surgery patients. Baseline status may moderate these effects. The study has been approved by the medical ethics committee of the Philipps University of Marburg and has been pre-registered at www.clinicaltrials.gov (NCT01407055) on August 1, 2011.
IntroductionComplete recovery after surgery depends on psychological factors such as preoperative information, expectations, and surgery-associated anxiety. Prior studies have shown that even a short preoperative psychological intervention aiming at optimized expectations (EXPECT) can improve postoperative outcomes in coronary artery bypass patients. However, this intervention may benefit only a small subgroup of heart surgery patients since implementing preoperative psychological interventions into the daily clinical routine is difficult due to the additional time and appointments. It is unclear whether the EXPECT intervention can be shortened and whether heart valve patients would also benefit from interventions that optimize patients’ expectations. The multicenter ValvEx trial aims (i) to adapt an effective preoperative psychological intervention (EXPECT) to make it brief enough to be easily integrated into the preoperative routine of heart valve patients and (ii) to examine if the adapted preoperative psychological intervention improves the subjectively perceived illness-related disability (PDI) up to 3 months after surgery.Materials and analysisIn two German university hospitals, N = 88 heart valve patients who undergo heart surgery are randomized into two groups [standard of care (SOC) vs. standard of care plus interventional expectation manipulation (SOC and EXPECT)] after baseline assessment. Patients in the EXPECT group additionally to standard of care participate in the preoperative psychological intervention (30–40 min), focusing on optimizing expectations and have two booster-telephone calls (4 and 8 weeks after the surgery, approx. 15 min). Both groups have assessments again on the evening before the surgery, 4 to 6 days, and 3 months after the surgery.DiscussionThe trial demonstrates excellent feasibility in the clinical routine and a high interest by the patients.Ethics and disseminationThe Ethics Committees of the Department of Medicine of the Philipps University of Marburg and the Department of Medicine of the University of Giessen approved the study protocol. Study results will be published in peer-reviewed journals and presented at congresses.Clinical trial registrationClinicalTrials.gov, identifier NCT04502121.
Behandlungsmanual und Behandlungsmaterialien für die psychologische Kurzintervention zur Erwartungsoptimierung von Patienten vor herzchirurgischen Eingriffen im Rahmen der randomisiert-kontrollierten mulitzentrischen PSY-HEART-II-Studie.
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