Salzmann Stefan, Laferton Johannes A C, Shedden-Mora Meike C, Horn Nicole, Gärtner Laura, Schröder Lara, Rau Jörn, Schade-Brittinger Carmen, Murmann Kirsten, Rastan Ardawan, Andrási Térezia B, Böning Andreas, Salzmann-Djufri Miriam, Löwe Bernd, Brickwedel Jens, Albus Christian, Wahlers Thorsten, Hamm Alfons, Hilker Lutz, Albert Wolfgang, Falk Volkmar, Zimmermann Tanja, Ismail Issam, Strauß Bernhard, Doenst Torsten, Schedlowski Manfred, Moosdorf Rainer, Rief Winfried
Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.
Department of Medicine, Health and Medical University, Potsdam, Germany.
Am Heart J. 2022 Dec;254:1-11. doi: 10.1016/j.ahj.2022.07.008. Epub 2022 Aug 5.
The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.
PSY-HEART-I试验表明，心脏手术前进行一次简短的以期望为重点的干预，可改善冠状动脉搭桥术（CABG）后6个月的残疾状况和生活质量。然而，为了研究这种干预措施的临床效用，需要开展一项大型多中心试验，以推广研究结果及其对医疗保健系统的意义。PSY-HEART-II研究旨在探讨针对患者期望的术前心理干预（EXPECT）能否改善CABG（无论是否进行心脏瓣膜置换）后6个月的治疗效果。将EXPECT与标准治疗（SOC）以及一种不针对期望提供情感支持的干预措施（SUPPORT）进行比较。在一项三臂多中心随机对照前瞻性试验（RCT）中，计划接受CABG手术的567例患者将被随机分配至单独的SOC组，或SOC与EXPECT组，或SOC与SUPPORT组。患者将以3:3:1的固定不均衡比例（EXPECT: SUPPORT: SOC）进行随机分组，以比较EXPECT与SOC以及EXPECT与SUPPORT。两种心理干预措施均包括术前一周内的2次面对面 sessions（每次50分钟）、2次电话咨询（每次20分钟），以及术后6周的1次强化电话咨询。评估将在基线时（术前约3-10天）、手术前一天、术后4-6天以及术后6个月进行。该研究的主要终点将是术后6个月患者与疾病相关的残疾状况。次要结局将包括患者的期望、主观疾病信念、生活质量、住院时间以及血液样本参数（例如，炎症参数如IL-6、IL-8、CRP）。这项大型多中心试验有可能证实并推广PSY-HEART-I试验在心脏手术患者常规护理方面的有前景的结果，并促使心脏手术治疗指南的修订。
