Optimizing Expectations in Cardiac Surgery Patients

Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients

The purpose of this study is to evaluate the potential benefit of targeting patients' expectations before coronary artery bypass graft surgery through a brief psychoeducational intervention.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Patients' Expectations; Coronary Artery Bypass Graft Surgery (CABG)
• Intervention / Treatment: Behavioral: Supportive Therapy; Behavioral: Expectation Manipulation Intervention

Detailed Description

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention.It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient's expectation. Targeting patients' expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients' outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group ("supportive therapy"). The main goal is to enhance positive expectations (surgery 'non-specific effects') about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient's expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients' expectations.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35032
      • Philipps University of Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled on the elective waiting list for first time coronary artery bypass graft surgery wiht the use of heart-lung-apparatus at the Department of Cardiovascular Surgery, Medical School, University of Marburg
• Sufficient knowledge of German language
• Ability to give informed consent

Exclusion Criteria:

• Emergency surgery
• Presence of a serious comorbid psychiatric condition
• Presence of a life threatening comorbid medical condition
• Current participation in other research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Medical Care; Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery
ACTIVE_COMPARATOR: Attention Control Group; In addition to standard medical care patients receive a comparable amount of therapist´s attention (common and unspecific factors = supportive therapy) to the intervention group, without targeting patients' expectations.	Behavioral: Supportive Therapy; Supportive therapy employs common factors such as elicitation of affect, reflective listening, feeling understood, but provides no explicit theoretical formulation to the patient. Supportive therapy thus provides a control condition for common factors and therapist attention but lacks the specific intervention part. It will be delivered in the same frequency and at the same time points as the Expectation Manipulation Intervention (2 individual sessions, 2 phone calls).
EXPERIMENTAL: Expectation Manipulation Intervention; In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention.	Behavioral: Expectation Manipulation Intervention; The Expectation Manipulation Intervention targets patients' expectations prior to surgery (2 individual sessions, 2 phone calls). Main goal is to enhance positive outcome expectancies, as well as to improve patients' control expectations about possible side effects of the surgery and about their personal management of their coronary heart disease. Further EMI tries to correct dysfunctional beliefs about the coronary heart disease and tries to minimize fears about expected negative consequences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patients' Expectations from Baseline/Pre-Intervention (expected average of 10 days before surgery) to hospital admission/Post-Intervention (expected average of 1 day before surgery).	Prospective Illness Perception 6 months after surgery (Expected Illness Perception Questionnaire; IPQ-E), Positive Health Expectation Scale (PHES), Expected Disability (PDI-E)	From 10 days before surgery untill 1 day before surgery
Change in Cardiac Anxiety (Cardiac Anxiety Questionnaire; CAQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.		From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery.		From 10 days before surgery to 6 months after surgery
Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery.		From 10 days before surgery to 6 months after surgery
Change in physical symptoms, subjective side effects and post-surgery complaints (Generic Assessment of Side Effects Scale; GASE-P)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.		From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
Change in Hospital Anxiety and Depression Scale (HADS)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.		From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
Change in Beliefs about Medications (Beliefs about Medications Questionaire; BMQ)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.		From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery.		From 10 days before surgery to 6 months after surgery.
Satisfaction wiht the intervention.		Expected average of 1 day before surgery (but after the intervention).
Cardiothoracic surgeons' rating of the surgery success		Expected average of 1 day after surgery
Additional treatments during follow-up	Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.	6 months after surgery
Blinded Expert Rating of medical and psychological status at follow-up		6 months after surgery
Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.		From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
Change in neuroendocrine and immunological measures from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.	cortisol, inflammatory processes, catecholamines	From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file	From Patient file: Left ventricular ejection fraction (EF), Body Mass Index, Blood pressure, Smoking status, Cardiac Operative Risk (EuroSCORE), New York Heart Association classification (NYHA), Canadian Cardiovascular Society grading of angina pectoris (CCS), Number of diseased coronary vessels, Previous myocardial infarctions, extra-cardiac arteriopathy, non-cardiac comorbidities, surgery procedure, surgery complications and in-hospital post surgery complications, time spent on the intensive care unit, inpatient days until discharge	6 months after surgery
Patients' experience with prior surgeries	Rating of experience with own prior surgeries. Rating of experience with surgeries of close others.	Baseline (expected average of 10 days before surgery)
Enriched Social Support Inventory		Baseline (expected average 10 days before surgery)
Occurrence of major life events since surgery		6 months after surgery
Change in Patients' Illness Perception (Brief Illness Perception Questionnaire (B-IPQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.		From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
Satisfaction with the intervention		6 months after surgery

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Prof. Dr., Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg; Principal Investigator: Rainer Moosdorf, Prof. Dr., Department of Cardiac and Thoracic Vessel Surgery, Heart Centre, Philipps University of Marburg

Publications and helpful links

General Publications

• Laferton JA, Shedden Mora M, Auer CJ, Moosdorf R, Rief W. Enhancing the efficacy of heart surgery by optimizing patients' preoperative expectations: study protocol of a randomized controlled trial. Am Heart J. 2013 Jan;165(1):1-7. doi: 10.1016/j.ahj.2012.10.007. Epub 2012 Nov 14.
• Horn N, Laferton JAC, Shedden-Mora MC, Moosdorf R, Rief W, Salzmann S. Baseline depressive symptoms, personal control, and concern moderate the effects of preoperative psychological interventions: the randomized controlled PSY-HEART trial. J Behav Med. 2022 Jun;45(3):350-365. doi: 10.1007/s10865-022-00319-0. Epub 2022 May 6.
• Salzmann S, Euteneuer F, Laferton JAC, Shedden-Mora MC, Schedlowski M, Moosdorf R, Rief W. IL-8 and CRP moderate the effects of preoperative psychological interventions on postoperative long-term outcomes 6 months after CABG surgery - The randomized controlled PSY-HEART trial. Brain Behav Immun. 2021 Jan;91:202-211. doi: 10.1016/j.bbi.2020.09.028. Epub 2020 Sep 28.
• Salzmann S, Euteneuer F, Laferton JAC, Auer CJ, Shedden-Mora MC, Schedlowski M, Moosdorf R, Rief W. Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial. Psychosom Med. 2017 Sep;79(7):806-814. doi: 10.1097/PSY.0000000000000483.
• Auer CJ, Laferton JAC, Shedden-Mora MC, Salzmann S, Moosdorf R, Rief W. Optimizing preoperative expectations leads to a shorter length of hospital stay in CABG patients: Further results of the randomized controlled PSY-HEART trial. J Psychosom Res. 2017 Jun;97:82-89. doi: 10.1016/j.jpsychores.2017.04.008. Epub 2017 Apr 19.
• Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.

Helpful Links

• Homepage of the transregional DFG research unit FOR 1328: Expectation and conditioning as basic processes of the placebo and nocebo response: From neurobiology to clinical applications

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (ESTIMATE): August 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Patients' Expectations; Coronary Heart Disease; Coronary Artery Bypass Graft Surgery (CABG); Illness Perception Intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: DFG RI574/21-1