Clinical trial NCT01407055: Optimizing Expectations in Cardiac Surgery Patients
Official title: Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Bypass Graft Surgery (CABG)
Patients' Expectations
Coronary Heart Disease
Keywords: Coronary Artery Bypass Graft Surgery (CABG)
Patients' Expectations
Coronary Heart Disease
Illness Perception Intervention
Randomized Controlled Trial
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)
timeFrame: 6 months after surgery
Secondary outcomes:
measure: 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).
timeFrame: From 10 days before surgery untill 1 day before surgery
measure: 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.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
measure: Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery.
timeFrame: From 10 days before surgery to 6 months after surgery
measure: Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery.
timeFrame: From 10 days before surgery to 6 months after surgery
measure: 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.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
measure: 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.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
measure: 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.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
measure: Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery.
timeFrame: From 10 days before surgery to 6 months after surgery.
measure: Satisfaction wiht the intervention.
timeFrame: Expected average of 1 day before surgery (but after the intervention).
measure: Cardiothoracic surgeons' rating of the surgery success
timeFrame: Expected average of 1 day after surgery
measure: Additional treatments during follow-up
timeFrame: 6 months after surgery
measure: Blinded Expert Rating of medical and psychological status at follow-up
timeFrame: 6 months after surgery
measure: Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
measure: 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.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery.
measure: Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file
timeFrame: 6 months after surgery
measure: Patients' experience with prior surgeries
timeFrame: Baseline (expected average of 10 days before surgery)
measure: Enriched Social Support Inventory
timeFrame: Baseline (expected average 10 days before surgery)
measure: Occurrence of major life events since surgery
timeFrame: 6 months after surgery
measure: 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.
timeFrame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
measure: Satisfaction with the intervention
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University of Marburg
state: Hessen
Study officials:
affiliation: Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiac and Thoracic Vessel Surgery, Heart Centre, Philipps University of Marburg
name: Rainer Moosdorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.