Optimizing Expectations in Cardiac Surgery Patients
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ClinicalTrials.gov Identifier: NCT01407055 |
Recruitment Status
:
Completed
First Posted
: August 1, 2011
Last Update Posted
: February 3, 2016
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Bypass Graft Surgery (CABG) Patients' Expectations Coronary Heart Disease | Behavioral: Expectation Manipulation Intervention Behavioral: Supportive Therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 124 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
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No Intervention: Standard Medical Care
Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery
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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.
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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).
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Experimental: Expectation Manipulation Intervention
In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention.
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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.
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- Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI) [ Time Frame: 6 months after surgery ]
- 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). [ Time Frame: From 10 days before surgery untill 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)
- 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From 10 days before surgery to 6 months after surgery. ]
- Satisfaction wiht the intervention. [ Time Frame: Expected average of 1 day before surgery (but after the intervention). ]
- Cardiothoracic surgeons' rating of the surgery success [ Time Frame: Expected average of 1 day after surgery ]
- Additional treatments during follow-up [ Time Frame: 6 months after surgery ]Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.
- Blinded Expert Rating of medical and psychological status at follow-up [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ]cortisol, inflammatory processes, catecholamines
- Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file [ Time Frame: 6 months after surgery ]
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
- Patients' experience with prior surgeries [ Time Frame: Baseline (expected average of 10 days before surgery) ]Rating of experience with own prior surgeries. Rating of experience with surgeries of close others.
- Enriched Social Support Inventory [ Time Frame: Baseline (expected average 10 days before surgery) ]
- Occurrence of major life events since surgery [ Time Frame: 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ]
- Satisfaction with the intervention [ Time Frame: 6 months after surgery ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407055
Germany | |
Philipps University of Marburg | |
Marburg, Hessen, Germany, 35032 |
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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Winfried Rief, Prof. Dr. Winfried Rief, Philipps University Marburg Medical Center |
ClinicalTrials.gov Identifier: | NCT01407055 History of Changes |
Other Study ID Numbers: |
DFG RI574/21-1 |
First Posted: | August 1, 2011 Key Record Dates |
Last Update Posted: | February 3, 2016 |
Last Verified: | February 2016 |
Keywords provided by Winfried Rief, Philipps University Marburg Medical Center:
Coronary Artery Bypass Graft Surgery (CABG) Patients' Expectations Coronary Heart Disease Illness Perception Intervention Randomized Controlled Trial |
Additional relevant MeSH terms:
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |