Coronary Artery Bypass Graft Surgery (CABG)Phase 2NCT01407055
Optimizing Expectations in Cardiac Surgery Patients
A Phase 2 study testing Expectation Manipulation Intervention and Supportive Therapy in people with Coronary Artery Bypass Graft Surgery (CABG) and Patients' Expectations, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery (CABG), Patients' Expectations, Coronary Heart Disease
- What is being tested?
- Expectation Manipulation Intervention and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Emergency surgery
- Presence of a serious comorbid psychiatric condition
- Presence of a life threatening comorbid medical condition
- Current participation in other research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Bypass Graft Surgery (CABG), Patients' Expectations, Coronary Heart Disease
- Being tested
- Expectation Manipulation Intervention, Supportive Therapy
- Keywords
- Coronary Artery Bypass Graft Surgery (CABG), Patients' Expectations, Coronary Heart Disease, Illness Perception Intervention, Randomized Controlled Trial
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectation Manipulation InterventionBehavioural
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.
Supportive TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Care | No intervention | Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery |
| Attention Control Group | Active comparator | 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. Receives: Behavioral: Supportive Therapy |
| Expectation Manipulation Intervention | Experimental | In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention. Receives: Behavioral: Expectation Manipulation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)
Measured: 6 months after surgery
Secondary outcomes (20)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 10 days before surgery to 6 months after surgery.
Satisfaction wiht the intervention.
Measured: Expected average of 1 day before surgery (but after the intervention).
Cardiothoracic surgeons' rating of the surgery success
Measured: Expected average of 1 day after surgery
Additional treatments during follow-up
Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.
Measured: 6 months after surgery
Blinded Expert Rating of medical and psychological status at follow-up
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months after surgery
Patients' experience with prior surgeries
Rating of experience with own prior surgeries. Rating of experience with surgeries of close others.
Measured: Baseline (expected average of 10 days before surgery)
Enriched Social Support Inventory
Measured: Baseline (expected average 10 days before surgery)
Occurrence of major life events since surgery
Measured: 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.
Measured: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery
Satisfaction with the intervention
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft Surgery (CABG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Department of Clinical Psychology and Psychothearpy, Philipps University of MarburgRainer Moosdorf, Prof. Dr., Principal investigator, Department of Cardiac and Thoracic Vessel Surgery, Heart Centre, Philipps University of Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407055
- Sponsor's protocol ID
- DFG RI574/21-1
- Status last verified
- Feb 2016
- First submitted
- 25 Jul 2011
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23237127Horn 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.
PubMed 35522399Salzmann 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.
PubMed 33002633Salzmann 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.
PubMed 28846584Auer 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.
PubMed 28606503Rief 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.
PubMed 28069021
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT01407055
- Acronym / sponsor ID
- DFG RI574/21-1
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Care | No intervention | –Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery |
| Attention Control Group | Active comparator | Behavioral: Supportive TherapyIn 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. |
| Expectation Manipulation Intervention | Experimental | Behavioral: Expectation Manipulation InterventionIn addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Emergency surgery
- Presence of a serious comorbid psychiatric condition
- Presence of a life threatening comorbid medical condition
- Current participation in other research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectation Manipulation InterventionThe 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. | Behavioural | Expectation Manipulation Intervention |
| Supportive TherapySupportive 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). | Behavioural | Attention Control Group |
Primary outcome
Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)
Time frame: 6 months after surgery
20 secondary outcomes
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
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
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.
Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file
Time frame: 6 months after surgery
Patients' experience with prior surgeries
Time frame: Baseline (expected average of 10 days before surgery)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 23237127Laferton 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.
- Derived from this study: PubMed 35522399Horn 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.
- Derived from this study: PubMed 33002633Salzmann 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.
- Derived from this study: PubMed 28846584Salzmann 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.
- Derived from this study: PubMed 28606503Auer 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.
- Derived from this study: PubMed 28069021Rief 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.
- 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 applicationsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Prof. Dr. principal investigator
Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Rainer Moosdorf, Prof. Dr. principal investigator
Department of Cardiac and Thoracic Vessel Surgery, Heart Centre, Philipps University of Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Expectation Manipulation Intervention and Supportive Therapy in people with Coronary Artery Bypass Graft Surgery (CABG) and Patients' Expectations, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI) (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407055, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.