NCT01407055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

July 25, 2011

Last Update Submit

February 2, 2016

Conditions

Coronary Artery Bypass Graft Surgery (CABG)Patients' ExpectationsCoronary Heart Disease

Keywords

Coronary Artery Bypass Graft Surgery (CABG)Patients' ExpectationsCoronary Heart DiseaseIllness Perception InterventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)

    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).

    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

  • +15 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: Expectation Manipulation Intervention

Interventions

Expectation Manipulation InterventionBEHAVIORAL

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.

Expectation Manipulation Intervention
Supportive TherapyBEHAVIORAL

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).

Attention Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps University of Marburg

Marburg, Hesse, 35032, Germany

Location

Related Publications (6)

  • 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.

    PMID: 23237127BACKGROUND

  • 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.

    PMID: 35522399DERIVED

  • 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.

    PMID: 33002633DERIVED

  • 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.

    PMID: 28846584DERIVED

  • 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.

    PMID: 28606503DERIVED

  • 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.

    PMID: 28069021DERIVED

Related Links

MeSH Terms

Conditions

Coronary Disease

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Winfried Rief

Study Record Dates

First Submitted

July 25, 2011

First Posted

August 1, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

DE(1)