Condition category
Surgery
Date applied
04/12/2008
Date assigned
23/12/2008
Last edited
23/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We examined how much psychological and spiritual treatments improve recovery after coronary bypass surgery. One of our goals was to investigate if psychological or spiritual treatments are more effective for patients who actively chose one of these treatments compared to patients who wished to have treatment but didn’t mind whether it was psychological or spiritual. Furthermore, we wanted to see whether patients who are at psychosocial risk (those who are anxious or depressed) before an operation might benefit from supportive treatments.

Who can participate?
The BYPASS study aimed to recruit about 1,000 female and male patients undergoing non-emergency coronary bypass surgery partially combined with valve surgery, over 18 years of age, from the Jena University Hospital and the Heart Centre Brandenburg, Bernau, Germany.

What does the study involve?
Upon hospital admission, patients were asked about their preference regarding supportive treatments: whether they preferred psychological treatments, spiritual treatments, treatments regardless of the profession of the therapist or if they did not want any supportive treatment. In one time period, patients got treatments according to their preference; in another time period, patients were asked about their preference but did not get any supportive treatment. At the end of the study, we compared patients who received psychological or spiritual support with patients, who stated a preference for, but did not get supportive treatments.

What are the possible benefits and risks of participating?
Patients who received supportive treatments benefited from an improvement in their mood. There were no known risks associated with participating in this trial.

Where is the study run from?
Jena University Hospital of Jena and the Heart Centre Brandenburg, Bernau, Germany.

When is study starting and how long is it expected to run for?
This trial started in October 2007 and finished in December 2009.

Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]), Germany.

Who is the main contact?
Dr Jenny Rosendahl
jenny.rosendahl@med.uni-jena.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernhard Strauss

ORCID ID

Contact details

Institute of Psychosocial Medicine and Psychotherapy
University Hospital Jena
Stoystrasse 3
Jena
07743
Germany
bernhard.strauss@med.uni-jena.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AL 562/4-1, STR 306/21-1

Study information

Scientific title

Differential treatment effects of psychological and spiritual support on recovery and quality of life after coronary artery bypass surgery

Acronym

BYPASS

Study hypothesis

1. Spiritual or psychological interventions, either according to the patients' therapeutic preference or randomly assigned, will have an positive impact on recovery and health-related quality of life following bypass surgery
2. Spiritual or psychological interventions, that are applied to the patients according to their preference, will have a greater positive impact on recovery and health-realted quality of life than randomly assigned interventions
3. Patients that are pre-operatively at psychosocial risk (high levels of anxiety or depression, lack of social support) will benefit from spiritual or psychological interventions more than patients not being at psychosocial risk

Ethics approval

Ethics Committee of the Friedrich Schiller University of Jena, approved on the 13th December 2005 (ref: 1663-11/05)

Study design

Partially randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery bypass surgery partially combined with valve surgery

Intervention

Interventions, psychological as well as spiritual, are manualised and applied to the patient according to his/her individual needs at least once pre-operatively and at least once post-operatively. The total number of intervention sessions and the duration of each session depends on each participant's need.

Psychological interventions include hypnotherapeutic interventions, relaxation techniques and emotional support. Spiritual interventions include patient-oriented conversations, intercessory prayer, Lords prayer, Lords supper, anointing or blessing.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Presence of any complication following surgery within hospital stay, and following three and six months after surgery.

Secondary outcome measures

1. Patient mobility (measured with the two-minute-walking-test) at discharge
2. Patient satisfaction, assessed by the Client Satisfaction Questionnaire (CSQ-8) at discharge
3. Health-related quality of life, assessed by the 12-item Short Form (SF-12) Health Survey at three- and six-month follow-up
4. Wellbeing, assessed by a German Mood and Wellbeing scale (BFS) at discharge, three- and six-month follow-up
5. Anxiety and depression, assessed by the Hospital Anxiety and Depression Scale (HADS) at discharge, three- and six-month follow-up
6. Self-reported pain, assessed by a Visual Analogue Scale (VAS) at discharge, three- and six-month follow-up

Overall trial start date

01/10/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients aged 18 years or older
2. Scheduled for non-emergency coronary bypass surgery partially combined with valve surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,000

Participant exclusion criteria

Emergency cases

Recruitment start date

01/10/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Institute of Psychosocial Medicine and Psychotherapy
Jena
07743
Germany

Sponsor information

Organisation

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53175
Germany

Sponsor type

Research council

Website

http://www.dfg.de

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: AL 562/4-1, STR 306/21-1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19540386
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23147203

Publication citations

  1. Protocol

    Rosendahl J, Tigges-Limmer K, Gummert J, Dziewas R, Albes JM, Strauss B, , Bypass surgery with psychological and spiritual support (the By.pass study): study design and research methods., Am. Heart J., 2009, 158, 1, 8-14.e1, doi: 10.1016/j.ahj.2009.04.017.

  2. Results

    Rosendahl J, Tigges-Limmer K, Gummert J, Dziewas R, Albes JM, Strauss B, Bypass surgery with psychological and spiritual support (the BY.PASS Study): results of a pragmatic trial based on patients' preference., Psychother Psychosom, 2013, 82, 1, 35-44, doi: 10.1159/000339170.

Additional files

Editorial Notes