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Open Access 01-12-2013 | Study protocol

A genotype-specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial

Authors: Daniela Hauer, Iris-Tatjana Kolassa, Rüdiger Paul Laubender, Ulrich Mansmann, Christian Hagl, Benno Roozendaal, Dominique J-F de Quervain, Gustav Schelling

Published in: Trials | Issue 1/2013

Abstract

Background

Cardiac surgery is one of the most commonly performed surgical procedures worldwide with >700,000 surgeries in 2006 in the US alone. Cardiac surgery results in a considerable exposure to physical and emotional stress; stress-related disorders such as depression or post-traumatic stress disorder are the most common adverse outcomes of cardiac surgery, seen in up to 20% of patients. Using information from a genome-wide association study to characterize genetic effects on emotional memory, we recently identified a single nucleotide polymorphism of the glucocorticoid receptor gene (the Bcl l single nucleotide polymorphism) as a significant genetic risk factor for traumatic memories from cardiac surgery and symptoms of post-traumaticstress disorder. The Bcl l high-risk genotype (Bcl l GG) has a prevalence of 16.6% in patients undergoing cardiac surgery and is associated with increased glucocorticoid receptor signaling under stress. Concomitant animal experiments have confirmed an essential role of glucocorticoid receptor activation for traumatic memory formation during stressful experiences. Early cognitive behavioral intervention has been shown to prevent stress-related disorders after heart surgery.

Methods/Design

The proposed study protocol is based on the above mentioned earlier findings from animal experiments and preclinical studies in volunteers. Patients (n = 872) will be genotyped for the Bcl l single nucleotide polymorphism before surgery, which should result in 120 homozygous high-risk carriers of the Bcl l GG allele and 240 randomly selected low-risk heterozygous or non-carriers of the single nucleotide polymorphism. All patients will then undergo randomization to either cognitive behavioral intervention or a control intervention consisting of non-specific general information about the role of stress in heart disease. The primary efficacy endpoint will be post-traumatic stress levels at one year after surgery as determined by a standardized questionnaire that has been specifically validated in patients after critical illness.

Discussion

The proposed randomized controlled trial intends to demonstrate that a preoperatively administered minimal cognitive behavioral intervention targeted to homozygous carriers of the Bcl l *G high-risk allele reduces traumatic memories and post-traumatic stress disorder symptoms after heart surgery to a level seen in non-carriers of the mutation, and thus improves the neuroemotional outcome of cardiac surgery.

Trial registration number

The trial will be registered at http://www.clinicaltrials.gov/ before commencing with the study.

Available only for authorised users

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Title: A genotype-specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial
Authors: Daniela Hauer
Iris-Tatjana Kolassa
Rüdiger Paul Laubender
Ulrich Mansmann
Christian Hagl
Benno Roozendaal
Dominique J-F de Quervain
Gustav Schelling
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-14-89

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A genotype-specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial

Abstract

Background

Methods/Design

Discussion

Trial registration number

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration number

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