Impact of Stress Management Training After Cardiac Transplantation

Study Overview
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Brief Summary
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In spite of major medical advances in heart transplant patients, psychiatric comorbidity remains very high in pre-and post-transplant phases. Anxiety and depression are especially frequent. They impact significantly morbidity and mortality. Especially because they are associated with poor therapeutic adherence and risks of infection and rejection. The inability to make beneficial therapeutic choice can be explained by the negative perception of events, associated with anxio-depressive disorders. This results in an important deterioration in quality of life of patients. The investigators assume that better management of emotions might reduce the stress of waiting situation and its psychopathological and somatic consequences pre-and post-transplant.

Official Title
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Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.

Conditions
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Heart Transplant

Intervention / Treatment
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* Behavioral: Stress management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women on the cardiac transplantation waiting list Patients aged 18 years and older Signed written informed consent Patients under the social security Patients with a somatic condition allowing travels Patients mastering the French language Class II or III NYHA patients Exclusion Criteria: Patients minor or under protection measures Patient who have not signed written informed consent Patients not mastering the French language Patients with psychiatric illness characterized by the axis 1 of DSM IV R Patients receiving a psychotherapy or with a psychiatric care class IV NYHA patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychotherapeutic intervention<br>The psychotherapeutic intervention stress management is based on therapeutic, behavioral and cognitive strategies. They are active and put the patient actor of his adaptation of the heart transplantation entire process. The approached components are emotional, cognitive and behavioral (techniques of communication and problem solving). | Behavioral: Stress management<br> <br> * Other names: - generalization of stress management in everyday situations;|
| No Intervention: Usual medical care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients. | The quality of life is assessed with the MLHFQ - Minnesota Living with Heart Failure Questionnaire. | The quality of life is evaluated before the cardiac transplantation and during the 12 months after the cardiac transplantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety manifestations pre-and post-transplant | Anxiety manifestations pre-and post-transplant measured with the State-Trait Anxiety Inventory | Before the cardiac transplantation and during 12 months after the cardiac transplantation | 
| Depressive symptoms pre-and post-transplant | depressive symptoms pre-and post-transplant measured using the Beck Depression Inventory (BDI-II) | Before the cardiac transplantation and during 12 months after the cardiac transplantation | 
| Pre and post-transplant major clinical events |  | Before the cardiac transplantation and during 12 months after the cardiac transplantation | 
| Hospitalization modalities around the graft | by measuring the duration of stay in hospital, number of surgery necessary | Before the cardiac transplantation and during 12 months after the cardiac transplantation | 
| Somatic complications after the heart transplantation | by measuring the mortality rate and number of graft rejection | During 12 months after the cardiac transplantation | 
| The therapeutic adherence pre-and post-transplant | using an adherence questionnaire | Before the cardiac transplantation and during 12 months after the cardiac transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapeutic intervention, stress management, cardiac transplantation, quality of life