Impact of Stress Management Training After Cardiac Transplantation
- Conditions
- Heart Transplant
- Interventions
- Behavioral: Stress management
- Registration Number
- NCT02163629
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description psychotherapeutic intervention Stress management 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).
- Primary Outcome Measures
Name Time Method Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients. The quality of life is evaluated before the cardiac transplantation and during the 12 months after the cardiac transplantation. The quality of life is assessed with the MLHFQ - Minnesota Living with Heart Failure Questionnaire.
- Secondary Outcome Measures
Name Time Method Anxiety manifestations pre-and post-transplant Before the cardiac transplantation and during 12 months after the cardiac transplantation Anxiety manifestations pre-and post-transplant measured with the State-Trait Anxiety Inventory
Somatic complications after the heart transplantation During 12 months after the cardiac transplantation by measuring the mortality rate and number of graft rejection
Pre and post-transplant major clinical events Before the cardiac transplantation and during 12 months after the cardiac transplantation Hospitalization modalities around the graft Before the cardiac transplantation and during 12 months after the cardiac transplantation by measuring the duration of stay in hospital, number of surgery necessary
Depressive symptoms pre-and post-transplant Before the cardiac transplantation and during 12 months after the cardiac transplantation depressive symptoms pre-and post-transplant measured using the Beck Depression Inventory (BDI-II)
The therapeutic adherence pre-and post-transplant Before the cardiac transplantation and during 12 months after the cardiac transplantation using an adherence questionnaire
Trial Locations
- Locations (2)
Service de Psychiatrie d'Adultes Liaison/Consultation,
🇫🇷Bron, France
Pôle de Psychiatrie et de Neurologie
🇫🇷Grenoble, France