Heart Transplant
Conditions
Keywords
Psychotherapeutic intervention, stress management, cardiac transplantation, quality of life
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.
Interventions
BEHAVIORALStress management
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Pre and post-transplant major clinical events | Before the cardiac transplantation and during 12 months after the cardiac transplantation | — |
| 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 |
| The therapeutic adherence pre-and post-transplant | Before the cardiac transplantation and during 12 months after the cardiac transplantation | using an adherence questionnaire |
| 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 |
Countries
France
Contacts
Primary ContactMohamed SAOUD, Pr
Outcome results
None listed