Clinical trial NCT02163629: Impact of Stress Management Training After Cardiac Transplantation
Official title: Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Transplant
Keywords: Psychotherapeutic intervention
stress management
cardiac transplantation
quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients.
timeFrame: The quality of life is evaluated before the cardiac transplantation and during the 12 months after the cardiac transplantation.
Secondary outcomes:
measure: Anxiety manifestations pre-and post-transplant
timeFrame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
measure: Depressive symptoms pre-and post-transplant
timeFrame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
measure: Pre and post-transplant major clinical events
timeFrame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
measure: Hospitalization modalities around the graft
timeFrame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
measure: Somatic complications after the heart transplantation
timeFrame: During 12 months after the cardiac transplantation
measure: The therapeutic adherence pre-and post-transplant
timeFrame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Psychiatrie d'Adultes Liaison/Consultation,
city: Grenoble
country: France
facility: Pôle de Psychiatrie et de Neurologie
Study officials:
affiliation: Hospices Civils de Lyon
name: Mohamed SAOUD, Pr
role: PRINCIPAL_INVESTIGATOR
References: