Impact of Stress Management Training After Cardiac Transplantation (QUIET)
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|ClinicalTrials.gov Identifier: NCT02163629|
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : September 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant||Behavioral: Stress management||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: psychotherapeutic intervention
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
|No Intervention: Usual medical care|
- Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients. [ Time Frame: 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.
- Anxiety manifestations pre-and post-transplant [ Time Frame: 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
- Depressive symptoms pre-and post-transplant [ Time Frame: 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 [ Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation ]
- Hospitalization modalities around the graft [ Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation ]by measuring the duration of stay in hospital, number of surgery necessary
- Somatic complications after the heart transplantation [ Time Frame: During 12 months after the cardiac transplantation ]by measuring the mortality rate and number of graft rejection
- The therapeutic adherence pre-and post-transplant [ Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation ]using an adherence questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163629
|Contact: Mohamed SAOUD, Prfirstname.lastname@example.org|
|Service de Psychiatrie d'Adultes Liaison/Consultation,||Recruiting|
|Bron, France, 69677|
|Contact: Mohamed SAOUD, PR 4 72 11 80 64 ext +33 email@example.com|
|Principal Investigator: Mohamed SAOUD, MD|
|Pôle de Psychiatrie et de Neurologie||Not yet recruiting|
|Contact: Thierry BOUGEROL, MD firstname.lastname@example.org|
|Principal Investigator: Thierry BOUGEROL, MD|
|Principal Investigator:||Mohamed SAOUD, Pr||Hospices Civils de Lyon|