Impact of Stress Management Training After Cardiac Transplantation

Heart Transplant Clinical Trial

— QUIET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02163629
• Other study ID #: 2014-842
• Status: Recruiting
• Phase: Phase 3
• First received: May 27, 2014
• Last updated: September 21, 2015
• Start date: April 2015
• Est. completion date: December 2020

Study information

• Verified date: September 2015
• Source: Hospices Civils de Lyon
• Contact: Mohamed SAOUD, Pr
• Email: mohamed.saoud[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Transplant

Intervention

Behavioral:
• Stress management

Locations

Country	Name	City	State
France	Service de Psychiatrie d'Adultes Liaison/Consultation,	Bron
France	Pôle de Psychiatrie et de Neurologie	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	Pre and post-transplant major clinical events		Before the cardiac transplantation and during 12 months after the cardiac transplantation	Yes
Secondary	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	No
Secondary	Somatic complications after the heart transplantation	by measuring the mortality rate and number of graft rejection	During 12 months after the cardiac transplantation	No
Secondary	The therapeutic adherence pre-and post-transplant	using an adherence questionnaire	Before the cardiac transplantation and during 12 months after the cardiac transplantation	No