Impact of Stress Management Training After Cardiac Transplantation (QUIET)

Civil Hospices of Lyon

Status and phase: Unknown; Phase 3

Conditions: Heart Transplant

Treatments: Behavioral: Stress management

Study type: Interventional

Funder types: Other

Identifiers

NCT02163629

2014-842

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

psychotherapeutic intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Stress management

Usual medical care

No Intervention group