Impact of Stress Management Training After Cardiac Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Stress management

Intervention Type BEHAVIORAL

Usual medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stress management

Intervention Type BEHAVIORAL

Other Intervention Names

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The program of "stress management" will include six group sessions at a rate of one session of 2 hours every 15 days. 6 components will be approached: - stress and relaxation - cognitive strategies of the stress adaptation - communication techniques and stress - problem solving techniques and stress - stress adaptation - generalization of stress management in everyday situations

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No