Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual medical care
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).
干预措施: Stress management (Behavioral)
结局指标
主要结局
Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients.
时间窗: 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.
次要结局
- Anxiety manifestations pre-and post-transplant(Before the cardiac transplantation and during 12 months after the cardiac transplantation)
- Somatic complications after the heart transplantation(During 12 months after the cardiac transplantation)
- Pre and post-transplant major clinical events(Before the cardiac transplantation and during 12 months after the cardiac transplantation)
- Hospitalization modalities around the graft(Before the cardiac transplantation and during 12 months after the cardiac transplantation)
- Depressive symptoms pre-and post-transplant(Before the cardiac transplantation and during 12 months after the cardiac transplantation)
- The therapeutic adherence pre-and post-transplant(Before the cardiac transplantation and during 12 months after the cardiac transplantation)