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临床试验/NCT04143178
NCT04143178已完成不适用

Effectiveness of a Psychological Intervention Focused on Expressive Writing in Patients Undergoing to Kidney Transplant

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Alexithymia - difficulties in identifying, recognizing and describing emotions

研究概览

简要总结

Kidney transplantation is a replacement treatment for chronic renal failure that improves quality of life. However, it can be experienced as traumatic in relation to the changes it entails in terms of lifestyle, redefinition of one's body and social and family role. A negative personal experience could affect adherence to the treatment, a protective factor in reducing the risk of organ rejection and mortality. Some studies have shown the effectiveness of expressive writing in reducing the symptoms and management of the disease in patients undergoing surgery or suffering from cancer. It is hypothesized that this technique allows the processing of traumatic events linked to the disease, favoring an improvement in the expression and emotional regulation skills.

The aim of the present study was to evaluate the effectiveness of a psychological intervention focused on expressive writing on the post-operative course in patients underwent to kidney transplantation. Thirty-five patients were recruited at the kidney transplant center of the Policlinico Umberto I, Rome. The sample was divided into 2 groups: the psychological intervention focused on expressive writing group and the control group which carried out a neutral writing task. Each patient filled some self-report questionnaires and carried out blood analysis, before the operation, the day of discharge and at 3 month follow-up. The psychological intervention group was expected to have a greater improvement in the emotional skills, adherence and renal function, and a lower level of healthcare costs compared to the control group.

详细描述

Kidney transplantation is a replacement therapy in chronic renal failure which could allow a better quality of life. However, renal transplantation also represents an emotionally strong experience, which is associated with feelings of acceptance of the transplanted organ, change in lifestyle, side effects of pharmacotherapies, anxiety, depression, redefinition of one's body, as well as one's own social and family role. For these reasons it can be experienced as a traumatic event and be associated with an unfavorable post-operative course, in particular with regard to adherence to medical prescriptions and the consequent increase in the possibility of rejection.

Adherence, in fact, implies the correct management of drugs and the constant and assiduous presence at pre-established check-ups at the transplant center, taking the required exams and promptly reporting any complications. In kidney transplant patients, adherence to immunosuppressive therapies becomes fundamental to reduce the risk of organ rejection or, in the most extreme cases, the risk of death. Several studies show the importance of adherence to post-operative course treatment in different types of transplant. Furthermore, it has been shown that poor levels of adherence, recognized as a risk factor for organ rejection, are associated with an increase in healthcare costs.

Young age, depression, anxiety and avoidant-type adaptation strategies (eg avoiding the stressful event) are some of the risk factors of non-adherence in kidney transplant patients. Also alexithymia (known as the inability to identify and describe emotions), the inability to regulate intense emotional states, and attachment style, are associated with poor levels of post-transplant adherence.

Possemato and collaborators (2010), showed the efficacy of an intervention that uses expressive writing in the reduction of post-traumatic stress symptoms in kidney transplant patients. This technique seems to be effective also in patients with chronic pathologies and cancer, in particular in the reduction of symptoms , in the management of disease and psychophysical symptoms in cancer patients. The ways in which this technique acts are not yet clear, however it is hypothesized that the externalization and processing of traumatic events linked to the disease may favor an improvement in the ability to express emotions, and the reduction of negative thoughts and feelings associated. These studies suggest that using the technique of expressive writing in kidney transplant patients would allow them to externalize and process emotions, feelings and thoughts related to illness, transplantation and consequent changes (constant controls and therapies, sudden life style change, drug therapies and its effects, physical modifications), and this can favor a mental reorganization of negative events, a greater expression and emotions regulation, and an improvement in the interpersonal skills with family members and medical staff. Furthermore, this could be associated with a greater ability to cope with the consequences and psychophysical changes following transplantation and encourage greater levels of adherence with effects on the risk of organ rejection and health costs.

The objective of the study was to verify the effects of the expressive writing, on the post-operative course, in term of organ rejection, psychological well-being, adherence and healthcare spending in patients undergoing kidney transplantation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years) of Italian nationality with sufficient level of education in order to understand the questionnaires and to carry out the writing task required by the protocol.

排除标准

  • Patients with major psychopathology and/or cognitive impairment

结局指标

主要结局

Alexithymia - difficulties in identifying, recognizing and describing emotions

时间窗: 3 months

In order to evaluate the level of alexithymia the TAS-20 was administered before the operation, the day of the discharge and 3 months after the transplant. It is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (\> 60), not alexithymic (\< 51) and probably alexithymic patients (51-60).We expect that those patients undergoing expressive writing would have a lower score (\<51) compared to control group patients.

Adherence

时间窗: 3 months

In order to assess the level of adherence, each patient had to answer to the following question: "Have you ever forgotten to take the drugs prescribed by your treatment plan?" with dichotomous answer yes / no

Renal Function

时间窗: 3 months

In order to test the transplanted organ function the creatinine, CDK-EPI and azotemia level were measured through blood analysis at T0,T1,T2.

Healthcare spending

时间窗: 3 months

In order to test the healthcare spending to all participants were asked (through a specific questionnaire built ad hoc for the specific situation) the number of medical visits, the number of hospitalizations, the number of admissions to emergency room for acute episodes, the number of hospitalizations stay days in the last year, after the operation and 3 months later. The study hypothesized an lower number of medical visits, hospitalization's days and admissions to emergency room for those patients who performed the expressive writing task.

次要结局

  • Anxiety(3 months)
  • Depressive symptoms(3 months)
  • Health Locus of control (HLC)(3 months)
  • Empathy(3 months)
  • Resilience(3 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Lai

Associate Professor

University of Roma La Sapienza

研究点 (2)

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