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临床试验/NCT04212247
NCT04212247已完成不适用

Randomized Controlled Trial for Testing the Efficacy of Well-Being Therapy in Patients With Systemic Sclerosis

University of Florence3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
3
主要终点
Disability due to systemic sclerosis

研究概览

简要总结

Systemic sclerosis (SSc) is a rare and potentially life-threatening autoimmune disorder with a significant impact on health and quality of life. The non-pharmacological interventions address to psychological sequalae currently available are limited and have poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. WBT has never been tested in SSc and it might represent a useful complementary therapeutic option to improve SSc patients' well-being. The aim of the present study is to evaluate the psychological status of the SSc patients and to test the efficacy of WBT in a sample of SSc patients if compared to a control condition.

详细描述

Systemic sclerosis (SSc) is a rare, multisystem, chronic autoimmune connective tissue disease characterized by fibrosis of the skin and internal organs, skin thickening, and decreased organ functioning leading to dermatologic, vascular, pulmonary, cardiac, gastrointestinal, neurological, musculoskeletal, and renal complications. SSc patients often suffer from psychological impairments, such as depression, anxiety about disease progression, body image dissatisfaction and low self-esteem. The non-pharmacological interventions for the treatment of the psychological sequelae of systemic sclerosis currently available are limited and have shown poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has been manualized in 2016 and has shown efficacy in randomized clinical trials. It showed to be effective in decreasing the relapse rates of depression in adults, it showed to be effective in generalized anxiety disorder and in cyclothymia. No psychological treatment aimed at empowering the level of psychological well-being rather than at working on distress in SSc patients have been implemented although it was shown that such kind of interventions directly increase the level of psychological well-being and indirectly decrease the level of psychological distress (i.e., anxious and depressive symptoms) in subjects affected by chronic diseases. The aim of the present study is to evaluate the psychological status of SSc patients with specific attention to suffering and mental pain, and to test the efficacy of WBT in SSc subjects if compared to a control condition. Thus, sixty outpatients with a diagnosis of SSc will be enrolled and will receive WBT or the control condition.

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
Single (Participant)

盲法说明

Participants will not be informed if they will receive WBT or the control condition. At the end of the study they will receive this information.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • able and interested in participating to the research, as proved by signed Informed consent;
  • a diagnosis of SSc (limited or diffuse) according to LeRoy et al. (1998);
  • age higher than 18 years

排除标准

  • co-occurrence of psychiatric disorder(s) according to the Diagnostic and Statistical Manual of mental disorders, 5th edition (American Psychiatric Association, 2013) as diagnosed via the Mini-International Neuropsychiatric Interview;
  • currently under psychotherapy;
  • change of the pharmacological treatment (including psychotropic medications) during the last three months.
  • any other condition that, according to the Investigators' opinion, may alter the ability of the patient to follow study procedures.

结局指标

主要结局

Disability due to systemic sclerosis

时间窗: change from baseline to 6-month follow up

The primary outcome will be the level of disability due to systemic sclerosis, assessed via the Health Assessment Questionnaire Disability Index (minimum: 0, maximum: 40, the highest the score the highest the level of disability).

次要结局

  • Psychological well-being(change from baseline to 6-month follow up)
  • Euthymia(change from baseline to 6-month follow up)
  • Psychiatric status(change from baseline to 6-month follow up)
  • Well-being(change from baseline to 6-month follow up)
  • Suffering(change from baseline to 6-month follow up)
  • Pain in the body(change from baseline to 6-month follow up)
  • Psychiatric symptoms(change from baseline to 6-month follow up)
  • Harmony(change from baseline to 6-month follow up)
  • Mental pain(change from baseline to 6-month follow up)
  • Psychosomatic status(change from baseline to 6-month follow up)
  • Psychological distress(change from baseline to 6-month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiammetta Cosci

Associate Professor in Clinical Psychology

University of Florence

研究点 (3)

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