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临床试验/NCT04936139
NCT04936139已完成不适用

Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)

Elisenda Campreciós Suñol2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2021年2月21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
224
试验地点
2
主要终点
Hospital Anxiety and Depression Scale (HAD scale)

研究概览

简要总结

Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered.

Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.

详细描述

Introduction: The passage of a cancer through a person leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve your emotional well-being is considered.

Research Project Hypothesis: Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.

Objectives: To evaluate the effectiveness of art therapy in reducing the levels of anxiety and depression in cancer patients, as well as in improving the quality of life and coping strategies.

Methodology: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial. Eight centers will participate in the study with an N of 423 patients. Patients older than 18 years of age who are diagnosed with cancer at any stage of treatment with the intention of radical treatment or palliative treatment with a life expectancy of more than 12 months will be included. If it is carried out in an online format, the person must have access to the internet. Patients who suffer from a current or previous serious psychological / psychiatric illness or those who have participated in an art therapy program structured in the context of oncological process will be excluded. Patients will be assigned to the control group (they will receive the usual follow-up from the center) or to the intervention group (art therapy program). Patients assigned to the intervention group will participate in an art therapy workshop once a week for 12 weeks, which will be done in person / online depending on the epidemiological situation of covid-19 and the needs of each center, The group will maintain the format (online / face-to-face) with which it has started throughout all the sessions.

Art therapy is a discipline that offers a space to meet with oneself, where one can dialogue with different artistic languages, with the aim of promoting emotional integration and looking for new ways to integrate difficult experiences through creative language.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age
  • Intention for radical treatment or palliative treatment with a life expectancy of more than 12 months
  • Have internet access in case the intervention is done online
  • Agree to participate and sign informed consent

排除标准

  • Patient with active diagnosis or personal history of severe psychological / psychiatric illness
  • Patient who has participated in an art therapy program structured in the context of the oncological process

结局指标

主要结局

Hospital Anxiety and Depression Scale (HAD scale)

时间窗: 6 months

The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.

次要结局

  • World Health Organization Quality of Life (WHOQOL-BREF scale)(6 months)
  • Mini-Mental Adjustment to Cancer Scale (MINI-MAC)(6 months)

研究者

发起方
Elisenda Campreciós Suñol
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elisenda Campreciós Suñol

Principal Investigator (Bachelor's in Nursing, MSc)

Althaia Xarxa Assistencial Universitària de Manresa

研究点 (2)

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