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临床试验/NCT05645666
NCT05645666已完成不适用

The Effectiveness of Well-being Therapy on Mental Health and Self-efficacy of Patients With Ulcerative Colitis

Islamic Azad University, Isfahan (Khorasgan) Branch1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Pre-test level

研究概览

简要总结

Ulcerative colitis (UC) is a chronic and lifelong disease that causes disabilities for sufferers and causes mental health disorders in the patients. For this reason, it is important to know which psychotherapy is more effective for UC patient's problems, and since no research has been done on the effectiveness of well-being therapy on the mental health problems of these patients, this research can help psychologists and other specialists in this field to help patients with UC and other chronic disease.

The present study is conducted with the aim of determining the effectiveness of mental well-being on the mental health and quality of life of patients with ulcerative colitis. The research method was a semi-experimental type with a pre-test-post-test design with a control group. The study population included all patients with ulcerative colitis who were previously diagnosed with ulcerative colitis by a gastroenterologist and referred to one of the gastroenterology centers for treatment. The criteria for entering the patients into the study were: definitive diagnosis of ulcerative colitis according to the opinion of a gastroenterologist, consent to participate in the study, having at least a high-school education and an age range of 18 to 60 years. The patients who were excluded from the study were: patients who have acute Psychiatric or other medical disorders , patients who have participated in counseling or psychotherapy sessions in the last six months and patients who lose motivation to participate in the interview or are absent for more than two sessions. The convenience sampling method was used. The list of patients with inflammatory bowel diseases was provided to the researcher after the consent of the head of the Digestive Disease Research Institute. 300 ulcerative colitis patients of this list were contacted according to the criteria for entering the study, and they were invited to participate in the treatment sessions after a brief explanation about the objectives of the sessions, sessions duration and time. Finally, 32 patients volunteered and were randomly assigned to one of the following groups:

16 people (9 women and 7 men) were in the well-being therapy group and 16 people (8 men and 8 women) were in the control group. In the post-test phase, one person in the study group stopped working, and in the follow-up phase, which was done 6 months later , the study did face any shortages.

研究设计

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

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •definitive diagnosis of ulcerative colitis according to the opinion of a gastroenterologist, consent to participate in the study, having at least a high-school education and an age range of 16 to 60 years.

排除标准

  • •patients who have acute Psychiatric or other medical disorders , patients who have participated in counseling or psychotherapy sessions in the last six months and patients who lose motivation to participate in the interview or are absent for more than two sessions

研究组 & 干预措施

Well being therapy

Experimental

The group of 16 which recieved well-being therapy

干预措施: Well-being therapy (Behavioral)

Control group

No Intervention

The group of 16 which did not recieve well-being therapy

结局指标

主要结局

Pre-test level

时间窗: Immediately after the intervention

The results demonstrated that the effectiveness of this treatment on the level of self-efficacy and mental health was significant in the pretest phase.

Follow-up level

时间窗: 6 months after the intervention

The results demonstrated that the effectiveness of this treatment on the level of self-efficacy and mental health was significant in the follow-up phase

次要结局

未报告次要终点

研究者

发起方
Islamic Azad University, Isfahan (Khorasgan) Branch
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arezoo Ziaei

M.A Student

Islamic Azad University, Isfahan (Khorasgan) Branch

研究点 (1)

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