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临床试验/NCT05894759
NCT05894759招募中不适用

Psychodermatological Approaches of Psoriasis

Grigore T. Popa University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
105
试验地点
2
主要终点
Psychological stress

研究概览

简要总结

Two mind-relaxing techniques will be applied to psoriasis patients with an elevated psychological stress profile at baseline

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 (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

入选标准

  • clinical diagnosis of psoriasis
  • adequate psychological stress profile
  • access to a personal computer/ laptop/ smartphone with internet connection
  • agreement to the informed consent form

排除标准

  • other dermatological conditions which impair the life quality
  • psychological disorders under psychiatric treatment
  • hearing impairment
  • other on-going medical studies
  • pregnancy
  • aliteracy

结局指标

主要结局

Psychological stress

时间窗: 6 months

A visual analog scale will be used at baseline, 1 month and 6 months. Analog scale minimum value = 0 (no stress) Analog scale maximum value = 10 (maximum stress)

General Anxiety Disorder-7

时间窗: 6 months

General Anxiety Disorder-7 questionnaire will be applied at baseline, 1 month and 6 months. General anxiety disorded-7 minimum score = 0 (no anxiety) General anxiety disorded-7 maximum score = 21 (maximum anxiety)

Patient Health Questionnaire-9

时间窗: 6 months

Patient Health Questionnaire-9 will be applied at baseline, 1 month and 6 months. Patient Health Questionnaire-9 minimum score = 0 (no depression) Patient Health Questionnaire-9 maximum score = 27 (maximum depression)

Dermatological Life Quality Index

时间窗: 6 months

Dermatological Life Quality Index Score will be calculated at baseline, 1 month and 6 months. Dermatological Life Quality Index minimum score = 0 (no impairment of life quality) Dermatological Life Quality Index maximum score = 30 (maximum impairment of life quality)

次要结局

  • Psoriasis Area and Severity Index(6 months)
  • The Revised Illness Perception Questionnaire(6 months)
  • Dermatological treatment compliance(6 months)
  • Self Administered Psoriasis Area and Severity Index(6 months)

研究者

发起方
Grigore T. Popa University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bogdan-Marian Tarcau

Principal investigator

Grigore T. Popa University of Medicine and Pharmacy

研究点 (2)

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