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临床试验/NCT03165331
NCT03165331Enrolling By Invitation不适用

Online Psychosocial Support for Young People Distressed by Appearance-altering Conditions: A Randomised Control Trial (RCT)

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
130
试验地点
1
主要终点
Body Esteem Scale (BES)

研究概览

简要总结

A visible difference can have a profound impact in a society with a massive emphasis on appearance and "looks". A vulnerable group is adolescents with a condition affecting their appearance as a result of injuries (burns, accidents), treatment (cancer), skin conditions or congenital anomalies (birthmarks, craniofacial conditions). Research has identified potential psychological difficulties, which, if not addressed, can lead to anxiety, depression, and eating disorders.

In addition to medical treatment options, aiming at diminishing a difference that may be visible to others, young people with appearance concerns also need self-management skills. However, evidence-based interventions are scarce and specialised psychological treatment is difficult to reach.

The Centre for Appearance Research (Bristol, UK) has developed an online intervention for adolescents, now translated into Norwegian (www.ungfaceit.no). UNG Face IT provides easy access to specialist advice and support via a home computer, using information, videos, and interactive activities. It provides advice, teaches coping and social skills, strengthening psychological adjustment to a visible difference.

A systematic evaluation of the Norwegian version is needed. UNG Face IT could potentially address unmet needs, provide a cost-effective tool to reduce the need for "face-to-face" psychological and surgical/medical services, and contribute to make online health care available for young people with a visible difference.

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
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 12-17 with an appearance-altering condition, and experiencing appearance-related distress, teasing, or bullying
  • Access to a home computer/tablet and internet
  • Reading level > 12 years of age. Audio recordings for all written text available on the website for those who may struggle with reading
  • Normal/corrected-to-normal vision

排除标准

  • Clinical depression, psychosis, eating disorder (alternative support necessary)
  • Post-traumatic stress disorder (PTSD) or within 12 months of traumatic injury (alternative support necessary)
  • Learning disability that would impede understanding of the programme's content
  • Currently receiving psychological intervention

结局指标

主要结局

Body Esteem Scale (BES)

时间窗: 6 months

Includes three subscales, only the subscale BE_Appearance used in this study. Measures general feelings about appearance.

次要结局

  • Life Engagement Scale (LES)(6 months)
  • Resource Use Questionnaire (Parents)(6 months)
  • Perceived Stigmatisation Questionnaire(6 months)
  • EQ-5D-5L(6 months)
  • Harter's Self-Perception Profile for Adolescents(6 months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Billaud Feragen

Research Coordinator at the Centre for Rare Disorders

Oslo University Hospital

研究点 (1)

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