跳至主要内容
临床试验/DRKS00029918
DRKS00029918已完成未知

Effectiveness of mobile application-based cognitive-behavioural therapy in women treated for breast cancer: a randomized controlled pilot study in Germany

Prosoma GmbH0 个研究点目标入组 70 人开始时间: 2022年7月29日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
70

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
Female

入选标准

  • Women with a diagnosis of primary cancer of breast (C50)
  • - Active oncological treatment with the intention-to-treat (survival prognosis > 6 months)
  • - Aged 18-75 years
  • - Ability to read and write fluently in German
  • - Ability to use the app (general suitability to use mobile applications)
  • - Performance status assessment by using Eastern Cooperative Oncology Group (ECOG) score = 2
  • - Informed consent to participate in the study and associated documentation

排除标准

  • - Existing comorbidities that affect the mental health or quality of life (especially chronic illnesses: neurological, rheumatological, chronic pain, schizophrenia)
  • - Current psychotherapeutic treatment aimed at depression, anxiety, and distress disorders
  • - Other (digital or analogue) CBT therapy aimed at depression, anxiety, and distress disorders ongoing or in the two years prior
  • - Lack of internet access/smartphone
  • - Alcohol or drug abuse
  • - Active psychotic symptoms
  • - Suicidal tendencies
  • - Impairment of vision which prevents the product from being used as intended
  • - Severe cognitive impairments

研究者

发起方
Prosoma GmbH

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