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临床试验/NCT02670200
NCT02670200Unknown不适用

MAC-CBT Used as Internet-delivered Psycho-oncological Support

Neuropsychiatrischen Zentrums Hamburg-Altona2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Scores of Prime-MD

研究概览

简要总结

Cancer patients develop a high psychological burden of the underlying disease. To support patients in outpatient phases psychotherapists are not sufficiently available for establish regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet (called Incobeth®) in cancer patients.

详细描述

In this study, a randomized trial is conducted in which the online users are allocated into two different care services (MAC-CBT® vs. psycho-educational support program). Participants are cancer patients who have been advised by their treating oncologists, family doctors or psychotherapists on the online support. All patients are randomized, based on the information the referring physician give about type of tumor, treatment status, prognosis and psychosocial factors. Initial will be done an extensive psychometric survey. The MAC-CBT® group receives an intervention program based on ten modules, in which the aspects of Mindfulness, Acceptance and Commitment in detail are included to start a process-oriented self-treatment with regular feedback by the individually assigned psychologists through the internet-portal and email and through live contacts (via video-telephony). The control group will have access to six modules with a psychoeducational support program, which is also constructed according to the MAC principle. Both groups can use crisis modules (in case of pain, psychological crisis, fear of dying) without access restriction. The control group, upon completion of 6 weeks (for each module one week) can switch to active treatment arm. Input and output results are determined using validated survey instruments. Randomisation is done by a physician not involved in the further course of the evaluation.

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
Triple (Participant, Investigator, 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

  • Cancer patient
  • psychological distress
  • informed consent

排除标准

  • no informed consent
  • no cancer

结局指标

主要结局

Scores of Prime-MD

时间窗: Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3)

Recording of change of score PRIME-MD, depression, anxiety and other mental health issues

次要结局

  • Scores of Quality of Life(Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3))
  • Resilience(Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3))

研究者

发起方
Neuropsychiatrischen Zentrums Hamburg-Altona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Tonn

Managing director of the Department

Neuropsychiatrischen Zentrums Hamburg-Altona

研究点 (2)

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