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临床试验/NCT07124481
NCT07124481尚未招募不适用

Early Mindfulness Based Cognitive Therapy for Prevention of Psychological Distress in Cancer Patients

Isala0 个研究点目标入组 208 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Isala
入组人数
208
主要终点
Psychological distress

研究概览

简要总结

The goal of this clinical trial is to learn if early provision of mindfulness based cognitive therapy can prevent psychological distress in adult patients with cancer one year after diagnosis.

Researchers will compare mindfulness based cognitive therapy to usual care to see if psychological distress is lower in patients that followed mindfulness.

Participants will follow 8 weekly sessions of mindfulness and fill in questionnaires.

研究设计

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

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

  • Diagnosed with urological cancer or breast cancer
  • <6 weeks since cancer diagnosis
  • Planned curative treatment or palliative treatment with life expectation >1 year
  • Good proficiency in Dutch language

排除标准

  • Serious psychiatric history or current psychiatric treatment (interfering with study participation): 1) current suicidal ideation, 2) current psychosis or bipolar disorder, 3) psychosis or bipolar disorder in history
  • Unable to understand study procedure
  • A priori unable to be available for 8 week MBCT

结局指标

主要结局

Psychological distress

时间窗: From enrollment to 2 years after diagnosis

Anxiety and depression as measured with the Hospital Anxiety and Depression Scale

次要结局

未报告次要终点

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marit Mentink

PhD

Isala

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