跳至主要内容
临床试验/jRCT1030210687
jRCT1030210687招募中不适用

Study on effectiveness of behavioral activation therapy program for depression in advanced cancer patients: a pilot-multicenter randomized controlled trial (pilot BA-RCT)

National Cancer Center0 个研究点目标入组 38 人开始时间: 2022年6月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
38
主要终点
-

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 Trial
干预模型
Crossover Assignment
主要目的
Treatment Purpose
盲法
Single Blind

入排标准

年龄范围
20age old over 至 No limit(—)
性别
All

入选标准

  • Physical condition: Those who meet the following (a) to (c).
  • (a) Cancer patients who have been diagnosed or have been notified of recurrence for more than 1 month and whose clinical stages are stage III or IV and whose attending physician has determined that they cannot aim for radical cure.
  • (b) Expected prognosis is expected to be about 1 year or more
  • (c) Those who can participate in all sessions of the program
  • Patients with depression: 16 points or more in Beck Depression Inventory-II (BDI-II)
  • Age: 20-64 years old, 65 years old and over with MMSE-J 24 points or more
  • PS (Performance status): ECOG performance status score is 0 or 1
  • Patients who can speak Japanese
  • Patients who have consented to participate in the study and wish to continue intervention

排除标准

  • Patients with severe physical or psychological symptoms (cognitive dysfunction, impaired consciousness, severe depression with psychotic symptoms, imminent suicidal ideation, and history of suicide attempt)
  • Patients who have received psychological intervention, such as behavioral activation, by mental health professionals before enrollment
  • Patients taking or planning to use any psychotropic drug during the program
  • Patients with substance dependence based on the diagnostic criteria of DSM-5
  • Patients who are deemed to have difficulty in participating this program by the attending physician or the researcher due to other reasons.

结局指标

主要结局

-

Depression(Beck Depression Inventory-II: BDI-II)

次要结局

未报告次要终点

研究者

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