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临床试验/NL-OMON47013
NL-OMON47013招募中2 期

Smartphone based Monitoring and cognition Modification Against Recurrence of Depression - SMARD

Radboud Universitair Medisch Centrum0 个研究点目标入组 224 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
224

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a patient must meet all of the following criteria:
  • - recurrent MDD diagnoses (assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) (SCID) [First 1996])
  • - at least 3 previous MDD-episodes (as assessed with the SCID-interview)
  • - a 17-item Hamilton Depression Rating Scale (HDRS17) <=10 [Hamilton 1967], not fulfilling the criteria for a current MDD episode (as assessed with the SCID-interview)
  • - having a stable remission (>=8 weeks)
  • - age 18-65 years
  • - in possession of smartphone and experienced in use thereof
  • For the focus-groups in WP1, assessment of unipolarity, number of recurrences and non-depressed state will be assessed by history only (no SCID/HDRS17) as more thorough assessments are not proportional to the aim of the focus-groups.

排除标准

  • For both WPs:
  • - diagnosis of bipolar, primary psychotic or borderline personality disorder or strong suspicion of this type of disorder
  • - primary diagnosis of substance use or anxiety disorder with secondary MDD (comorbid secondary anxiety disorder allowed for participation)
  • - electroconvulsive therapy within two months before inclusion
  • - average alcohol intake of >3 units/day
  • - daily use of benzodiazepines (>=5mg diazepam or equivalent)
  • - Incompatible smartphone to install BeHapp ;Additional exclusion-criteria for WP2:
  • - ongoing psychotherapy during the CCT/ABM training
  • - previous CCT/ABM ;For the add-on MRI-part of WP2, standard MRI exclusion criteria will apply:
  • - Metal objects in the body
  • - Claustrophobia
  • - A history of head trauma or neurological disease, severe general physical illness

研究者

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