NL-OMON47013招募中2 期
Smartphone based Monitoring and cognition Modification Against Recurrence of Depression - SMARD
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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