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临床试验/NL-OMON55394
NL-OMON55394已完成不适用

Sleep as a window to target traumatic memories - Sleep and traumatic memories

Vrije Universiteit Medisch Centrum0 个研究点目标入组 92 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92

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

  • PTSD patients
  • * PTSD diagnosis according to DSM-5 criteria as assessed with the CAPS-5
  • * PTSD as primary diagnosis
  • * 18-65 years of age
  • * Capability to provide informed consentTrauma controls
  • * Having experienced a type A-trauma according to DSM-5 criteria as assessed
  • with the LEC-5 (as part of the CAPS-5).
  • * No PTSD diagnosis according to DSM-5 criteria as assessed with the CAPS-5
  • * 18-65 years of age

排除标准

  • PTSD patients
  • * Current bipolar disorder, psychotic disorder, alcohol or substance dependence
  • as assessed with the M.I.N.I. International Neuropsychiatric Interview. Note
  • comorbid depressive or anxiety disorders will be allowed if PTSD is the primary
  • * Current personality disorder as assessed with the SCID-5-P (preceded by a
  • * Active suicidal ideation
  • * Major head trauma or neurological disease, current or in history
  • * MRI contraindications such as metal implants, claustrophobia, pregnancy
  • * Self-reported inability or unease to cease smoking for 24 hours prior to
  • testing (for salivary cortisol sampling)
  • * Endocrinological disorders or regular use of corticosteroids (for salivary
  • cortisol sampling)
  • * Use psychotropic medication up to 6 weeks pre-study (or in case of
  • benzodiazepines or other sleep medication 1 week)
  • * Use of recreational drugs over the entire study period (Day -7 to Day 11).
  • * Use of alcohol during Day -7, Day 1, Night 1, Day 2, Night 2, Day 3 and Day
  • * Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline
  • * A sleep window outside 10 pm and 10 am
  • Trauma controls
  • * Any current psychiatric disorder as assessed with the M.I.N.I. International
  • Neuropsychiatric Interview or known to the patient her/himself.
  • * Lifetime PTSD diagnosis
  • * Impossibility to isolate a circumscribed traumatic memory that can be used
  • for the audioscript and for target selection in EMDR.
  • * Reactivation of the traumatic memory that is used for the audioscript and for
  • target selection in EMDR, leads to severe dissociative complaints/signs*
  • * Not speaking/understanding Dutch sufficiently
  • * Active suicidal ideation
  • * Major head trauma with co-occurring loss of consciousness in the recent past
  • * (Neurological) disorder of the central nervous system, current or in history
  • * MRI contraindications such as metal implants, claustrophobia, pregnancy
  • * Use of psychotropic medication (other than benzodiazepines or other sleep
  • medication), except when on a stable dose for at least 6 weeks (after start or
  • alteration of dosage). Use of benzodiazepines or other sleep medication in the
  • period of 1 week prior to study until end of study (Day 10).
  • * Use of recreational drugs over the entire study period (Day -7 to Day 10).
  • * Use of alcohol during Day -7, Day 1, Night 1, Day 2, Night 2, Day 3 and Day
  • * Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline
  • * A sleep window outside 10 pm and 10 am
  • * Sleep walking or REM sleep behaviour disorder

研究者

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