跳至主要内容
临床试验/NCT04917419
NCT04917419招募中不适用

Prise en Charge infirmière Des Anomalies du Sommeil et du Rythme Circadien Par luminothérapie et/ou un Programme Court de psychoéducation Chez Des Patients Souffrant de Troubles Bipolaires

Centre Hospitalier Henri Laborit2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2022年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
170
试验地点
2
主要终点
Number of days in-hospital

研究概览

简要总结

Bipolar disorder affects more than 1% of the population. This pathology is considered as one of the most serious psychiatric disorder because of it is high suicide rates. It impacts patients life quality on many aspects, and specially their sleeping and circadian Rhythms. This can lead to more severe symptoms up to for thymic relapses. It was shown that Luminotherapy and Psychoeducation Program have a positive impact on these type of symptoms.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Main inclusion Criteria:
  • Bipolar disorder (type 1 and 2 according to DSM V)
  • Mood Disorder Questionnaire MDQ ˂ 7
  • Sleeping and Circadian Rhythms Disorders
  • Under treatment

排除标准

  • No addiction except for tobacco
  • Narcolepsy
  • Sleep Apnea
  • Psychiatric comorbidities
  • Suicidal ideation

研究组 & 干预措施

Luminotherapy and Psychoeducation Program

Experimental

干预措施: Luminotherapy and /or Psychoeducation Program (Other)

Psychoeducation Program

Active Comparator

干预措施: Luminotherapy and /or Psychoeducation Program (Other)

结局指标

主要结局

Number of days in-hospital

时间窗: Day 0 to Day 365

Number of days patients spent in the hospital

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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