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
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
- 否
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
研究点 (2)
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