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临床试验/NCT02503124
NCT02503124终止不适用

Wake and Bright Light Therapy for Depression Among Admitted Patients

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
32
试验地点
1
主要终点
MADRS-S score reduction of 50%

研究概览

简要总结

A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • •Depressive episode requiring admission to a psychiatric hospital (including unipolar and bipolar depression).

排除标准

  • •Psychotic symptoms/agitation
  • •Compulsory admission
  • •Confusion
  • •Active substance use disorder
  • •Eye disease preventing bright light therapy

研究组 & 干预措施

Chronobiological intervention

Experimental

Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.

干预措施: Bright light (Device)

Chronobiological intervention

Experimental

Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.

干预措施: Single night's wake therapy (Behavioral)

Control

Active Comparator

Treatment as usual including a private educational meeting in sleep hygiene.

干预措施: Treatment as usual - inpatient care (Other)

Control

Active Comparator

Treatment as usual including a private educational meeting in sleep hygiene.

干预措施: Treatment as usual - medicine (Drug)

Chronobiological intervention

Experimental

Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.

干预措施: Treatment as usual - inpatient care (Other)

Chronobiological intervention

Experimental

Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.

干预措施: Treatment as usual - medicine (Drug)

Control

Active Comparator

Treatment as usual including a private educational meeting in sleep hygiene.

干预措施: Informative meeting (Other)

结局指标

主要结局

MADRS-S score reduction of 50%

时间窗: One week

Montgomery Asberg Depression Rating Scale

次要结局

  • MADRS-S score at discharge(Participants will be followed at discharge, an expected average of 2-3 weeks)
  • MADRS-S score at follow-up(10-14 weeks)
  • ISI score score at discharge(Participants will be followed at discharge, an expected average of 2-3 weeks)
  • ISI score score at follow-up(10-14 weeks)
  • ISI score reduction of 50%(One week)
  • Length of stay(The number of days between admission and discharge)
  • Re-admission(10-14 weeks)
  • CGI score(10-14 weeks)
  • Medication use(10-14 weeks)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Steinn Steingrimsson

MD, PhD, resident in psychiatry

Sahlgrenska University Hospital, Sweden

研究点 (1)

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