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临床试验/NCT05713305
NCT05713305已完成不适用

Effect of an Online Self-help Psychological Intervention on the Physical and Mental Health of Non-professional Staff Who Supported the ICU During the Omicron Outbreak: a Randomized Controlled Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention

研究概览

简要总结

Timely interventions may reduce the occurrence of post-traumatic stress disorder (PTSD) in ICU medical staff. Existing research suggests that either self-learning psychological relief methods or seeking online counseling or therapy from professional psychotherapists during the SARS-CoV-2 Omicron outbreak has the potential to alleviate the emotional distress and promote the physical and mental health of health care workers. Web-based online mental health interventions complemented by joint effective mental health advice can further reduce harmful negative effects.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Age 18 years or older
  • •Non-ICU professional staff providing direct health care services to critically ill SARS-CoV-2 Omicron patients in the ICU
  • •Signing the informed consent form

排除标准

  • •No reported acute suicidal tendencies
  • •No history of psychotic or dissociative symptoms
  • •Pregnancy or lactation
  • •Major family changes within the last 12 weeks( For e.g. death of immediate family member)
  • •Participated in other clinical trials

研究组 & 干预措施

Intervention group

Experimental

Daily members of the intervention group were thought to provide three different forms of daily sessions each day, averaging 10-20 minutes. These sessions included psycho-educational and cognitive-behavioral exercises, music therapy, sleep hygiene, stress relief methods. Weekly online lecture sessions presented by professional mental health therapists. In-depth interviews are conducted both before and after the experiment to explore the feasibility of the intervention

干预措施: Online-based self-help psychological intervention (Procedure)

Control group

Placebo Comparator

They will receive official mental health recommendations on how to cope mentally with the pandemic. These recommendations inform about the importance of a daily structure, social contact, acceptance of negative emotions and strengthening of positive emotions, and stimulus control to assimilate SARS-CoV-2 Omicron-related news. In-depth interviews are conducted both before and after the experiment to explore the feasibility of the intervention

干预措施: Provide online mental health knowledge (Procedure)

结局指标

主要结局

Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention

时间窗: 28 days after intervention

DASS-21 changes( 0-63), The larger the score, the worse the result

次要结局

  • Proportion of depression and anxiety problems among different types of staff(28 days after intervention)
  • The degrees to which depression and anxiety problems occur in different types of staff(28 days after intervention)
  • Well-being was measured with the WHO-5 well-being index(28 days after intervention)
  • Improvement in sleep quality(28 days after intervention)
  • Incidence of posttraumatic stress disorder(28 days after intervention)
  • Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention(Three months after intervention)
  • Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention(6 months after intervention)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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