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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05713305
Other study ID # 2023-0023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 18, 2023
Est. completion date September 20, 2023

Study information

Verified date January 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Min Yan, doctor
Phone +8613757118632
Email zryanmin@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date September 20, 2023
Est. primary completion date April 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 years or older 2. Non-ICU professional staff providing direct health care services to critically ill SARS-CoV-2 Omicron patients in the ICU 3. Signing the informed consent form Exclusion Criteria: 1. No reported acute suicidal tendencies 2. No history of psychotic or dissociative symptoms 3. Pregnancy or lactation 4. Major family changes within the last 12 weeks( For e.g. death of immediate family member) 5. Participated in other clinical trials

Study Design


Intervention

Procedure:
Online-based self-help psychological intervention
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
Provide online mental health knowledge
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

Locations

Country Name City State
China The Second Affiliated Hospital of Zhejiang University anesthesiology department Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention DASS-21 changes( 0-63), The larger the score, the worse the result 28 days after intervention
Secondary Proportion of depression and anxiety problems among different types of staff Proportion of depression and anxiety 28 days after intervention
Secondary The degrees to which depression and anxiety problems occur in different types of staff The degrees to which depression and anxiety problems 28 days after intervention
Secondary Incidence of posttraumatic stress disorder Incidence of posttraumatic stress disorder 28 days after intervention
Secondary Well-being was measured with the WHO-5 well-being index Well-being was measured with the WHO-5 well-being index ( 0-25), The higher the score, the higher the happiness index 28 days after intervention
Secondary Improvement in sleep quality Improvement in sleep quality( ISI), insomnia severity index ( 0-28) , The larger the score, the worse the result 28 days after intervention
Secondary Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention DASS-21 changes( 0-63), The larger the score, the worse the result ,after three months of intervention Three months after intervention
Secondary Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention DASS-21 changes( 0-63), The larger the score, the worse the result, after 6 months of intervention 6 months after intervention
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