Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713305
• Other study ID #: 2023-0023
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Mental Health Issue
• SARS-CoV-2 Infection
• Staff Attitude

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