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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; SARS-CoV-2 Infection; Mental Health Issue; Staff Attitude
• Intervention / Treatment: Procedure: Online-based self-help psychological intervention; Procedure: Provide online mental health knowledge

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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	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
Placebo Comparator: Control group; 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of depression and anxiety problems among different types of staff	Proportion of depression and anxiety	28 days after intervention
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
Incidence of posttraumatic stress disorder	Incidence of posttraumatic stress disorder	28 days after intervention
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2023-0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No