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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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SARS-CoV-2 Infection, Staff Attitude, Anxiety, Mental Health Issue

Intervention / Treatment
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* Procedure: Online-based self-help psychological intervention
* Procedure: Provide online mental health knowledge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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<br>|
| Placebo Comparator: Control group<br>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<br>* 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<br>|

What is the study measuring?
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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 |