Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2023
CompletedStudy Start
First participant enrolled
January 18, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedAugust 5, 2024
January 1, 2023
5 months
January 18, 2023
August 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
Incidence of posttraumatic stress disorder
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
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALDaily 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
Control group
PLACEBO COMPARATORThey 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2023
First Posted
February 6, 2023
Study Start
January 18, 2023
Primary Completion
June 20, 2023
Study Completion
June 20, 2023
Last Updated
August 5, 2024
Record last verified: 2023-01