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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05713305
Enrollment
110
Registered
2023-02-06
Start date
2023-01-18
Completion date
2023-06-20
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREOnline-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

PROCEDUREProvide 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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention28 days after interventionDASS-21 changes( 0-63), The larger the score, the worse the result

Secondary

MeasureTime frameDescription
Proportion of depression and anxiety problems among different types of staff28 days after interventionProportion of depression and anxiety
The degrees to which depression and anxiety problems occur in different types of staff28 days after interventionThe degrees to which depression and anxiety problems
Incidence of posttraumatic stress disorder28 days after interventionIncidence of posttraumatic stress disorder
Well-being was measured with the WHO-5 well-being index28 days after interventionWell-being was measured with the WHO-5 well-being index ( 0-25), The higher the score, the higher the happiness index
Improvement in sleep quality28 days after interventionImprovement in sleep quality( ISI), insomnia severity index ( 0-28) , The larger the score, the worse the result
Results of the Depression Anxiety Stress Scale 21 scale after 3 months of interventionThree months after interventionDASS-21 changes( 0-63), The larger the score, the worse the result ,after three months of intervention
Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention6 months after interventionDASS-21 changes( 0-63), The larger the score, the worse the result, after 6 months of intervention

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026