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Completed

NCT Number: NCT05713305

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

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.

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Key information

Conditions

Sars-CoV-2 Infection Anxiety Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Mental Health Issue Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Staff Attitude Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online-based self-help psychological intervention

Procedure

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

Procedure

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

Primary outcomes

  1. Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention

    Time frame: 28 days after intervention

    DASS-21 changes( 0-63), The larger the score, the worse the result

Secondary outcomes

  1. Proportion of depression and anxiety problems among different types of staff

    Time frame: 28 days after intervention

    Proportion of depression and anxiety

  2. The degrees to which depression and anxiety problems occur in different types of staff

    Time frame: 28 days after intervention

    The degrees to which depression and anxiety problems

  3. Incidence of posttraumatic stress disorder

    Time frame: 28 days after intervention

    Incidence of posttraumatic stress disorder

  4. Well-being was measured with the WHO-5 well-being index

    Time frame: 28 days after intervention

    Well-being was measured with the WHO-5 well-being index ( 0-25), The higher the score, the higher the happiness index

  5. Improvement in sleep quality

    Time frame: 28 days after intervention

    Improvement in sleep quality( ISI), insomnia severity index ( 0-28) , The larger the score, the worse the result

  6. Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention

    Time frame: Three months after intervention

    DASS-21 changes( 0-63), The larger the score, the worse the result ，after three months of intervention

  7. Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention

    Time frame: 6 months after intervention

    DASS-21 changes( 0-63), The larger the score, the worse the result， after 6 months of intervention

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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