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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05713305
Collaborator
(none)
110
1
2
8
13.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Online-based self-help psychological intervention
  • Procedure: Provide online mental health knowledge
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 18, 2023
Anticipated Primary Completion Date :
Apr 20, 2023
Anticipated Study Completion Date :
Sep 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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

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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Proportion of depression and anxiety problems among different types of staff [28 days after intervention]

    Proportion of depression and anxiety

  2. The degrees to which depression and anxiety problems occur in different types of staff [28 days after intervention]

    The degrees to which depression and anxiety problems

  3. Incidence of posttraumatic stress disorder [28 days after intervention]

    Incidence of posttraumatic stress disorder

  4. Well-being was measured with the WHO-5 well-being index [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 [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 [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 [6 months after intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Zhejiang University anesthesiology department Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05713305
Other Study ID Numbers:
  • 2023-0023
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2023