Back to resultsEffect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
Primary Purpose
SARS-CoV-2 Infection, Staff Attitude, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Online-based self-help psychological intervention
Provide online mental health knowledge
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection
Eligibility Criteria
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
Sites / Locations
- The Second Affiliated Hospital of Zhejiang University anesthesiology departmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of depression and anxiety problems among different types of staff
Proportion of depression and anxiety
The degrees to which depression and anxiety problems occur in different types of staff
The degrees to which depression and anxiety problems
Incidence of posttraumatic stress disorder
Incidence of posttraumatic stress disorder
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
Improvement in sleep quality
Improvement 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 intervention
DASS-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 intervention
DASS-21 changes( 0-63), The larger the score, the worse the result， after 6 months of intervention
Full Information
NCT ID
NCT05713305
First Posted
January 18, 2023
Last Updated
April 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05713305
Brief Title
Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
April 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, Staff Attitude, Anxiety, Mental Health Issue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Online-based self-help psychological intervention
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Provide online mental health knowledge
Intervention Description
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 Outcome Measure Information:
Title
Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention
Description
DASS-21 changes( 0-63), The larger the score, the worse the result
Time Frame
28 days after intervention
Secondary Outcome Measure Information:
Title
Proportion of depression and anxiety problems among different types of staff
Description
Proportion of depression and anxiety
Time Frame
28 days after intervention
Title
The degrees to which depression and anxiety problems occur in different types of staff
Description
The degrees to which depression and anxiety problems
Time Frame
28 days after intervention
Title
Incidence of posttraumatic stress disorder
Description
Incidence of posttraumatic stress disorder
Time Frame
28 days after intervention
Title
Well-being was measured with the WHO-5 well-being index
Description
Well-being was measured with the WHO-5 well-being index ( 0-25), The higher the score, the higher the happiness index
Time Frame
28 days after intervention
Title
Improvement in sleep quality
Description
Improvement in sleep quality( ISI), insomnia severity index ( 0-28) , The larger the score, the worse the result
Time Frame
28 days after intervention
Title
Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention
Description
DASS-21 changes( 0-63), The larger the score, the worse the result ，after three months of intervention
Time Frame
Three months after intervention
Title
Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention
Description
DASS-21 changes( 0-63), The larger the score, the worse the result， after 6 months of intervention
Time Frame
6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Yan, doctor
Phone
+8613757118632
Email
zryanmin@zju.edu.cn
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University anesthesiology department
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Email
zryanmin@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
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