SARS-CoV-2 InfectionNCT05713305
Effect of an Online Self-help Psychological Intervention on Non-ICU Specialty Care During the COVID-19 Outbreak
A study testing Online-based self-help psychological intervention and Provide online mental health knowledge in people with SARS-CoV-2 Infection and Staff Attitude, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Staff Attitude, Anxiety
- What is being tested?
- Online-based self-help psychological intervention and Provide online mental health knowledge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
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
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.
- Conditions
- SARS-CoV-2 Infection, Staff Attitude, Anxiety, Mental Health Issue
- Being tested
- Online-based self-help psychological intervention, Provide online mental health knowledge
- Medical subject headings
- COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online-based self-help psychological interventionProcedure or surgery
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 knowledgeProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Procedure: Online-based self-help psychological intervention |
| Control group | Placebo comparator | 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 Receives: Procedure: Provide online mental health knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days after intervention
Secondary outcomes (7)
Proportion of depression and anxiety problems among different types of staff
Proportion of depression and anxiety
Measured: 28 days after intervention
The degrees to which depression and anxiety problems occur in different types of staff
The degrees to which depression and anxiety problems
Measured: 28 days after intervention
Incidence of posttraumatic stress disorder
Incidence of posttraumatic stress disorder
Measured: 28 days after intervention
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
Measured: 28 days after intervention
Improvement in sleep quality
Improvement in sleep quality( ISI), insomnia severity index ( 0-28) , The larger the score, the worse the result
Measured: 28 days after intervention
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
Measured: Three months after 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
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start18 Jan 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713305
- Sponsor's protocol ID
- 2023-0023
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05713305
- Acronym / sponsor ID
- 2023-0023
- Conditions
- SARS-CoV-2 Infection, Staff Attitude, Anxiety, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Online-based self-help psychological interventionDaily 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 comparator | Procedure: Provide online mental health knowledgeThey 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online-based self-help psychological interventionDaily 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 | Procedure or surgery | Intervention group |
| Provide online mental health knowledgeThey 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 | Procedure or surgery | Control group |
Primary outcome
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
7 secondary outcomes
Proportion of depression and anxiety problems among different types of staff
Time frame: 28 days after intervention
The degrees to which depression and anxiety problems occur in different types of staff
Time frame: 28 days after intervention
Incidence of posttraumatic stress disorder
Time frame: 28 days after intervention
Well-being was measured with the WHO-5 well-being index
Time frame: 28 days after intervention
Improvement in sleep quality
Time frame: 28 days after intervention
Results of the Depression Anxiety Stress Scale 21 scale after 3 months of intervention
Time frame: Three months after intervention
Results of the Depression Anxiety Stress Scale 21 scale after 6 months of intervention
Time frame: 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online-based self-help psychological intervention and Provide online mental health knowledge in people with SARS-CoV-2 Infection and Staff Attitude, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in medical staff DASS-21( Depression Anxiety Stress Scale 21) after 28 days of intervention (time frame: 28 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.