COVID-19 PandemicNCT06613529
Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adult
A study testing online mindfulness training in people with COVID-19 Pandemic and Emotions, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
During the COVID-19 pandemic, adults may experience emotional stress and impact. To reduce the risk of cross-infection, this study aims to use online mindfulness training to improve emotional well-being during the pandemic and assess their effectiveness. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COVID-19 Pandemic, Emotions, Online Mental Health Program
- What is being tested?
- online mindfulness training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2022to 8 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 20 years of age
- Conscious
- Able to communicate in Taiwanese
Who cannot join
- Patients currently receiving antidepressant or anti-anxiety medications
- Patients unable to communicate verbally
- Patients who refuse to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adults During the COVID-19 Pandemic: a Randomized Control Trial
During the COVID-19 pandemic, adults may experience emotional stress and impact. To reduce the risk of cross-infection, this study aims to use online mindfulness training to improve emotional well-being during the pandemic and assess their effectiveness.
Read the detailed description
he COVID-19 pandemic had a detrimental global impact on the health of most populations. It causes and also generates further damage to physiology and psychology. Mindfulness is recognized as an effective method for improving the symptoms of physical and mental problems. The purpose of this review will explore the efficacy of an online mindfulness intervention for individuals or groups that impacted symptoms of physiology and psychology in adults during the pandemic base on the principle of evidence-based medicine. At the same time, a set of mindfulness intervention plans will be developed based on the best evidence searched, and a pilot study will be conducted. Therefore, this research design will be divided into two stages. In the first stage, six electronic bibliographic databases will be comprehensively searched for randomized controlled trials that have been published from February 2020 to currently published articles. The research subjects are adults who live in the community and accept online mindfulness intervention. Quality assessment will be performed according to the Cochrane Collaboration's Risk of Bias tool will be used for randomized controlled clinical trials (RCTs). A meta-analysis of the intervention timing and measurements will be performed using Review Manager 5.1 software. The second phase will be a randomized controlled trial pilot study of mindfulness interventions, The research subjects will be divided into two groups, namely the mindfulness intervention experimental group (E) and the control group (C). The researcher uses structured questionnaires to collect data before intervention (To) and at 4 weeks (T1), 8 weeks (T2) after the intervention. Data will be analyzed using the Generalized Estimating Equation to analyze the repeated measurements and intention-to-treat analysis for reducing attrition bias.
- Conditions
- COVID-19 Pandemic, Emotions, Online Mental Health Program
- Being tested
- online mindfulness training
- Keywords
- COVID-19, physiology, psychology, Mindfulness, online mindfulness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mindfulness trainingOther
Use publicly available online mindfulness training resources. The training content was to guide patients to practice mindfulness techniques, including "where the body is, the mind is" and "relaxation learning".
| Study group | Role | What they receive |
|---|---|---|
| online mindfulness group | Experimental | Patients in the experimental group received online mindfulness interventions at least once a week approximately 15-20 minutes each time. Receives: Other: online mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of anxiety
Anxiety levels were assessed using the odd-numbered questions of the Hospital Anxiety and Depression Scale (HADS-14). The full title of HADS-14 is Hospital Anxiety and Depression Scale. This scale consists of 14 items, with 7 items specifically measuring anxiety, known as the Anxiety Subscale (HADS-A).
Each item in the Anxiety Subscale is rated on a 4-point Likert scale, ranging from 0 (no symptoms) to 3 (significant symptoms). The total score for the anxiety subscale can range from 0 to 21. Higher scores indicate worse outcomes, specifically reflecting greater levels of anxiety.
The scoring is categorized as follows:
- 0-7: Normal anxiety levels
- 8-10: Borderline abnormal anxiety (suggesting possible anxiety)
- 11-21: Abnormal anxiety (indicating clinical levels of anxiety)
Measured: Anxiety was assessed before the intervention, and at 4 and 8 weeks after the intervention.
Secondary outcomes (1)
Assessment of depression
Depression levels were assessed using the even-numbered questions of the Hospital Anxiety and Depression Scale (HADS-14). This scale consists of 14 items, with 7 items specifically measuring depression, known as the The full title of HADS-14 is Hospital Anxiety and Depression Scale. Depression Subscale (HADS-D).
Each item in the Depression Subscale is rated on a 4-point Likert scale, ranging from 0 (no symptoms) to 3 (significant symptoms). The total score for the depression subscale can range from 0 to 21. Higher scores indicate worse outcomes, specifically reflecting greater levels of depression.
The scoring is categorized as follows:
- 0-7: Normal depression levels
- 8-10: Borderline abnormal depression (suggesting possible depression)
- 11-21: Abnormal depression (indicating clinical levels of depression)
Measured: Depression was assessed before the intervention, and at 4 and 8 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start9 Nov 2022
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613529
- Sponsor's protocol ID
- N202207017
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adults During the COVID-19 Pandemic: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06613529
- Acronym / sponsor ID
- N202207017
- Conditions
- COVID-19 Pandemic, Emotions, Online Mental Health Program
- Keywords
- COVID-19, physiology, psychology, Mindfulness, online mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 26 Sep 2024 (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.
During the COVID-19 pandemic, adults may experience emotional stress and impact. To reduce the risk of cross-infection, this study aims to use online mindfulness training to improve emotional well-being during the pandemic and assess their effectiveness.
Detailed description
he COVID-19 pandemic had a detrimental global impact on the health of most populations. It causes and also generates further damage to physiology and psychology. Mindfulness is recognized as an effective method for improving the symptoms of physical and mental problems. The purpose of this review will explore the efficacy of an online mindfulness intervention for individuals or groups that impacted symptoms of physiology and psychology in adults during the pandemic base on the principle of evidence-based medicine. At the same time, a set of mindfulness intervention plans will be developed based on the best evidence searched, and a pilot study will be conducted. Therefore, this research design will be divided into two stages. In the first stage, six electronic bibliographic databases will be comprehensively searched for randomized controlled trials that have been published from February 2020 to currently published articles. The research subjects are adults who live in the community and accept online mindfulness intervention. Quality assessment will be performed according to the Cochrane Collaboration's Risk of Bias tool will be used for randomized controlled clinical trials (RCTs). A meta-analysis of the intervention timing and measurements will be performed using Review Manager 5.1 software. The second phase will be a randomized controlled trial pilot study of mindfulness interventions, The research subjects will be divided into two groups, namely the mindfulness intervention experimental group (E) and the control group (C). The researcher uses structured questionnaires to collect data before intervention (To) and at 4 weeks (T1), 8 weeks (T2) after the intervention. Data will be analyzed using the Generalized Estimating Equation to analyze the repeated measurements and intention-to-treat analysis for reducing attrition bias.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| online mindfulness group | Experimental | Other: online mindfulness trainingPatients in the experimental group received online mindfulness interventions at least once a week approximately 15-20 minutes each time. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 20 years of age
- Conscious
- Able to communicate in Taiwanese
Key exclusion criteria (3 listed)
- Patients currently receiving antidepressant or anti-anxiety medications
- Patients unable to communicate verbally
- Patients who refuse to provide informed consent
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 mindfulness trainingUse publicly available online mindfulness training resources. The training content was to guide patients to practice mindfulness techniques, including "where the body is, the mind is" and "relaxation learning". | Other | online mindfulness group |
Primary outcome
Assessment of anxiety
Time frame: Anxiety was assessed before the intervention, and at 4 and 8 weeks after the intervention.
Anxiety levels were assessed using the odd-numbered questions of the Hospital Anxiety and Depression Scale (HADS-14). The full title of HADS-14 is Hospital Anxiety and Depression Scale. This scale consists of 14 items, with 7 items specifically measuring anxiety, known as the Anxiety Subscale (HADS-A). Each item in the Anxiety Subscale is rated on a 4-point Likert scale, ranging from 0 (no symptoms) to 3 (significant symptoms). The total score for the anxiety subscale can range from 0 to 21. Higher scores indicate worse outcomes, specifically reflecting greater levels of anxiety. The scoring is categorized as follows: * 0-7: Normal anxiety levels * 8-10: Borderline abnormal anxiety (suggesting possible anxiety) * 11-21: Abnormal anxiety (indicating clinical levels of anxiety)
1 secondary outcome
Assessment of depression
Time frame: Depression was assessed before the intervention, and at 4 and 8 weeks after the 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 3 Oct 2024.
- Individual participant dataSharing planned: No
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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 mindfulness training in people with COVID-19 Pandemic and Emotions, run by Taipei Medical University at 1 site in Taiwan.
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 3 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 3 Oct 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 Taiwan. 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. 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?
Assessment of anxiety (time frame: Anxiety was assessed before the intervention, and at 4 and 8 weeks after the 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 3 Oct 2024.