CClinicalTrials.gg
CompletedNCT06613529Updated Oct 3, 2024

Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adult

An interventional study of online mindfulness training in COVID-19 Pandemic, Emotions and Online Mental Health Program, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Nov 2022, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • COVID-19 Pandemic
  • Emotions
  • Online Mental Health Program

Browse trials for

Keywords

  • COVID-19, physiology, psychology
  • Mindfulness
  • online mindfulness
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients over 20 years of age
  • Conscious
  • Able to communicate in Taiwanese

Exclusion criteria

Exclusion Criteria:

  • Patients currently receiving antidepressant or anti-anxiety medications
  • Patients unable to communicate verbally
  • Patients who refuse to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    online mindfulness group

    Patients in the experimental group received online mindfulness interventions at least once a week approximately 15-20 minutes each time.

    Other: online mindfulness training

Interventions

  • Otheronline mindfulness training

    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".

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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)

    Time frame: Depression was assessed before the intervention, and at 4 and 8 weeks after the intervention.

Other outcomes

  1. Assessment of stress

    Stress levels were assessed using the Perceived Stress Scale (PSS-10). The full title of PSS-10 is Perceived Stress Scale. This scale consists of 10 items. Each item in the scale is rated on a 5-point Likert scale, ranging from 0 (Never) to 4 (Very Often). The total score ranges from 0 to 40. Higher scores indicate worse outcomes, specifically reflecting a higher perceived level of stress.

    Time frame: Stress levels were assessed before the intervention, and at 4 and 8 weeks after the intervention.

07

Study locations

1 site
  • Taipei Medical University Hospital
    Taipei, Xinyi District 110, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06613529
Lead sponsor
Taipei Medical University
Responsible party
Sponsor
First posted
Sep 26, 2024
Start date
Nov 9, 2022
Primary completion
Mar 8, 2023
Completion
Mar 8, 2023
Last update
Oct 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion