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NCT Number: NCT06613529

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

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.

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Key information

Conditions

COVID-19 Pandemic COVID-19 Coronaviridae Infections Coronavirus Infections Emotions Infections Lung Diseases Nidovirales Infections Online Mental Health Program Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital

Taipei, Xinyi District, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Online mindfulness training

Other

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".

Primary outcomes

  1. 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)

Secondary outcomes

  1. Assessment of depression

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

    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)

Other outcomes

  1. Assessment of stress

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

    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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adults During the COVID-19 Pandemic: a Randomized Control Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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