Clinical trial NCT06613529: Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adult
Official title: Effectiveness of Online Mindfulness Platform in Improving Anxiety, Depression, and Stress in Adults During the COVID-19 Pandemic: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pandemic
Emotions
Online Mental Health Program
Keywords: COVID-19, physiology, psychology
Mindfulness
online mindfulness
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of anxiety
timeFrame: Anxiety was assessed before the intervention, and at 4 and 8 weeks after the intervention.
Secondary outcomes:
measure: Assessment of depression
timeFrame: Depression was assessed before the intervention, and at 4 and 8 weeks after the intervention.
Other outcomes:
measure: Assessment of stress
timeFrame: Stress levels were assessed before the intervention, and at 4 and 8 weeks after the intervention.
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
state: Xinyi District
Study officials:
References: