NCT06613529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
Last Updated

October 3, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 29, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

COVID-19, physiology, psychologyMindfulnessonline mindfulness

Outcome Measures

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)

    Anxiety was assessed before the intervention, and at 4 and 8 weeks after the intervention.

Secondary Outcomes (1)

  • Assessment of depression

    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 before the intervention, and at 4 and 8 weeks after the intervention.

Study Arms (1)

online mindfulness group

EXPERIMENTAL

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

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".

online mindfulness group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, Xinyi District, 110, Taiwan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 26, 2024

Study Start

November 9, 2022

Primary Completion

March 8, 2023

Study Completion

March 8, 2023

Last Updated

October 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations