NCT04346082

Brief Summary

The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. The investigators hypothesize that this intervention is feasible and acceptable by the participants. As secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence This will be a quasi-experimental study. Participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). Participants will be identified by their e-mail and therefore serial data could be obtained.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

April 7, 2020

Last Update Submit

July 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • rate of recruitment

    the rate of recruitment to recruit participants

    from recruitment to end of study, up to 1 year

  • rate of attendence

    the number of attendance to the mindfulness online group

    from recruitment to end of study, up to 1 year

Secondary Outcomes (2)

  • Depression, Anxiety and Stress Scale (DASS-21)

    on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year

  • Sense of Coherence Scale

    on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year

Study Arms (1)

online mindfulness group

EXPERIMENTAL
Behavioral: online mindfulness group

Interventions

Each weekly mindfulness session will last 45 to 60 minutes and will be held on an online platform (e.g. Zoom) via a livestream video. It will consist of short mindfulness exercise(s) of 10-30 minutes, including mindful tasting, mindful stretching, mindful walking, and body scan followed by group discussion to share, explore and make sense of the meditative experience. The intervention will be held in Cantonese.

online mindfulness group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of old,
  • able to speak and communicate in Cantonese
  • can read Chinese or English (because they will be asked to fill in an online questionnaire).

You may not qualify if:

  • actively suicidal,
  • currently abusing restricted psychoactive substances
  • diagnosed to have an active psychotic disorder and self-reported active psychotic symptoms (including schizophrenia, bipolar disorder and dementia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of public health and primary care

Hong Kong, Hong Kong

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: participants receiving online mindfulness session(s)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 15, 2020

Study Start

August 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations