Feasibility of Online Based Mindfulness Interventions During COVID-19 Outbreak

Feasibility and Acceptability of Online Based Mindfulness Interventions to Relieve Distress During COVID-19 Outbreak in a Chinese Population: a Proof-of-concept Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Stress
• Intervention / Treatment: Behavioral: online mindfulness group

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of public health and primary care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: online mindfulness group

Behavioral: online mindfulness group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety and Stress Scale (DASS-21)	Depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scale (DASS-21), which was validated in Chinese population with high internal consistency. The 21-item DASS-21 has three subscales designed to measure depression, anxiety and stress, with each subscale containing 7 items. Participants are required to rate each statement in DASS-21 using a 4-point Likert scale from "did not apply to me at all" to "applied to me very much or most of the time" in the prior one week. Higher scores represent higher level of psychological distress.	on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year
Sense of Coherence Scale	Sense of Coherence (SOC) will be assessed by the 13-item Sense of Coherence Scale (SOC-13) based on Antonovsky (1987)'s measurement of the comprehensibility, manageability, and meaningfulness of a person's life events . Participants will rate each statement in SOC-13 on a 7-point Likert scale from "very often" to "very seldom or never". SOC-13 has been validated in Chinese population with high internal consistency. The higher the score, the higher the sense of coherence	on recruitment, after each online mindfulness sessions (weekly) until end of study, up to 1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: online-mind

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: may share data on request of investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No