Feasibility of Online Based Mindfulness Interventions During COVID-19 Outbreak

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04346082
• Other study ID #: online-mind
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stress

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	School of public health and primary care	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of recruitment	the rate of recruitment to recruit participants	from recruitment to end of study, up to 1 year
Primary	rate of attendence	the number of attendance to the mindfulness online group	from recruitment to end of study, up to 1 year
Secondary	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
Secondary	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