A Brief Body-mind-spirit Intervention to Promote Positive Emotions

November 3, 2020 updated by: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong

A Brief Body-mind-spirit Intervention to Promote Positive Emotions - a Pilot Trial

Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote well-being. Research has shown the positive effects of a body-mind-spirit (BMS) approach in enhancing health and well-being. We will develop and assess a pilot trial involving a holistic BMS approach to promote positive emotion change, emotion regulation and self-awareness through an ICT-supported program in a community setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The body-mind-spirit (BMS) approach views the three components as a connected, balanced system that interacts with one another harmoniously. With the well-established academic-community partnership between HKU and Caritas-Hong Kong, our pilot trial aims to build upon the previous experiences by Caritas-Hong Kong and investigate the feasibility and effectiveness of a BMS approach in enhancing positive emotions and well-being among community participants. This trial is an innovative attempt at conducting an ICT-supported online intervention with community participants. It would also help meet the urgent need for brief, community-based preventive mental health promotion, especially in the context of the COVID-19 pandemic.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese-speaking;
  • Individuals aged 18 years and above;
  • No history of diagnosed mental illness;
  • Access to an internet-connected computer.

Exclusion Criteria:

  • Individuals who cannot meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
BMS program
Behavioral: BMS program
A BMS program with three components: relaxation exercises, healthy eating, expressive arts therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive emotion
Time Frame: Baseline and one month
Change assessed by the Subjective Happiness Scale (SHS). The minimum and maximum of SHS are 4 to 24, respectively. A higher score means a better outcome.
Baseline and one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress level
Time Frame: Baseline and one month
Change assessed by the Perceived Stress Scale (PSS). The minimum and maximum of SHS are 0 to 16, respectively. A higher score means a worse outcome.
Baseline and one month
Personal well-being
Time Frame: Baseline and one month
Change assessed by a one-item Personal Happiness scale. The minimum and maximum of SHS are 0 to 10, respectively. A higher score means a better outcome.
Baseline and one month
Family well-being
Time Frame: Baseline and one month
Change assessed by a 3-item Family well-being scale. The minimum and maximum are 0 to 30, respectively. A higher score means a better outcome.
Baseline and one month
Negative emotion
Time Frame: Baseline and one month
Change assessed by the Patient Health Questionnaire-4. The minimum and maximum of SHS are 0 to 28, respectively. A higher score means a worse outcome.
Baseline and one month
Sleep quality
Time Frame: Baseline and one month
Change assessed by the Insomnia Severity Index (ISI). The minimum and maximum of SHS are 0 to 28, respectively. A higher score means a worse outcome.
Baseline and one month
Knowledge and attitudes towards and practice of the holistic BMS health care approach
Time Frame: Baseline and one month
Change assessed by outcome-based questions. A score of each question ranges from 1-5. A higher score a better outcome.
Baseline and one month
Perceived benefits of the BMS program
Time Frame: One month
Assessed by outcome-based questions with categorical choices
One month
Sharing of BMS with others
Time Frame: One month
Assessed by outcome-based questions with categorical choices
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Caritas Medical Centre, Hong Kong

Investigators

  • Principal Investigator: Agnes Y Lai, PhD, School of Nursing, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UW 20-668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Shirley Sit (email shirlsit@hku.hk), (School of Public Health, The University of Hong Kong) for further information.

IPD Sharing Time Frame

After the study finished and the related papers were published

IPD Sharing Access Criteria

The access should be requested through the written application with the reason of data used, and subject to the permission of principal investigator

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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