NCT04582526

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

September 29, 2020

Last Update Submit

November 3, 2020

Conditions

Keywords

Personal well-beingFamily well-being

Outcome Measures

Primary Outcomes (1)

  • Positive emotion

    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 Outcomes (8)

  • Stress level

    Baseline and one month

  • Personal well-being

    Baseline and one month

  • Family well-being

    Baseline and one month

  • Negative emotion

    Baseline and one month

  • Sleep quality

    Baseline and one month

  • +3 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

BMS program

Behavioral: BMS program

Interventions

BMS programBEHAVIORAL

A BMS program with three components: relaxation exercises, healthy eating, expressive arts therapy

Intervention arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Chan C, Ho PS, Chow E. A body-mind-spirit model in health: an Eastern approach. Soc Work Health Care. 2001;34(3-4):261-82. doi: 10.1300/j010v34n03_02.

    PMID: 12243428BACKGROUND
  • Ho RT, Sing CY, Wong VP. Addressing holistic health and work empowerment through a body-mind-spirit intervention program among helping professionals in continuous education: A pilot study. Soc Work Health Care. 2016 Nov-Dec;55(10):779-793. doi: 10.1080/00981389.2016.1231153. Epub 2016 Sep 22.

    PMID: 27805500BACKGROUND
  • Lau BHP, Chow AYM, Ng TK, Fung YL, Lam TC, So TH, Chan JSM, Chan CHY, Zhou J, Tam MYJ, Tsang MW, Cheng NSY, Lim PFM, Chow SF, Chan CLW, Wong DFK. Comparing the efficacy of integrative body-mind-spirit intervention with cognitive behavioral therapy in patient-caregiver parallel groups for lung cancer patients using a randomized controlled trial. J Psychosoc Oncol. 2020 Jul-Aug;38(4):389-405. doi: 10.1080/07347332.2020.1722981. Epub 2020 Mar 9.

    PMID: 32146876BACKGROUND

Study Officials

  • Agnes Y Lai, PhD

    School of Nursing, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Y Lai, PhD

CONTACT

Tai-hing Lam, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 9, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2022

Study Completion

January 1, 2023

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After the study finished and the related papers were published
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