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EmotionsNCT04582526

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

A study testing BMS program in people with Emotions and Stress, run by The University of Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Emotions, Stress
What is being tested?
BMS program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Nov 2020to Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Individuals who cannot meet the inclusion criteria.

Trial locations and contacts

No sites are listed yet.

Agnes Y Lai, PhD contact

39176779

agneslai@hku.hk

Tai-hing Lam, MD contact

39179287

hrmrlth@hku.hk

About this study

Official title: 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.

Read the 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.

Conditions
Emotions, Stress
Being tested
BMS program
Keywords
Personal well-being, Family well-being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS programBehavioural

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

Study groups in NCT04582526
Study groupRoleWhat they receive
Intervention armExperimentalBMS program
Receives: Behavioral: BMS program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and one month

Secondary outcomes (8)

  1. Stress level

    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.

    Measured: Baseline and one month

  2. Personal well-being

    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.

    Measured: Baseline and one month

  3. Family well-being

    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.

    Measured: Baseline and one month

  4. Negative emotion

    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.

    Measured: Baseline and one month

  5. Sleep quality

    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.

    Measured: Baseline and one month

  6. Knowledge and attitudes towards and practice of the holistic BMS health care approach

    Change assessed by outcome-based questions. A score of each question ranges from 1-5. A higher score a better outcome.

    Measured: Baseline and one month

  7. Perceived benefits of the BMS program

    Assessed by outcome-based questions with categorical choices

    Measured: One month

  8. Sharing of BMS with others

    Assessed by outcome-based questions with categorical choices

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study startNov 2020 (estimated)
  3. Primary completionNov 2022 (estimated)
  4. Study completionJan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582526
Sponsor's protocol ID
UW 20-668
Status last verified
Nov 2020
First submitted
29 Sep 2020
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 12243428

  • 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.

    PubMed 27805500

  • 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.

    PubMed 32146876

Questions about this trial

What is this clinical trial studying?

A study testing BMS program in people with Emotions and Stress, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Agnes Y Lai, PhD (39176779, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive emotion (time frame: Baseline and one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582526, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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