AzTrials
AzTrials

Quality of Life (QOL)BMSNCT07105761

Body-Mind-Spirit Action Group on the Well-being

A study testing Body-Mind-Spirit in people with Quality of Life (QOL) and Depression, run by Taipei City Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Purpose: To evaluate the effectiveness of a culturally adapted BMS group intervention on holistic well-being, depressive symptoms, sleep parameters, and quality of life in individuals with visual impairment. Read more about this study

Who is it for?
Ages 20 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Quality of Life (QOL), Depression
What is being tested?
Body-Mind-Spirit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTaiwan
Study dates
26 Apr 2023to 1 Jul 2024
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 20 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Possession of a valid disability certificate indicating visual impairment
  • Age between 20 and 95 years
  • Provision of informed consent by both the participant and their legal guardian
  • Willingness to participate in group discussions and to consent to the audio recording of sessions
  • Ability to communicate verbally

Who cannot join

  • Presence of deafness or muteness that prevents effective verbal communication
  • Current involvement in any form of psychological or group therapy
  • A Mini-Mental State Examination (MMSE) score below 3, indicating an inability to express personal intentions verbally.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chinese Visually Impaired Anyang Welfare Association

    Taipei, No. 37, Yining St., Datong Dist.,, 103041

Other trials in Taiwan

About this study

Official title: Effects of Body-mind-spirit Group Therapy on Holistic Well-being and Depression in Individuals With Visual Impairment

Primary Purpose:

To evaluate the effectiveness of a culturally adapted BMS group intervention on holistic well-being, depressive symptoms, sleep parameters, and quality of life in individuals with visual impairment.

Read more

Study Objective:

This study aims to find out whether a 10-week BMS group program can help people with visual impairment feel emotionally better, improve their overall well-being, enhance sleep quality, and experience a higher quality of life.

Intervention Description:

The BMS group meets once a week for 10 weeks, with each session lasting about 2 hours. Sessions include guided discussions, storytelling, and experiential activities drawn from both Eastern and Western philosophies. These practices focus on:

Appreciating kindness in others Letting go of past hurt (forgiveness) Practicing mindfulness and living in the present moment

What the Researchers Want to Know:

Does the program help participants feel less depressed? Does it help them feel more balanced, hopeful, and connected in daily life? Does it improve their sleep and overall well-being?

Participants:

About 30 community-dwelling adults with visual impairment will take part in the study. They will be randomly assigned to one of two groups:

The intervention group will join the BMS sessions for 10 weeks. The control group will continue their usual community activities with no new program.

All participants will complete surveys at three points: before the program starts, at the midpoint (week 5), and after the program ends (week 10). These surveys assess levels of depression, well-being, sleep quality, and life satisfaction. Some participants in the BMS group will also be invited to join short interviews to share their experiences-such as feeling more grateful, confident, or resilient.

Overall Goal:

The goal of this study is to determine whether a supportive, culturally adapted group program can help people with vision loss feel stronger, less depressed, more connected, and better equipped to manage their daily lives. Previous findings suggest that BMS group therapy effectively enhances sleep duration and significantly improves quality of life-especially in psychological well-being-among visually impaired individuals. These findings support the integration of BMS therapy into holistic care strategies to promote emotional resilience, well-being, and personal growth in this population.

Read the detailed description

This study aims to evaluate the effects of a culturally adapted BMS group intervention on holistic well-being, depressive symptoms, sleep quality, and overall quality of life among individuals with visual impairment. The BMS model integrates principles of Eastern and Western psychological and spiritual care. Through practices such as awareness cultivation, forgiveness, gratitude, and mindfulness, it seeks to enhance emotional resilience and psychological recovery.

A quasi-experimental controlled design will be adopted. Thirty community-dwelling adults with visual impairment will be recruited and randomly assigned to either an intervention group or a control group. The intervention group will participate in a 10-week BMS group program, meeting once a week for approximately two hours per session. Each session includes thematic discussions, mindfulness exercises, therapeutic storytelling, and activities focused on gratitude and forgiveness. All materials and course designs are adapted to meet the specific needs of individuals with visual impairment and are delivered by a trained professional team.

All participants will complete standardized questionnaires at three time points: pre-intervention (baseline), mid-intervention (week 5), and post-intervention (week 10). These assessments will measure levels of depression, psychological well-being, sleep quality, and life satisfaction. In addition, a subset of participants from the intervention group will be invited to participate in interviews to collect qualitative data and supplement quantitative findings.

This study aims to explore the potential mechanisms by which BMS intervention promotes psychological health and quality of life in individuals with visual impairment. The findings may serve as empirical support for the development of non-pharmacological mental health interventions and community care models, offering valuable implications for practice and policy advancement.

Being tested
Body-Mind-Spirit
Keywords
Body-mind-spirit, group therapy, quality of life, sleep quality, depression, holistic well-being
Medical subject headings
Depression, Sleep Initiation and Maintenance Disorders

What participants receive

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

  • Body-Mind-SpiritBehavioural

    The experimental group participated in a 10-week BMS group intervention, with weekly 130-minute sessions. The intervention combined Eastern philosophy and Western psychotherapy to enhance emotional balance and psychological resilience. Core components included observing merits (recognizing strengths), cultivating gratitude, and practicing forgiveness. Physical activities such as finger dexterity training, diaphragmatic breathing, and stretching supported autonomic regulation and flexibility. Psychological strategies involved positive thinking, emotional expression, and life story sharing. All materials were adapted with audio descriptions for accessibility. Participants with visual impairment received orientation training and volunteer support for transportation and on-site assistance.

Study groups in NCT07105761
Study groupRoleWhat they receive
Body-Mind-SpiritExperimentalThe experimental group participated in a 10-week BMS group intervention , consisting of weekly 130-minute sessions that incorporated thematic discussions, mindfulness practices, therapeutic storytelling, and gratitude/forgiveness activities tailored to the needs of individuals with visual impairment.
Receives: Behavioral: Body-Mind-Spirit
routine activitiesNo interventionＴhe control group participated in routine activities without body-mind-spirit intervention

What is being measured

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

  1. Holistic Well-being Scale (HWS)

    The HWS scale comprises 30 items designed to assess the physical, psychological, and spiritual dimensions that enhance life satisfaction and well-being. It evaluates two major constructs:

    1. Perceived affliction, including psychological vulnerability, bodily irritability, and spiritual disorientation
    2. Equanimity, including vitality, mindful awareness, non-attachment, and spiritual self-care Participants respond on a scale from 0 (complete disagreement) to 10 (complete agreement) for each item. Higher scores on perceived affliction indicate lower spiritual resilience, while higher scores on equanimity indicate greater spiritual resilience and well-being.

    Measured: Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 10)

  2. Beck Depression Inventory-II scores(BDI-II)

    The BDI-II scores is a self-administered 21-item questionnaire designed to assess the severity of depressive symptoms. Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms (worse outcome)

    Measured: Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 10)

  3. World Health Organization Quality of Life Questionnaire-Taiwan version (WHOQOL-BREF TW)

    The WHOQOL-BREF TW is a 28-item questionnaire assessing four domains: physical health (7 items), psychological well-being (6 items), social relationships (4 items), and environmental factors (9 items). Each item uses a 5-point Likert scale, with higher scores indicating better quality of life. Domain scores are calculated by summing the item scores within each domain, multiplying by 4, and dividing by the number of items, resulting in scores ranging from 4 to 20. Higher scores represent better quality of life. This questionnaire provides a comprehensive reflection of an individual's multidimensional health status and subjective satisfaction, making it suitable for people with visual impairments..

    Measured: Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 10)

  4. sleep quality

    Subjective Assessment of Sleep Quality To evaluate participants' perceived sleep quality, this study utilized Item 16 from the WHOQOL-BREF Taiwan version, which asks: "Are you satisfied with your sleep?" Responses were rated on a 5-point Likert scale, reflecting overall subjective satisfaction with sleep Objective Assessment of Sleep Quality Objective sleep parameters were measured using a wrist-worn accelerometer (e.g., XA-5), which recorded data on total sleep time, sleep efficiency, and nighttime awakenings. The device estimates sleep states based on three-axis movement patterns.

    Measured: Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 10)

  5. qualitative inquiry

    The question design was informed by Yalom's recommendations regarding therapeutic mechanisms and primarily addressed the following topics: participants' personal definitions of well-being; whether well-being improved after attending the program and in which specific dimensions (physical, mental, and spiritual); experience of growth and transformation before and after participation; the most impressive and interesting event that occurred in the group; and suggestions for enhancing the practicality and adaptability of the course content

    Measured: Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 10)

Timeline

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

  1. First posted6 Aug 2025
  2. Study start26 Apr 2023
  3. Primary completion25 Jul 2023
  4. Study completion1 Jul 2024

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
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
This study employed a quasi-experimental design with matched groups, where participants were assigned to either the intervention or the control group based on their registration order and availability
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105761
Sponsor's protocol ID
TCHIRB-11107010
Acronym
BMS
Status last verified
Aug 2025
First submitted
18 Jul 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 1. Quantitative Data Pre- and Post-Measurement Scores: Tool A: Pre-test, Post-test Tool B: Pre-test, Post-test Tool C: Pre-test, Post-test 2. Attendance Rate and Participation Records Attendance Rate: Percentage of participants attending each intervention session. Participation Records: Number of participation sessions and times for each participant. 3. Data Availability Timeline and Conditions Availability Timeline: Applications will open 6 months after the main results are published. Usage Conditions: Data is available only to researchers approved by IRB or ethical review. Research purposes must be clear and comply with ethical standards. 4. Research Results Summary of Results: Analyze the impact of changes in pre- and post-test scores on participants. Statistical Analysis: Use t-tests or ANOVA to assess group differences. Qualitative Analysis: Conduct thematic analysis on participant feedback

Publications

  • Yeh HC, Yang S, Fu JS, et al. Developing college students' critical thinking through reflective writing. Higher Educ Res Dev. 2023;42(1):244-259. doi: 10.1080/07294360.2022.2043247.

  • Martínez-Martí ML, Hernández-Lloreda MJ, Avia MD. Appreciation of beauty and excellence: relationship with personality, prosociality, and well-being. J Happiness Stud. 2016;17(6):2613-2634. doi: 10.1007/s10902-015-9709-6.

  • Ho CYY, Yu BCL, Mak WWS. Nonattachment mediates the associations between mindfulness, well-being, and psychological distress: A meta-analytic structural equation modeling approach. Clin Psychol Rev. 2022 Jul;95:102175. doi: 10.1016/j.cpr.2022.102175. Epub 2022 Jun 3.

    PubMed 35690041

  • Zamzam AM. Understanding the correlation between visual impairment and mental health: a literature review. Sriwijaya J Ophthalmol. 2021;4(1):58-63. doi: 10.37275/sjo.v4i1.57.

  • Martina BI, Mazzi C, Colombari E, et al. The interplay between visual perception and psychopathological conditions in adult patients: a systematic review. J Psychosom Res. 2024;181:111709.

  • Demmin DL, Silverstein SM. Visual Impairment and Mental Health: Unmet Needs and Treatment Options. Clin Ophthalmol. 2020 Dec 3;14:4229-4251. doi: 10.2147/OPTH.S258783. eCollection 2020.

    PubMed 33299297

  • Liu CR, Tseng MY, Sharma D, Hsieh WD, Liu WS, Chang CS, Jou JH. A pilot study of body-mind-spirit group therapy on sleep and quality of life in individuals with visual impairment. Qual Life Res. 2026 May 3;35(6):155. doi: 10.1007/s11136-026-04260-6.

    PubMed 42070200

Questions about this trial

What is this clinical trial studying?

A study testing Body-Mind-Spirit in people with Quality of Life (QOL) and Depression, run by Taipei City Hospital at 1 site in Taiwan.

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Holistic Well-being Scale (HWS) (time frame: Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 10)). The study lists 5 primary outcomes in all. 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 NCT07105761, which also lists 7 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 13 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in