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

NCT ID: NCT07105761

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2024-07-01

Brief Summary

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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.

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.

Detailed Description

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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.

Conditions

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Quality of Life (QOL) Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Measurement points were set at weeks 1, 5, and 10 during the intervention. The study was approved by the Institutional Review Board of Taipei City Hospital Research Ethics Committee (Taiwan) (TCHIRB-11107010) and adheres to the ethical guidelines of the Declaration of Helsinki.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

Study Groups

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Body-Mind-Spirit

The 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.

Group Type EXPERIMENTAL

Body-Mind-Spirit

Intervention Type BEHAVIORAL

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.

routine activities

The control group participated in routine activities without body-mind-spirit intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Body-Mind-Spirit

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chuen-Ru Liu

Registered Nurse in Public Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chuen-Ru Liu, PhD

Role: STUDY_CHAIR

Taipei City Hospital Songde Branch

Locations

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Chinese Visually Impaired Anyang Welfare Association

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

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35690041 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 33299297 (View on PubMed)

Study Documents

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Document Type: Study Protocol

The de-identified individual participant data (IPD) and supporting documents will be available to qualified researchers upon request, following review and approval by a data access committee. Data will be shared via a secure institutional repository beginning 6 months after study completion, for up to 3 years.

View Document

Related Links

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https://zenodo.org/records/15862065

Storage of study design, informed consent forms, study rota, and study results.

Other Identifiers

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TCHIRB-11107010

Identifier Type: -

Identifier Source: org_study_id

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