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

NCT07105761 | Completed

• 1 other identifier: TCHIRB-11107010
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Quality of Life (QOL); Depression

Keywords

Body-mind-spirit; group therapy; quality of life; sleep quality; depression; holistic well-being

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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)

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

• 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..

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

• 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.

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

• 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

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

Study Arms (2)

Body-Mind-Spirit

EXPERIMENTAL

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.

Behavioral: Body-Mind-Spirit

routine activities

NO INTERVENTION

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

Interventions

Body-Mind-Spirit 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.

Body-Mind-Spirit

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Chinese Visually Impaired Anyang Welfare Association

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

Location

Related Publications (6)

• 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.

  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.

  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.

  PMID: 35690041 BACKGROUND

• 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.

  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.

  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.

  PMID: 33299297 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Chuen-Ru Liu, PhD

  Taipei City Hospital Songde Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse in Public Service

Model Details: 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 Record Dates

• First Submitted: July 18, 2025
• First Posted: August 6, 2025
• Study Start: April 26, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 1, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: July 2025 - July 2026
• Access Criteria: Who can access the data: Qualified researchers affiliated with academic institutions or research organizations may request access to the individual participant data and supporting documents. What information they can access: De-identified individual participant data related to the outcomes reported in this study, including supporting documents such as the study protocol, statistical analysis plan, informed consent form, and data dictionary. How they can access the data: Interested researchers must submit a formal data access request including a research proposal, data use plan, and documentation of ethics approval. Upon review and approval by the data access committee, data will be made available through a secure data-sharing platform under a data use agreement.

Locations

TW (1)