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Completed

NCT Number: NCT07105761

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

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.

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Key information

Conditions

Quality of Life (QOL) Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese Visually Impaired Anyang Welfare Association

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Holistic Well-being Scale (HWS)

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

    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:

    • Perceived affliction, including psychological vulnerability, bodily irritability, and spiritual disorientation
    • 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.

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

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

    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)

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

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

    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..

  4. sleep quality

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

    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.

  5. qualitative inquiry

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

    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

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Official study title

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

Acronym: BMS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 6, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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