VR-based Mindfulness for Dementia Caregivers in the Home Environment (Mind-body Interventions)

Официальное название

A Feasibility Study on the Efficacy of a VR-based Mindfulness Intervention for Dementia Caregivers in the Home Environment: A Pilot Randomized Control Trial

Обзор

To explore the feasibility, acceptability, and potential effectiveness among dementia caregivers of the mindfulness-based interventions delivered by VR technology (VR-based MBI) in improving psychological well-being and caregiver-recipient relationship. This study hypothesized that caregivers in the VR-based MBI group will have a greater improvement in psychological wellbeing than those in the audio-based MBI group and the waitlist care-as-usual group. This is a 3-arm, parallel, single-blinded, pilot randomised control trial comparing VR-based MBI with audio-based MBI and care-as-usual. The target sample includes 90 caregivers of community-dwelling persons with dementia. Each arm (n=30) will receive an eight-week exercise with instruction, with outcome assessment at baseline, post-treatment, and 2-month follow-up. Qualitative interviews will also be conducted to assess the feasibility and acceptance. The VR-based MBI group will engage in mindfulness exercises using a mobile app and VR technology, incorporating different natural environments. The intervention duration is eight weeks. The primary outcome is the caregivers' psychological well-being regarding depression, anxiety, and stress. The secondary outcomes include caregiver burden, mindfulness level, quality of life and caregiver-recipient relationship. Following intention-to-treat analysis, quantitative data on effectiveness will be analysed using between-group t-tests and group-by-time effect size (Cohen's d). The six-step thematic analysis will be utilized for qualitative data. The intervention group will accept the VR-based MBI, rate the intervention as feasible and show significant improvements in outcome measurements.

Вмешательства

• Поведенческое VR Mindfulness intervention
  Parallel randomized controlled trial
• Поведенческое Audio-based MBI
  Parallel randomized controlled trial
• Поведенческое Waitlist control
  Parallel randomized controlled trial

Первичные конечные точки

• Depression, Anxiety, Stress scale [Срок оценки: Baseline (pre-test), immediately post-test, and 2 months post-test]
• The Chinese Version of the Personal Well-being (ONS4) [Срок оценки: Baseline (pre-test), immediately post-test, and 2 months post-test]

Вторичные конечные точки (4)

• Cantonese Zarit Burden Scale Short Version [Срок оценки: Baseline (pre-test), immediately post-test, and 2 months post-test]
• EuroQol 5-Dimension 5-Level [Срок оценки: Baseline (pre-test), immediately post-test, and 2 months post-test]
• five-facet mindfulness questionnaire [Срок оценки: Baseline (pre-test), immediately post-test, and 2 months post-test]
• Relationship Closeness Scale [Срок оценки: Baseline (pre-test), immediately post-test, and 2 months post-test]

Критерии участия

Критерии включения

• Aged 18 years or older;
• Primary informal caregivers who spend over four hours/day taking care of a community-dwelling person who has been clinically diagnosed with any type of mild-to-moderate dementia at least 6 months;
• Self-reported psychological distress
• Able to speak and read Cantonese.

Критерии исключения

Have practiced mindfulness-based intervention for at least 3 months in the past;

• Have hearing or visual impairment that cannot practice mindfulness via wearing VR
• glasses embedded in a mobile phone app;

--Do not own a smart phone that can install the VR-based MBI app;

• Caring for a person with dementia living in a residential care setting;
• Caring a person with severe level of dementia;
• Have been diagnosed with any mental disorder or on-site of psychotic disorders;
• Receiving any other type of mental health intervention;
• Participants with a history of motion sickness (due to the risk of VR triggering motion sickness)
• Unable to understand Cantonese.

sickness)

-Unable to understand Cantonese.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Wang Q, Yu D, Wong G, Zhang D, Knapp M, Amoah PA, Li J, Shi C. A feasibility study on the efficacy of a VR-based mindfulness intervention for dementia caregivers in the home environment: A pilot randomized control trial protocol. PLoS One. 2026 Apr 29;21(4):e0347988. doi: 10.1371/journal.pone.0347988. eCollection 2026. PMID 42054400

Идентификаторы

NCT: NCT07103434 · 20250701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗