Mindfulness-Based VR for Family Caregivers of People With Dementia

Study Overview
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Brief Summary
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The goal of this clinical trial is to explore the effectiveness of mindfulness-based VR could enhance depression, sleep quality, and overall quality of life for family caregivers providing care for people with dementia. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.

Detailed Description
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The inclusion criteria for participants were as follows: (1) being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution, (2) having the ability to communicate in Mandarin or Taiwanese, and (3) providing informed consent to participate in the study by signing the consent form. Individuals with visual and auditory impairments were excluded from the study. Outcome measure: basic characteristics of participants; The Center for Epidemiologic Studies Depression Scale; Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version.

Official Title
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The Effect of Mindfulness-Based VR on Depression, Sleep and Quality of Life Among Family Caregivers of People With Dementia

Conditions
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Caregivers of People With Dementia, Quality of Life

Intervention / Treatment
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* Behavioral: Mindfulness-Based VR
* Behavioral: Audio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being a family caregiver responsible for caring for a family member diagnosed with dementia by a medical institution, having the ability to communicate in Mandarin or Taiwanese, and providing informed consent to participate in the study by signing the consent form. Exclusion Criteria: Visual and auditory impairments were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial (RCT) design was used. Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. The control group will only be given the mindfulness-based audio files for six weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group: Mindfulness-Based VR group<br>Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices. | Behavioral: Mindfulness-Based VR<br>* Participants will be ask to attend the six-week course encompassed various mindfulness practices, including breathing observation, body scanning, mindful yoga, mindful walking, holistic meditation, and non-selective awareness practices.<br>|
| Placebo Comparator: Control Group: Mindfulness-based Audio Files<br>The control group will only be given the mindfulness-based audio files for six weeks. | Behavioral: Audio<br>* The mindfulness-based audio files for six weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | The Center for Epidemiologic Studies Depression Scale (CES-D) The minimum value= 0, maximum value= 60, higher score mean higher frequency of depressive symptoms. | Baseline and six-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | Chinese Pittsburgh Sleep Quality Index (CPSQI) The minimum value= 0, maximum value= 21, higher score mean worse sleep quality. | Baseline and six-week | 
| QoL | Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version The minimum value= 4, maximum value= 20, higher score mean better quality of life. | Baseline and six-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Depression, Sleep Quality