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OpenTrials
Completed

NCT Number: NCT06034249

Mindfulness-Based VR for Family Caregivers of People With Dementia

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.

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Key information

Conditions

Caregivers of People With Dementia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Quality of Life Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Mindfulness-Based VR

Behavioral

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.

Audio

Behavioral

The mindfulness-based audio files for six weeks.

Primary outcomes

  1. Depression

    Time frame: Baseline and six-week

    The Center for Epidemiologic Studies Depression Scale (CES-D) The minimum value= 0, maximum value= 60, higher score mean higher frequency of depressive symptoms.

Secondary outcomes

  1. Sleep

    Time frame: Baseline and six-week

    Chinese Pittsburgh Sleep Quality Index (CPSQI) The minimum value= 0, maximum value= 21, higher score mean worse sleep quality.

  2. QoL

    Time frame: Baseline and six-week

    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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • National Science and Technology Council

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 21, 2023

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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