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Mindfulness-Based VR for Family Caregivers of People With Dementia

Primary Purpose

Caregivers of People With Dementia, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mindfulness-Based VR
Audio
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregivers of People With Dementia focused on measuring Virtual Reality, Depression, Sleep Quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group: Mindfulness-Based VR group

Control Group: Mindfulness-based Audio Files

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2023
Last Updated
September 17, 2023
Sponsor
Taipei Medical University
Collaborators
National Science and Technology Council
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1. Study Identification

Unique Protocol Identification Number
NCT06034249
Brief Title
Mindfulness-Based VR for Family Caregivers of People With Dementia
Official Title
The Effect of Mindfulness-Based VR on Depression, Sleep and Quality of Life Among Family Caregivers of People With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
National Science and Technology Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers of People With Dementia, Quality of Life
Keywords
Virtual Reality, Depression, Sleep Quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Mindfulness-Based VR group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group: Mindfulness-based Audio Files
Arm Type
Placebo Comparator
Arm Description
The control group will only be given the mindfulness-based audio files for six weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based VR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audio
Intervention Description
The mindfulness-based audio files for six weeks.
Primary Outcome Measure Information:
Title
Depression
Description
The Center for Epidemiologic Studies Depression Scale (CES-D) The minimum value= 0, maximum value= 60, higher score mean higher frequency of depressive symptoms.
Time Frame
Baseline and six-week
Secondary Outcome Measure Information:
Title
Sleep
Description
Chinese Pittsburgh Sleep Quality Index (CPSQI) The minimum value= 0, maximum value= 21, higher score mean worse sleep quality.
Time Frame
Baseline and six-week
Title
QoL
Description
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.
Time Frame
Baseline and six-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan F Liu, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

Mindfulness-Based VR for Family Caregivers of People With Dementia

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