Mindfulness-Based VR for Family Caregivers of People With Dementia

Sponsor

Taipei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT06034249

Collaborator

National Science and Technology Council (U.S. Fed)

Enrollment

Location

Arms

9.4

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Caregivers of People With Dementia Quality of Life	Behavioral: Mindfulness-Based VR Behavioral: Audio	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 23, 2022

Actual Primary Completion Date :

Nov 21, 2022

Actual Study Completion Date :

Jun 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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 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.
Placebo Comparator: Control group The control group will only be given the mindfulness-based audio files for six weeks.	Behavioral: Audio The mindfulness-based audio files for six weeks.

Arm

Intervention/Treatment

Experimental: Experimental group

Behavioral: Mindfulness-Based VR

Placebo Comparator: Control group

The control group will only be given the mindfulness-based audio files for six weeks.

Behavioral: Audio

The mindfulness-based audio files for six weeks.

Outcome Measures

Primary Outcome Measures

Depression [Baseline and six-week]
The Center for Epidemiologic Studies Depression Scale (CES-D)

Secondary Outcome Measures

Sleep [Baseline and six-week]
Chinese Pittsburgh Sleep Quality Index (CPSQI)
QoL [Baseline and six-week]
Questionnaire of Taiwan's World Health Organization Quality of Life Brief Version

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University	Taipei		Taiwan	110

Sponsors and Collaborators

Taipei Medical University
National Science and Technology Council

Investigators

Principal Investigator: Megan F Liu, PhD, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Megan F. Liu, Associate Professor, Taipei Medical University

ClinicalTrials.gov Identifier:

NCT06034249

Other Study ID Numbers:

20230816

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Megan F. Liu, Associate Professor, Taipei Medical University

Virtual Reality

Depression

Sleep Quality

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Sep 13, 2023