Mindfulness-Based VR for Family Caregivers of People With Dementia

Not Applicable

Completed

• Conditions: Quality of Life; Caregivers of People With Dementia
• Interventions: Behavioral: Mindfulness-Based VR; Behavioral: Audio

• Registration Number: NCT06034249
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Study Start: 2022-08-23
• Primary Completion: 2022-11-21
• Study Completion: 2023-06-06
• Status Verified: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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.

Exclusion Criteria

Visual and auditory impairments were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group: Mindfulness-Based VR group	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.
Control Group: Mindfulness-based Audio Files	Audio	The control group will only be given the mindfulness-based audio files for six weeks.

Primary Outcome Measures

Name	Time	Method
Depression	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 Outcome Measures

Name	Time	Method
Sleep	Baseline and six-week	Chinese Pittsburgh Sleep Quality Index (CPSQI) The minimum value= 0, maximum value= 21, higher score mean worse sleep quality.
QoL	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.

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan