跳至主要内容
临床试验/NCT05531513
NCT05531513已完成不适用

The Effects of a Nature-Based Mindfulness-Compassion Intervention for Older Adults Delivered Using Virtual Reality: A Randomized Controlled Trial

McGill University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年7月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change from Baseline in Scores on the General Self-Efficacy Scale (GSE)

研究概览

简要总结

The global population is aging at an unprecedented rate, increasing the necessity for effective interventions targeting the mental health needs of older adults. Virtual reality (VR) is a type of technology with the potential to improve mental health and well-being that allows users, via electronic devices such as headsets or goggles, to interact within simulated environments. VR programs using nature, mindfulness-meditation, and compassion may be more immersive and engaging, with research showing that these programs are effective at improving mental health and well-being outcomes in younger adults. However, evidence in this area for older adults is currently lacking.

The present project intends to pilot and examine a multi-user 360-High Definition (HD) video VR application, called "Toujours Dimanche", developed in partnership with Super Sublime, a Montreal-based not-for-profit company. This VR application aims to support older adults through incorporating elements of nature, mindfulness-meditation, and compassion via a 4-week program of twice weekly, 10 to 20-minute meditation sessions, for a total of 8 sessions. Thus, this study seeks to pilot, revise and iteratively evaluate, via randomized control trial (RCT) methodology, the acceptability, feasibility, and effectiveness of a multi-user 360-HD video VR application (Toujours Dimanche) at improving older adult mental health and well-being.

It is hypothesized that engagement with the 4-week VR-Meditation intervention will lead to lower scores on stress and negative affect and improved scores on well-being, positive affect, and mindfulness, in addition to increased scores on coping self-efficacy, connection with nature, embodied mindfulness, and self-compassion, over time and as compared to the active control group (who will receive psycho-educational pamphlets 1x/week for 4 weeks).

详细描述

INTRODUCTION:

There is a need for effective health strategies to help older adults' psychological well-being; thus, the proposed study seeks to better understand how to support older adults' mental health through the use of a virtual reality (VR)-based nature, mindfulness-and-compassion meditation intervention.

Technology developed to meet older adults' quality of life needs, or Gerontechnology has been increasingly integrated into daily life routines and may have the potential to ameliorate treatment accessibility and quality. However, to maximize the effectiveness of these technology-based modalities, it is necessary to move beyond conventional telehealth methodologies and investigate fresh modalities of mental health provision for older adults, such as VR.

One way proposed to utilize VR 360-degree video technology most effectively is through the incorporation of natural settings in the VR experience. A growing body of research highlights the therapeutic efficacy of 360-degree nature videos, pointing to nature-based VR's capability to rapidly improve mood, as well as its potential to decrease physiological stress levels and enhance cognitive functioning.

Additionally, through its capacity to capture participants' attention and provide users the illusion of "being there" in the 3D computer-generated environment, VR may be particularly effective when incorporating mindfulness-based activities. Mindfulness can be described as the process of purposefully, and with acceptance, paying attention non-judgmentally to the present moment. By providing people with an interesting setting to practice mindfulness (e.g., simulated natural settings), limiting distractions from the real world, and increasing a sense of presence, VR may facilitate mindfulness practice. This is significant, given that mindfulness-based interventions (MBIs) are particularly suited to meet the needs of older adults. Together with mindfulness, self-compassion, defined as thinking, feeling, and acting kindly towards oneself, can be used as a complementary strategy in MBIs and has been shown to augment their effectiveness, with evidence linking self-compassion to improved well-being in later life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to baseline assessment.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Must reside at a Résidence Enharmonie private residence for autonomous older adults in the Montreal, Quebec region
  • •Must be 60 years of age or older
  • •Ability to speak English or French

排除标准

  • •History of recurrent migraines/seizures/Traumatic Brain Injury during the past year
  • •Glaucoma or recovery phase of any eye surgery
  • •Diagnosed epilepsy or severe vertigo

研究组 & 干预措施

Virtual Reality (VR) Meditation

Experimental

The VR Meditation intervention will be administered in Arm 1.

干预措施: Virtual Reality (VR) Meditation (Behavioral)

Psychoeducational Pamphlets

Active Comparator

The Psychoeducation Pamphlet intervention will be administered in Arm 2.

干预措施: Psychoeducational Pamphlet (Behavioral)

结局指标

主要结局

Change from Baseline in Scores on the General Self-Efficacy Scale (GSE)

时间窗: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

The GSE is a 10-item scale that measures an individual's confidence in their ability to effectively cope with life challenges. Participants are asked to rate statements on a 4-point scale ranging from 1 (not at all true) to 4 (exactly true). English and French versions available.

Change from Baseline in Scores on the Scale of Positive and Negative Experience (SPANE)

时间窗: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

SPANE is a 12-item questionnaire with six items to assess positive feelings and six items to assess negative feelings. Participants are asked to rate their levels of affect using a 5-point scale ranging from 1 (rarely or never) to 5 (very often or always). English and French versions available.

Change from Baseline in Scores on the Flourishing Scale (FS)

时间窗: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

The FS is a brief 8-item measure assessing participants' self-perceived success (e.g., purpose, self-esteem, relationships, optimism) and provides a single psychological well-being score. Participants are asked to rate their levels of well-being on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). English and French versions available.

Change from Baseline in Scores on the Perceived Stress Scale (PSS)

时间窗: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

PSS is a 14-item scale used to measure the degree to which life events are experienced and appraised as stressful. It asks respondents how often they have felt certain ways in the past month, with responses ranging from 0 (never) to 4 (very often). English and French versions available.

次要结局

  • Change from Baseline in Scores on the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-24)(At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9))
  • Change from Baseline in Scores on the Embodied Mindfulness Questionnaire (EMQ)(At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9))
  • Change from Baseline in Scores on the Self-Compassion Questionnaire-Self (CQS)(At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9))
  • Change from Baseline in Scores on the Connectedness to Nature Scale (CNS)(At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bassam Khoury, PhD

Associate Professor

McGill University

研究点 (2)

Loading locations...

相似试验