Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:53 PM
Ignite Modification Date: 2025-12-24 @ 11:53 PM
NCT ID: NCT06973551
Brief Summary: This randomized controlled trial investigates the effects of a nostalgia-based cognitive training intervention delivered via Virtual Reality (VR) on emotional well-being and cognitive functioning among community-dwelling older adults (≥65 years) in northern Taiwan, specifically targeting those with mild cognitive impairment (MCI) or mild dementia. The study, conducted at National Taiwan Normal University, aims to assess whether engaging older adults in nostalgic VR experiences can enhance nostalgia proneness, life satisfaction, and psychological well-being, while also reducing depressive symptoms and improving cognitive functions. Participants who meet inclusion criteria (aged 65+, capable of communicating in Mandarin or Taiwanese, without severe psychiatric conditions, with sufficient vision/hearing) will be randomly assigned to either the experimental group receiving the "Brain Health Nostalgic VR Program" or a control group engaged in routine weekly activities. Each weekly session spans 60-90 minutes in total, including setup, support, and breaks, while the actual VR usage time is 10-30 minutes depending on individual tolerance. Research staff will provide close support and safety monitoring during all sessions. Pre- and post-intervention outcomes will be measured using standardized assessments: Southampton Nostalgia Scale (SNS), Short-Form Life Satisfaction Index (LSI-SF), Geriatric Depression Scale (GDS-15), Short-Form Chinese version of Ryff's Psychological Well-being Scale (PWB-18), and the Montreal Cognitive Assessment Taiwan Version (MoCA-T). The study emphasizes participant safety and data confidentiality throughout its duration. Findings aim to demonstrate VR's potential as a non-invasive, preventive strategy for cognitive decline and mental health enhancement among older populations.
Detailed Description: This randomized controlled trial (RCT) examines the effectiveness of a culturally tailored, nostalgia-based virtual reality (VR) program in promoting cognitive health and emotional well-being among older adults (≥65 years) in northern Taiwan. The study is designed in response to Taiwan's rapid transition into a super-aged society, where dementia prevalence and caregiving burdens are expected to rise significantly. Mild cognitive impairment (MCI) represents a critical transitional state with cognitive plasticity, providing a valuable opportunity for early non-pharmacological intervention. Theoretical Framework The intervention is guided by Expectation Confirmation Theory (ECT), which emphasizes how perceptions of usefulness, ease of use, and enjoyment influence participants' satisfaction and long-term intention to adopt health-related technologies. This framework allows the study to move beyond clinical outcomes and assess the feasibility and sustainability of VR interventions among older adults. Intervention Features The Brain Health Nostalgic VR Program integrates reminiscence therapy with cognitive training within immersive VR. The content is uniquely designed with Taiwan-specific cultural elements, such as traditional wedding rituals, historical films, and familiar objects from everyday life, to evoke strong nostalgic responses and enhance emotional engagement. Cognitive exercises are embedded in the VR environment and target seven domains:Attention, Memory, Reasoning, Reading comprehension, Thinking skills, Imagination and creativity, Observational skills. Each weekly session lasts approximately 60-90 minutes, including preparation, VR exposure (10-30 minutes depending on tolerance), discussion, and breaks. The intervention continues for 12 times, with both short-term (8-12 weeks) and longer-term (24 weeks) follow-up assessments. Sessions are delivered within participants' own care facilities to ensure safety and comfort. Distinguishing Characteristics Unlike conventional reminiscence therapy, which often uses photos or group conversations, the immersive VR environment minimizes external distractions and enhances the sense of presence. This approach is expected to amplify the therapeutic benefits of reminiscence by combining emotional stimulation with structured cognitive tasks. Previous studies in Asia and Europe have shown promising results from VR-based reminiscence and cognitive training, but most were limited by small sample sizes or short-term pilot designs. This trial is one of the first large-scale, culturally adapted RCTs in Taiwan, addressing both psychological outcomes (e.g., life satisfaction, well-being, depressive symptoms) and cognitive performance in older adults with MCI or mild dementia. Anticipated Contributions This study aims to: Demonstrate the efficacy of a VR-based nostalgia and cognitive training program as an innovative non-pharmacological intervention. Provide empirical evidence on how culturally tailored VR content can enhance reminiscence, reduce depressive symptoms, and improve cognitive functioning in older adults. Evaluate user acceptance and long-term adoption intentions, offering insights into the scalability of digital health interventions in community and institutional settings. By integrating cultural reminiscence, cognitive stimulation, and immersive VR technology, this trial contributes to both the scientific evidence base and practical strategies for dementia prevention, elderly mental health promotion, and caregiver burden reduction.
Study: NCT06973551
Study Brief:
Protocol Section: NCT06973551