Clinical Research Directory

Intergenerational Interaction Program for Nursing Home Residents and Nursing Students

This pilot randomized controlled trial aims to examine the effect of a 6-week intergenerational interaction program, conducted between older adults living in a nursing home and nursing students, on joy of life and loneliness in older adults and on ageism in nursing students. Older adults living in Istanbul Darülaceze will be randomly assigned to an intervention group or a control group. In the intervention group, each older adult will be paired with a nursing student, and the same pair will meet once a week for about 2 hours over 6 weeks. The pairs will jointly decide on activities such as games (e.g., backgammon, dominoes, puzzles), reading and cultural sharing, creative work (e.g., drawing, collage, life-story albums), and sharing skills and experiences. Each session will end with a structured, mutual reflection. Older adults in the control group will continue their usual daily routine and will be offered the same program after the study ends, if they wish. Joy of life and loneliness in older adults, and ageism in nursing students, will be measured before and after the program.

Ageing and Health. Spanish Longitudinal Study

Ageing with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. The data that makes up the baseline was collected from a nationally representative sample of non-institutionalized adults as part of the "Collaborative Research on Aging in Europe (COURAGE in Europe)" project between July 2011 and May 2012. The second wave was carried out as part of the "Age with Health" project between December 2014 and June 2015, and three years later, in 2018, the third wave was carried out. In 2019-2021, a new cohort of participants were brought in (2019 cohort), some of whom were interviewed again by telephone during the first Coronavirus (COVID-19) lockdown, in early 2020. In 2022, the fourth wave of the 2011 cohort was evaluated, and in 2023, the second wave of the 2019 cohort was evaluated. Finally, in 2025, the fifth wave of the 2011 cohort and the third wave of the 2019 cohort were evaluated, which are the last follow-ups in this study.

Loneliness as Risk Factor for Dementia

This study aims to determine whether loneliness is associated with a higher incidence of dementia in older adults with a prior diagnosis of mild cognitive impairment after 12 months of follow-up.

LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation

Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising.

Music Breathing in Enhancing Resilience Among Elders at Risk of Mental Health Problems

The goal of this pilot randomised controlled trial is to examine the effects of a mindfulness-based music breathing intervention in enhancing resilience (primary outcome), and in reducing anxiety, depressive symptoms, loneliness, and improving health-related quality of life (secondary outcomes) among community-dwelling older adults at risk of mental health problems. It is hypothesised that compared with the control group, participants in the intervention group will report enhanced resilience, reduced anxiety, depressive symptoms, and loneliness, and improved health-related quality of life immediately post-intervention.

Applying Comfort Theory to an AI-Assisted Group Music Intervention: Psychosocial and Physiological Outcomes and Feasibility in Long-Term Care Residents.

The research design adopts a sequential two-phase framework. The study will be conducted in three residential LTC facilities located in Taichung City or Changhua County, with a total planned enrollment of 60 residents. In Phase 1, 20 residents from one facility will participate in a six-week group music intervention, with one session per week. This phase will focus on multimodal image data construction and AI model development. Facial expression data will be manually annotated to establish reference standards for emotion recognition, while upper-limb movements will be analyzed using pose estimation and skeletal recognition techniques to extract dynamic features. These data will be used to develop and preliminarily validate an AI-based emotion and activity response monitoring model. In Phase 2, 40 residents who did not participate in Phase 1 will be recruited and divided into four groups to participate in a six-week group music intervention, with one session per week. The AI model developed in Phase 1 will be implemented in the LTC setting to transform residents' facial emotional expressions and upper-limb activity responses into low-interference visual information for the music therapist as an adjunct to activity facilitation and professional judgment. Evaluation indicators include subjective psychosocial measures of loneliness, anxiety, and depression, with heart rate variability (HRV) assessed in Phase 2 as an objective physiological measure. This study expects to establish a multimodal dataset and an AI-based emotion and activity response monitoring model for group music activities in LTC settings and to preliminarily evaluate the feasibility of a human-AI collaborative approach characterized by "AI-assisted monitoring and human professional decision-making.

Digital Storytelling-Based Psychoeducation for Loneliness and Self-Efficacy in Adults Aged 65-74

This study is testing whether a psychoeducation program developed using digital storytelling affects loneliness and self-efficacy in adults aged 65 to 74. Participants are randomly assigned to an intervention group or a comparison group. The study team assesses loneliness and self-efficacy in both groups and compares the results to examine the effects of the program.

The Effects of Virtual Tours on Elderly People Living Alone

This experimental study aimed to determine the effect of virtual museum tours on the psychological well-being and loneliness levels of individuals aged 65 years and older living alone. Individuals aged 65 years and older who were living alone at home were included in the study. The required sample size was calculated using G\*Power software and determined to be 42 participants, with 21 participants in the intervention group and 21 in the control group. Data were collected using a Personal Information Form, the Psychological Well-Being Scale for Older Adults (YPİOÖ), and the UCLA Loneliness Scale (UCLA-LS). Following the pre-test assessment, participants in the intervention group participated in virtual museum tours through the "Virtual Tour" website provided by the Republic of Türkiye Ministry of Culture and Tourism (https://sanalmuze.gov.tr/?\_Dil=1). The virtual museum tours were conducted once a week for six weeks. After completion of the intervention, the questionnaires were administered again as a post-test. No intervention was applied to the control group until the completion of the study; participants in the control group were subsequently offered the opportunity to experience the virtual museum tour. Data were analyzed using descriptive statistics (mean, standard deviation, median, frequency, and percentage), Student's t-test, and paired-samples t-test. A p-value of \<0.05 was considered statistically significant. All necessary permissions were obtained prior to conducting the study.

CommunityRx-Dementia + Peer Navigation (CRxDpeer)

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

Immersive Group Dance in Virtual Reality and Perceived Social Cohesion in Older Adults

This is a two-arm, parallel-group randomized controlled trial designed to evaluate the effects of an immersive virtual reality (VR)-based group dance program on perceived social cohesion among community-dwelling older adults, compared with a dose-matched conventional light physical activity program. A total of 180 eligible participants (men and women) will be randomized (1:1) to either the VR group dance condition or the control condition. Both interventions are delivered three times per week for five weeks (15 sessions total). The primary outcome is perceived social cohesion, measured using the Perceived Cohesion Scale (PCS) at baseline, post-intervention (week 5), and 30-day follow-up. Sex differences in response to the intervention will be examined as a secondary objective. This study has been approved by the Institutional Ethics Committee of Capital University of Physical Education and Sports (Approval No. IEC/CUPES/345KJB).

Community Occupational Therapy for People With Acquired Disabilities in Rural Settings

This pilot study evaluated the effects of Re-Construir Juntes, a rural community-based occupational therapy group intervention, on engagement in meaningful occupations and loneliness among people with acquired disabilities experiencing occupational disengagement and social disconnection. Secondary outcomes included occupational balance, emotional wellbeing, perceived social support, health-related quality of life, and self-perceived health. The study used a mixed-methods explanatory sequential design comprising a non-randomised controlled pre-post quantitative component and a post-intervention focus group with intervention participants.

Social Prescribing for a Mindful Lifestyle

The goal of this clinical trial is to evaluate the effectiveness of an 8-week mindfulness lifestyle social prescribing program in community-dwelling older adults aged 55 and older. The main questions it aims to answer are: To establish a mindfulness lifestyle social prescribing model applied to the psychological and social health promotion of middle-aged and older populations. To evaluate the effectiveness of the intervention on improving depressive symptoms, loneliness, and quality of life in this population. Participants will receive an 8-week group intervention program, with each weekly session lasting approximately 3 hours. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). Researchers will collect and evaluate data from pre- and post-intervention assessments to measure changes in depressive symptoms, loneliness risk, and overall quality of life.

Thrive at Home: A Virtual Reality Social Intervention for Older Adults

The goal of this clinical trial is to evaluate whether a virtual reality (VR) based social platform can improve mental health and social connection for older adults who receive in-home care. Specifically, the study aims to determine if the VR program reduces loneliness, depressive symptoms, and boredom while increasing social connection and well-being among older adult participants. It also explores whether access to the VR program reduces caregiver burden and depressive symptoms for family caregivers. Researchers will compare an immediate-start group to a waitlist control group to assess whether the VR program improves outcomes compared to standard home care alone. Both groups will eventually receive the intervention. Older adult participants will use a VR headset at home to join group activities three times a week. These sessions include social activities with local peers and live-hosted group activities. A family caregiver or home care professional may be present during sessions if needed for support. Over a 12-week study period, older adult participants will complete three surveys assessing their mood, social connection, and well-being. Family caregivers of participating older adults are also invited to join an optional caregiver substudy. Caregivers who enroll in the substudy will not participate in the VR activities themselves, but will complete three surveys at the same time points over the 12 weeks to share their own well-being and caregiving experiences.

A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

Effectiveness of a Psychological Intervention to Reduce Social Isolation and Promote Social Connectedness in Young Adults

The purpose of this randomized controlled trial is to evaluate the effectiveness of a psychological intervention aimed at reducing social isolation and promoting social connectedness among young adults. Specifically, the study investigates the impact of an 8-week, digitally assisted face-to-face group social skills training program on individuals aged 19 to 34 who experience difficulties in interpersonal relationships and social isolation. Participants will be randomly assigned to either the active intervention group or a waitlist control group. The study aims to determine whether this structured psychosocial intervention improves interpersonal competence and social performance, reduces social isolation, and improves other psychosocial variables. Outcomes will be evaluated at three time points-pre-intervention, post-intervention, and a 1-month follow-up-utilizing a combination of self-report questionnaires and performance-based role-play assessments.

A Mechanism Randomised Controlled Trial of a Three-Agent LLM-Augmented mHealth Intervention for Late-Life Loneliness in Older Adults

This study examines how a smartphone conversational application affects feelings of loneliness in Cantonese-speaking older adults living in Hong Kong. Seventy-two adults aged 60 or above who report at least moderate loneliness will be randomly assigned to one of two versions of the same application. Both versions look and work the same way, offer the same three conversational companions, and provide the same set of in-app tools. The two versions differ only in how the companions' replies are produced: in one version replies are generated by a large language model, and in the other they are assembled from pre-written templates selected by keyword and conversation state. Participants use the application for four weeks and are then followed for a further four weeks with continued access. The main question is whether any difference between the two versions in emotional loneliness operates through how understood, validated and cared for participants feel during individual conversations. Participants are not told which version they are using, and the researcher who carries out the assessments is also unaware of the assignment.

Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults

Develop and test an effective machine learning enabled application-based (app-based) mindfulness intervention for reducing loneliness of Hong Kong Chinese older adults.

Planetary Health and Loneliness

The aim of this 3-phase study is the evaluation of planetary health behaviors and its cognitive processes in relation to levels of eco-anxiety, general well-being, and levels of loneliness. As climate change progresses at a dangerous rate, it is important to establish and maintain lifestyles that are productive, fulfilling, environmentally conscious, and low in anxiety. Through a better understanding of the interconnected nature of planetary health behaviors with other aspects of healthy living and perception of social isolation, and the effect of an intervention, this research will add to current state of science to help inform the creation of interventions promoting sustainable, healthy, happy living among the general public and specific subgroups.

A Novel Conditioning Approach to Counter Loneliness in Adults

This study aims to test the efficacy of a 6-session conditioning paradigm by investigating the conditioning-induced change in the socio-affective processing, loneliness, depressive symptoms, and neural correlates of lonely adults.

Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults

The proposed study is a pilot study that aims to understand if the Pi Electronics adaptive music intervention (AM) is effective to promote positive psychosocial and cognitive outcomes, over and above a traditional music intervention (TM) among healthy older adults. This study will contribute to the ongoing literature on the benefits of music interventions and provide insight on how emerging technology can enhance the therapeutic effects of music as a viable intervention for older adults. The study will adopt a three-arm randomized controlled trial (RCT). Eligible participants will be randomized into one of three groups: traditional music therapy group (TM), Pi Electronic's adaptive music program (AM), and a waitlist control group (CG). Informed consent will be collected from all participants. All three groups will complete outcome measures at three sessions: pretest, posttest, and at a three-month follow-up, but only the TM and AM group will receive music between the pretest and posttest sessions, spanning for 4 weeks, with 4 music therapy sessions per week, and each session lasting 30 minutes. Data will be analyzed for each outcome variables to understand the group differences in the performance on the psychosocial and cognitive outcome measures. The study will also validate the Pi Electronics EEG headset with the BioSemi, 64-channel EEG system.

Autobiographical Time Travel to Alleviate Loneliness in Older Adults

The goal of this clinical trial is to examine whether updating fundamental beliefs about self, others and the world using a mental time-travel group program can reduce loneliness and improve well-being in older adults when combined with multimodal social engagement opportunities. Over the span of eight sessions, participants within the experimental group will be guided to complete autobiographical simulations grounded in therapeutic techniques including reminiscence, imagery rescripting and positive future thinking. Participants within the active control group will be instructed to continue with their usual social group activities.

The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women

Many older women live alone and may experience loneliness, reduced social participation, and declining physical health. Regular physical activity can improve health and independence, but it is not known whether exercising in a supervised group setting provides additional social and psychological benefits compared with exercising independently. The ALIVE study is a 16-week randomized controlled trial that will investigate the effects of fitness club participation on loneliness, social connectedness, quality of life, mental health, physical activity, and physical fitness in women aged 75 years and older who live alone and are insufficiently physically active. Participants will be randomly assigned to one of three groups: (1) supervised group exercise at a fitness club combined with opportunities for social interaction, (2) fitness club membership with independent exercise, or (3) a control group continuing their usual daily activities. A total of 213 women will be recruited from Oslo, Norway. Outcomes will be assessed before and after the intervention using questionnaires, physical performance tests, body composition measurements, cardiovascular risk assessments, and device-based measurement of physical activity. In addition, qualitative interviews will be conducted to explore participants' experiences, barriers, facilitators, and perceptions of social connection and belonging. The study aims to determine whether supervised group exercise in fitness clubs can reduce loneliness and improve health and well-being among older women, while generating knowledge about practical community-based strategies to support healthy and socially connected ageing.

A Trial of a Positive Psychology Intervention for Older Adults (RESET)

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

Engage Coaching (R33 Phase)

The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.