Clinical Research Directory

The Presence of Humanoid Robot With Older Adults at Homes

Background Older adults experience significant physical, cognitive and environmental losses in their later life. Self-supported 'aging-in-place' has benefits for mental health and the quality of life for older people. In the field of gerontological nursing, person-centered holistic care highlights the importance of enabling older people and their significant others (such as older spouse or other family caregivers) to establish healthful relationships so to improve older adults' physical, psychological, mental and social wellbeing. However, globally and also most recommended by Hong Kong government, home-based care services for older adults have not been fully developed. Research on the use of robots supporting older adults is given increasing attention in the globe, but most of them were focused on aiding older adults who are living with dementia or residing in nursing homes. More robotic research needs to be conducted at their own homes in the community and support older people in having an independent lifestyle. Study Aim This study aims to investigate the feasibility and acceptability of home-based physical robot HUMANE by community-dwelling Chinese older adults and soon-to-be-aged adults and their family caregivers. Study design and method This study will employ a two-arm pilot randomized control trial with qualitative interviews. People aged 50 or above who are receiving home care from family members will be recruited to this study. Purposive sampling will be adopted in recruitment. The robot HUMANE will be used by the intervention group for a 6-week trial. Loneliness, cognitive function, emotional status, self-efficacy, and sense of coherence will be measured at baseline (day-1) and immediately post-intervention (week-6) to examine preliminary effect of using robot at home. System usage will be measured at immediately post-intervention (week-6) for assessing the perceived usability of the robot. Data analysis SPSS Statistics 26 will be adopted for all analyses. Descriptive statistics, generalized estimating equations (GEE) models and a deductive content analysis approach will be used in data analysis. Significances of the study The study will add evidences in the field that social robot may be able to address some of the unmet needs of older people living at their own homes in the community, particularly relating to loneliness, enhancing the development of home-based care services for older adults.

Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment

Apathy, a profound loss of initiative and motivation, is often seen in older Veterans with memory problems. Apathy leads to serious health problems, increases dependency, and caregiver burden. If untreated, apathy hastens the progression to frank dementia. In a pilot study, the investigators found that apathy, working memory, and function can be restored using magnetic stimulation in some but not all older Veterans. The reason for this variation is unknown. The investigators propose a three-phase study in 125 older Veterans with mild memory problems. Their motivation, memory, and function will be measured periodically. Veterans with apathy that are eligible for treatment will receive either real or sham magnetic stimulation to the front part of their brain over 20 sessions. Genetic testing and biomarkers will be used to differentiate those who respond to magnetic stimulation from those who do not. Impact on function, quality of life, and rates of progression to dementia will also be studied. A project modification was obtained to conduct a cross-sectional study, the COVID Dementia study. The cross-sectional study will examine the effect of the pandemic on MCI and AD patients and their caregivers ("individual COVID-related factors" such as, personally infected, death of a friend/family member, economic hardship, disruption in care, isolation), barriers to telehealth, caregiver distress, NPS, cognition (including onset of delirium), and function. Our goal is to develop a multi-pronged, remotely deliverable intervention to address consequences of healthcare disruptions in older Veterans with cognitive impairment. Aim 1. To explore the association between COVID-related factors and neuropsychiatric symptoms in individuals with MCI and AD. Hypothesis: The number of COVID-related factors endorsed by caregivers will be positively correlated with the severity of NPI-Q in individuals with MCI and AD. Aim 2. To assess cognition (telephonic version of the Montreal Cognitive Assessment; tMoCA12, and daily function (Functional Activities Questionnaire; FAQ13). Hypothesis: The number of COVID-related factors will be positively correlated with the severity of cognitive and functional deficits in individuals with MCI and AD. Aim 3. To explore the associations among COVID-related factors and caregiver distress. Hypothesis: Caregiver resilience and perceived social support will modify the association between COVID-related factors and severity of distress in caregivers.

Application for Arts-Based Social Prescribing

The goal of this clinical trial is to learn if a personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app (SocialRx App) can improve mental health and social connectedness in adolescents aged 15-18 with depression or anxiety enrolled in Medicaid managed care. The main question it aims to answer is: Compared to stable treatment, does participation in the Art Pharmacy program through the SocialRx App improve depression, anxiety, social connectedness, and loneliness? Researchers will compare participants receiving the Art Pharmacy program and digital companion to those receiving stable treatment (no change to existing care) to evaluate its effects on mental health and social connectedness. Participants will: Be randomly assigned to either the Art Pharmacy program delivered through the SocialRx App or a control group receiving stable treatment. Complete online surveys at baseline and follow-up time points (e.g., 3, 6, 9, and 12 months). If assigned to the intervention group, Art Pharmacy, participants will receive monthly arts and cultural activity recommendations, attend activities, and interact with a care navigator delivered through the SocialRx App.

Evaluating the Effectiveness of Interventions to Reduce Loneliness in Chinese Young Adults

This study aims to evaluate the effectiveness of a group-based Positive Affect (PA) intervention compared to an active control condition, Social Skills Training (SST), in reducing loneliness among young adults in Hong Kong and mainland China. It further examines the psychological mechanisms underlying intervention effects, specifically the roles of positive affect and perceived social support as mediators, and rejection sensitivity as a moderator influencing both treatment responsiveness and outcome translation.

Community-Based Social Connection Intervention Program to Improve Cardiovascular and Brain Health

This study evaluates the effectiveness of a community-based social connection intervention program (SCIP) designed to reduce social isolation and loneliness and improve cardiovascular and brain health among older adults living in rural Ecuador. Loneliness and social isolation are recognized risk factors for poor cardiovascular outcomes, cognitive decline, depression, and reduced quality of life. However, evidence from low- and middle-income countries, particularly in rural Latin American settings, remains limited. This protocol describes a quasi-experimental, longitudinal study conducted in three rural villages that have been part of a long-standing population-based cohort. The intervention will be implemented in one community and compared with two similar communities that will continue receiving usual community activities. SCIP consists of three components: (1) monthly community activities and educational talks designed to promote social participation; (2) monthly peer-support group sessions facilitated by trained personnel; and (3) individualized home-based coaching delivered twice per month, incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy. The program aims to strengthen social networks, enhance coping skills, and promote healthier behaviors. Participants aged 60 years and older will be enrolled and followed for 12 months. Assessments will occur at baseline, 6 months, and 12 months. Primary outcomes include changes in social isolation (Lubben Social Network Scale-6) and loneliness (De Jong Gierveld Scale). Secondary outcomes include cardiovascular health (Life's Essential 8), sleep quality (Pittsburgh Sleep Quality Index), cognitive performance (Montreal Cognitive Assessment), depressive symptoms (DASS-21), and quality of life (SF-36). Exploratory outcomes include incident stroke, cardiovascular events, and mortality, monitored through ongoing community surveillance. This study will generate evidence on the feasibility and impact of a culturally adapted, community-based intervention to promote social connection and healthy aging in a resource-limited rural setting. Findings may inform scalable public health strategies for older adults in similar contexts.

INcreasing Adolescent Social and Community SupporT - Full Trial

Background: Social Prescribing is a mechanism of connecting patients with non-medical forms of support within the community and has been shown to improve loneliness. Yet update from young people has been lower than for adults. This is thought to be due to accessibility issues as young people are less likely to draw on primary care, where social prescribing is based, for wellbeing support. The INACT pilot sought to test the feasibility and acceptability of a Social Prescribing pathway via schools to support young people who are lonely through a randomised controlled trial. Findings suggested that study procedures, including the measures were appropriate and that Social Prescribing was deemed by young people, social prescribers and school staff as feasible, acceptable and suitable and there was evidence of impact in the social prescribing arm when compared to signposting. Given the positive pilot findings, the aim of the INACT full trial is to build upon the pilot work and conduct a clinical and cost effectiveness trial into the impact of Social Prescribing in schools for loneliness and low community connection, compared to signposting. Methods: A minimum of 215 pupils reporting loneliness will be recruited across 30 mainstream schools in England and be randomly allocated to signposting or Social Prescribing. Pupils in the control group will receive signposting to sources of support from school staff. The co-produced social prescribing intervention includes up to 6 sessions with a Link Worker who will work with individuals to understand 'what matters to them' and connect them with local sources of support. The clinical and cost effectiveness of Social Prescribing for young people with loneliness will be assessed using measures of loneliness, mental health, wellbeing, quality of life, and service use. Data will be collected at baseline and 3, 6, and 12 months later. Qualitative interviews will also be conducted to explore barriers, facilitators, mechanisms of change and impact. Discussion: INACT will provide evidence of the clinical and cost effectiveness of Social Prescribing in schools for supporting young people experiencing loneliness. It will also establish what types of community and social activities young people engage in and what factors affect participation.

Creating Encounters Between Generations - Together Instead of Alone (GemsE)

Elderly people and children and young people (CYP) and from families with mentally ill parents are particularly affected by loneliness. The GemsE project is investigating whether intergenerational mentoring between seniors and children or young people helps to reduce loneliness and improve the mental well-being and quality of life of both groups. The aim of the study is to scientifically record the effect of these sponsorships and to find out how such encounters can be successfully organized.

Improving Social Connectedness Through Digital Health to Enhance Recovery From OUD Among the Justice Involved Population

People with a history of Opioid Use Disorder and criminal justice involvement are more likely to experience loneliness following release from jail/prison leading to negative outcomes such as treatment dropout and increased substance use. Providing peer recovery support, particularly through a highly accessible, digital health platform, is a potential way to decrease loneliness in this population. The current study seeks to test whether a mobile peer recovery support app, delivered to individuals with a recent history of taking medication for opioid use disorder while in jail/prison, will improve outcomes for this vulnerable population.

Reducing Loneliness of Older Adults in Long Term Care Facilities Through Collaborative Augmented Realities

The goal of this clinical trial is to test the use of head-mounted display (HMD) augmented reality (AR) in older adults residing in communities or assisted care facilities. The main questions it aims to answer are: what is the feasibility, acceptability, and satisfaction of HMD AR vs two-dimensional audio-video communication? Older adults and their designated family member will complete HMD AR activities in 8 session visits over 4 weeks. Researchers will compare HMD AR to 2-D audio-visual (AV) comparison group on feasibility, acceptability, and satisfaction with the interactive communication technology.

Social Factors in the Mental Health of Young Adults: Bridging Psychological and Network Analysis

The central goal of this project is to produce a novel, precise, and comprehensive account of social factors in young adult mental health - using a novel combination of network nominations, ecological momentary assessment, and neuroimaging methods. To that end, the investigators will collect data from two successive classes of college undergraduates (i.e., classes of 2023 and 2024) over the course of their collegiate tenure.

Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention

This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.

Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content

This study evaluates the effectiveness of additional content on loneliness offered alongside the Wellbeing Course - an internet-delivered cognitive behavioral therapy (ICBT) intervention for symptoms of depression and anxiety- in improving treatment outcomes for individuals with elevated scores on loneliness seeking treatment for depression and anxiety at a routine care online therapy clinic (the Online Therapy Unit). In this partially randomized control trial, the investigators aim to contribute to the literature by examining whether providing additional content on loneliness alongside the Wellbeing Course enhances engagement, satisfaction, and treatment outcomes among clients experiencing frequent loneliness compared to those completing only the Wellbeing Course. Over 8 weeks, participants will review course materials (with the addition of the loneliness content for those assigned to the loneliness content condition) online and complete questionnaires assessing changes in various outcomes over time.

Sauna for Offline Connections and Interactive, Authentic Living

This pilot trial will test an intervention (sauna visits) targeting reductions in loneliness in adults aged 19-22 years. Participants will: * Visit a sauna in San Francisco once per week for 2 hours by themselves or with a friend, for 8 weeks total * Complete online surveys throughout their participation The main question this pilot trial aims to answer are: * To what extent do participants find the study design acceptable? * To what extent do participants complete the weekly sauna visits? * To what extent do participants complete the weekly online surveys?

The Effects of Group Music Therapy on the Emotional Health of Residents in Long-Term Care Facilities: A Pilot Study

The goal of this pilot study is to learn whether group music therapy improves the emotional health of residents living in long-term care facilities. It will also examine the feasibility of integrating an artificial intelligence (AI)-based emotion recognition model into routine psychosocial interventions. The main questions it aims to answer are: Does group music therapy improve positive affect and reduce negative affect, depression, and loneliness among long-term care residents? Are AI-based facial emotion recognition results consistent with residents' self-reported emotional assessments? Researchers will use a one-group pretest-posttest quasi-experimental design to evaluate changes before and after a 6-week group music therapy program. The study will also compare subjective questionnaire results with objective facial emotion recognition outputs generated by the PaLI Gemma 2 multimodal model. Participants will: Attend one 60-minute group music therapy session per week for 6 weeks Complete emotional health questionnaires before the first session and after the sixth session Be recorded during sessions using a non-invasive camera system for facial emotion analysis Have their questionnaire results compared with AI-based emotion recognition outputs to evaluate consistency and feasibility This pilot study will provide preliminary evidence regarding both the psychological benefits of group music therapy and the feasibility of applying AI-supported multimodal emotion assessment in long-term care settings.

Technology Exposure and Child Health: Wellness Impact and Social Effects: An Observational Product Registry Study

The goal of this study is to understand how children's mobile device usage (smartphones or tablets), including social media use and online games, are related to their mental wellness and mental health, as well as some aspects of their physical activity and sleep. This study is available to all children between the ages of 8 and 17 years and a parent/caregiver. Researchers will compare participant mobile device usage with their survey responses on sleep, stress, mental health, and physical activity, as well as their parent/caregiver's survey responses. Participants will: * run the Aura app with parental controls on their dedicated mobile device * complete monthly surveys * answer daily questions on mood, stress, sleep and physical activity The study is fully virtual. Duration is 3 months.

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.

The Role of Solo Music Listening in Reducing Loneliness and Increasing Social Connectedness in Older Adults

Loneliness has become an increasingly prevalent concern among older adults. A number of adverse physical and mental health outcomes may result from loneliness in this age group including cognitive decline and depression. These outcomes may lead to a higher strain on healthcare systems. Finding accessible and cost-effective strategies for reducing loneliness and increasing feelings of social connectedness is important for the well-being of older adults. Solo music listening is commonly used to regulate emotions and to promote well-being. While some preliminary evidence suggests that these benefits may extend to loneliness, research has not been clear on the functions or qualities of music that are most effective for older adults. This research project will consist of two parts. In Part 1, an interview will be conducted with older adults to determine what functions of music are most often used and most beneficial when their goal is to reduce loneliness. Part 2 will consist of a between-subjects experiment with four conditions. The top three characteristics obtained from Part 1 will represent the three music conditions, and the fourth condition will be a pink-noise control. Prior to the experiment, participants will self-select three pieces from each of the three music conditions. After selecting their music, they will be randomly assigned to either a music or pink-noise condition. Participants in the three music conditions will listen to the three self-selected pieces that adhere to their assigned condition. Loneliness and social connection outcomes will be assessed before and after listening using a Visual Analogue Scale (VAS). Potential moderators will be assessed after listening, which include nostalgia, absorption in music, and music reward. The results of this project will clarify whether psychological benefits of decreased loneliness and increased social connectedness can be found through music listening to enhance well-being, and whether singing along provides additional benefits. These findings may also be useful in developing future music-based interventions for reducing loneliness.

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.

The Impact of Social Worker Referrals on Diabetes and Loneliness

The goal of this clinical trial is to learn if referral to a social worker (social prescribing) can help reduce loneliness and improve blood sugar control (A1C) in older adults with diabetes. It will also help us understand how this approach can support overall well-being in seniors. The main questions it aims to answer are: * Does referral to a social worker reduce feelings of loneliness in older adults with diabetes? * Does this support improve blood sugar control (A1C)? Researchers will compare social worker referral to usual diabetes care to see if this approach improves both social well-being and diabetes outcomes. Participants will: * Be assigned (like flipping a coin) to either meet with a social worker or continue their usual care * Complete a short 3-question loneliness survey at the start and again after 6 months * Have their A1C levels reviewed from their routine medical records

An Innovative App-based Intervention to Promote Social Connectedness and Well-being in Older Adults

This study evaluates the impact of a group-based intervention designed to promote social connectedness and enhance psychological well-being among older adults. The intervention lasts four months and is supported by a dedicated mobile application that helps participants discover local social activities, connect with peers who share similar interests, and stay informed about community events, with the aim of supporting (not replacing) in-person interactions. This randomized controlled trial assigns participants either to a treatment group, which receives digital literacy training, access to the app, and structured support from the research team to facilitate social engagement within their local community, or to a waitlist control group, which receives access to the app only after the study period. Assessments are conducted at baseline, post-intervention (4 months), and at a 2-month follow-up. The study evaluates changes in social connectedness, loneliness, psychological well-being, and technology use, using a mixed-methods approach combining self-report questionnaires, app-usage data, and qualitative feedback.

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.

Keep Social Study for Young Adults

The Keep Social randomized control trial (RCT) is a 6-week, online study which will test whether, relative to a placebo control condition, an intervention that encourages high-quality in-person social interactions with strangers and acquaintances reduces young adults' (ages 18 - 29) social isolation and loneliness. Participants will complete our 6-week protocol, which includes 6 weeks of passive ecological behavior sampling (i.e., geotracking) and Day Reports, our 4-week Invibe social media messages, plus recurrent Biweekly Assessments (BW1-BW4) that include both self-reported and behavioral measures. The first Monday following enrollment, participants complete the BW1 baseline survey to assess demographic characteristics and initial levels of all outcome variables (primary and secondary, \~20 min). They also (optionally) activate passive geotracking on this day and leave it activated, continuously, for the duration of the study. During the 2-week baseline and 4-week Invibe phases, time-varying psychological and behavioral mediators and moderators will be assessed three times per week via Day Reports. To increase ecological validity, each week, two weekdays (i.e., Monday, Tuesday, Wednesday, or Thursday), and one weekend day (i.e., Friday, Saturday or Sunday) will be randomly selected. Day reports will not be assigned on Mondays if there is a biweekly assessment scheduled.

Social Media Diet and Psychological Outcomes in University Students

This study aims to examine the effect of a social media diet intervention on loneliness, fear of missing out (FoMO), and sleep quality among university students. Excessive social media use has been associated with several negative psychological outcomes, including increased loneliness, heightened FoMO, and poor sleep quality. In this randomized controlled trial, university students will be randomly assigned to either an experimental group or a control group. Participants in the experimental group will follow a social media diet intervention that involves limiting daily social media use for a specified period, while participants in the control group will continue their usual social media use without restrictions. Loneliness, FoMO, and sleep quality will be measured at baseline and after the intervention using validated scales. The findings of this study are expected to provide evidence on whether reducing social media use can improve psychological well-being and sleep quality among university students.

Adapting and Pilot Testing a Loneliness Intervention for Cancer Survivors

Loneliness, which is the perceived lack of social support and connection, has increased substantially in the past decade and is adversely affecting the health and wellbeing of cancer survivors. The study seeks to test an intervention that builds on the principles of social prescribing, and targets loneliness to determine if it improves overall wellness and quality of life among cancer survivors.