Clinical Research Directory

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.

STEPS - Stress Training and Engagement Via Phone-Based Systems

This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application. Participants will be individually randomized to one of several app-based training programs using a stratified randomization procedure. Each program consists of guided daily lessons completed over a 14-day period and is designed to support stress management and well-being through structured skill development activities. Primary objectives include evaluating user satisfaction and usability of the digital platform and assessing changes in mindfulness-related skills and mental distress over time. Participants will: Complete surveys assessing demographics and psychological well-being at baseline, post-intervention, and one-month follow-up. Complete a 14-day smartphone-delivered training program consisting of guided lessons while physiological data are collected using wearable sensors. Some participants may receive additional in-app features designed to support personalized learning or engagement with training lessons. Some participants will complete brief questionnaires before and after selected lessons to assess short-term changes associated with lesson participation.

A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise).

Music Program for Hong Kong Adolescents: Improving Emotion Regulation and Reducing Depression, Anxiety, and Loneliness

This study is a clinical trial that aims to test and validate a music-based program called "Tuned In" in helping adolescents in Hong Kong improve their mental well-being. The researchers want to find out if the program can help participants enhance their ability to regulate their emotions, reduce mood symptoms and feelings of loneliness. Participants in the study will be randomly assigned to either the group that receives the program right away (intervention group) or the group that waits for four weeks before receiving the program (wait list group). They will take part in a group-based weekly program for four weeks. Additionally, they will be asked to complete questionnaires before and after the program to see if there are any changes in their mental well-being. The program will be delivered by a facilitator with a psychology background, and a registered music therapist. By addressing the gaps in mental health interventions for young people in Hong Kong, this study aims to contribute to the development of effective strategies to support their emotional well-being.

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.

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.

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.

Student Precarity and Psychiatry

Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship. Students often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment. The aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services. Our study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.

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.

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.

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.

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.

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.

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.

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 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.