Clinical Research Directory

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.

BLOOM: Boldly Living outdOOrs for Mental Health

In 2019, the Office of the California Surgeon General launched the ACEs Aware Initiative in collaboration with the California Department of Health Care Services. This ambitious campaign aims to develop a network of care model of healthcare delivery that explicitly links health resources within communities to clinicians screening patients for ACEs. The ACEs Aware Initiative recognizes nature experiences as one of seven "stress busters." Indeed, California boasts many outdoor resources for clinicians to integrate into the network of care. Through a calming effect on the autonomic nervous system, providing a setting for supportive relationships to develop and physical activity to occur, time in nature may help California prevent, heal and treat ACEs and the clinical sequelae. As one of the most common psychiatric disorders in youth, anxiety remains one of the most important sequelae of ACEs. There is a gap in evidence evaluating nature-based programs for child mental health. This study will evaluate BLOOM \[Boldly Living outdOOrs for Mental health\], a new intervention which is a modified version of an existing nature-based curriculum called SHINE (Stay Healthy In Nature Everyday) curriculum currently in place at UCSF Benioff Children's Hospital Oakland, which takes youth and their families into nature once a month for stress relief. This new intervention mirrors SHINE except that it will be tailored to children ages 9-12 with a history of ACEs and current anxiety. This study will evaluate the benefits of a group intervention model, an independent nature-outing model, and a comparison to a wait-listed control group. Our goal is to provide a scalable model for low-cost mental health care to the California Department of Health Care Services.

Sauna for Offline Connections and Interactive, Authentic Living

This pilot trial will test an intervention (sauna visits) targeting reductions in loneliness in adults aged 19-25 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?

Modifiers and Mechanisms of Loneliness Interventions

A specific aim of this research is to identify the role of emotion regulation in response to social threat in caregivers' response to a behavioral coaching intervention for loneliness. A second aim of the study is to determine the benefit of a digitized, social engagement prioritization tool for improving coaches' intervention fidelity and caregiver outcomes. This study is funded through the Pilot Award Program of the Rochester Roybal Center for Social Ties \& Aging Research, a UR Center funded by the National Institute on Aging by grant P30AG064103.

Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.

Meditation and Psychophysical Well-Being in Elderly

The goal of this experimental study is to assess whether a mindfulness-based meditation intervention can reduce loneliness and improve psychophysical well-being in older adults (aged 65 and above). The main questions it aims to answer are: * Does the intervention reduce the perception of loneliness in older adults? (primary outcome) * Does it improve various aspects of psychological well-being, including social isolation, depression, life satisfaction, mindfulness, emotional regulation, self-acceptance, and sleep quality? (secondary outcomes) Researchers will compare the intervention group with a passive control group (waiting-list control) to determine whether the mindfulness-based intervention leads to significant improvements in the measured outcomes. Participants will: Complete baseline assessments, including neuropsychological tests and validated questionnaires, before the intervention. Undergo a 12-session mindfulness-based intervention over 6 weeks, consisting of guided breathing, focused attention, physical relaxation, and emotional awareness exercises. Complete post-intervention assessments to measure changes in their psychological and physiological well-being.

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.

Latin Dance and Psychological Health in Primary School Children

This study aims to examine the effects of a 12-week Latin dance intervention on loneliness, anxiety, depression, perceived stress, physical activity enjoyment, and well-being among primary school children in Gansu, China. Eligible participants will be randomly assigned to either a Latin dance intervention group or a control group. The intervention group will participate in two supervised Latin dance sessions per week, including Rumba, Cha-cha, and Jive, while the control group will participate in regular physical education activities. The outcomes will be assessed before and after the 12-week intervention using validated questionnaires. The findings may provide evidence regarding the effectiveness of school-based Latin dance as a strategy for promoting children's psychological health and well-being.

Geriatric Trauma Care Program for Living Alone Older Adults With Injuries

To examine the long-term effects of the Geriatric Trauma Care Program (GTCP) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone.

Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth. The main questions this study aims to answer are: * Does using the chatbot improve postpartum pelvic floor health knowledge? * Does using the chatbot help reduce feelings of loneliness during the postpartum period? * Does using the chatbot impact pelvic floor symptoms? Researchers will compare standard postpartum care to standard care plus the chatbot. Participants will: Be assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot. If in the chatbot group, participants will receive education and support via the chatbot over a 4-week period. Both groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress. The chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.

BabaCare: Testing a Care Copilot

Baba is a novel AI "care copilot" designed to improve emotional well-being, cognitive stimulation, and social connection through emotionally present conversations, proactive engagement, and personalized communication. Unlike many existing solutions, Baba operates through SMS text and voice calls, requiring no apps, Wi-Fi, or new devices, making it particularly accessible to older adults.

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.

Technology and Family Thriving Study

The purpose of this project is to test the impact of different forms of technology (virtual reality vs. video chat) on quality of life and family relationships in older adults who reside in senior living communities and an adult child who lives at a distance. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

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.

Structured Opportunities for Connection to Improve Aging-related Loneliness

The goal of this early phase clinical trial is to determine the impact of participation in planned social activities among adults 55 years of age or older, who report feelings of loneliness. The main questions the study aims to answer are: * With the availability of a personalized community activity plan, will patients with loneliness participate in two hours of social activity each week? * Will 2 hours/week of planned social activities in the community reduce individual reports of loneliness? Participants will meet with a community coordinator to identify community activities of interest to them and then participate, in-person or virtually, in these activities over a 6 month period. Patients will complete a series of surveys at the start of the study and then at 1, 3 and 6 months later.

The Effects of Psilocybin on Social Connectedness

The study is a randomized, double-blind, placebo-controlled, expectancy-controlled, mechanistic trial. This study looks to explore whether a single dose of psilocybin (25mg) reduces amygdala reactivity to negative socioemotional stimuli during the Facial Emotion Recognition Task (FERT) compared to a placebo in adults who feel lonely or those with unresolved grief symptoms.

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.

Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention

The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels.