Clinical Research Directory

AYA-PeerConnect: A Communication Coaching Intervention for Adolescent/Young Adult Cancer Survivors (AYACS)

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

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.

CAPABLE Care + Connect

In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.

Optimizing Medical Decisions and Care for Adult Orphans

This study aims to evaluate the effectiveness of a training program designed to improve clinicians' ability to care for adult orphans. A randomized controlled trial will be conducted to examine the effects of the training program on clinicians' knowledge, self-efficacy, and clinical practice related to caring for adult orphans at baseline, 1 month, and 3 months after the intervention.

Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection

Despite the high risk of suicide among LGBTQ+ Veterans, there is currently no suicide-focused intervention for this population. This study will refine and pilot Qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. The project will involve Veterans with lived experience in further refining Qnnections, and then will examine feasibility and acceptability of Qnnections and of study procedures in a pilot randomized clinical trial.

Social Prescribing and Relationship Cognitive Strategies (SPARCS)

The study team is testing the acceptability and feasibility of two treatments for improving loneliness: Social Prescribing and Brief Cognitive Therapy. For this pilot study, the study team have adapted these treatments for Collaborative Care and are studying whether these are practical and well-received by patients that might use them.

Need to be Needed (N2BN) Intervention

The proposed study is a randomized, controlled trial (RCT) that will examine the effectiveness of an intervention designed to reduce social isolation and loneliness of adults with serious mental illness (SMI). The intervention will focus on improving their sense of mattering by using acts of kindness and experiencing gratitude through volunteering. 120 participants will be randomly assigned to the intervention group or the attention control group. Over the course of the 6-month intervention, participants in the intervention arm, will receive weekly support from the interventionist. The interventionist and the participant will collaboratively set goals and develop an initial intervention plan, which is informed by the participants interests, values and goals. The attention control group will receive non-directive listening support through research assistants. Data collection for all participants will occur at baseline, at the mid-point of the intervention at 3 months, and at the end of the 6-month intervention. Participants will be asked questions about quality of experience, social context and satisfaction, mattering components, kindness, gratitude, and loneliness. We will gather data on demographic background, life transitions, social network characteristics, internalized stigma, neighborhood climate, depression, and trait measures of mattering and loneliness during intake and exit interviews. Additionally, participants of the intervention arm will be asked to provide feedback about the intervention.

Digital Nutrition Intervention for Older Adults

The "digital divide" or gap in technological access and knowledge, for older adults has worsened during the COVID-19 pandemic, leading to disruptions in services like congregate meal programs funded by the Older Americans Act. Seven San Antonio congregate meal sites remained partially open biweekly to distribute meals but no longer offer in-person nutrition education, physical activity classes, and social activities. The proposed project will test the efficacy of digital nutrition intervention with at-risk older adults who attend congregate meal center in areas of high poverty and digital exclusion. The study is uses a stepped-wedge cluster clinical trial. Key community partners with the Department of Health Services Senior Services Division and Older Adult Technology Services (OATS) will participate in the planning phase, research design, and implementation of the study. The study aims are: 1. To test the impact of a technology-based intervention on the primary outcomes of food security and diet quality; 2. To determine the effect of the intervention on secondary outcomes of technology knowledge and usage, physical activity, and social isolation and loneliness; 3. To examine the long-term impact and sustainability of technology use on food security, diet quality, physical activity, and social isolation. If successful, the impact of this program could be applied throughout the national OATS network and to similar CMPs to bridge the digital divide beyond the COVID-19 pandemic

Intervening on Opioid Use and Loneliness

This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.

Sisters of Heart (Hermanas de Corazón): A Community Health Worker Initiative for Improving Heart Health in Migrant Farmworker Women

The goal of this hybrid Type 1 effectiveness-implementation trial is to test the extent to which a peer support and community resource navigation intervention improves psychological well-being, addresses social determinants of health and thus reduces cardiometabolic risk among rural, migrant, low-income farmworker women aged 18-45 years. The main questions it aims to answer are: * If and to what extent does the intervention reduce stress, social isolation, and psychological distress by improving social support and access to needed resources? * If and to what extent does the intervention improve cardiometabolic health, measured by the American Heart Association's Life's Essential 8 (LE8) score? Researchers will compare the CHW-led Sisters of Heart (Hermanas de Corazón) intervention to a Basic intervention (LE8 assessment and resource information) to assess the effect of peer support and community resource navigation on heart health outcomes.

Fostering Agricultural Relationships and Meaning - Thriving on Kinship

This study aims to enroll 65 participants who will be assigned to one of two groups. Each group will receive an intervention consisting of six weekly sessions of 40-60 minutes each. Eligibility includes residing in an agricultural area and reporting loneliness or feeling alone or disconnected.

Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming

Older adults in Canada are experiencing increasing levels of social isolation, loneliness, and mental health challenges, including anxiety and depression - trends that have worsened during and following the COVID-19 pandemic. Research consistently shows that loneliness and social isolation are associated with poorer mental and physical health outcomes, increased risk of dementia, and increased mortality. At the same time, social connection has a strong protective impact on health and well-being. Community-based programs that promote both social engagement and psychological support are urgently needed, particularly since older adults are less likely to access formal mental health services. Approximately 3-11% of older adults meet diagnostic criteria for mood or anxiety disorders each year, with even more experiencing elevated symptoms that greatly influence quality of life. Subsyndromal depression in late life is estimated to occur two to three times more often than major depressive disorder. Despite these needs, up to 70% of older adults with anxiety or mood disorders do not access psychological services, often due to low mental health literacy or practical barriers to care. At the same time, participation in community activities is associated with improved emotional well-being, greater social support, and lower rates of depression and anxiety. To bridge this need for support, our team developed and pilot-tested The CONNECT Program - a group-based mental health intervention for adults 55 years and older, delivered via telephone or virtually. The CONNECT Program is grounded in Acceptance and Commitment Therapy (ACT), self-compassion, and theories of successful aging, and aims to improve psychological flexibility; reduce loneliness, social isolation, and co-occurring symptoms of depression and anxiety. A Manitoba pilot study (N = 34) demonstrated promising outcomes in terms of feasibility, acceptability, and preliminary effectiveness with the telephone-based group intervention. The current trial will evaluate the implementation and effectiveness of The CONNECT Program in four Canadian provinces (British Columbia, Manitoba, New Brunswick, Saskatchewan), using an implementation-effectiveness hybrid design and a crossover randomized controlled trial. This study compares The CONNECT Program, delivered via telephone or virtually, to routine community programming (i.e., community participation as usual), which may occur in telephone, virtual, or in-person formats. The primary outcome is psychological flexibility; secondary outcomes include loneliness, social isolation, anxiety, depression, emotional support, mental health literacy. Implementation outcomes will be evaluated following the Proctor et al. framework. This trial will contribute evidence on the mental health needs of adults 55+ and the value of low-barrier, community-based programs delivered remotely. Findings will guide further national and international implementation of The CONNECT Program and similar initiatives aimed at addressing the challenges of loneliness, social isolation, and mental health problems in late life.

Health Surveillance at University of Applied Science Hamburg (HAW)

The aim of Health Surveillance 2025 is to analyze and describe the state of health of employees at University of Applied Science Hamburg, key influencing factors and individual resources.

Increasing Veterans' Social Engagement and Connectedness

Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.

The VESPA Pilot Study

Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change. A half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are: Specific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults. Specific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.

Effectiveness of a Mobile Application in Improving Employees' Social Well-being.

The goal of this cluster randomized controlled trial is to learn if using Frendie PRO mobile application at workplaces improves social well-being in employees. The main questions it aims to answer are: Does using Frendie PRO mobile application at work for 6 months reduce loneliness in employees? Does using Fendie PRO mobile application at work for 6 months reduce social isolation in employees? Researchers will compare employees from workplaces that use the Frendie PRO mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms). Participants will be given access to the Frendie PRO mobile application and encouraged to use it by employers.

Evaluating Implementation and Impact of Provincial Scale-up of the Adapted Choose to Move (CTM) Program

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In this project, the investigators will support community-based seniors' services (CBSS) organizations across BC through a readiness-building process so they can adapt CTM and deliver the program to more diverse groups of underserved older adults than have previously participated in CTM.

Evaluating Implementation and Impact of the Adapted Choose to Move (CTM) Program

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In Phase 5, the goal of CTM is to enhance physical activity, mobility and social connectedness in three target populations: South Asian older adults, older men, and older adults living in Northern BC. To do so, the investigators will support community-based seniors' services (CBSS) organizations through a readiness-building process so they can adapt CTM and deliver the program to these populations. This study has two main research questions: 1. How are adapted CTM programs delivered ('implementation outcomes') and what factors influence delivery ('implementation determinants')? 2. What is the impact of the adapted CTM programs on health outcomes of older adults?

Walk and Talk: Connecting People With Psoriasis

The main aim of this study is to determine the acceptability, representativeness (e.g. age, sex, ethnicity and body mass index) and ideal format of a Walk and Talk intervention for people with psoriasis. Secondary aims are determining outcome measures of the intervention (patient related outcome measures, social connectedness, physical activity, cardiovascular risk) Other objectives are to determine relevant outcome measures and sample size needed to statistically evaluate a future, larger study. There have been no similar studies evaluating social interventions in people with psoriasis, so an exploratory study is needed to calculate how many people are needed to participate. Measures will include social connectedness (loneliness), physical activity, cardiovascular risk, psychological wellbeing, quality of life and psoriasis severity. Psoriasis is a systemic disease with multiple co-existent health issues. People with psoriasis are more socially isolated and inactive than the general population. The health implications of social isolation are now recognised and thought to be equivalent to smoking. Consequently social prescribing is increasingly used for people living with long-term conditions. Specifically group walking activities are effective at increasing physical activity and improving mood. Additionally, disease specific walking groups provide peer psychosocial support. It seems likely that a group walking intervention for people with psoriasis could promote social connectedness, increase physical activity and provide peer psychosocial support. However, as people with psoriasis avoid social contact, have low levels of physical activity and difficulty in discussing feelings, it is possible a Walk and Talk activity may not be taken up by many, or only by specific sub-groups such as young, slim, white people. Hence the need for an exploratory study before committing to a larger adequately powered study. Ultimately the investigators anticipate a format for Walk and Talk groups that is specifically tailored for people with psoriasis may enable groups to be rolled out at centres nationwide

Community Navigators

The Temple University Collaborative on Community Inclusion (TU Collaborative) is testing a community navigation intervention study based upon effective health navigation models by conducting a randomized controlled trial of the intervention to establish feasibility, efficacy, and outcomes among adults with serious mental illness (SMI).

Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults

In this study, participants will be randomly assigned to receive either the intervention or control treatment for up to 6 months. Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant: (i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences). Participants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans. We are interested in learning about the number and demographic characteristics of participants we will be able to recruit to the study, who will remain in the study and who will be adherent to their prioritized treatment recommendations. We are also interested in learning about changes in participants' quality of life, proportion of IADLs being completed independently or with support, emergency department visit rate, and hospitalization rate at 3 and 6 months.

e-Intervention Enhancing Mental Health in Adolescents

The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study will co-design, test, evaluate, and facilitate the upscaling of a modular eHealth intervention platform that aims to improve mental health and wellbeing, early detect mental health problems and prevent common mental problems in adolescents. IMPROVA will be implemented in school settings and will include components for adolescents, parents, teachers, and other school staff in complementary and synergistic modules based on materials designed and tested in \>20 projects carried out by the consortium members. After alpha, beta and pilot testing of the platform, the IMPROVA program will be implemented via a randomised controlled trial in secondary education schools in France, Germany, Romania and Spain, including approximately 6,000 adolescents. A 360º evaluation of IMPROVA will include Effectiveness, Implementation, Economic, and Social Return on Investment analysis. The primary outcome to assess the effectiveness of the IMPROVA program is the overall mental health of adolescents. A series of secondary outcomes will also evaluate the potential impact of the platform on other health-related outcomes (e.g., wellbeing, social isolation, anxiety, life satisfaction). Using implementation science methodology, IMPROVA will co-design transferable evidence-based guidance for scaling up the platform with users and policymakers. IMPROVA aims to provide an evidence-based, innovative, large-scale, comprehensive intervention, and a scale-up plan to promote mental health and prevent mental disorders in adolescents; empower adolescents and families to make better decisions regarding their mental health; and provide schools and the community with tools to achieve a society with better mental health and lower stigma.

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.

Telepsychiatry for Social Isolation in Youths

This clinical trial aims to implement multimodal digital interventions for adolescents and young adults with social isolation (SI) and their family members. Furthermore, the neurobiological basis of SI will be explored by analyzing blood neuroinflammation biomarkers in socially isolated participants. The main questions that this project aims to answer are: * What is the general feasibility and applicability of the proposed digital interventions? * What is the effect of the proposed digital interventions on the SI-related clinical symptoms and the cognitive and global functioning of participants with SI? Participants will be asked to undergo: * A detailed clinical and neuropsychological evaluation (pre-post treatment) * A blood sample (pre-post treatment) * A telepsychiatry intervention (cognitive behavioural therapy (CBT) and/or cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members) The researchers will compare SI participants treated with CBT+CR (experimental group) with SI patients treated only with CBT (control group) to see if the combined intervention of the experimental group leads to more durable and generalizable effects. The same PE intervention will be offered to the family members of all recruited SI participants.