Social Isolation

20

Review clinical trials related to Social Isolation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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.

Participants needed: 264
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Jun 29, 2026Locations: 1
Eligibility criteria

Must be Veterans at the Roudebush Veterans Affairs Medical Center or its Communi... [+1]

Active suicidal ideation needing immediate mental health treatment [+3]

Status: Not yet recruiting

Social Prescribing for a Mindful Lifestyle

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

Participants needed: 50
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: Buddhist Tzu Chi General HospitalUpdated: Jun 25, 2026Locations: 1
Eligibility criteria

People aged 55 years or older. [+2]

People that are unable to cooperate with the project or follow-up. [+4]

Status: Recruiting

Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in 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 non-biologic drivers of health (access to healthcare, supportive services, nutrition, housing stability, transportation, chronic stress, social support), and thus reduces cardiometabolic risk among rural, low-income farmworker women aged 18-50 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 for Heart Health 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.

Participants needed: 269
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Emory UniversityUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Self-identified female employed as a farmworker; [+2]

Cognitive or psychological impairment precluding informed consent and/or active... [+1]

Status: Recruiting

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.

Participants needed: 450
Trial details
Age: 50+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jun 2, 2026Locations: 1
Eligibility criteria

Any patient currently in JHOME [+12]

Terminally ill [+2]

Status: Recruiting

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.

Participants needed: 10
Trial details
Age: 18-35Biological sex: AllType: InterventionalSponsor: Milton S. Hershey Medical CenterUpdated: May 22, 2026Locations: 1
Eligibility criteria

Participant is currently ≥18-35 years old [+4]

Participant is not fluent in written and spoken English [+2]

Status: Not yet recruiting

Testing a Peer-Support Group for Veterans Who Hear Voices

Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.

Participants needed: 160
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Apr 29, 2026Locations: 2
Eligibility criteria

Has been experiencing auditory hallucinations at least weekly within the past 6... [+2]

Psychosis exclusively due to substance use [+4]

Status: Recruiting

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.

Participants needed: 66
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Mar 12, 2026Locations: 1
Eligibility criteria

Veterans who report past-month active suicidal ideation (C-SSRS [Columbia-Suicid... [+3]

cannot provide informed consent; [+4]

Status: Recruiting

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.

Participants needed: 120
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: Temple UniversityUpdated: Jan 21, 2026Locations: 1
Eligibility criteria

A research diagnosis of Major Depression, Bipolar I, II, or Schizophrenia Spectr... [+4]

Having a legal guardian [+2]

Status: Recruiting

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.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of RochesterUpdated: Dec 9, 2025Locations: 1
Eligibility criteria

Must be 18+ [+3]

does not understand consent [+1]

Status: Recruiting

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.

Participants needed: 65
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Ohio State UniversityUpdated: Oct 21, 2025Locations: 1
Eligibility criteria

18 years of age or older [+5]

unable to give informed consent [+4]

Status: Recruiting

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.

Participants needed: 128
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: University of ManitobaUpdated: Sep 19, 2025Locations: 1
Eligibility criteria

Adults aged 55 years or older [+3]

Cannot communicate in English (verbal or written)

Status: Recruiting

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.

Participants needed: 30
Trial details
Age: 45-80Biological sex: AllType: InterventionalSponsor: Wake Forest UniversityUpdated: Jul 16, 2025Locations: 1
Eligibility criteria

Age of 45-80 years [+10]

Current involvement in other physical activity research studies [+9]

Status: Recruiting

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

Participants needed: 170
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Royal Free Hospital NHS Foundation TrustUpdated: Dec 10, 2024Locations: 1
Eligibility criteria

Aged 18 years or over [+3]

Participants who are not capable of understanding the information leaflet or con... [+3]

Status: Not yet recruiting

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.

Participants needed: 60
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Unity Health TorontoUpdated: Sep 19, 2024
Eligibility criteria

Not listed

Status: Not yet recruiting

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).

Participants needed: 96
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: Temple UniversityUpdated: Sep 19, 2024
Eligibility criteria

meet the criteria for an SMI diagnosis of schizophrenia, schizoaffective, bipola... [+4]

inability to provide consent (legal guardian) [+1]

Status: Not yet recruiting

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.

Participants needed: 6,000
Trial details
Age: 10+Biological sex: AllType: InterventionalSponsor: Fundació Sant Joan de DéuUpdated: Aug 23, 2024
Eligibility criteria

Adolescents enrolled in the selected secondary schools will be eligible. [+4]

Status: Recruiting

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.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Cedars-Sinai Medical CenterUpdated: Aug 22, 2024Locations: 1
Eligibility criteria

Verbal informed consent obtained from subject and ability for subject to comply... [+5]

Current diagnosis of dementia

Status: Recruiting

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.

Participants needed: 80
Trial details
Age: 11-80Biological sex: AllType: InterventionalSponsor: Azienda Ospedaliera Universitaria Integrata VeronaUpdated: Jul 30, 2024Locations: 2
Eligibility criteria

age11-17 years (adolescents) 18-45 years (adults) [+8]

primary medical conditions or vision/hearing deficits that interfere with the ab... [+2]

Status: Recruiting

Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes

Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs. Physical activity is an accepted intervention to improve the physical health, cognition, and well-being of older adults. Moreover, systematic reviews have found that exergaming (i.e. physical activity gamified with technology) offers physical, cognitive, and social benefits by means of dual-task activities that engage both motor and cognitive abilities. The effect of exergaming for older adults in LTC is less clear, as this population has greater health needs related to physical health conditions, cognitive impairment, and functional dependence. Given the increased global demand for LTC, there is a need to develop and assess innovative exergaming technologies that can support the physical and cognitive health of LTC residents. MouvMat is an exergaming technology intervention with an interactive digital gaming surface designed for older adults (OA) in LTC settings. Participants can play familiar games, like Simon or Bingo, by stepping on or tapping the surface with an assistive pointing device. Games can be played individually or with multiple players. LED lights on the surface provide an adaptive digital display and embedded pressure sensors respond to players' input. The investigators collaboratively designed a preliminary prototype with OA aged 65 and older in a pilot project. The overall objective of this proposal is to conduct a pilot RCT of the Mouvmat to evaluate the feasibility, acceptability and efficacy of the exergaming technology to improve the primary outcome of mobility, and the secondary outcomes of cognitive function and social isolation compared to a usual care control group receiving standard recreational programming by recreational therapists.

Participants needed: 60
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: University of TorontoUpdated: Jun 13, 2024Locations: 2
Eligibility criteria

All residents at the participating long-term care homes are eligible if they are... [+5]

Residents will be ineligible to participate in the study is they cannot communic... [+5]

Status: Recruiting

The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD)

The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD 1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD; 2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation; 3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions; 4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients.

Participants needed: 209
Trial details
Age: 45-85Biological sex: AllType: ObservationalSponsor: The First Affiliated Hospital with Nanjing Medical UniversityUpdated: Mar 28, 2024Locations: 1Duration: 5 Years
Eligibility criteria

SCD [+3]

(a) Aged under 45 years or older than 85 years; (b) Vascular dementia or other c...