Loneliness

60

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

Condition / disease
Location
Status: 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: Oct 2, 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: Not yet recruiting

Thrive at Home: A Virtual Reality Social Intervention for Older Adults

The goal of this clinical trial is to evaluate whether a virtual reality (VR) based social platform can improve mental health and social connection for older adults who receive in-home care. Specifically, the study aims to determine if the VR program reduces loneliness, depressive symptoms, and boredom while increasing social connection and well-being among older adult participants. It also explores whether access to the VR program reduces caregiver burden and depressive symptoms for family caregivers. Researchers will compare an immediate-start group to a waitlist control group to assess whether the VR program improves outcomes compared to standard home care alone. Both groups will eventually receive the intervention. Older adult participants will use a VR headset at home to join group activities three times a week. These sessions include social activities with local peers and live-hosted group activities. A family caregiver or home care professional may be present during sessions if needed for support. Over a 12-week study period, older adult participants will complete three surveys assessing their mood, social connection, and well-being. Family caregivers of participating older adults are also invited to join an optional caregiver substudy. Caregivers who enroll in the substudy will not participate in the VR activities themselves, but will complete three surveys at the same time points over the 12 weeks to share their own well-being and caregiving experiences.

Participants needed: 250
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: University of California, Santa BarbaraUpdated: Sep 25, 2026
Eligibility criteria

Aged 65 years or older. [+8]

History of severe motion sickness or vertigo. [+9]

Status: Recruiting

A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

Participants needed: 50
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Montefiore Medical CenterUpdated: Sep 25, 2026Locations: 1
Eligibility criteria

Age 60 and over [+2]

Dementia based on Aging and Dementia (AD8) score of ≥4 or previous dementia diag... [+2]

Status: Not yet recruiting

Effectiveness of a Psychological Intervention to Reduce Social Isolation and Promote Social Connectedness in Young Adults

The purpose of this randomized controlled trial is to evaluate the effectiveness of a psychological intervention aimed at reducing social isolation and promoting social connectedness among young adults. Specifically, the study investigates the impact of an 8-week, digitally assisted face-to-face group social skills training program on individuals aged 19 to 34 who experience difficulties in interpersonal relationships and social isolation. Participants will be randomly assigned to either the active intervention group or a waitlist control group. The study aims to determine whether this structured psychosocial intervention improves interpersonal competence and social performance, reduces social isolation, and improves other psychosocial variables. Outcomes will be evaluated at three time points-pre-intervention, post-intervention, and a 1-month follow-up-utilizing a combination of self-report questionnaires and performance-based role-play assessments.

Participants needed: 80
Trial details
Age: 19-34Biological sex: AllType: InterventionalSponsor: Korea UniversityUpdated: Sep 24, 2026
Eligibility criteria

Adults aged 19 to 34 years [+5]

Psychiatric or neurological hospitalization within the past 6 months [+9]

Status: Not yet recruiting

A Mechanism Randomised Controlled Trial of a Three-Agent LLM-Augmented mHealth Intervention for Late-Life Loneliness in Older Adults

This study examines how a smartphone conversational application affects feelings of loneliness in Cantonese-speaking older adults living in Hong Kong. Seventy-two adults aged 60 or above who report at least moderate loneliness will be randomly assigned to one of two versions of the same application. Both versions look and work the same way, offer the same three conversational companions, and provide the same set of in-app tools. The two versions differ only in how the companions' replies are produced: in one version replies are generated by a large language model, and in the other they are assembled from pre-written templates selected by keyword and conversation state. Participants use the application for four weeks and are then followed for a further four weeks with continued access. The main question is whether any difference between the two versions in emotional loneliness operates through how understood, validated and cared for participants feel during individual conversations. Participants are not told which version they are using, and the researcher who carries out the assessments is also unaware of the assignment.

Participants needed: 72
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Sep 16, 2026
Eligibility criteria

Aged 60 years or above [+6]

Acute suicidality, defined as a PHQ-9 item 9 score above 1 with reported active... [+5]

Status: Recruiting

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.

Participants needed: 136
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Education University of Hong KongUpdated: Sep 10, 2026Locations: 1
Eligibility criteria

No histories of learning impairment, major psychiatric disorders or neurological... [+2]

On medication or treatments within 2 weeks prior to the beginning of the study t...

Status: Not yet recruiting

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.

Participants needed: 144
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: BaycrestUpdated: Aug 28, 2026Locations: 1
Eligibility criteria

Age ≥65 [+3]

A diagnosis of dementia, mild cognitive impairment, stroke, other neurodegenerat... [+2]

Status: Recruiting

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.

Participants needed: 213
Trial details
Age: 75-100Biological sex: FemaleType: InterventionalSponsor: Norwegian School of Sport SciencesUpdated: Aug 27, 2026Locations: 1
Eligibility criteria

Women aged ≥75 years [+3]

Dementia or other cognitive impairment [+1]

Status: Recruiting

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.

Participants needed: 120
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: University of RochesterUpdated: Aug 17, 2026Locations: 1
Eligibility criteria

Age 60 or older [+2]

Current problem drinking [+3]

Status: Recruiting

Using Virtual Reality Travel to Reduce Loneliness in Older Adults

This study aims to investigate whether and how virtual reality travel (VRT) can reduce loneliness among older adults. It will utilize a mixed-methods research design that combines an randomly assigned experiment with follow-up semi-structured interviews. This is a pilot study and it is essential to establish the feasibility and acceptability of the protocol, assess the tolerability of VR technology in this population prior to conducting a full-scale RCT, and generate preliminary effect size estimates to inform future sample size calculations.

Participants needed: 40
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Indiana UniversityUpdated: Aug 14, 2026Locations: 3
Eligibility criteria

Adults aged 65 years or older [+1]

Status: Recruiting

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?

Participants needed: 15
Trial details
Age: 19-25Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Aug 13, 2026Locations: 1
Eligibility criteria

Aged 19-25 [+6]

Self-reported heat intolerance [+7]

Status: Not yet recruiting

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.

Participants needed: 60
Trial details
Age: 6-12Biological sex: AllType: InterventionalSponsor: Xu ShuishuiUpdated: Aug 10, 2026Locations: 1
Eligibility criteria

Primary school children aged 6-12 years. [+6]

A medical condition, physical disability, or musculoskeletal injury that would m... [+4]

Status: Not yet recruiting

The WISE Study (WhatsApp Intervention for Sleep in the Elderly)

Sleep hygiene education is an educational effort to teach healthy sleep habits and behaviors to improve sleep quality, duration, and regularity naturally without the use of medication; however, this approach has not been established in Indonesia. This study aims to establish a sleep hygiene education care model among lonely older adults with insomnia in Indonesia and to examine the immediate effects of the WISE Study (WhatsApp Intervention for Sleep in the Elderly) led by nurses to older adults loneliness with insomnia using a Digital Booklet. In this assessor-blinded, randomized controlled trial, participants will be randomly allocated to either the nurse-led WISE experimental group or the control group provided with usual care. The outcomes will include sleep parameters measured using the Indonesian version of the Insomnia Severity Index (ISI), Generalized Anxiety Disorder-7 (GAD-7), Geriatric Depression Scale-Short Form (GDS-SF), Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale (ESS), and sleep diaries. The questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. Generalized estimating equations will be used to test the research hypotheses. Questionnaires will be assessed at pre-treatment, post-treatment, and one-month follow-up. We hypothesized that older adults who were loneliness with insomnia who underwent nurse-led WISE would experience greater improvements in sleep quality compared to participants in a control group who received usual care.

Participants needed: 50
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Halu Oleo UniversityUpdated: Aug 7, 2026Locations: 1
Eligibility criteria

Elderly individuals diagnosed with loneliness [+3]

Elderly individuals with dementia, delirium, severe mental retardation, or cogni... [+1]

Status: Recruiting

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.

Participants needed: 80
Trial details
Age: 12+Biological sex: AllType: InterventionalSponsor: Universitätsklinikum Hamburg-EppendorfUpdated: Aug 10, 2026Locations: 1
Eligibility criteria

Older adults aged 60 years and older who are residents of Hamburg [+3]

Children and adolescents with severe acute psychological symptoms requiring inpa... [+2]

Status: Recruiting

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.

Participants needed: 40
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Lives alone [+3]

Significant cognitive impairment that prevents consent or participation [+2]

Status: Recruiting

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.

Participants needed: 130
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of California, San DiegoUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Has the capacity to provide informed consent [+8]

Multiparous [+11]

Status: Recruiting

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.

Participants needed: 90
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Kaohsiung Medical UniversityUpdated: Aug 6, 2026Locations: 1
Eligibility criteria

willing to join this study for three months [+5]

with an ISS greater than 16 (severe injuries) [+2]

Status: Recruiting

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.

Participants needed: 70
Trial details
Age: 17-25Biological sex: AllType: InterventionalSponsor: Gümüşhane UniversıtyUpdated: Aug 3, 2026Locations: 1
Eligibility criteria

Being between the ages of 18-25. [+4]

Having a diagnosed clinical sleep disorder (e.g., sleep apnea, chronic insomnia)... [+4]

Status: Recruiting

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.

Participants needed: 300
Trial details
Age: 18-30Biological sex: AllType: InterventionalSponsor: Equa HealthUpdated: Jul 20, 2026Locations: 1
Eligibility criteria

Ages 18-30 years of Age [+7]

Currently pregnant [+1]

Status: Recruiting

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.

Participants needed: 50
Trial details
Age: 55+Biological sex: AllType: InterventionalSponsor: Endeavor HealthUpdated: Jul 17, 2026Locations: 1
Eligibility criteria

Patients 55 years of age or older attending an outpatient visit at an Endeavor H... [+3]

Prisoners, pregnant women, children [+2]

Status: Not yet recruiting

Mindfulness for Lonely Older Adults With Emigrant Children

This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.

Participants needed: 90
Trial details
Age: 65-75Biological sex: AllType: InterventionalSponsor: Hong Kong Metropolitan UniversityUpdated: Jul 17, 2026Locations: 1
Eligibility criteria

Chinese adults aged 65 to 75 years, [+4]

Acute or severe physical symptoms such as impaired mobility, COPD or respiratory... [+4]

Status: Recruiting

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.

Participants needed: 1,344
Trial details
Age: 65+Biological sex: AllType: InterventionalSponsor: Education University of Hong KongUpdated: Jul 8, 2026Locations: 1
Eligibility criteria

aged 65 years or older [+3]

cognitive impairments, psychiatric disorders, learning disabilities, or active s... [+1]

Status: Not yet recruiting

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.

Participants needed: 51
Trial details
Phase: Phase 1Age: 21-65Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Jul 9, 2026Locations: 1
Eligibility criteria

Medically healthy [+3]

Any unstable medical condition, psychiatric disorder, or circumstance that, in t... [+2]

Status: Not yet recruiting

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.

Participants needed: 45,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Jun 15, 2026
Eligibility criteria

Student enrolled at Paris Sciences et Lettres University (PSL, 17,000 students)... [+3]

Applicants under the age of 18, [+2]

Status: Recruiting

Lonely in Depression

The goal of this prospective study is to better understand the link between loneliness and depression in the inpatient psychiatric treatment of depression. It aims to answer: Do lonely and not lonely persons benefit the same way from inpatient depression treatment? Is loneliness a clinical relevant factor in inpatient treatment of depression? What are the underlying biopsychosocial mechanisms? Participants will be asked to do some * self-report questionnaires * clinical interview * biosampling (blood, saliva, stool) at three main measurement timepoints (1. begin of inpatient treatment, 2. day of discharge, 3. three months after discharge).

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Friedrich-Alexander-Universität Erlangen-NürnbergUpdated: Jun 15, 2026Locations: 2Duration: 3 Months
Eligibility criteria

primary diagnosis of depression according to ICD-10 (F32 or F33), as diagnosed b... [+3]

a current lack of capacity to provide consent (e.g., pronounced psychotic sympto... [+3]