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Loneliness clinical trials

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NCT ID: NCT05244733 Recruiting - Suicidal Ideation Clinical Trials

Culture and Well-Being for Latinos

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The proposed K23 study is an intervention study using an experimental therapeutics approach. This pilot RCT asks: "Does SOCIAL-ENGAGE increase cultural-social engagement and decrease suicide risk among Spanish-speaking adults?" We will first optimize a behavioral intervention - SOCIAL ENGAGE (S-ENGAGE) - for target engagement using human-centered design approaches with Spanish-speaking adults at risk for suicide (n=5) and then conduct a pilot RCT (n=60) to test target engagement (cultural-social engagement) and clinical impact (suicide risk) of S-ENGAGE with this population. The ultimate goal is for S-ENGAGE to be offered as a suicide prevention program for Hispanics at risk for suicide.

NCT ID: NCT05228782 Recruiting - Loneliness Clinical Trials

COVID-19 and Social Isolation and Loneliness Trial

SIL
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada. We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers. Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm. We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.

NCT ID: NCT05149963 Recruiting - Loneliness Clinical Trials

Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People

Start date: May 27, 2020
Phase: N/A
Study type: Interventional

Loneliness is a significant problem for young people and is associated with a range of physical and mental health difficulties. Meta-analyses have identified that interventions aimed at young people who report loneliness as their primary problem are lacking within the literature. In adults, the most effective interventions for loneliness are those which target the underlying maladaptive social cognitions. Therefore, the investigators have developed a modular Cognitive Behavioural Therapy (CBT) intervention for children and young people aiming to reduce their feelings of loneliness. The aim of this study is to conduct a multiple baseline single-case experimental design (SCED) to assess the efficacy, feasibility and acceptability of this intervention. In total 6-8 11-18-year-olds and their families will be recruited. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. Participants will complete a baseline assessment, before being randomised to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). Participants will then complete an average of 12 sessions of CBT, with the aim being to reduce their feelings of loneliness over 12 weeks. Participants will then complete a 12-day post-intervention phase. Participant loneliness will be repeatedly assessed throughout the three phases of the intervention using the Three-item Loneliness Scale, which will be the primary outcome. Secondary outcomes will be reliable and clinically meaningful change on the UCLA-LS-3, RCADS and SDQ. Feasibility and participant satisfaction will also be assessed and reported.

NCT ID: NCT05000255 Recruiting - Covid19 Clinical Trials

Coping With Covid-19: Loneliness, Self-Efficacy, Social Support, Depression & Anxiety in Patients in Medical Rehab.

Start date: January 18, 2021
Phase: N/A
Study type: Interventional

Aim of the study is to investigate possible predictors and factors that may be associated with the development and maintenance of mental and physical health constrains including depression and anxiety symptomatology as well as loneliness in hospitalized post-COVID patients and non-COVID patients in Germany. Furthermore, it will be investigated whether psychological interventions have an effect on anxiety and depression symptomatology, on loneliness values, self-efficacy and perceived social support values. Specifically, the research aim is to examine the relationships between loneliness, self-efficacy, and social support and to address the question of what factors increase the risk of post covid depression/anxiety, and to test the buffering effect of physical and social activities. For this purpose an experimental group comparison will be applied, in which two interventions will be performed on post-COVID patients and non-COVID patients in the unit of Physical Medicine and Geriatrics in Medical Rehabilitation. (PhD Project by Annika Roskoschinski, M.Sc., Psychology, Principal Investigator)

NCT ID: NCT04792086 Recruiting - Dementia Clinical Trials

Disease Containment Measures Among Older Adults During the Covid-19 Pandemia

Co-AiT
Start date: February 18, 2021
Phase:
Study type: Observational

This study will examine which impact lockdown strategies intending to prevent the spread of COVID-19 had on people with cognitive impairment and dementia. Comprehensive data from two large health studies in Norway, conducted before and after the COVID-19 outbreak, will be linked with health register data on the use of health care services and medication. Further, it will be conducted a survey addressing questions on social isolation and use of communicative technology, from March 2020 to January 2021. The knowledge gained from this study can improve the health care system's ability to respond more adequately to pandemics and other unforeseen events, so that the negative consequences for older adults with dementia and cognitive impairment can be reduced.

NCT ID: NCT04756245 Recruiting - Exercise Clinical Trials

The VESPA Pilot Study

VESPA
Start date: December 17, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04733300 Recruiting - Physical Activity Clinical Trials

Online Mindfulness-Based College for Young Adults

MBC
Start date: October 9, 2020
Phase: N/A
Study type: Interventional

MB-College (MBC) is an 9-week, 9 session program (i.e., the study intervention being tested in the RCT) providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to college students and young adults. The MBC intervention will be administered live, online via the free video conferencing platform, Zoom, to all eligible study participants enrolled in the active arms of the study. In addition to the 9-week, 9 session MBC class, referred to as "standard dose MBC" from here on out, investigators will also be testing a "low-dose MBC" version of the intervention, where each weekly session will run 1.5 hours in length rather than 2.5 hours. This is a 3-arm randomized controlled trial. The standard-dose and low-dose versions of the MBC intervention will be compared to a third arm of the study, a health education active control group. Members of the control group will be offered the MBC class upon completion of the research study. The Study Aims are to: (1) Evaluate feasibility and acceptability of MBC delivered in two online formats (standard dose vs. low dose). (2) Evaluate impacts of MBC standard-dose vs. MBC low-dose vs. health education control group on health conditions relevant for emerging adults, demonstrated to be influenced by MBC in a prior study, specifically depressive symptoms, loneliness, and sedentary activity. (3) Explore mechanisms by which MBC may exert effects on aforementioned health conditions, including interoceptive awareness, decentering, and perceived stress. Participant Population: young adults aged 18-29 years of age, residing in the United States who screen eligible will be invited to enroll. Students will be screened using a two-part process taking place online. Research assessments at baseline and 3-month will take place digitally using Qualtrics, LLC (Provo, UT, USA) survey management tool. Participants will be sent secure links via email that can be accessed with their participant identification number. Enrolled participants will be randomly assigned to one of three groups: (1) standard MBC; (2) low-dose MBC or (3) health education control group. The control group will be given the opportunity to participate in the intervention after the study MBC course is completed and follow-up assessments have been administered.

NCT ID: NCT04577911 Recruiting - Loneliness Clinical Trials

How is Social Connection Represented in the Brain?

Start date: April 1, 2021
Phase:
Study type: Observational

Nearly half of the U.S. population sometimes or always experiences loneliness, which is alarming given that loneliness confers risk for negative mental and physical health outcomes. Extensive research suggests loneliness is characterized by subjective isolation: many lonely individuals maintain a number of relationships but still report feeling lonely. The goal of this proposal is to use functional magnetic resonance imaging to reveal how the brain represents our subjective connection to and isolation from other people, which will ultimately inform optimal ways to intervene to reduce loneliness.

NCT ID: NCT04336553 Recruiting - Loneliness Clinical Trials

Social Prescribing in Sweden (SPiS)

SPiS
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Loneliness among older adults has become an issue of public concern, as it is associated with increased morbidity and mortality. Yet, despite the urgency, there is little information on how to reduce or prevent loneliness. The focus of this project is using experiences from the United Kingdom's initiative social prescribing, which gives General Practitioners the option of referring clients in need to a coordinator, who in dialogue with the client finds activities for the client to engage in within the local community. Until now, social prescribing has not been tested in Sweden. Therefore, with the overarching goal of reducing loneliness and improving health and wellbeing, the aim of the project is to develop and test a Swedish social prescribing program in order to explore circumstances under which the program can reduce loneliness and improve wellbeing in older adults. The project will be carried out in collaboration between researchers, a primary healthcare center, and a community activity initiative. In the first phase, the research group will bring potential end-users and stakeholders together in workshops to discuss, develop, and design a Swedish program for social prescribing. Interviews with potential end-users and stakeholders will be carried out to analyze challenges and possibilities with the program. In a second phase, the Swedish program will be implemented to evaluate experiences and the effect of Social prescribing in Sweden regarding loneliness, health, wellbeing among older adults (65 yrs or older) in Sweden. The study will be carried out in a feasibility study and a large-scale RCT study. including both qualitative and quantitative data Based on the results of this study, there will be new knowledge gained concerning if and how social prescribing can be used among older adults in a Swedish context.

NCT ID: NCT04301167 Recruiting - Loneliness Clinical Trials

Loneliness and Health: The Moderating Role of Befriending Services

HALO
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Befriending services deliver companionship to older adults through regular volunteer visits. ALONE is a charitable organisation providing befriending services to older adults in Ireland. It is the mission statement of ALONE to use befriending to reduce the negative impact loneliness has on health, but evidence for this use of befriending is yet to be sufficiently provided. Providing such evidence would help organisations like ALONE to convince policymakers of the need for, and importance of, their services. The research uses a rigorous scientific approach to evaluate the effect of befriending services on health. Two domains of health thought to be particularly important for ageing adults are evaluated: health-related quality of life (HrQoL), and cognitive function. Maximising HrQoL should be a goal of any healthcare intervention, while cognitive function is associated with dementia risk, a major factor threatening independence in later life. The research is also investigating whether befriending can reduce the negative effect that loneliness is known to have on health of older adults. Service users, befriending volunteers, and professionals involved with the service, will be interviewed by researchers, to see if there are other ways that befriending might improve health. An economic analysis of the service, to evaluate its cost, is also planned. Findings will then be translated all findings into befriending service recommendations for the Department of Health. To conduct this research, 85 new befriending service users are needed. 10-15 pairs of befriender-befriendees will also be interviewed, and 5-10 health and social care professionals involved with the service. Expected outcomes are to provide ALONE with scientific evidence related to the effects of befriending services on health, and to influence policymakers by clarifying the extent of the economic and health benefits of befriending services.