Dataset Information

Study protocol for 'The Project About Loneliness and Social networks (PALS)': a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially isolated people.

ABSTRACT:

Introduction

Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations.

Methods and analysis

The PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context.

Ethics and dissemination

This study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners.

Trial registration number

ISRCTN19193075.

SUBMITTER: Band R

PROVIDER: S-EPMC6701612 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Study protocol for 'The Project About Loneliness and Social networks (PALS)': a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially isolated people.

Band Rebecca R Ewings Sean S Cheetham-Blake Tara T Ellis Jaimie J Breheny Katie K Vassilev Ivaylo I Portillo Mari Carmen MC Yardley Lucy L Blickem Christian C Kandiyali Rebecca R Culliford David D Rogers Anne A

BMJ open 20190818 8

<h4>Introduction</h4>Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implem ...[more]

PMID: 31427326

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Project description:BackgroundAlthough literature provides support for cognitive behavioral therapy (CBT) as an efficacious intervention for social phobia, more research is needed to improve treatments for children.MethodsForty four Caucasian children (ages 8-14) meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA, 1994) were randomly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells (n = 21) or a wait-list control group (n = 23). The primary outcome measure was clinical improvement. Secondary outcomes included improvements in anxiety coping, dysfunctional cognitions, interaction frequency and comorbid symptoms. Outcome measures included child report and clinican completed measures as well as a diagnostic interview.ResultsSignificant differences between treatment participants (4 dropouts) and controls (2 dropouts) were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children. Furthermore, in the treatment group, significantly more children were free of diagnosis than in wait-list group at post-test. Additional child completed and clinician completed measures support the results.DiscussionThe study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia. Future research will need to compare this treatment to an active treatment group. There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate.ConclusionPreliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children. Active comparators should be established with other evidence-based CBT programs for anxiety disorders, which differ significantly in their dosage and type of cognitive interventions from those of the manual under evaluation (e.g. Coping Cat).

Project description:BACKGROUND:Loneliness in later life is largely presented as a problem of the individual focusing upon antecedents such as demographic or health factors. Research examining the role of the broader living environments is much rarer. We examined the relationship between loneliness and three dimensions of the lived environment: geographical region, deprivation, and area classification (urban or rural). METHODS:Our sample consisted of 4663 core members (44% males) aged 50+ (wave 7 mean age 72.8, S.D.?=?7.1) present both in waves 3 (2006) and 7 (2014) of the English Longitudinal Study of Ageing (ELSA). Loneliness was measured using two approaches, individual and area-based, and both waves included these questions. Individual-based (self-reported) loneliness was assessed using the three item University of California Los Angeles (UCLA) scale (ranging from 3?=?not lonely to 9?=?lonely) with a score of 6+ defining loneliness. We also used a novel question which asked participants to evaluate how often they felt lonely in their area of residence (area-based; ranging from 1?=?often to 7?=?never, using cut off 4+ to define loneliness). The lived environment was classified in three different ways: the Index of Multiple Deprivation (IMD), Government Office Regions (GOR), and area classification (urban or rural). Covariates with established relationship with loneliness including demographic factors, social engagement and health, were included in the analyses. RESULTS:In wave 7, the prevalence of individual-based loneliness was 18% and area-based was 25%. There was limited congruence between measures: 68% participants reported no individual- or area-based loneliness and 9% reported loneliness for both measures. After adjusting for individual co-variates only one significant relationship was observed between loneliness and area -based characteristics. A significant association was observed between area-based loneliness and deprivation score, with higher levels of loneliness in more deprived areas (OR?=?1.4 for highest quintile of deprivation). CONCLUSIONS:Our results indicate that loneliness in older adults is higher in the most deprived areas independent of individual-level factors. In order to develop appropriate interventions further research is required to investigate how area-level factors combine with individual-level loneliness vulnerability measures to generate increased levels of loneliness in deprived areas.

Project description:Clinical care alone at the end of life is unlikely to meet all needs. Volunteers are a key resource, acceptable to patients, but there is no evidence on care outcomes. This study aimed to determine whether support from a social action volunteer service is better than usual care at improving quality of life for adults in the last year of life.A pragmatic, multi-centre wait-list controlled trial, with participants randomly allocated to receive the volunteer support intervention either immediately or after a 4 week wait. Trained volunteers provided tailored face-to-face support including befriending, practical support and signposting to services, primarily provided within the home, typically for 2-3 hours per week. The primary outcome was rate of change of quality of life at 4 weeks (WHO QOL BREF, a general, culturally sensitive measure). Secondary outcomes included rate of change of quality of life at 8 weeks and Loneliness (De Jong Gierveld Loneliness Scale), social support (mMOS-SS), and reported use of health and social care services at 4 and 8 weeks.In total, 196 adults (61% (n?=?109) female; mean age 72 years) were included in the study. No significant difference was found in main or secondary outcomes at 4 weeks. Rate of change of quality of life showed trends in favour of the intervention (physical quality of life domain: b?=?3.98, CI, -0.38 to 8.34; psychological domain: b?=?2.59, CI, -2.24 to 7.43; environmental domain: b?=?3, CI, -4.13 to 4.91). Adjusted analyses to control for hours of volunteer input found significantly less decrease in physical quality of life in the intervention group (slope (b) 4.43, CI, 0.10 to 8.76). While the intervention also favoured the rate of change of emotional (b?=?-0.08; CI, -0.52 to 0.35) and social loneliness (b?=?-0.20; CI, -0.58 to 0.18), social support (b?=?0.13; CI, -0.13 to 0.39), and reported use of health and social care professionals (b?=?0.16; CI, -0.22 to 0.55), these were not statistically significant. No adverse events were reported.Clinicians can confidently refer to volunteer services at the end of life. Future research should focus on 'dose' to maximise likely impact.The trial was prospectively registered. ISRCTN Registry: ISRCTN12929812 , registered 20 May 2015.

Project description:BackgroundInformal family caregivers constitute an important and increasingly demanding role in the cancer healthcare system. This is especially true for caregivers of patients with primary malignant brain tumors based on the rapid progression of disease, including physical and cognitive debilitation. Informal social network resources such as friends and family can provide social support to caregivers, which lowers caregiver burden and improves overall quality of life. However, barriers to obtaining needed social support exist for caregivers. To address this need, our team developed and is assessing a multi-component caregiver support intervention that uses a blend of technology and personal contact to improve caregiver social support.MethodsWe are currently conducting a prospective, longitudinal 2-group randomized controlled trial which compares caregivers who receive the intervention to a wait-list control group. Only caregivers directly receive the intervention, but the patient-caregiver dyads are enrolled so we can assess outcomes in both. The 8-week intervention consists of two components: (1) The electronic Social Network Assessment Program, a web-based tool to visualize existing social support resources and provide a tailored list of additional resources; and (2) Caregiver Navigation, including weekly phone sessions with a Caregiver Navigator to address caregiver social support needs. Outcomes are assessed by questionnaires completed by the caregiver (baseline, 4-week, 8-week) and the cancer patient (baseline, and 8-week). At 8 weeks, caregivers in the wait-list condition may opt into the intervention. Our primary outcome is caregiver well-being; we also explore patient well-being and caregiver and patient health care utilization.DiscussionThis protocol describes a study testing a novel social support intervention that pairs a web-based social network visualization tool and resource list (eSNAP) with personalized caregiver navigation. This intervention is responsive to a family-centered model of care and calls for clinical and research priorities focused on informal caregiving research.Trial registrationclinicaltrials.gov , Registration number: NCT04268979 ; Date of registration: February 10, 2020, retrospectively registered.

Dataset Information

Study protocol for 'The Project About Loneliness and Social networks (PALS)': a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially isolated people.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Study protocol for 'The Project About Loneliness and Social networks (PALS)': a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially isolated people.

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