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Background: Loneliness is associated with poor health outcomes at all ages, including shorter life expectancy and greater risk of developing depression. People with mental health problems are particularly vulnerable to loneliness and, for those with anxiety or depression, loneliness is associated with poorer outcomes. Interventions which support people to utilise existing networks and access new social contact are advocated in policy but there is little evidence regarding their effectiveness. People with mental health problems have potential to benefit from interventions to reduce loneliness, but evidence is needed regarding their feasibility, acceptability and outcomes. An intervention to reduce loneliness for people with anxiety or depression treated in secondary mental health services was developed for this study, which will test the feasibility and acceptability of delivering and evaluating it through a randomised controlled trial.Methods: In this feasibility trial, 40 participants with anxiety or depression will be recruited through two secondary mental health services in London and randomised to an intervention (n = 30) or control group (n = 10). The control group will receive standard care and written information about local community resources. The coproduced intervention, developed in this study, includes up to ten sessions with a 'Community Navigator' over a 6-month period. Community Navigators will work with people individually to increase involvement in social activities, with the aim of reducing feelings of loneliness. Data will be collected at baseline and at 6-month follow-up - the end of the intervention period. The acceptability of the intervention and feasibility of participant recruitment and retention will be assessed. Potential primary and secondary outcomes for a future definitive trial will be completed to assess response and completeness, including measures of loneliness, depression and anxiety. Qualitative interviews with participants, staff and other stakeholders will explore experiences of Community Navigator support, the mechanisms by which it may have its effects and suggestions for improving the programme.Discussion: Our trial will provide preliminary evidence of the feasibility and acceptability of Community Navigator support and of trial procedures for testing this. The results will inform a future definitive randomised controlled trial of this intervention.Trial Registration: ISRCTN10771821 . Registered on 3 April 2017. [ABSTRACT FROM AUTHOR]

Background: Health anxiety, hypochondriasis and personality disturbance commonly coexist. The impact of personality status was assessed in a secondary analysis of a randomised controlled trial (RCT).Aims: To test the impact of personality status using ICD-11 criteria on the clinical and cost outcomes of treatment with cognitive-behavioural therapy for health anxiety (CBT-HA) and standard care over 2 years.Method: Personality dysfunction was assessed at baseline in 444 patients before randomisation and independent assessment of costs and outcomes made on four occasions over 2 years.Results: In total, 381 patients (86%) had some personality dysfunction with 184 (41%) satisfying the ICD criteria for personality disorder. Those with no personality dysfunction showed no treatment differences (P = 0.90) and worse social function with CBT-HA compared with standard care (P<0.03) whereas all other personality groups showed greater improvement with CBT-HA maintained over 2 years (P<0.001). Less benefit was shown in those with more severe personality disorder (P<0.05). Costs were less with CBT-HA except for non-significant greater differences in those with moderate or severe personality disorder.Conclusions: The results contradict the hypothesis that personality disorder impairs response to CBT in health anxiety in both the short and medium term. [ABSTRACT FROM AUTHOR]

Background: Protein energy malnutrition (PEM) predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents in the United Kingdom are especially vulnerable, with an estimated 30 to 42 % at risk. Evidence for nutritional interventions to address PEM in the care home setting is lacking. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements. To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting, a cluster randomised feasibility trial with a 6-month intervention was undertaken.Methods: Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013. Homes were cluster randomised to standard care (SC), food-based intervention (FB) or oral nutritional supplement intervention (ONS), for 6 months. Key outcomes were trial feasibility and the acceptability of design, allocated interventions and outcome assessments. Anthropometry, dietary intake, healthcare resource usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months.Results: All six care homes approached were recruited and retained. Of the 110 residents at risk of malnutrition, 85 % entered the trial, and 68 % completed the 6-month intervention. Pre-specified success criteria for feasibility were met for recruitment and retention, intervention acceptability (resident compliance ≥60 %) and measurement of weight, body mass index (BMI), mid-upper arm circumference and dietary intake (data completeness >80 %). Measurement of handgrip strength and triceps skinfold thickness was not found to be feasible in this population. The 95 % confidence interval (CI) data suggested sensitivity to change in dietary intake for weight, BMI and energy intake between baseline and 3 months when each intervention (FB and ONS) was compared with SC.Conclusions: A definitive trial comparing the efficacy of nutritional support interventions in increasing weight and BMI in malnourished care home residents can be conducted. However, whilst the design was feasible, this trial has highlighted the lack of clinically and patient-relevant outcome measures that are appropriate for use in this setting for both research and clinical practice. In particular, this trial identified a need for a more simple measure of functional status, which considers the limitations of functional tests in the care home population.Trial Registration: Current Controlled Trials ISRCTN38047922 , Date assigned: 22 April 2014. [ABSTRACT FROM AUTHOR]