Psychological interventions as vaccine adjuvants: a systematic review

Objectives: The effectiveness of vaccines is known to be altered by a range of psychological factors. We conducted a systematic review to evaluate the effects of psychological interventions on the ability of vaccines to protect against disease, as measured by antibody responses. Methods: Electronic databases (EMBASE, Medline, PsychINFO, CINAHL) were searched from their inception to 6th February 2018.Results: The search yielded 9 eligible trials conducted with 1603 participants and four broad categories of intervention: meditation/mindfulness (n=3), massage (n=3), expressive writing (n=2) and cognitive behavioural stress management (n=1). Some evidence of benefit on the antibody response to vaccination was observed in 6/9 of all trials and in 4/7 of randomised controlled trials. However, effects on antibody levels were often mixed, with only 3 of 6 trials showing benefit demonstrating an improvement in all antibody outcomes and at all time points assessed. Trials demonstrating benefit also provided direct or indirect evidence of adequate adherence with the intervention; and in 50% of these trials, there was also evidence that the intervention was effective in changing the mediating psychological constructs targeted by the intervention.Conclusions: This literature is characterised by considerable heterogeneity in terms of intervention type, vaccine type, age of participants and the temporal relationship between vaccination and intervention. We conclude that there is early evidence to suggest that psychological interventions may enhance the antibody response to vaccination. However, the effects are inconsistent, with the greatest likelihood of benefit seen in trials evidencing adequate adherence with the intervention. Future work would benefit from rigorous intervention development that focuses on achieving adequate adherence and large well-controlled randomised trials with a focus on an agreed set of outcomes

Illness Beliefs Predict Mortality in Patients with Diabetic Foot Ulcers

Background - Patients’ illness beliefs have been associated with glycaemic control in diabetes and survival in other conditions. Objective - We examined whether illness beliefs independently predicted survival in patients with diabetes and foot ulceration. Methods - Patients (n = 169) were recruited between 2002 and 2007. Data on illness beliefs were collected at baseline. Data on survival were extracted on 1st November 2011. Number of days survived reflected the number of days from date of recruitment to 1st November 2011. Results - Cox regressions examined the predictors of time to death and identified ischemia and identity beliefs (beliefs regarding symptoms associated with foot ulceration) as significant predictors of time to death. Conclusions - Our data indicate that illness beliefs have a significant independent effect on survival in patients with diabetes and foot ulceration. These findings suggest that illness beliefs could improve our understanding of mortality risk in this patient group and could also be the basis for future therapeutic interventions to improve survival

Psychological impact of lung cancer screening using a novel antibody blood test followed by imaging : the ECLS randomized controlled trial

This work was supported by the Scottish Government and Oncimmune Ltd. Follow-up data collection for psychological outcome measures was supported by Oncimmune Ltd.Background: The Early CDT®-Lung antibody blood test plus serial computed tomography scans for test-positives (TPGs) reduces late-stage lung cancer presentation. This study assessed the psychological outcomes of this approach. Methods: Randomized controlled trial (n = 12 208) comparing psychological outcomes 1-12 months post-recruitment in a subsample (n = 1032) of TPG, test-negative (TNG) and control groups (CG). Results: Compared to TNG, TPG had lower positive affect (difference between means (DBM), 3 months (3m: -1.49 (-2.65, - 0.33)), greater impact of worries (DBM 1m: 0.26 (0.05, 0.47); 3m: 0.28 (0.07, 0.50)), screening distress (DBM 1m: 3.59 (2.28, 4.90); 3m: 2.29 (0.97, 3.61); 6m: 1.94 (0.61, 3.27)), worry about tests (odds ratio (OR) 1m: 5.79 (2.66, 12.63) and more frequent lung cancer worry (OR 1m: 2.52 (1.31, 4.83); 3m: 2.43 (1.26, 4.68); 6m: 2.87 (1.48, 5.60)). Compared to CG, TPG had greater worry about tests (OR 1m: 3.40 (1.69, 6.84)). TNG had lower negative affect (log-transformed DBM 3m: -0.08 (-0.13, -0.02)), higher positive affect (DBM 1m: 1.52 (0.43, 2.61); 3m: 1.43 (0.33, 2.53); 6m: 1.27 (0.17, 2.37)), less impact of worries (DBM 3m: -0.27 (-0.48, -0.07)) and less-frequent lung cancer worry (OR 3m: 0.49 (0.26, 0.92)). Conclusions: Negative psychological effects in TPG and positive effects in TNG were short-lived and most differences were small.Publisher PDFPeer reviewe

Relationship between hair and salivary cortisol and pregnancy in women undergoing IVF

Evidence for an association between cortisol and clinical pregnancy in women undergoing In Vitro Fertilisation (IVF) is mixed with previous studies relying exclusively on short term measures of cortisol in blood, saliva, urine, and/or follicular fluid. Hair sampling allows analysis of systemic levels of cortisol over the preceding 3–6 months. The present study sought to explore the relationship between cortisol and clinical pregnancy outcome in women undergoing IVF utilising multiple indices of cortisol derived from both saliva and hair measured prior to commencing gonadotrophin treatment. A total of 135 women (mean age 34.5 SD +/−4.8) were recruited from an English fertility clinic (December 2012–April 2014) 60% of whom became pregnant (n = 81). Salivary cortisol data were obtained over two days: upon awakening, 30 min post awakening, and at 22:00. A subsample (n = 88) of the women providing salivary samples were approached consecutively to provide hair samples for the measurement of cortisol. Independent Logistic regression analyses revealed that salivary cortisol measures including cortisol awakening response (CAR) (p = 0.485), area under the curve with respect to ground (AUCg) (p = 0.527), area under the curve with respect to increase (AUCi) (p = 0.731) and diurnal slope (p = 0.889) did not predict clinical pregnancy. In contrast, hair cortisol concentrations significantly predicted clinical pregnancy (p = 0.017). Associations between hair cortisol and clinical pregnancy remained when controlling for accumulations of salivary cortisol (p = 0.034) accounting for 26.7% of the variance in pregnancy outcome. These findings provide preliminary evidence that longer term systemic cortisol may influence reproductive outcomes; and in turn suggests that interventions to reduce cortisol prior to commencing IVF could improve treatment outcomes

A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) – A Protocol

© 2019 The Author(s). Background: People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness. Methods: We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective. Discussion: We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia. Trial registration: ISRCTN, ISRCTN15320670. Registered on 4 September 2018

Students’ Views Towards SARS-CoV-2 Mass Asymptomatic Testing, Social Distancing and Self-Isolation in a University Setting during the COVID-19 Pandemic: A Qualitative Study

We aimed to explore university students’ perceptions and experiences of SARS-CoV-2 mass asymptomatic testing, social distancing and self-isolation during the COVID-19 pandemic. This qualitative study comprised of four rapid online focus groups conducted at a higher education institution in England during high alert (tier 2) national COVID-19 restrictions. Data were analysed thematically. Participants were purposively sampled university students (n = 25) representing a range of gender, age, living circumstances (on/off campus) and SARS-CoV-2 testing/self-isolation experiences. Six themes with 16 sub-themes emerged from the analysis of the qualitative data: ‘Term-time Experiences’, ‘Risk Perception and Worry’, ‘Engagement in Protective Behaviours’, ‘Openness to Testing’, ‘Barriers to Testing’ and ‘General Wellbeing’. Students described feeling safe on campus, believed most of their peers are adherent to protective behaviours and were positive towards asymptomatic testing in university settings. University communications about COVID-19 testing and social behaviours need to be timely and presented in a more inclusive way to reach groups of students who currently feel marginalised. Barriers to engagement with SARS-CoV-2 testing, social distancing and self-isolation were primarily associated with fear of the mental health impacts of self-isolation, including worry about how they will cope, high anxiety, low mood, guilt relating to impact on others and loneliness. Loneliness in students could be mitigated through increased intra-university communications and a focus on establishment of low COVID-risk social activities to help students build and enhance their social support networks. These findings are particularly pertinent in the context of mass asymptomatic testing programmes being implemented in educational settings and high numbers of students being required to self-isolate. Universities need to determine the support needs of students during self-isolation and prepare for the long-term impacts of the pandemic on student mental health and welfare support services

Exploring recruitment barriers and facilitators in early cancer detection trials: the use of pre-trial focus groups

Background Recruiting to randomized controlled trials is fraught with challenges; with less than one third recruiting to their original target. In preparation for a trial evaluating the effectiveness of a blood test to screen for lung cancer (the ECLS trial), we conducted a qualitative study to explore the potential barriers and facilitators that would impact recruitment. Methods Thirty two people recruited from community settings took part in four focus groups in Glasgow and Dundee (UK). Thematic analysis was used to code the data and develop themes. Results Three sub-themes were developed under the larger theme of recruitment strategies. The first of these themes, recruitment options, considered that participants largely felt that the invitation to participate letter should come from GPs, with postal reminders and face-to-face reminders during primary care contacts. The second theme dealt with understanding randomization and issues related to the control group (where bloods were taken but not tested). Some participants struggled with the concept or need for randomization, or for the need for a control group. Some reported that they would not consider taking part if allocated to the control group, but others were motivated to take part even if allocated to the control group by altruism. The final theme considered perceived barriers to participation and included practical barriers (such as flexible appointments and reimbursement of travel expenses) and psychosocial barriers (such as feeling stigmatized because of their smoking status and worries about being coerced into stopping smoking). Conclusions Focus groups provided useful information which resulted in numerous changes to proposed trial documentation and processes. This was in order to address participants information needs, improve comprehension of the trial documentation, enhance facilitators and remove barriers to participation. The modifications made in light of these findings may enhance trial recruitment and future trials may wish to consider use of pretrial focus groups

The Vaccination Model in Psychoneuroimmunology Research: A Review

This chapter explores the reasoning behind using the vaccination model to examine the influence of psychosocial factors on immunity. It then briefly discusses the mechanics of the vaccination response and the protocols used in psychoneuroimmunology vaccine research, before giving examples from the research literature of the studies examining relationships such as the association between stress and vaccination response. It also explores the ways the vaccination model can be used to answer key questions in psychoneuroimmunology, such as the following: “Does it matter when stressful life events occur relative to when the vaccine is received?” “What are the effects of prior exposure to the antigen?” “Do other psychosocial factors influence vaccine response besides stress?” Finally, it briefly considers the mechanisms underlying psychosocial factors and vaccination response associations and the future research needed to understand these better, and indeed to use current and future knowledge to improve and enhance vaccine responses in key at-risk populations