Background There are increasing numbers of cancer survivors who have finished their primary treatment, but whose quality of life remains consistently poor over years. There is limited evidence for pragmatic, brief interventions to support cancer survivors in primary care, where most patients are managed. Objective To develop, trial and assess the effectiveness and cost-effectiveness of a digital intervention to support cancer survivors (named ‘Renewed’) designed to require minimal health service resources. Design Qualitative development of the intervention, then open randomised controlled trial, with a process analysis and health economic analysis. Setting United Kingdom primary care Interventions: Development of the intervention We systematically reviewed the relevant qualitative and quantitative literature to inform initial intervention planning, intervention content and design features of a digital intervention. This was followed by iterative development and optimisation of intervention content and the human support component – in qualitative studies of the views of cancer survivor, and of National Health Service, volunteer and charity workers. Main trial: Participants People who had finished primary treatment for colorectal, breast or prostate cancer with lower quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 score < 85) within the last 10 years. Participants were randomised to one of three groups: (1) ‘generic’ advice: detailed digital National Health Service support for healthier living (‘Living Well’), (2) a bespoke digital intervention (‘Renewed’) addressing symptom management, physical activity, diet, weight, distress and/or fear of recurrence, or (3) ‘Renewed’ plus support (additional brief support by e-mail, telephone, or face to face) Main outcome measures Primary outcome: European Organization for Research and Treatment of Cancer QLQ-C30 (overall score). Secondary outcomes: subscales of European Organization for Research and Treatment of Cancer QLQ-C30 (global self-rated health; functional subscales; symptom subscales), EuroQol-5 Dimensions, five-level version, psychological measures and costs. Results At the primary time point of 6 months, there were clinically important improvements in European Organization for Research and Treatment of Cancer QLQ-C30 score contrary to the expected trajectory of quality of life in this population, but with no evidence of differences between groups. By 12 months, the Renewed plus support group had continued to improve and was better than generic advice (1.42, 95% confidence intervals 0.33 to 2.51), with the largest differences in the prostate cancer subgroup. 13 of the 14 subscales also improved compared to generic advice, statistically significant for self-rated global health (Renewed: 3.06, 1.39 to 4.74; Renewed plus support: 2.78, 1.08 to 4.48), dyspnoea, constipation and enablement. For Renewed plus support, there were also statistically significant differences for physical, cognitive and emotional functioning and fatigue. Renewed and Renewed plus support were dominant given improved effectiveness combined with and lower mean primary care National Health Service costs per patient (respectively −£141, −153 to −128; −£77, −90 to −65). Limitations Of those sent invitation letters, 14% (7883/59,295) were assessed for eligibility and 35% (2732/7883) of those assessed were eligible and agreed to participate – which is normal with the ‘cold calling’ method of invitation. The digital intervention would not suit people who find technology or the internet difficult to access, but only 25% (2649/10,697) of those who gave reasons for declining did so due to lack of internet access. The extensive generic advice available to participants in the National Health Service limited the ability to assess the specific benefits of Renewed in the short term, but nevertheless longer-term benefit and lower National Health Service costs are likely to be achieved with the bespoke intervention. Conclusions Cancer survivors with lower quality of life given detailed generic online support improve significantly. Providing robustly developed, low-cost, bespoke digital support can provide further modest long-term improvements in enablement, symptom management and self-rated global health, with substantially lower National Health Service costs. Future work The cost-effectiveness and benefits for symptom management on self-rated health suggest a more widespread implementation study should be undertaken. Trial registration This trial is registered as Current Controlled Trials ISRCTN 96374224. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0514-20001) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 4. See the NIHR Funding and Awards website for further award information. Plain language summary We aimed to make and assess a website for use in general practices to support people who have poor quality of life after their initial cancer treatment. We made our website, called ‘Renewed’, based on the few studies about websites or apps. We tested ‘Renewed’ with people who had finished their initial treatment, National Health Service staff and others, and used their feedback to improve it. Then we asked others to join a study to see how well ‘Renewed’ works. Each person invited to join the study had finished initial treatment for bowel, breast or prostate cancer but had poor quality of life. We placed them at random (by chance) into one of three groups: given general advice from the NHS website for more healthy living (‘Living Well’) given ‘Renewed’, with help designed for cancer survivors in managing symptoms, exercise, diet, weight, distress, and fear of cancer coming back given ‘Renewed’, plus brief support by e-mail, telephone or face to face. After 6 months, all groups reported better quality of life. After 12 months, the Renewed plus support group carried on improving and was a little better than general advice for quality of life. At this time both the Renewed groups had improved in their rating of their health, shortness of breath, constipation and feeling more able to manage their problems. People in the Renewed plus support group also had improved physical and emotional functioning and less fatigue. Both Renewed and Renewed plus support not only had improved outcomes but also lower costs for the NHS. This study suggests that the online support provided by the Renewed website can help improve the quality of life of people who have finished initial cancer treatment, with both better outcomes and lower costs for the National Health Service. Scientific summary Background There are increasing numbers of cancer survivors who have finished their primary treatment, but quality of life remains consistently poor over years for many patients. There is limited evidence for pragmatic, brief interventions to support cancer survivors in primary care, where most patients are managed. Objective To develop, trial and assess the effectiveness and cost-effectiveness of a digital intervention to support cancer survivors (‘Renewed’) designed to require minimal health service resources. Methods Intervention development Collating the evidence Rapid review of web-based interventions designed to improve quality of life in adults who have completed primary treatment for breast, prostate and colorectal cancer. A range of study designs were included, and information about intervention characteristics, experiences and outcomes was extracted. The data were analysed using thematic analysis. Rapid scoping review of barriers and facilitators. A search identified studies during the past 20 years and further studies were identified by experts in the team and examination of reference lists. Development of Guiding Principles The rapid scoping review was used to identify key context-specific behavioural issues, and key intervention features were developed to meet each design objective. These Guiding Principles were improved in consultation with the development team and an expert stakeholder panel. Behavioural analysis A behavioural analysis table documented likely barriers for target behaviours, and for each barrier, interventions were described and coded according to three theoretical frameworks [Behaviour Change Techniques Taxonomy (BCTv1); Behaviour Change Wheel (BCW); Normalisation Process Theory (NPT)]. Logic model Using Medical Research Council guidance, the behavioural analysis was used to develop the logic model – describing the problem, intervention targets/ingredients to resolve the problem, mechanisms of action, and outcomes. Qualitative research: think-aloud interviews with cancer survivors Think-aloud interviews were conducted with 32 cancer survivors. Positive and negative comments were then collated, modifications made, and further rounds of interviews conducted with the modified versions of the prototype until no important further changes were required. Qualitative research: focus groups with National Health Service and cancer charity staff and volunteers Seven focus groups were carried out with staff from five general practitioner practices, staff and volunteers from two cancer charities, addressing support and training materials, and the integration of the intervention in everyday practice. Modifications were made and further rounds of focus groups were organised until no further improvements were identified. Main trial Participants For the main trial, people who had finished primary treatment for colorectal, breast or prostate cancer up to 10 years previously, reporting suboptimal quality of life [European Organization for Research and Treatment of Cancer QLQ-C30 (EORTCQLQ-C30) score < 85]. Interventions Participants were randomised to one of three groups: (1) ‘Generic’ advice: detailed digital NHS support for healthier living (‘Living Well’), (2) a bespoke digital intervention (‘Renewed’) addressing symptom management, physical activity, diet, weight loss, distress management and/or fear of recurrence, or (3) ‘Renewed’ with additional brief support by e-mail, telephone, and face to face. Automated randomisation with stratification was implemented using LifeGuide software (www.lifeguideonline.org) with a 1 : 1 allocation ratio stratified by: cancer type: breast/prostate/colorectal and EORTCQLQ-C30 score (64 or less/65 or more). Main outcome measures Primary outcome: EORTCQLQ-C30 (overall score). Secondary outcomes: subscales of EORTCQLQ-C30 (global self-rated health; functional subscales; symptom subscales), psychological measures, quality of life measured by EuroQol-5 Dimensions, five-level version (EQ-5D-5L) and costs. Main statistical analysis All participant data were analysed on an intention-to-treat basis, that is, as randomised. The primary analysis used imputed data, employing a chained equation multiple imputation model for missing data. A complete-case analysis was a sensitivity analysis. Generalised linear mixed regression models were used for continuous variables, controlling for baseline and stratification variables, including a random effect for practice. Pre-planned subgroup analyses were set out in the statistical analysis plan for age, gender and comorbidities. We also performed post hoc within-group analyses documenting the changes from baseline. Health economic analysis Cost per quality-adjusted life-year (QALY) was estimated. The base case took an NHS perspective using primary care consultation and medication costs, but with sensitivity analyses including secondary care costs. Resource use data were collected by a medical record review in primary care. Unit costs of primary care consultation, community services, outpatient visits and accident and emergency attendances were costed based on the Personal Social Services Research Unit. National reference costs were used to cost hospital stay based on corresponding diagnostic categories. Medications were priced based on the British National Formulary. All costs were based on 2019 prices. QALYs were estimated using the EQ-5D-5L and were based on the recommended national tariff. Process analyses Qualitative analysis Forty-two patients were interviewed to explore their experiences of using the Renewed intervention and to understand the potential barriers and facilitators to using Renewed. Quantitative analysis Patients were included if they completed the 12-month follow-up measures and were classified according to how much of the intervention was accessed, and this was then related to the impact on outcomes. Results Intervention development Rapid review The database search identified 6327 papers, and 16 relevant papers relating to 9 interventions fulfilled eligibility criteria. Identified themes addressed aspects of intervention design (participant factors, characteristics of the online intervention, techniques used to change behaviour and preferred features of web-based interventions), including issues of uptake, adherence and attrition, engagement, feasibility, efficacy, positive behaviour change and acceptability of the interventions. Scoping review Facilitators and barriers were grouped according to key characteristics, including factors influencing participation; information included in the intervention; motivation/self-esteem/self-efficacy; self management/monitoring; emotions/mood; social support; intervention design/content; technical aspects and various practical issues. Guiding principles Target users did not see themselves as having health needs, so the content promoted well-being, rather than illness management. Cancer survivors felt that their usual behaviour in part caused their cancer, so suggestions for behavioural change did not stigmatise users’ current behaviour. Target users form a heterogeneous group; hence the intervention provided tailored information to each user, based on answers to baseline questions. Participants wanted brief accessible information; hence short sessions on specific topics were provided and the intervention targeted behaviours which had the potential to improve multiple symptoms. Behavioural analysis Three target behaviours were identified (physical activity, diet and intervention engagement) and specific intervention components included to minimise barriers to each, mapped to elements of the BCTv1, BCW and NPT theoretical frameworks. Qualitative research: think-aloud interview with cancer survivors Participants found the intervention to be generally easy to navigate and the content being relevant and useful. Negative comments described barriers to engagement which resulted in modifications to the prototype; for example some were worried about overdoing physical activity, so changes emphasised that increasing physical activity should be done gradually. Qualitative research: focus groups with National Health Service and cancer charity staff and volunteers Several concerns were raised which led to further modifications; for example some questioned the use of the Congratulate, Ask, Reassure, Encourage approach, so additional information about how to provide support with patients who had not achieved their goals was added. Main trial At the primary time point of 6 months, there were clinically important improvements in EORTCQLQ-C30 score contrary to the expected trajectory of quality of life in this population, but with no evidence of differences between groups. By 12 months, the Renewed plus support group continued to improve and was better than generic advice (1.42, 95% confidence intervals 0.33 to 2.51), with the largest differences in the prostate cancer subgroup. Thirteen of the 14 functional and symptom subscales also improved compared to generic advice, statistically significant for self-rated global health (Renewed: 3.06, 1.39 to 4.74; Renewed plus support: 2.78, 1.08 to 4.48), dyspnoea, constipation and enablement. For Renewed plus support, there were also significant differences for physical, cognitive and emotional functioning and fatigue. Renewed and Renewed plus support demonstrated little or no change in QALY estimates using the EQ-5D-5L, but were dominant – with both a range of better health outcomes while incurring lower mean NHS primary care costs per patient (respectively −£141, −153 to −128; −£77, −90 to −65). Process analyses Qualitative process study The results showed that even limited usage of Renewed Online may provide enough information to motivate behaviour change in those with less need for more tailored support. Novel information may need to be presented earlier in the intervention to motivate further engagement with Renewed in those who need more detailed and tailored information to make behaviour changes. Quantitative process analysis The majority of patients accessed the Core content of Renewed and completed the Core content. Approximately half of participants continued to use Renewed past the Homepage to access the Optional content. Those who used Optional content had higher quality of life (QoL) scores compared to those who only accessed the Core content. Conclusions Cancer survivors with lower quality of life given detailed generic online support improve significantly. Providing robustly developed, low cost, bespoke digital support can provide further modest long-term improvements in enablement, symptom management, and self-rated global health, with substantially lower primary care NHS costs. Implications for health care The current study provides reasonable evidence that a novel bespoke intervention to support cancer survivors could be integrated into current practice since there are both some longer-term benefits combined with lower costs to the NHS. However, all trial participants by definition had to engage with the trial and trial procedures, and so may not represent the wider patient population, and all were followed up with questionnaires and with phone calls where questionnaires were not returned. This could be mimicked in routine practice by brief follow-up contacts, which could be assessed in a larger implementation study. Recommendations for research The cost-effectiveness and benefits for symptom management self-rated health for both Renewed interventions suggest that an implementation study is the next step, including further assessment of the impact in different socio-economic groups and cancer types. To consider using and/or developing more sensitive primary outcome measures among cancer survivors, particularly for briefer, low resource interventions – since the overall EORTCQLQ-C30 summary score is not sensitive to change, in contrast to both symptom subscales and self-rating of health. To develop QALY measures that capture the benefit to QoL for low intensity, low resource interventions among cancer survivors given that neither the EQ-5D-5L or the EORTC-8d reflected important changes in patients’ self-rating of health. Further work is indicated to explore why people with some cancers may not be as willing to use the intervention as others and exploration of the key barriers for those from ethnic minority backgrounds to take part. Trial registration This trial is registered as Current Controlled Trials ISRCTN 96374224. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0514-20001) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 4. See the NIHR Funding and Awards website for further award information.

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.

The COVID-19 outbreak meant that using public transport was potentially unsafe for risk of catching and transmitting the virus. UK anxiety is high with lockdowns preventing a normal way of life for over a year. A lack of ability to travel freely causes numerous declines in quality of life including social isolation and poor physical and mental health. People need crowding information to choose safer travel options and subdue coronavirus. To provide effective guidance, it is essential to empirically formulate messaging to create clarity and trust which can be acted upon in confidence. Behaviour Change Techniques incorporating the Behaviour Change Wheel and COM-B model have been utilised in vast areas of public health intervention development and messaging. There is consensus that public transport information needs to be clearer and more accessible but BCTs have not been utilised in the development of public transport advice. This paper outlines the development of crowding messaging for public transport on a platform available to UK travellers. Barriers and facilitators were explored; related behaviours, intervention functions and behaviour change techniques were mapped. Specific message phrasing was developed utilising the mapped functions and advice from the literature. With the COVID-19 outbreak, having accessible and effective messaging for safely using public transport is a continuation of the work recently conducted examining the best ways to present public health information. It is important to be transparent when developing messaging and interventions accessible to the public and this work forms a basis for continued exploration and development in this area.

Background Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. Objective In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. Methods In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). Results Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. Conclusions The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. Trial Registration International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980 International Registered Report Identifier (IRRID) DERR1-10.2196/18929

Objectives Healthcare staff can be prone to high levels of stress and research investigating mindfulness-based courses for this population is showing promise. Given the demands of healthcare work, shortened mindfulness courses may be more appropriate. The aim of the study was to evaluate the utility of a workplace-adapted mindfulness course (MBOE) in a hospital setting, including research on workplace-specific outcomes beyond stress reduction and data relating to home practice with a mobile app. Method The effects of assignment to a workplace-adapted, 6-week mindfulness course or a waitlist control condition on dispositional mindfulness, perceived stress and fulfilment of basic psychological needs at work were examined in a sample of 65 hospital staff. Results Compared with waitlist, staff taking the course showed significant increases in mindfulness and psychological need fulfilment and reductions in perceived stress. Mean levels of perceived stress reduced from a high level to within published norms. Reductions in stress and increases in mindfulness, autonomy and competence remained stable at follow-up. Increased mindfulness mediated improvements in need fulfilment and reductions in stress. Attendance and use of a mobile app for home practice were associated with positive outcomes. Social factors (relatedness) associated with the delivery and outcome of the course were also explored. Conclusions The results indicate that a workplace-adapted, short-format mindfulness course can achieve positive results in line with mindfulness courses for other contexts. Questions were raised regarding which distinct elements may improve outcomes, e.g. home practice and dispositional mindfulness vs. learning environment on more general improvements.

This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors’ needs, including barriers and facilitators to intervention success. Review evidence ( N = 49 papers) informed the intervention’s Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews ( N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers ( N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

BACKGROUND:Hospital antimicrobial stewardship strategies, such as 'Start Smart, Then Focus' in the UK, balance the need for prompt, effective antibiotic treatment with the need to limit antibiotic overuse using 'review and revise'. However, only a minority of review decisions are to stop antibiotics. Research suggests that this is due to both behavioural and organizational factors.OBJECTIVES:To develop and optimize the Antibiotic Review Kit (ARK) intervention. ARK is a complex digital, organizational and behavioural intervention that supports implementation of 'review and revise' to help healthcare professionals safely stop unnecessary antibiotics.METHODS:A theory-, evidence- and person-based approach was used to develop and optimize ARK and its implementation. This was done through iterative stakeholder consultation and in-depth qualitative research with doctors, nurses and pharmacists in UK hospitals. Barriers to and facilitators of the intervention and its implementation, and ways to address them, were identified and then used to inform the intervention's development.RESULTS:A key barrier to stopping antibiotics was reportedly a lack of information about the original prescriber's rationale for and their degree of certainty about the need for antibiotics. An integral component of ARK was the development and optimization of a Decision Aid and its implementation to increase transparency around initial prescribing decisions.CONCLUSIONS:The key output of this research is a digital and behavioural intervention targeting important barriers to stopping antibiotics at review (see http://bsac-vle.com/ark-the-antibiotic-review-kit/ and http://antibioticreviewkit.org.uk/). ARK will be evaluated in a feasibility study and, if successful, a stepped-wedge cluster-randomized controlled trial at acute hospitals across the NHS.

To ensure patients continue to get early access to antibiotics at admission, while also safely reducing antibiotic use in hospitals, one needs to target the continued need for antibiotics as more diagnostic information becomes available. UK Department of Health guidance promotes an initiative called ‘Start Smart then Focus’: early effective antibiotics followed by active ‘review and revision’ 24–72 h later. However in 2017, < 10% of antibiotic prescriptions were discontinued at review, despite studies suggesting that 20–30% of prescriptions could be stopped safely. Antibiotic Review Kit for Hospitals (ARK-Hospital) is a complex ‘review and revise’ behavioural intervention targeting healthcare professionals involved in antibiotic prescribing or administration in inpatients admitted to acute/general medicine (the largest consumers of non-prophylactic antibiotics in hospitals). The primary study objective is to evaluate whether ARK-Hospital can safely reduce the total antibiotic burden in acute/general medical inpatients by at least 15%. The primary hypotheses are therefore that the introduction of the behavioural intervention will be non-inferior in terms of 30-day mortality post-admission (relative margin 5%) for an acute/general medical inpatient, and superior in terms of defined daily doses of antibiotics per acute/general medical admission (co-primary outcomes). The unit of observation is a hospital organisation, a single hospital or group of hospitals organised with one executive board and governance framework (National Health Service trusts in England; health boards in Northern Ireland, Wales and Scotland). The study comprises a feasibility study in one organisation (phase I), an internal pilot trial in three organisations (phase II) and a cluster (organisation)-randomised stepped-wedge trial (phase III) targeting a minimum of 36 organisations in total. Randomisation will occur over 18 months from November 2017 with a further 12 months follow-up to assess sustainability. The behavioural intervention will be delivered to healthcare professionals involved in antibiotic prescribing or administration in adult inpatients admitted to acute/general medicine. Outcomes will be assessed in adult inpatients admitted to acute/general medicine, collected through routine electronic health records in all patients. ARK-Hospital aims to provide a feasible, sustainable and generalisable mechanism for increasing antibiotic stopping in patients who no longer need to receive them at ‘review and revise’. ISRCTN Current Controlled Trials, ISRCTN12674243 . Registered on 10 April 2017.

Background Mindfulness courses are being offered to numerous groups and while a large body of research has investigated links between dispositional mindfulness and mood, few studies have reported this relationship during pregnancy. The aim of this study was to investigate this relationship in pregnant women to offer insight into whether an intervention which may plausibly increase dispositional mindfulness would be beneficial for this population. Methods A cross-sectional analysis was conducted to explore potential relationships between measures of mindfulness and general and pregnancy-specific mood. A sample of pregnant women (n = 363) was recruited using online advertising and community-based recruitment and asked to complete a number of questionnaires online. Results Overall, higher levels of mindfulness were associated with improved levels of general and pregnancy-related mood in pregnant women. Controlling for general stress and anxiety, higher scores for mindfulness in (psychologically) healthy women were associated with lower levels of pregnancy-related depression, distress and labour worry but this relationship was not apparent in those with current mental health problems. In participants without children, higher mindfulness levels were related to lower levels of pregnancy-related distress. Conclusions These results suggest a promising relationship between dispositional mindfulness and mood though it varies depending on background and current problems. More research is needed, but this paper represents a first step in examining the potential of mindfulness courses for pregnant women. Increasing mindfulness, and therefore completing mindfulness-based courses, is potentially beneficial for improvements in mood during pregnancy.

An evaluation of mindfulness-based childbirth and parenting courses for pregnant women and prospective fathers/partners within the UK NHS (MBCP-4-NHS). Objective: To explore the usefulness within the National Health Service (NHS) of a brief (four week, ten hour) course based upon the Mindfulness Based Childbirth and Parenting (MBCP) programme (Duncan and Bardacke, 2010) described here as MBCP-4-NHS. Background: The National Maternity Review (2016) and report of The Independent Mental Health Taskforce to the NHS (2016a, 2016b) in England highlight the need for significant investment into perinatal mental health services, with the Government pledging funding to improve such services through a range of measures. Whilst the field of mindfulness during the perinatal period is in need of well controlled trials and studies exploring the mechanisms of action (Hall et al., 2016) the limited research to date supports the potential for mindfulness based interventions in pregnancy and the need for further scientific study in this area (Dhillon et al., 2017; Shi and Macbeth, 2017). Particularly because it may broaden women's repertoire of coping strategies with the potential to improve the developmental trajectory of both parents and infants (Dunn et al., 2012; Duncan and Bardacke, 2010; Vieten and Astin, 2008). However, most of the studies to date have involved lengthy courses of around 8-9 weeks (24 h) duration, which may not be feasible or economical within a UK NHS setting and therefore, would be unlikely to be adopted as routine practice. Design: An initial pilot study to discover if MBCP-4-NHS is acceptable and feasible within NHS maternity services, comparing maternal and paternal pre and post intervention self-report measures of mental health to begin to explore the effectiveness of this intervention. Setting: NHS antenatal education classes held in children's centres for expectant parents across Oxfordshire. Participants: All expectant parents receiving Oxfordshire maternity services between October 2014 and January 2015 were invited to self-refer into the intervention, of which 155 individuals (86 women and 69 men) took part. Intervention: 'MBCP-4-NHS' - A brief (four week, ten hour) course developed from the nine week Mindfulness Based Childbirth and Parenting (MBCP) intervention. Measures: Self-report measures of mental health including low mood/depression, mindfulness, stress, anxiety, pregnancy related distress and experiences. Findings: The results showed a significant increase in both maternal and paternal mental health with women demonstrating a significant improvement in symptoms of stress, anxiety, depression, pregnancy-related distress, labour worry and positive and negative pregnancy experiences; and men improving significantly in symptoms of anxiety, depression and showing a trend for improvement in self-reported symptoms of perceived stress. Conclusions: This is a promising antenatal intervention that can be feasibly implemented within NHS which might have the potential to impact upon parental mental health and, therefore, possibly also the health of next generation. However, caution is needed interpreting these findings given that this study did not include an active control group.

OBJECTIVE:Physical activity (PA) and a healthy diet can improve the well-being of cancer survivors. However, cancer survivors often do not engage in these behaviours. This study aimed to explore barriers and facilitators to engaging in these behaviours following cancer treatment. METHODS:During the development of a Web-based intervention to enhance health-related quality of life in cancer survivors, 32 people who had completed treatment for breast, colon, or prostate cancer were presented with an intervention for PA and healthy eating. In-depth think-aloud and semi-structured interviewing techniques were used to elicit perceptions of both behaviours. Data were analysed using thematic analysis. RESULTS:Some individuals reported implementing positive health behaviour changes to maintain health and prevent recurrence, or to help them to move forward after cancer. However, others reported feeling abandoned, and many did not report an intention to engage in lifestyle changes. Individuals discussed contextual and health-related barriers that were specifically linked to their situation as post-treatment cancer survivors: individuals described uncertainty about how to implement adaptive changes and perceived a lack of support from health care providers. Others viewed behaviour change as unnecessary or undesirable, with some arguing that non-modifiable factors contributed more to their cancer diagnosis than lifestyle-related factors. CONCLUSIONS:For many participants in this study, the period that follows treatment for cancer did not represent a "teachable moment." A variety of complex and heterogeneous factors appeared to impact motivation and may limit cancer survivors from engaging with diet and PA changes.

Objective: Prenatal depression, stress and anxiety are significant predictors of postnatal depression and also have a direct negative impact on the family. Helpful psychological interventions during pregnancy are scarce and expensive, and usually only available for a small percentage of those suffering or deemed to be at risk. The aim of this study was to evaluate the potential of an online mindfulness course for expectant mothers. Design: A randomised study was conducted to explore differences between control and active participants allocated to take an online mindfulness course, offered free to research participants, or wait. Setting: The course provided was online and already available but given to study participants for free. Measures were also taken online using a secure site to collect the data. Participants: 185 mothers were recruited and randomised to the online course (n = 107) or a waitlist control (n = 78), with 72 completers at post-course (n = 22 active, n = 50 control) and 48 completers at postnatal followup (n = 16 active and n = 32 control). Intervention: The online mindfulness course is available at www.bemindfulonline.com and comprises a four-week, condensed version of an eight-week mindfulness course, with videos and written instructions for guided meditation and other mindfulness-based exercises. Measurements and findings: A number of psychological well-being measurements were taken including stress, anxiety, depression and pregnancy-specific measure such as labour worry. Intention to treat analysis (baseline carried forwards) showed no group difference in stress from pre to post intervention or control. Key conclusions: Results indicated that the course was potentially beneficial for those who completed it, but levels of drop out from the course were very high. Implications for practice: Although outcomes for mothers completing the intervention were improved relative to a waitlist control, high rates of drop out indicate that the online course has low completion rates for pregnant women in its current format.

BackgroundRandomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized.PurposeWe examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression.MethodsWe describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources.ResultsPoster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important.LimitationsIt may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in other geographical locations. Recruitment source was unavailable for participants who could not be reached after the initial contact. Thus, it is possible that the efficiency of certain methods of recruitment was poorer than estimated. Efficacy and costs of other recruitment initiatives, such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly, were not analysed.ConclusionWebsite advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting. Future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future RCTs.

Objective: We compared mindfulness-based cognitive therapy (MBCT) with both cognitive psychological education (CPE) and treatment as usual (TAU) in preventing relapse to major depressive disorder (MDD) in people currently in remission following at least 3 previous episodes. Method: A randomized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU, CPE plus TAU, and TAU alone, and data were analyzed for the 255 (93%; MBCT = 99, CPE = 103, TAU = 53) retained to follow-up. MBCT was delivered in accordance with its published manual, modified to address suicidal cognitions; CPE was modeled on MBCT, but without training in meditation. Both treatments were delivered through 8 weekly classes. Results: Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up, hazard ratio for MBCT vs. CPE = 0.88, 95% CI [0.58, 1.35]; for MBCT vs. TAU = 0.69, 95% CI [0.42, 1.12]. However, severity of childhood trauma affected relapse, hazard ratio for increase of 1 standard deviation = 1.26 (95% CI [1.05, 1.50]), and significantly interacted with allocated treatment. Among participants above median severity, the hazard ratio was 0.61, 95% CI [0.34, 1.09], for MBCT vs. CPE, and 0.43, 95% CI [0.22, 0.87], for MBCT vs. TAU. For those below median severity, there were no such differences between treatment groups. Conclusion: MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma, but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression.

Background: This report assesses the association between age of onset of major depression and later suicidality in a sample of 276 recurrently depressed patients recruited for the Oxford/Bangor Staying Well after Depression (SWAD) Trial, and interviewed when in remission.Methods: The study enrolled adult patients with a history of at least three episodes of non-psychotic major depressive disorder from primary care and psychiatric care practices and through community advertisements. At study entry, all participants estimated the age of their first onset of a major depressive episode and completed both self-report and interview-based assessments of past and current suicidal ideation and behavior. Participants were divided into pre-adult and adult onset groups using a cut-off age of 18.Results: Forty-eight percent of the sample reported a pre-adult age of onset. Pre-adult age of onset was significantly associated with suicidality, both from self-report and from interviewer assessment even when adjusting for differences in age, gender, employment status, length of the disorder and early adversity.Limitations: Relevant variables were all assessed through retrospective reports.Conclusions: Pre-adult age of onset is closely associated with risk for and severity of later suicidality, replicating, in a sample of patients assessed when in remission, findings from studies that assessed patients when currently depressed. The association of pre-adult age of onset with suicidality is not due to differences in sociodemographic variables, length of the disorder and early adversity. (C) 2012 Elsevier B.V. All rights reserved.

Objectives Stress has been shown to have a number of negative effects on health over time. Mindfulness interventions have been shown to decrease perceived stress but access to interventions is limited. Therefore, the effectiveness of an online mindfulness course for perceived stress was investigated. Design A preliminary evaluation of an online mindfulness course. Participants This sample consisted of 100 self-referrals to the online course. The average age of participants was 48 years and 74% were women. Interventions The online programme consisted of modules taken from Mindfulness Based Stress Reduction and Mindfulness Based Cognitive Therapy and lasted for approximately 6 weeks. Primary and secondary outcome measures Participants completed the Perceived Stress Scale (PSS) before the course, after the course and at 1-month follow-up. Completion of formal (eg, body scan, mindful movement) and informal (eg, mindful meal, noticing) mindfulness activities was self-reported each week. Results Participation in the online mindfulness course significantly reduced perceived stress upon completion and remained stable at follow-up. The pre-post effect size was equivalent to levels found in other class-based mindfulness programmes. Furthermore, people who had higher PSS scores before the course reported engaging in significantly more mindfulness practice, which was in turn associated with greater decreases in PSS. Conclusions Because perceived stress significantly decreased with such limited exposure to mindfulness, there are implications for the accessibility of mindfulness therapies online. Future research needs to evaluate other health outcomes for which face-to-face mindfulness therapies have been shown to help, such as anxiety and depressive symptoms.