Yes

Background: Recent empirical research and theoretical models acknowledge that impulsive processes, can often undermine peoples’ attempts to lose weight despite currently available and effective support (Chapter 2). Aim: To develop, deliver, and evaluate an impulse management intervention to support weight loss in adults. Methods: A systematic review was conducted to identify available impulse management techniques for influencing eating behaviour (Chapter 3). Intervention Mapping was used to develop the intervention (Chapter 4) which drew on various sources including the findings from the systematic review, stakeholder consultations, existing guidance, and qualitative interviews. A two-arm randomised controlled feasibility trial (Chapter 5), with nested mixed-methods process evaluation and two cycles of intervention delivery and data collection (Chapter 6), was conducted. This assessed the feasibility and acceptability of, and informed refinements to, both the intervention and trial procedures in preparation for a full-scale effectiveness evaluation. Weight was measured as the proposed primary outcome for a full-scale trial at baseline, one-month, and three-months of follow-up, app usage data were collected at both follow-up time points, and semi-structured interviews were conducted at one-month with a subsample of intervention group participants only. Results: The systematic review critically appraised and synthesised evidence on 17 identified techniques which were categorised as Impulse-focused or Reflective techniques. Promising changes in eating behaviour and craving were found for the techniques of visuospatial loading, physical activity, and implementation intentions. Intervention Mapping resulted in development of a novel smartphone app-based intervention (ImpulsePal) aimed to reduce unhealthy snacking, overeating, and alcoholic and sugary drink consumption using impulse management techniques identified in the systematic review. Eighty-eight adults with a Body Mass Index of ≥25kg/m2 and wishing to lose weight, were recruited and randomised in a 2:1 ratio to use ImpulsePal (n=58) or to a waiting list control (n=30) group. Data were available for 74 participants (84%) at one-month and 67 (76%) at three months. Exploratory analyses suggest that the ImpulsePal group (n=43) lost 1.03kg (95% CI 0.33 to 1.74) more than controls (n=26) at one-month, and 1.01kg (95% CI -0.45 to 2.47) more at three months. Participants reported high satisfaction with the intervention and trial procedures. The process evaluation suggests that ImpulsePal and the impulse management techniques are feasible to deliver and acceptable to users. Interviews with twenty-two participants suggest that they valued having access to in-the-moment support, felt more aware of their own eating behaviour and influences on it, and felt an increased ability to resist temptations. Conclusions: This work has developed a novel, theory- and evidence-informed, person-centred app which showed potential to improve impulse management, promote healthier eating, and support weight loss. ImpulsePal is acceptable to overweight and obese adults who want to lose weight and is now ready for evaluation in a full-scale trial. The thesis discusses theoretical, methodological, and practical implications for the future development, evaluation, and implementation of digital behaviour change interventions.

Background: Informal caregivers provide unpaid support to a family member, which has been shown to more positively affect their relatives’ health outcomes than equivalent paid caregivers. The provision of this support, however, comes at a cost to the carers’ health and wellbeing through meeting the demands of the caring role. Efforts have been made to alleviate these consequences through various forms of interventions aimed to enable the carers to meet these demands. The reported success of these interventions is varied in regards to their effectiveness; an argument supported by literature review papers on the subject that questions the methodologies and evaluations of these interventions. Rationale: There is a need to explore the ways to enhance the health and wellbeing of informal carers by means of a robust design and evaluation. This thesis reports a study, the aim of which is to provide information about how to reduce the negative effects of the carer role whilst enhancing the positive effects using an intervention developed using lived experience. Method: The self-care intervention was developed and piloted with those caring for a relative with bipolar disorder. This was achieved in three stages: (i) qualitative interviews with carers to explore and understand the role, (ii) developing the intervention informed by qualitative findings, and finally by (iii) piloting the intervention. Effectiveness of the intervention was determined using health and wellbeing outcomes, the results of which were compared to a control group who did not take part in the intervention. Results: A positive potential for psychoeducational, cognitive behavioural and mindfulness techniques in enhancing the health and wellbeing of those caring for a relative diagnosed with bipolar disorder was found. From the exploration of lived experience, “Being Bound” was elicited from the data representing the conflict between the detrimental effects of providing care and being unable to take respite or reprieve through guilt and anxiety. Conclusion: Professionals who work with family members, individually or as part of a family unit, should consider the benefits of targeted information for carers. Provision of information is not enough to engage the carer in the process of understanding their relative’s behaviours, but requires a process of interaction and personalisation. In contributing to existing research, the use of hermeneutic phenomenology provided new insight in to the experiences of those providing care. The outcome of the intervention pilot shows positive potential for the use of interventions beyond psychoeducation alone and the use of a self-care approach.

Background. Depression and anxiety are common and debilitating disorders, and at least one third of patients do not respond to available interventions. Morita Therapy, a Japanese psychological therapy which contrasts with established Western approaches, is currently untested in the UK and may represent a potentially effective alternative approach. Aim. To optimise and investigate the feasibility and acceptability of Morita Therapy as a treatment for depression and anxiety in the UK. Design. Three studies were undertaken in line with the MRC framework (2008) for complex interventions. Study One: scoping and systematic review to describe the extent, range and nature of Morita Therapy research activity reported in English. Study Two: intervention optimisation study, integrating literature synthesis with qualitative research, to develop the UK Morita Therapy outpatient protocol. Study Three: mixed methods feasibility study encompassing a pilot randomised controlled trial (RCT) and embedded qualitative interviews to prepare for a fully-powered RCT of Morita Therapy versus treatment as usual (TAU). Results. Study One: 66 papers meeting the inclusion criteria highlighted heterogeneity in the implementation of Morita Therapy, and an absence of both UK-based research and relevant unbiased RCTs. Study Two: a potentially deliverable and acceptable therapy protocol and tailored therapist training programme were developed for a UK population. Study Three: 68 participants were recruited and 94% retained at four month follow-up; 70.6% of Morita Therapy participants adhered to the minimum treatment dose, and 66.7% achieved remission in depressive symptoms (compared to 30.0% in TAU). Qualitative and mixed methods findings indicated that Morita Therapy was broadly acceptable to therapists and participants, and highlighted potential moderators of acceptability, treatment adherence and outcomes. Conclusions. Patients in the UK can accept the premise of Morita Therapy and find the approach beneficial. It is feasible to conduct a large-scale UK-based trial of Morita Therapy with minor modifications to the pilot trial protocols.

京都大学 / 0048 / 新制・課程博士 / 博士(工学) / 甲第21086号 / 工博第4450号 / 新制||工||1692(附属図書館) / 京都大学大学院工学研究科都市社会工学専攻 / (主査)教授 藤井 聡, 准教授 SCHMOECKER Jan-Dirk, 教授 宇野 伸宏 / 学位規則第4条第1項該当 / Doctor of Philosophy (Engineering) / Kyoto University / DFAM

Yes / Background: Experience-Based Co-Design (EBCD) is a participatory design method which was originally developed and is still primarily used as a healthcare quality improvement tool. Traditionally, EBCD has been sited within single services or settings and has yielded improvements grounded in the experiences of those delivering and receiving care. Method: In this article we present how EBCD can be adapted to develop complex interventions, underpinned by theory, to be tested more widely within the healthcare system as part of a multi-phase, multi-site research study. We begin with an outline of co-design and the stages of EBCD. We then provide an overview of how EBCD can be assimilated into an intervention development and evaluation study, giving examples of the adaptations and research tools and methods that can be deployed. We also suggest how to appraise the resulting intervention so it is realistic and tractable in multiple sites. We describe how EBCD can be combined with different behaviour change theories and methods for intervention development and finally, we make suggestions about the skills needed for successful intervention development using EBCD. Conclusion: EBCD has been recognised as being a collaborative approach to improving healthcare services that puts patients and healthcare staff at the heart of initiatives and potential changes. We have demonstrated how EBCD can be integrated into a research project and how existing research approaches can be assimilated into EBCD stages. We have also suggested where behaviour change theories can be used to better understand intervention change mechanisms.

This article details the process used to develop the revision of the original Guidelines that resulted in the development of the 2014 Health Care Quality and Outcomes Guidelines for Nursing of Children, Adolescents, and Families . Members of the 2014 Guidelines Revision Task Force conducted an extensive process of revision, which included the input and approval of 16 pediatric and child health nursing and affiliated organizational endorsements. The revised Guidelines were presented to and endorsed by the American Academy of Nursing Board. These Guidelines are designed for use by pediatric and child health nurses who work in a range of health care and community-based settings. The Guidelines are proposed to be used as a framework for nurse-directed services and intervention development and testing, as a model for undergraduate and graduate pediatric and child health nursing program curriculum development, and as the theoretical basis for nursing investigations on the care of children, adolescents, and families.

Background: Cigarette smoking is a leading preventable factor associated with complications in pregnancy including preterm birth and low birthweight. Past interventions have raised cessation rates by approximately 6% overall (Lumley et al. 2009). Methods: A three-part literature review, two qualitative studies with a total of 36 participants, and the development of an intervention to promote smoking cessation during pregnancy were completed. Central to the design of the research was the creation of the theoretical basis which was developed in line with recommendations from the MRC Framework for Complex Interventions (Craig et al. 2008, Campbell et al. 2000). For part one of the literature review, 24 qualitative and 44 quantitative studies were re-analysed to complete a mixed-methods secondary analysis of the active ingredients in interventions to promote smoking cessation during pregnancy. Part two consisted of an exploration of psychological models and constructs which are likely to predict or influence smoking behaviour during pregnancy. The final part was a discussion regarding the modes of delivery by which an intervention could feasibly be delivered. Qualitative interviews were carried out with participants from stakeholder groups to fill in gaps in literature and determine the acceptability and feasibility of the proposed intervention. The intervention was created using the theoretical basis developed from the findings. Further qualitative interviews, a focus group, and heuristic evaluation were used to determine the acceptability and usability of the intervention for the target group of pregnant smokers. Results and Conclusions: Findings from this work are potentially relevant for a wide range of behaviours and behavioural interventions. An intervention which has a strong grounding in theory and evidence, and is acceptable and feasible for the target group and in clinical practice was developed using evidence gathered in this thesis.

Alcohol misuse and related harm costs money, drains resource and takes lives. Alcohol brief interventional advice forms an important method to moderate alcohol consumption at both individual and population level. Alcohol exerts a significant negative influence on the oral cavity and is implicated in the development of oro-mucosal and dental disease. Alcohol and tobacco smoking are recognised a key aetiological agents in the development of oral cancer which is the 14th most common cancer, accounting for approximately 2% of new cases, killing over 2300 people in the UK every year. A crucial weapon to tackle the disease is prevention through management of those modifiable lifestyle factors. The role of the general dental practitioner (GDP) in providing alcohol advice has received sparse attention, however evidence suggests that GDPs do not routinely engage in this activity. The aim of this research was to identify factors preventing or facilitating GDP engagement and develop strategies to support them to deliver alcohol advice. GDPs salient beliefs were applied, using behaviour change theories (the Theory of Planned Behaviour and Social Cognitive Theory), to formulate a theory based questionnaire. A postal survey (n=300, RR 60%) identified that few (17%) GDPs routinely provide advice to patients exposing potential for improvement. Subsequent exploratory multiple regression analysis identified 5 key items which might act as targets. The resultant five-item model accounted for 41% of the variance in intention [Adjusted R2 for this model is .41; F = 15.34 (.001)].A theoretically informed intervention was administered as a multi-centre, parallel group, three-arm randomized controlled pilot study. The aims were to test the feasibility and acceptability of implementing an alcohol advice intervention in dental primary care. The intervention was not entirely acceptable to patients or dentists. Qualitative analysis revealed factors (not limited) to remuneration, perceived relevance, confidence, embarrassment and fear of consequences mar progress. Modifications to study processes and methods would seem a sensible prior to further study.

La prise optimale d’un traitement antirétroviral est la clé du succès de ces traitements. Cette prise devrait être d’au moins 95 % des médicaments antirétroviraux prescrits afin de supprimer à long terme la réplication virale et donc de restaurer et de préserver la fonction immunologique. Cependant, les personnes vivant avec le virus de l’immunodéficience humaine (PVVIH) éprouvent des difficultés à adopter et à maintenir ce niveau de prise dans le temps. Bien que certaines interventions aient démontré leur capacité à faciliter ce comportement, au Québec il n’y a pas d’intervention systématique pour soutenir ces personnes dans la prise quotidienne de ces traitements. Le but de cette étude était donc de développer et d’évaluer une intervention pour faciliter le comportement de prise optimale d’un traitement antirétroviral chez des personnes vivant avec le VIH. Pour guider le développement de l’intervention, la démarche appelée « intervention mapping » a été suivie. Le cadre théorique proposé par Godin et ses collègues (2005) qui inclut le sentiment d’efficacité personnelle et les attitudes positives face à la prise optimale d’un traitement antirétroviral a été ainsi utilisé non seulement pour prédire et expliquer le comportement de prise, mais aussi pour élaborer l’intervention. Selon ce modèle, le soutien social, la satisfaction envers les professionnels et le fait de ne pas ressentir d’effets indésirables sont autant de facteurs modifiables associés au sentiment d’efficacité personnelle et aux attitudes positives. L’intervention développée visait l’acquisition et la mobilisation des habiletés nécessaires pour influencer ces facteurs en vue de rehausser le sentiment d’efficacité personnelle et les attitudes positives ainsi que pour faciliter ce comportement. Cette intervention comportait quatre rencontres d’une durée de 45 à 75 minutes, s’échelonnant sur 12 semaines, avec une infirmière iii possédant une expertise en VIH. L’évaluation de l’effet de cette intervention sur le comportement et les variables explicatives a été effectuée à l’aide d’un essai clinique avec répartition aléatoire. La principale variable résultat a été mesurée à l’aide d’un questionnaire autoadministré, de la charge virale et du nombre de CD4. Autant la variable résultat principale que les variables explicatives ont été mesurées avant l’intervention et après celle-ci, soit à 12 et 24 semaines. L’échantillon était constitué de 51, personnes vivant avec le VIH et suivies dans une clinique à Montréal : 23 dans le groupe contrôle et 28 dans le groupe expérimental. Des analyses de variance (ANOVA) à mesures répétées ont été réalisées afin d’analyser l’effet de l’intervention sur la prise optimale d’un traitement antirétroviral et les autres variables intermédiaires dans le temps. Les résultats montrent une tendance positive (p = 0,056) quant à l’obtention d’une charge virale indétectable dans le groupe intervention. Ainsi, 43,8 % plus de personnes du groupe expérimental comparativement au groupe contrôle (78,6 % versus 34,8 %) avaient une charge virale indétectable à 12 semaines et 32,8 % de plus à 24 semaines (89,3 % versus 56,5 %). Bien qu’aucun effet significatif ait été trouvé en regard des variables explicatives, probablement à cause d’un manque de puissance statistique, les légères augmentations observées dans le groupe expérimental sont cohérentes avec le modèle théorique utilisé (Godin & al., 2005). Cette étude contribue à l’avancement des connaissances en proposant une intervention pour faciliter la prise optimale d’un traitement antirétroviral chez des personnes vivant avec le VIH. / The key to the success of antiretroviral treatment is optimal treatment taking. At least 95% of prescribed antiretroviral treatments (ARV) have to be taken to achieve long-term suppression of viral replication and so restore and preserve immunologic functioning. However, people living with acquired immunodeficiency virus (PLHIV) have problems adopting and sustaining this level of medication taking over time. Although some interventions have demonstrated they can facilitate this behaviour, in Quebec there are no systematic interventions to support PLHIV in daily treatment taking. The goal of this study was to develop and evaluate an intervention to facilitate optimal antiretroviral-treatment-taking behaviour among people living with HIV. Development of the intervention was guided by an approach known as “intervention mapping.” Accordingly, the theoretical framework put forward by Godin and his colleagues (2005), which includes the factors of self-efficacy and attitudes, was used not only to predict and explain treatment-taking behaviour but also to develop the intervention. In the model, self-efficacy and attitudes are associated with a number of modifiable factors: social support, satisfaction with health professionals and not feeling adverse effects. The goal of the intervention was therefore the acquisition and mobilization of skills in order to affect these factors and, consequently, enhance self-efficacy and positive attitudes towards taking one’s ARV treatment, thus facilitating the desired behaviour. The individualized intervention was structured as four 45- to 75-minute meetings held over a 12-week period with a nurse who had expertise in HIV. A randomized trial was conducted to evaluate the effect of the intervention on behaviour and on the explanatory variables. A self-administered questionnaire, viral load and CD4 count were used to measure the principal outcome variable. vi Measurements of the principal outcome and the explanatory variables were made before the intervention and at 12 weeks and at 24 weeks post-intervention. The sample comprised 51 people living with HIV who were being followed at a clinic in Montreal: 23 in the control group and 28 in the experimental group. Data were subjected to repeated measures analysis of variance (ANOVA). The intervention was found to have a positively trend (p = 0.056) in terms of achieving an undetectable viral load : 43.8 % more persons of the experimental group compared with the group control (78.6 % versus 34.8 %) had an undetectable viral load at 12 weeks and 32.8 % more at 24 weeks (89.3 % versus 56.5 %). Probably the lack of statistical power meant no significant effect was found on the explanatory variables, but the small increases observed in the experimental group are consistent with the theoretical model (Godin et al., 2005). This study contributes to knowledge by proposing an intervention to facilitate optimal antiretroviral-treatment taking among PLHIV.