Objectifs: Observer l’évolution de la stomatite prothétique dans le temps quant à la fréquence et la sévérité ainsi que son association avec de potentiels facteurs de risque au cours d’un suivi longitudinal de 2 ans. Matériels et méthodes : Cent trente-cinq patients âgés complètement édentés et en bonne santé ont été sélectionnés pour participer à cette étude et ont été divisés de façon randomisée en deux groupes. Ils ont tous reçu une prothèse dentaire amovible totale conventionnelle au maxillaire supérieur. La moitié d’entre eux a reçu une prothèse totale mandibulaire implanto-portée retenue par deux attachements boule et l’autre moitié une prothèse conventionnelle. Ils ont été suivis sur une période de deux ans. Les données sociodémographiques, d’habitudes de vie, d’hygiène et de satisfaction des prothèses ont été amassées à l’aide de questionnaires. Les patients ont aussi subi un examen oral complet lors duquel une évaluation de la stomatite prothétique, basée sur la classification de Newton, a été effectuée ainsi qu’un prélèvement de la plaque prothétique. Les analyses microbiologiques pertinentes afin de détecter la présence de Candida ont ensuite été effectuées. Des tests Chi-carré de Pearson et McNemar ont été utilisés pour analyser la fréquence de la stomatite, son association avec de possibles facteurs de risque ainsi que son évolution dans le temps. Des rapports de cotes (odds ratio) et leurs intervalles de confiance (95%) ont été effectués afin de déterminer la force d’association entre les facteurs de risque et la stomatite prothétique. Résultats : La prévalence de la stomatite a augmenté entre la première (63,6%) et la deuxième année de suivi (88,7%) avec une incidence de 78,8%. Les patients souffrant d’une stomatite de type 2 ou 3 et qui brossent leur palais ont environ 6 fois plus de chance de voir la sévérité de leur stomatite diminuer [p = 0,04 OR 5,88 CI (1,1-32,2)]. Il n’y a pas d’association statistiquement significative entre la fréquence de la stomatite et les facteurs de risque investigués. La prévalence de la candidose est demeurée stable dans le temps (45,8% et 49,2% à la première et deuxième année de suivi respectivement, p > 0,05). Il n’y a pas d’association entre la présence d’une candidose orale, la stomatite prothétique et les facteurs de risque étudiés. Conclusion : Les résultats de cette étude suggèrent que la stomatite prothétique progresse dans le temps indépendamment de la présence d’une candidose. Le brossage du palais pourrait être une approche simple à conseiller aux patients souffrant d’une stomatite prothétique de type 2 ou 3. / Objectives: To assess the evolution of denture stomatitis in term of frequency and severity and its association with potential risk factors over a two-year period. Methods: One hundred thirty five healthy edentulous elders who were randomly rehabilitated with a maxillary complete denture opposed by a conventional denture or an implant-supported overdenture retained by two ball attachments were followed over two years. Demographic and clinical data concerning oral and general health, smoking, denture status and hygienic habits were obtained from oral examination and standard questionnaires. Denture stomatitis was evaluated according to Newton’s classification. Microbiological analyses consist of detection of Candida species in denture plaque and inoculation in selective growth medium. Pearson Chi-square and McNemar tests were used to analyse the frequency of denture stomatitis, its association with potential risk factors and it’s evolution over time. Odds ratios and their 95% confidence intervals were calculated to determine the strength of association between risk factors and denture stomatitis. Results: The prevalence of denture stomatitis increased between the first (63.6%) and second year follow-up (88.7%) with an incidence rate of 78.8%. Those individuals suffering from type 2 or type 3 denture stomatitis and who brushed their palate had approximately 6 times more chance of observing a decrease in the severity of their condition [p=0.04 OR 5.88 CI (1.1-32.2)]. There was no statistically significant association between the frequency of denture stomatitis and classical risk factors at both follow-ups. The carriage rate of Candida species remained stable over time (45.8% and 49.2% first and second year of follow-up consecutively, p > 0.05). There was no association between the presence of oral candidiosis and denture stomatitis or its potential risk factors. Conclusion: The results of this study suggest that denture stomatitis progresses overtime independent of Candida carriage. Palatal brushing could be a preventive approach to minimise the inflammation in individuals suffering from type 2 or type 3 denture stomatitis.

<b>Background:</b> Defined by their mechanisms, social and psychological interventions are those interventions that work through mental processes and social phenomena. They are often complex and challenging to evaluate, so understanding randomised controlled trials (RCTs) of these interventions requires detailed reports of the interventions tested and the methods used to assess them. However, reports of these RCTs often omit important information. Poor reporting hinders critical appraisal and synthesis of RCTs in systematic reviews, thereby impeding the effective transfer of research evidence to policy and practice. The Consolidated Standards for Reporting Trials (CONSORT) Statement is a reporting guideline that has contributed to improvements in the quality of RCT manuscripts in journals publishing medical research. However, studies have shown persistent deficiencies in the reporting quality of social and psychological intervention trials. A new CONSORT extension for these interventions may be needed given their distinct and complex features. This DPhil thesis reports on a project to develop and disseminate an official CONSORT Extension for Social and Psychological Interventions: CONSORT-SPI. <b>Structure:</b> Following a preface, this DPhil thesis includes eight chapters. Chapter 1 provides an overview of the conceptual rationale that prompted the CONSORT-SPI project. Chapter 2 details the project protocol, which consists of a five-phase methodology that follows current best practices for reporting guideline development and dissemination. Chapter 3 discusses systematic literature reviews to assess reporting guidelines for and the reporting quality of publications of social and psychological intervention RCTs. Chapter 4 discusses an online, international Delphi process to generate a prioritised list of possible items to include in the CONSORT-SPI extension. Chapter 5 discusses a formal consensus meeting to select reporting items to add to or modify for the CONSORT-SPI Extension checklist. Chapter 6 involves drafts of the CONSORT-SPI checklist as well as a template for the Explanation and Elaboration (E&E) document providing detailed advice and examples of good reporting for each checklist item. These drafts have not yet been circulated to co-authors or other members of the project team; their purpose in this thesis is to give an indication of how previous project phases have led into initial prototypes of the checklist and E&E, which will undergo further development and revision by the project team before publication. Chapter 7 proposes a coordinated dissemination and implementation strategy informed by theoretical frameworks and tools used to guide the implementation of clinical guidelines and empirically-supported interventions. The final chapter summarises the information gained from the CONSORT-SPI project to date, assesses strengths and limitations of the project methodology, and discusses implications for future research. <b>Conclusion:</b> A CONSORT-SPI Extension could improve the reporting quality of social and psychological intervention RCTs. This extension could also facilitate better critical appraisal of this body of research and its use in evidence-based decision-making. With successful dissemination and implementation, the guideline will hopefully contribute to the improvement of intervention evaluations—as well as the methodology underpinning these studies—within the social and behavioural sciences.

<p>Enthusiasm for uvulopalatopharyngoplasty (UPPP) in the treatment of mild-to-moderate obstructive sleep apnea syndrome (OSAS) has declined in recent years, partly because of a lower success rate over time and partly because of adverse effects. In more severe cases, the patients are generally treated with nasal continuous positive airway pressure (CPAP). However, many patients do not satisfactorily tolerate CPAP as a result of frequent side-effects. Consequently, there is a need for an alternative treatment. Reports on the beneficial effects of mandibular advancement appliances in the treatment of mild-to-moderate OSA exist in the form of short–term evaluations.</p><p>One of the aims of the present thesis was to compare treatment effects with a mandibular advancement appliance and UPPP in patients with OSA with follow-up after one and four years. Ninety-five male patients with confirmed mild-to-moderate OSA (apnea index, AI >5 and <25) were randomised to treatment with a dental appliance or UPPP. Sleep studies were performed before and one and four years after intervention. According to the criteria for normalisation (AI<5 and apnea hypopnea index, AHI<10), 78% of the patients in the dental appliance group and 51% of the patients in the UPPP group had normalised after one year (p<0.05). Still after four years of treatment, 63% of the patients in the dental appliance group and 33% of the patients in the UPPP group were normalised. The dental appliance group had a higher normalisation rate than the UPPP group, but the efficacy was partly invalidated by the compliance rate of 62%.</p><p>Quality of life assessments in the dimensions of vitality, contentment and sleep improved in both groups at the one-year follow-up after treatment. There was no difference between the groups in terms of vitality and sleep. The UPPP group, however, reported a higher degree of contentment than the dental appliance group, even though the somnographic values were superior in the latter group. </p><p>Another aim was to conduct a randomised study to test the hypothesis that severe OSA patients will benefit from more pronounced mandibular advancement (MA) compared with a shorter advancement. Eighty-six males with severe OSA (AI>20) were randomly allocated to either 75% or 50% MA for a six-month treatment period. Treatment with a more pronounced mandibular advancement yielded a 20% higher normalisation rate than a shorter advancement. A mean normalisation rate of 45% was found for patients in this category with few side-effects, good patient satisfaction and a compliance of 92% after 6 months. </p><p>The overall conclusion is that dental appliance treatment is effective in patients with mild to moderate OSA and even for patients with severe OSA. The efficacy in terms of normalisation in patients with mild to moderate OSA was higher after the dental appliance treatment with a 50% degree of advancement than after the UPPP treatment. However, severe OSA patients might benefit from more pronounced advancement (75%) compared with a shorter degree of advancement (50%). QOL improved significantly after both dental appliance and UPPP treatment. </p>

Enthusiasm for uvulopalatopharyngoplasty (UPPP) in the treatment of mild-to-moderate obstructive sleep apnea syndrome (OSAS) has declined in recent years, partly because of a lower success rate over time and partly because of adverse effects. In more severe cases, the patients are generally treated with nasal continuous positive airway pressure (CPAP). However, many patients do not satisfactorily tolerate CPAP as a result of frequent side-effects. Consequently, there is a need for an alternative treatment. Reports on the beneficial effects of mandibular advancement appliances in the treatment of mild-to-moderate OSA exist in the form of short–term evaluations. One of the aims of the present thesis was to compare treatment effects with a mandibular advancement appliance and UPPP in patients with OSA with follow-up after one and four years. Ninety-five male patients with confirmed mild-to-moderate OSA (apnea index, AI &gt;5 and &lt;25) were randomised to treatment with a dental appliance or UPPP. Sleep studies were performed before and one and four years after intervention. According to the criteria for normalisation (AI&lt;5 and apnea hypopnea index, AHI&lt;10), 78% of the patients in the dental appliance group and 51% of the patients in the UPPP group had normalised after one year (p&lt;0.05). Still after four years of treatment, 63% of the patients in the dental appliance group and 33% of the patients in the UPPP group were normalised. The dental appliance group had a higher normalisation rate than the UPPP group, but the efficacy was partly invalidated by the compliance rate of 62%. Quality of life assessments in the dimensions of vitality, contentment and sleep improved in both groups at the one-year follow-up after treatment. There was no difference between the groups in terms of vitality and sleep. The UPPP group, however, reported a higher degree of contentment than the dental appliance group, even though the somnographic values were superior in the latter group. Another aim was to conduct a randomised study to test the hypothesis that severe OSA patients will benefit from more pronounced mandibular advancement (MA) compared with a shorter advancement. Eighty-six males with severe OSA (AI&gt;20) were randomly allocated to either 75% or 50% MA for a six-month treatment period. Treatment with a more pronounced mandibular advancement yielded a 20% higher normalisation rate than a shorter advancement. A mean normalisation rate of 45% was found for patients in this category with few side-effects, good patient satisfaction and a compliance of 92% after 6 months. The overall conclusion is that dental appliance treatment is effective in patients with mild to moderate OSA and even for patients with severe OSA. The efficacy in terms of normalisation in patients with mild to moderate OSA was higher after the dental appliance treatment with a 50% degree of advancement than after the UPPP treatment. However, severe OSA patients might benefit from more pronounced advancement (75%) compared with a shorter degree of advancement (50%). QOL improved significantly after both dental appliance and UPPP treatment.

Objectifs: Observer l’évolution de la stomatite prothétique dans le temps quant à la fréquence et la sévérité ainsi que son association avec de potentiels facteurs de risque au cours d’un suivi longitudinal de 2 ans. Matériels et méthodes : Cent trente-cinq patients âgés complètement édentés et en bonne santé ont été sélectionnés pour participer à cette étude et ont été divisés de façon randomisée en deux groupes. Ils ont tous reçu une prothèse dentaire amovible totale conventionnelle au maxillaire supérieur. La moitié d’entre eux a reçu une prothèse totale mandibulaire implanto-portée retenue par deux attachements boule et l’autre moitié une prothèse conventionnelle. Ils ont été suivis sur une période de deux ans. Les données sociodémographiques, d’habitudes de vie, d’hygiène et de satisfaction des prothèses ont été amassées à l’aide de questionnaires. Les patients ont aussi subi un examen oral complet lors duquel une évaluation de la stomatite prothétique, basée sur la classification de Newton, a été effectuée ainsi qu’un prélèvement de la plaque prothétique. Les analyses microbiologiques pertinentes afin de détecter la présence de Candida ont ensuite été effectuées. Des tests Chi-carré de Pearson et McNemar ont été utilisés pour analyser la fréquence de la stomatite, son association avec de possibles facteurs de risque ainsi que son évolution dans le temps. Des rapports de cotes (odds ratio) et leurs intervalles de confiance (95%) ont été effectués afin de déterminer la force d’association entre les facteurs de risque et la stomatite prothétique. Résultats : La prévalence de la stomatite a augmenté entre la première (63,6%) et la deuxième année de suivi (88,7%) avec une incidence de 78,8%. Les patients souffrant d’une stomatite de type 2 ou 3 et qui brossent leur palais ont environ 6 fois plus de chance de voir la sévérité de leur stomatite diminuer [p = 0,04 OR 5,88 CI (1,1-32,2)]. Il n’y a pas d’association statistiquement significative entre la fréquence de la stomatite et les facteurs de risque investigués. La prévalence de la candidose est demeurée stable dans le temps (45,8% et 49,2% à la première et deuxième année de suivi respectivement, p > 0,05). Il n’y a pas d’association entre la présence d’une candidose orale, la stomatite prothétique et les facteurs de risque étudiés. Conclusion : Les résultats de cette étude suggèrent que la stomatite prothétique progresse dans le temps indépendamment de la présence d’une candidose. Le brossage du palais pourrait être une approche simple à conseiller aux patients souffrant d’une stomatite prothétique de type 2 ou 3. / Objectives: To assess the evolution of denture stomatitis in term of frequency and severity and its association with potential risk factors over a two-year period. Methods: One hundred thirty five healthy edentulous elders who were randomly rehabilitated with a maxillary complete denture opposed by a conventional denture or an implant-supported overdenture retained by two ball attachments were followed over two years. Demographic and clinical data concerning oral and general health, smoking, denture status and hygienic habits were obtained from oral examination and standard questionnaires. Denture stomatitis was evaluated according to Newton’s classification. Microbiological analyses consist of detection of Candida species in denture plaque and inoculation in selective growth medium. Pearson Chi-square and McNemar tests were used to analyse the frequency of denture stomatitis, its association with potential risk factors and it’s evolution over time. Odds ratios and their 95% confidence intervals were calculated to determine the strength of association between risk factors and denture stomatitis. Results: The prevalence of denture stomatitis increased between the first (63.6%) and second year follow-up (88.7%) with an incidence rate of 78.8%. Those individuals suffering from type 2 or type 3 denture stomatitis and who brushed their palate had approximately 6 times more chance of observing a decrease in the severity of their condition [p=0.04 OR 5.88 CI (1.1-32.2)]. There was no statistically significant association between the frequency of denture stomatitis and classical risk factors at both follow-ups. The carriage rate of Candida species remained stable over time (45.8% and 49.2% first and second year of follow-up consecutively, p > 0.05). There was no association between the presence of oral candidiosis and denture stomatitis or its potential risk factors. Conclusion: The results of this study suggest that denture stomatitis progresses overtime independent of Candida carriage. Palatal brushing could be a preventive approach to minimise the inflammation in individuals suffering from type 2 or type 3 denture stomatitis.

Background: Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation. Methods/Design: EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in- and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo)affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD. Discussion: To our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.

Objective The aim of this study firstly, was to translate and test the validity and reliability of two diabetes-specific self-efficacy instruments (the Diabetes Management Self-Efficacy Scale; DMSES and the Perceived Therapeutic Efficacy Scale; PTES) in a Taiwanese population. The main aim of this study was then to develop an intervention based on self-efficacy theory that was appropriate for the Taiwanese population and to examine the effects of a self-efficacy enhancing intervention program (SEEIP). Background In Taiwan, the prevalence, mortality rate and healthcare cost of diabetes has dramatically increased. People with diabetes have low participation rates in performing self-care activities, with some two-thirds of diabetic patients not controlling their disease appropriately. Moreover, few studies in Taiwan have conducted randomised controlled trials or had improvement in patient self-care or self-management as their primary goal and no instruments that measure self-efficacy related to the management of diabetes (especially for outcome expectations) have yet been found and appropriately used to measure the effectiveness of self-management. Therefore, there is a particular need for research on self-efficacy enhancing intervention programs for people with type 2 diabetes. Design A convenience sample survey (n=230) was used in order to test the validity and reliability of C-DMSES and C-PTES in a Taiwanese population. Moreover, a randomised controlled trial (RCT) (n=145; the intervention group (72); the control group (73)) design was conducted in the main study with pre (baseline) and post-testing (undertaken at 3 months and 6 months following baseline collection). Intervention Both the control group and intervention group received the standard diabetic educational program in the outpatient clinic. The intervention group participants received the standard diabetic educational program and the following additional interventions: (1) viewed a 10-minute DVD (2) received a &quotDiabetes Self-Care" booklet (3) participated in four efficacy- enhancing counselling intervention sessions, and (4) participated in telephone follow-up. The self-efficacy model was adapted from Shortridge-Baggett & van der Bijl (1996). Diabetes self-management principles were used in program development and evaluation. Main outcome measures Instruments used in data collection included 1) Self-efficacy towards management of type 2 diabetes (as measured by the Chinese version of the Diabetes Management Self-Efficacy Scale; C-DMSES and the Chinese version of the Perceived Therapeutic Efficacy Scale; C-PTES); 2) self management behavior (as measured by the Summary of Diabetes Self-Care Activities; SDSCA); 3) health-related quality of life for diabetes (as measured by the Short Form-12; SF-12); 4) psychosocial well-being (as measured by the Medical Outcomes Study (MOS), Social Support Survey (SSS) tool and the Center for Epidemiology Studies Short Depression Scale; CES-D) and 5) health care utilisation (as measured by health care utilisation self report instrument). Data analysis Data were double-entered for verification using SPSS® statistical software. Study I: Descriptive statistics, regression analysis, Pearson's correlation, Cronbach's alpha-coefficients, factor analysis and Bland-Altman plots with 95% limits of agreement (LOA) were performed to evaluate validity and reliability of C-DMSES and C-PTES. Study II: Descriptive analysis was used to examine demographic variables and outcome variables. T-tests were used to analyse differences on continuous data between mean scores for the intervention and control groups. Categorical data were analysed using Chi-square statistics to test the significance of different proportions. To assess the group differences of dependent variable changes, repeated measures ANOVA/ ANCOVA were used. Results Study I: Convergent validity showed that C-DMSES correlated well with the validated measure of the General Self-Efficacy Scale (GSE) in measuring self-efficacy. Criterion-related validity showed that the C-DMSES was a significant predictor of the Summary of Diabetes Self-Care Activities (SDSCA) scores. Factor analysis supported the C-DMSES being composed of four subscales with good internal consistency (Cronbach's alpha=.77 to .93) and stability (ICC=.82). Similarly, significant criterion-related validity was demonstrated between the C-PTES and SDSCA scores. Convergent validity was confirmed as the C-PTES converged well with the GSE Scale in measuring self-efficacy. Construct validity of the C-PTES was confirmed through factor analysis and a single subscale formed. Internal consistency with a Cronbach's alpha was .95 and the test-retest reliability (ICC) was .77 and a Bland-Altman plot showed 97% of the subjects were within 2 standard deviations of the mean. Study II: The 3- and 6-month benefits of the intervention over usual care were increases in self-efficacy, outcome expectation, self-care activities, and social support. However, the results of the health-related quality of life and depression scores indicated that the change over time was not different in the two groups. A smaller proportion of the participants significantly in the intervention group, had been hospitalised and visited the emergency room than participants who were in the control group at the 6-month period. However, health-related quality of life and depression were not significantly increased in the intervention group at the 3- and 6-month compared to the control group. Conclusion Results of Study I support the psychometric properties of C-DMSES and C-PTES in providing a measure for self-efficacy specific to persons with type 2 diabetes in Taiwan. The main study revealed that the SEEIP for type 2 diabetes based on self-efficacy theory was culturally acceptable to Taiwanese people with diabetes and that the SEEIP was effective in the self-management of people with type 2 diabetes.

Background: There is a great need for effective treatments for mental health problems. Randomised controlled trials are the gold standard for evaluating treatments, however recruitment into trials is challenging, highlighting a clear need for evidence-based recruitment strategies. This thesis aimed to systematically develop a recruitment intervention and evaluate its effectiveness for improving the recruitment of participants into mental health trials. Methods: A mixed-methods approach, adopting the Medical Research Council’s complex interventions framework: 1) a systematic review to identify the evidence base and describe the factors affecting recruitment into depression trials; 2) a qualitative study to understand patients’ decision-making process in declining to enrol in a depression trial; 3) development of a recruitment intervention, using Participatory Design methods; and 4) evaluation of the recruitment intervention, using a randomised controlled trial, embedded in an ongoing mental health trial (the EQUIP trial). The primary outcome was the proportion of participants enrolled in EQUIP. Results: From the systematic review, a conceptual framework of factors influencing the decision to participate was developed, which highlighted that the decision to enrol involves a judgement between risk and reward. Findings suggested that patient and public involvement in research (PPIR) might be advertised to potential participants to reduce such perceived risk. The qualitative study found positive views of trials. Interviewees’ decision making resembled a four-stage process; in each stage they either decided to decline or progressed to the next stage. In Stage 1, those with an established position of declining trials opted out – they are termed ‘prior decliners’. In Stage 2, those who opted out after judging themselves ineligible are termed ‘self-excluders’. In Stage 3, those who decided they did not need the trial therapy and opted out are termed ‘treatment decliners’. In Stage 4, those who opted out after judging that disadvantages outweighed advantages are termed ‘trial decliners’. While ‘prior decliners’ are unlikely to respond to trial recruitment initiatives, the factors leading others to decline are amenable to amelioration as they do not arise from a rejection of trials. We recruited a host mental health trial (EQUIP), and worked with key stakeholders, including mental health service users and carers, to develop an intervention using a leaflet to advertise the nature and function of the PPIR in EQUIP to potential trial participants. 34 community mental health teams were randomised and 8182 patients invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR= 0.75, 95% CI= 0.53 to 1.07, p=0.113). Conclusions: This thesis reports the largest ever trial to evaluate the impact of a recruitment intervention. It also reports the largest trial of a PPIR intervention and makes a contribution to the evidence base on trial recruitment as well as to that assessing the impact of PPIR. Two further embedded trials are underway to evaluate the effectiveness of different versions of the recruitment intervention in different trial contexts and patient populations. This will also allow the results to be pooled to generate a more precise estimate of effect; to evaluate the impact of the intervention on trial retention; and to explore patient experiences of receiving the intervention.

This dissertation is a participant observer’s account of implementing a multisite, randomised controlled trial within Her Majesty’s Prison Service. It adds to a scarce literature detailing the steps involved in implementing experiments in custodial settings by providing a candid account of the route from planning to successful implementation. The randomised controlled trial was designed to evaluate the effectiveness of the Sycamore Tree Programme. This programme’s goal is to teach prisoners the wider harm of crime and includes a face-to-face meeting between a victim of crime and the participating offenders. It derives its rehabilitative potential from restorative justice and seeks to foster hope that change is possible for offenders, thus aiding them to desist from crime. Its development and theoretical basis are described for the first time. In an in-depth narrative the dissertation details how at every stage strategies were developed to manage participant procurement, random assignment, maintaining treatment integrity, and preparing for final outcome measurements. The randomised controlled trial was designed to produce an individual experiment in eight prisons. These will be combined in a meta-analysis as well as analysed as a pooled sample. Overall the implementation process took close to two years and involved a charitable body, Her Majesty’s Prison Service, the National Offender Management Service, and two police forces. This work has demonstrated how the unstable nature of English prison populations and the risk-averse climate must be addressed when conducting experiments in that environment. It has also illustrated the gap between the rhetoric of evidence-based policy and the facilitation of research designed to seek that evidence. Nevertheless, developing trusting relationships and combining rapidly learnt skills with inherent abilities ensured that the evaluation methodology was supported and protected through the various challenges it met. Finally, the dissertation suggests conditions for closer collaboration between government executive bodies and researchers that might increase the number of experiments undertaken in prisons. It also aims to encourage researchers that prison experiments, although not easy, are feasible, defendable, and, above all, worthwhile.

Background: Bipolar disorders (BD) are among the most severe mental disorders with first clinical signs and symptoms frequently appearing in adolescence and early adulthood. The long latency in clinical diagnosis (and subsequent adequate treatment) adversely affects the course of disease, effectiveness of interventions and health-related quality of life, and increases the economic burden of BD. Despite uncertainties about risk constellations and symptomatology in the early stages of potentially developing BD, many adolescents and young adults seek help, and most of them suffer substantially from symptoms already leading to impairments in psychosocial functioning in school, training, at work and in their social relationships. We aimed to identify subjects at risk of developing BD and investigate the efficacy and safety of early specific cognitive-behavioural psychotherapy (CBT) in this subpopulation. Methods/Design: EarlyCBT is a randomised controlled multi-centre clinical trial to evaluate the efficacy and safety of early specific CBT, including stress management and problem solving strategies, with elements of mindfulness-based therapy (MBT) versus unstructured group meetings for 14 weeks each and follow-up until week 78. Participants are recruited at seven university hospitals throughout Germany, which provide in- and outpatient care (including early recognition centres) for psychiatric patients. Subjects at high risk must be 15 to 30 years old and meet the combination of specified affective symptomatology, reduction of psychosocial functioning, and family history for (schizo)affective disorders. Primary efficacy endpoints are differences in psychosocial functioning and defined affective symptomatology at 14 weeks between groups. Secondary endpoints include the above mentioned endpoints at 7, 24, 52 and 78 weeks and the change within groups compared to baseline; perception of, reaction to and coping with stress; and conversion to full BD. Discussion: To our knowledge, this is the first study to evaluate early specific CBT in subjects at high risk for BD. Structured diagnostic interviews are used to map the risk status and development of disease. With our study, the level of evidence for the treatment of those young patients will be significantly raised.