No / Designing a large research trial to comprehensively evaluate the impact of a service initiative can be daunting but it is not beyond the skills and abilities of radiographers and non-medical professionals. This paper describes the development of a protocol and operational aspects of a multi-centre randomised controlled trial of radiographer immediate reporting. While the focus of the research is specific, the research design stages are transferable and not context dependent and therefore can be applied to different clinical fields. The intention of this paper is to make transparent and explicit the steps in the design and operation of this research and by doing so, offer an objective reflection on each phase of the process to enhance professional understanding of the practicalities of operating a clinical trial. Keywords

Bakgrund: Mindfulness är ett nytt koncept inom omvårdnad. Mindfulness-based stress reduction (MBSR) är ett program som utvecklats från mindfulness inom vården. MBSR har studerats i samband med olika sjukdomar däribland cancer. Bröstcancer är den vanligaste maligna cancern hos kvinnor världen över och att få en cancerdiagnos medför både fysiska och psykiska svårigheter. Syfte: Att beskriva effekter av MBSR på personer med bröstcancer. Metod: Litteraturöversikt baserad på RCT-studier (randomised controlled trials). Datainsamling gjordes via CINAHL, Medline och PsychINFO och tolv RCT-studier granskades med en induktiv ansats. Resultat: Resultatet bygger på tolv RCT studier som jämför MBSR med vanlig behandling (VB) och är indelat i effekter avseende fysiskt välmående, effekter avseende psykiskt välmående, effekter avseende hantering och effekter avseende socialt välmående. Slutsats: Generellt finns kortsiktiga positiva effekter till följd av MBSR-programmet hos personer med bröstcancer. Dock är dessa effekter ofta uppmätta direkt efter interventionen och flera studier visar att dess effekt minskar efter tolv månader. Evidensen för att använda MBSR i vården av personer med bröstcancer är ännu låg och fler studier med längre uppföljning bör göras. / Background: Mindfulness is a fairly new concept in nursing. The MBSR-programme (Mindfulness based stress reduction) was developed from mindfulness in healthcare. MBSR has been studied in relation to different healthcare settings and illnesses there among cancer. Breast cancer is the most common cancer amongst women worldwide. To live with cancer entails both psychological and physical issues. Aim: To describe the effects of MBSR on persons with breast cancer. Method: A literature review based on RCT-studies (randomised controlled trials). Data collection was done using CINAHL, Medline and PsychINFO and twelve RCT-studies was examined with an inductive approach. Results: The result is based on twelve RCT-studies comparing MBSR with standard treatment and presented in effects related to: physical wellbeing, psychological wellbeing, coping and social wellbeing. Conclusion: Generally, there are short term positive effects of the MBSR-programme on persons with breast cancer. These effects are often measured directly after the intervention and several studies show that the effects diminish after twelve months. Evidence to use MBSR in healthcare for persons with breast cancer is still low and more studies with longer follow up should be conducted.

The main aims of this thesis were to investigate the effect of distraction, midazolam and morphine on fear, distress, and pain during needle procedures, and to longitudinally describe parents’ perceptions of their children’s symptom burden during and after cancer treatment. The design in Study I-III was that of a randomized controlled trial (RCT) conducted in a medical setting; Studies II-III were placebo controlled. Study IV has a longitudinal design, and data were collected at three times during treatment and three times after the end of successful treatment. Participants in Study I were children aged 1 to 7 (n=28), in Study II children aged 1 to 19 (n=50), in Study III children aged 1 to 19 (n=50), and in Study IV parents (n=160) of children aged 1 to 19. Blowing soap bubbles or having a heated pillow reduces children’s fear and distress in connection with needle procedures. Low-dose oral midazolam 0.3mg/kg body weight is effective in reducing fear and distress, especially in younger children. Interestingly, oral morphine at a dose of 0.25mg/kg body weight does not reduce fear, distress or pain. These studies have evaluated interventions that may be of help for the most frightened children during needle procedures. We suggest that the first-line intervention against procedural fear, distress, and/or pain should be standard care (i.e. EMLA) in addition to distraction interventions when needed, and only when this is insufficient to add pharmacological interventions. According to parents, feeling drowsy, pain, and lack of energy are initially the most prevalent symptoms in their children, whereas less hair than usual is the most prevalent symptom during treatment. Pain, feeling sad, and nausea are initially the most distressing symptoms. Pain is both prevalent and distressing throughout treatment. The child’s symptom burden, as reported by parents, decreases over time. Information about distressing symptoms and when they can be expected may increase acceptance and adaptation in children and parents during and after cancer treatment.

With the advantages of low cost, high imaging speed, non-intrusive and non-invasive, electrical capacitance tomography (ECT) becomes one of most maturely developed industrial tomography modalities. However, ECT had not been considered for medical applications before this work. This thesis is to explore medical applications of ECT, especially for root canal treatment (RCT) and revision total hip replacement (THR).A dental ECT system based on impedance analyser has been designed for RCT for two purposes: (1) to visualise the tooth surface in real time and (2) to determine the position of an endodontic file. To adapt the limited space in oral cavity, a miniature two–plate dental ECT sensor with either 2×2 or 2×3 array has been designed and fabricated. The sensor has a similar performance to the conventional ECT sensor and can provide good image quality. By registering and fusing with the radiograph based on a Major-axis method, a real-time image with high resolution can be obtained. A piecewise linear function has been used to locate the axial position of the apex of an endodontic file. The results show that high accuracy can be achieved near the ‘End Point’ as it is one of the reference points, determined by the sudden change in capacitance when a grounded metallic file touches the root apex (conductive media or solution).For revision THR, a conventional 8-electrode single plane sensor has been used, generating real-time 3D images of a metallic rod using a model based method. By this method, the 3D image reconstruction is simplified to estimate the cross-sectional and axial potions of the rod in the sensing area and to draw an image of the rod with prior knowledge. A high accuracy can be achieved with the maximum absolute error of 0.13 cm in estimating cross-sectional position using a weighted mean method and 0.4 cm in estimating axial position by the linear function based on the relative change in capacitance between file and electrodes. A preliminary experiment has been carried out to generate an electrical impedance tomography (EIT) image of a metallic object in conductive solution with high permittivity. Using the impedance analyser based system, the EIT image can be obtained with a conventional ECT sensor and the result is promising, providing the possibility of obtained a real-time EIT 3D image of a milling/drilling tool during revision THR.

This PhD investigated the efficacy of individual therapies for depression and went on to test metacognitive therapy (MCT) for major depressive disorder (MDD) in individual therapy and in transdiagnostic groups consisting of a range of disordersStudy 1 included a systematic review of meta-analyses comparing the effects of individual therapy for MDD across studies. The findings show small to moderate effect sizes between g=0.25 to d= 0.69 and recovery rates 34% to 47.9% for ITT analyses. However, studies are biased and lack objective definitions of recovery, remission and clinically meaningful change which makes comparisons across studies challenging. Study 2 aimed to test MCT in a single case study with four depressed Danes in an outpatient setting. Three out of four patients reached recovery levels (BDI-II smaller or equal to 8) in only five to eleven sessions and all four patients were recovered at 6-months follow-up. Study 3 involved a large randomised clinical trial (n= 153) in which the effect of MCT was compared to cognitive behaviour therapy (CBT) for MDD. Patients were allocated to up to 24 sessions of treatment and were assessed at pre, post and 6 months follow-up on primary and secondary measures. The mean number of sessions were significantly lower for MCT (5.5; SD = 2.4 versus 6.7; SD = 4.7) and MCT showed a higher completion rate (73.6% versus 65.4%). Both treatments were associated with significant improvements in depression measured with the HDRS and BDI-II. MCT was superior in its effects on the BDI-II and on secondary measures, showing a clear advantage of MCT. . Large ES were detected in both MCT and CBT. Using Jacobson and Truax (1991) criteria revealed that 76% reached recovery levels at post-treatment in MCT whereas 54% reached recovery in CBT. These findings were maintained for both conditions at 6-months follow-up. Study 4 evaluated the effect of MCT in a 6-week treatment protocol for mixed groups of diagnosis in an open trial (n= 131). Significant improvements were observed in outcomes and 85% of patients were reliably improved at post-treatment as measured on the HADS. These findings were maintained at follow- up and the treatment appeared effective in both anxious and depressed cases. In conclusion existing treatments for depression are effective but there is much room for increasing efficacy. MCT appeared more effective than a current treatment of choice; CBT in depression. MCT was also associated with significant improvement in anxiety and depression in patients in a transdiagnostic group setting. The results support the future study and implementation of MCT as an effective treatment option.

Background There now exist a range of efficacious options for the treatment of psychosis in mental healthcare. The importance of recovery, empowerment, dignity and choice among patients with severe mental health diagnoses are important topics in contemporary research and practice. This thesis presents a meta-analytic review followed by a randomised controlled experimental study. These address distinct but related questions which aim to further our understanding of the choices available for intervention in psychosis and whether intervention may improve the ability of psychosis patients to make those choices. Aims The first objective aimed to offer a comprehensive review of the effectiveness of social skills training (SST), which is a psychological intervention for psychosis. SST has fallen out of favour in the UK and is not widely implemented in practice. We hypothesised that SST would demonstrate superiority for the negative symptoms of psychosis. The second objective was to determine whether decision-making capacity regarding treatment among psychosis patients could be improved by the application of a brief psycho-educational intervention targeting the jumping-to-conclusions (JTC) bias, which is a commonly observed cognitive bias in psychosis. We hypothesised that the intervention would improve decision-making capacity. Methods Firstly, a series of 70 meta-analyses are presented in a systematic review assessing the efficacy of social skills training across a number of psychosis outcome domains: positive symptoms, negative symptoms, general symptoms, overall symptoms and social functioning outcomes. Secondly, a randomised controlled experimental study is presented in which 36 psychosis patients in NHS Lanarkshire and 1 in NHS Dumfries & Galloway were allocated to receive either a brief meta-cognitive training (MCT) intervention or an non-specific control presentation lecture. Capacity was assessed at baseline and post-treatment while the impact of the intervention upon capacity was estimated by ANCOVA. Mediation analyses assessed whether changes in the JTC bias mediated outcome. Findings In the meta-analytic review, SST demonstrated superiority over treatment as usual (TAU. g=0.3), active controls (g=0.2-0.3) and comparators pooled (g=0.2- 0.3) for negative symptoms; and over TAU (g=0.4) and comparators pooled (g=0.3) for general psychopathology. In the randomised controlled study, MCT demonstrated large effects on two capacity outcomes; overall capacity (d=0.96, p < .05) and appreciation (d=0.87, p < .05). Exploratory analyses suggested a mediating effect of JTC (d=0.64, p < .05). Interpretation SST demonstrates a magnitude of effect for negative symptoms similar to those commonly reported for CBT for positive symptoms and may have potential for wider implementation in mental healthcare settings. The randomised controlled study suggests that psycho-educational interventions targeting capacity have clinical utility and may be developed for implementation. Limitations included lack of blinding, no fidelity checks and inclusion based on clinical diagnosis therefore a larger randomised controlled trial addressing these limitations is warranted.

Objectives: To evaluate the effects of ear points pressing at ear meridian points on obesity-related parameters( body weight, body fat, body mass index, waist, hip circumferences, and WC/HC ratio) between treatment and control groups, and we also apply the Self-Determination Theory to discuss the relationship between motivation and performance of body weight control. Methods: The study was an cross over open-parallel randomized control trial and the sample consisted of 189 volunteers who were randomly divided into two groups and the baseline characteristics were similar. In the experimental (immediate treatment) group (n=93), ear points pressing at five ear meridian points and lifestyle education were applied, while volunteers in the control (delay treatment) group (n=96) just receive lifestyle education in the first 8 weeks. At baseline, 24th, 32nd and each week of the sixteen weeks study, the outcomes mentioned above were examined in all volunteers, and related SDT questionnaires were checked during the period of 32 weeks study. Results: The result showed a statistically significant drop in BW, BMI, Waist circumference and Hip circumference during the 32 weeks in experimental (immediate treatment) and control (delay treatment) group, and better effect while using ear points pressing in the same group. But, no significant differences were found between the two groups. A SEM analysis showed that autonomous support, relatedness and original autonomy can get better competence and was related to positive consequences in BW control. And it was relative an adequate model to test the self determination theory. Conclusion: Even though the result showed a statistically significant drop in BW, BMI, WC, HC during the 32 weeks treatment in experimental (immediate treatment) and control (delay treatment) groups, and better effect while using ear points pressing in the same group. But, no statistical significance change in BW related parameters were found between the two groups. Further studies are needed to detect the effect of ear points pressing and model fit of SDT application by increasing research time, and sample sizes.

No description available.

Abstract: Hintergrund: In Deutschland leben derzeit über eine Million Menschen mit Demenz, welche vorrangig von ihren Angehörigen versorgt werden. Diese Pflege und Betreuung ist für den pflegenden Angehörigen mit erheblichen Belastungen insbesondere auf der psychischen, physischen und sozialen Ebene verbunden. Daher ist es notwendig geeignete Interventionen zur Stärkung und Entlastung der pflegenden Angehörigen zu etablieren und diese in die Versorgungslandschaft zu implementieren. Ziel der Untersuchung: Ziel der Arbeit war es, zu überprüfen, ob sich durch eine zugehende Multikomponentenintervention für pflegende Angehörige von Menschen mit Demenz, im Vergleich zum Angebot der Regelversorgung, die subjektiv empfundene Belastung der pflegenden Angehörigen verbessern lässt. Als Intervention wurde das amerikanische REACH II Programm (Resources for Enhance Alzheimer‘ Caregivers Health II) adaptiert. Methode: Die Studie wurde als prospektive randomisiert kontrollierte Studie mit einer Interventions- und einer Kontrollgruppe konzipiert. Rekrutiert wurden pflegende Angehörige von Menschen mit Demenz im Raum Leipzig, die gemeinsam in einem Haushalt wohnten. Die Interventionsgruppe erhielt über einen Zeitraum von sechs Monaten eine zugehende Multikomponentenintervention (DeREACH), welche neun Hausbesuche und drei telefonische Kontakte einschließt. Die Kontrollgruppe wurde im Rahmen der Regelversorgung behandelt. Das primäre Ergebnismaß bezog sich auf die Veränderung der Belastung der pflegenden Angehörigen nach sechs Monaten, gemessen anhand des Zarit Burden Interview. Ergebnisse: In die Studie wurden 92 pflegende Angehörige aufgenommen (Interventionsgruppe n=47, Kontrollgruppe n=45). Für das primäre Ergebnismaß konnten 82 Teilnehmer analysiert werden. Die Belastung reduzierte sich in der Interventionsgruppe nach sechs Monaten um 0,42 (SD=8,42) Skalenpunkte und verstärkte sich in der Kontrollgruppe um 7,05 (SD=8,09) Skalenpunkte. Die zusammengefasste Mittelwertdifferenz beträgt -7,47; KI95% (-11,11; -3,82) und ist zugunsten der Interventionsgruppe statistisch signifikant (p<0,000). Weitere signifikante Effekte zugunsten der Intervention bestehen für die sekundären Zielkriterien Somatisierung und psychische Gesundheit. Schlussfolgerung: Für die Intervention DeREACH bestätigt sich ein Nutzen in Bezug auf das Belastungserleben pflegender Angehöriger von Menschen mit Demenz. Die Intervention konnte in die Leipziger Versorgungslandschaft implementiert werden und wurde von den pflegenden Angehörigen sehr gut angenommen.

Background: One-in-three carers of stroke survivors experience depression with no psychological treatments tailored to meet their needs, such as barriers to attending traditional face-to-face psychological services. A cognitive behavioural therapy (CBT) self-help approach may represent an effective, acceptable solution. Methods: Informed by the MRC framework (2008) for complex interventions, six studies informed development, feasibility and piloting of a CBT self-help intervention for depressed carers of stroke survivors: Study One: Systematic review and meta-analysis of psychological interventions targeting depression and anxiety in carers of people with chronic health conditions; Study Two: Interviews to understand difficulties experienced by depressed and anxious carers; Study Three: Interviews to understand positive coping strategies used by non-depressed and non-anxious carers; Study Four: Drawing on results of Studies One to Three, iterative modelling to develop the CBT self-help intervention; Study Five: Feasibility randomised controlled trial to examine methodological and procedural uncertainties for a Phase III definitive trial; Study Six: Updated systematic review and meta-analysis. Results: Study One: 16 studies identified for inclusion yielding small and medium effect sizes for depression and anxiety respectively, with trends for individually delivered treatments over shorter session durations to be more effective for depression. Six additional studies were included in Study Six, replicating Study One results; Study Two: Depressed and anxious carers experience difficulties adapting to the caring role, managing uncertainty, lack of support and social isolation; Study Three: Non-depressed and non-anxious carers utilise problem-focused coping strategies to gain balance and adapt to caring role, use assertiveness, seek social support and positive reinterpretation; Study Four: Developed a theory-driven CBT self-help intervention; Study Five: Recruited 20 informal carers in 10-months, representing 0.08% of invited carers randomised with high attrition in the intervention arm. Lack of GP recognition, gatekeeping and barriers to accessing psychological support identified as reasons for poor recruitment. Conclusions: A greater appreciation is required concerning barriers experienced by informal carers of stroke survivors to accessing support for depression and type of acceptable psychological support.