Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial.

INTRODUCTION: Evidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their clinical effectiveness and cost-effectiveness are unclear. METHODS AND ANALYSIS: This is a multicentre, randomised, parallel-group, researcher-masked, superiority trial. Study participants will be aged 18 and over, have probable personality disorder and be treated by mental health staff in seven centres in England. We will exclude people who are: unwilling or unable to provide written informed consent, have a coexisting organic or psychotic mental disorder, or are already receiving psychological treatment for personality disorder or on a waiting list for such treatment. In the intervention group, participants will be offered up to 10 individual sessions of Structured Psychological Support. In the control group, participants will be offered treatment as usual plus a single session of personalised crisis planning. The primary outcome is social functioning measured over 12 months using total score on the Work and Social Adjustment Scale (WSAS). Secondary outcomes include mental health, suicidal behaviour, health-related quality of life, patient-rated global improvement and satisfaction, and resource use and costs. The primary analysis will compare WSAS scores across the 12-month period using a general linear mixed model adjusting for baseline scores, allocation group and study centre on an intention-to-treat basis. In a parallel process evaluation, we will analyse qualitative data from interviews with study participants, clinical staff and researchers to examine mechanisms of impact and contextual factors. ETHICS AND DISSEMINATION: The study complies with the Helsinki Declaration II and is approved by the London-Bromley Research Ethics Committee (IRAS ID 315951). Study findings will be published in an open access peer-reviewed journal; and disseminated at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13918289.

The state of mixed methods research in nursing: A focused mapping review and synthesis.

AIMS: To consider the scope and quality of mixed methods research in nursing. DESIGN: Focused mapping review and synthesis (FMRS). DATA SOURCES: Five purposively selected journals: International Journal of Nursing Studies, Journal of Nursing Scholarship, Journal of Advanced Nursing, Worldviews on Evidence-Based Nursing, and Journal of Mixed Methods Research. REVIEW METHODS: In the target journals, titles and abstracts from papers published between 2015-2018 were searched for the words or derivative words 'mixed methods'. Additional keyword searches were undertaken using each journal's search tool. We included studies that investigated nursing and reported to use a mixed methods approach. Articles that met the inclusion criteria were read in full and information was extracted onto a predetermined pro forma. Findings across journals were then synthesized to illustrate the current state of mixed methods research in nursing. RESULTS: We located 34 articles that reported on mixed methods research, conducted across 18 countries. Articles differed significantly both within and across journals in terms of conformity to a mixed methods approach. We assessed the studies for the quality of their reporting as regard the use of mixed methods. Nineteen studies were rated as satisfactory or good, with 15 rated as poorly described. Primarily, a poor rating was due to the absence of stating an underpinning methodological approach to the study and/or limited detail of a crucial integration phase. CONCLUSIONS: Our FMRS revealed a paucity of published mixed methods research in the journals selected. When they are published, there are limitations in the detail given to the underpinning methodological approach and theoretical explanation.