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Introduction The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.Methods and analysis The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.Ethics and dissemination Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.Trial registration number ISRCTN19674644

Abstract Background Patient and Public Involvement (PPI) in mental health research is increasing, especially in early (pre-funding) stages. PPI is less consistent in later stages, including in analysing qualitative data. The aims of this study were to develop a methodology for involving PPI co-researchers in collaboratively analysing qualitative mental health research data with academic researchers, to pilot and refine this methodology, and to create a best practice framework for collaborative data analysis (CDA) of qualitative mental health research. Methods In the context of the RECOLLECT Study of Recovery Colleges, a critical literature review of collaborative data analysis studies was conducted, to identify approaches and recommendations for successful CDA. A CDA methodology was developed and then piloted in RECOLLECT, followed by refinement and development of a best practice framework. Results From 10 included publications, four CDA approaches were identified: (1) consultation, (2) development, (3) application and (4) development and application of coding framework. Four characteristics of successful CDA were found: CDA process is co-produced; CDA process is realistic regarding time and resources; demands of the CDA process are manageable for PPI co-researchers; and group expectations and dynamics are effectively managed. A four-meeting CDA process was piloted to co-produce a coding framework based on qualitative data collected in RECOLLECT and to create a mental health service user-defined change model relevant to Recovery Colleges. Formal and informal feedback demonstrated active involvement. The CDA process involved an extra 80 person-days of time (40 from PPI co-researchers, 40 from academic researchers). The process was refined into a best practice framework comprising Preparation, CDA and Application phases. Conclusions This study has developed a typology of approaches to collaborative analysis of qualitative data in mental health research, identified from available evidence the characteristics of successful involvement, and developed, piloted and refined the first best practice framework for collaborative analysis of qualitative data. This framework has the potential to support meaningful PPI in data analysis in the context of qualitative mental health research studies, a previously neglected yet central part of the research cycle.