title: Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study)).
abstract: BACKGROUND
  The blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment. In addition, the relationship between reduced blood pressure and the change in cerebral blood flow and mood was to be investigated.
  
  
  METHODS
  A single centre pilot randomised controlled trial (RCT), with two parallel groups of intensive or normal treatment for hypertension, recruiting from primary and secondary care and newspaper advert, with an aim of recruiting 66 participants, was observed in this study. At the end of the recruitment period, in order to explore the reasons for failure to recruit to target, surveys were developed and issued to those involved in recruitment.
  
  
  RESULTS
  Recruitment rates were lower than expected which led to the study being expanded to further areas and opened to self-referral via advertisement. However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant.
  
  
  CONCLUSIONS
  Overall, the BRILiANT mood study was found not to be feasible, and results suggest that the expected patient population no longer exists. To overcome such recruitment difficulties, a prompt commencement of a study after funding so no relevant care changes occur might help prevent similar problems in future studies. In addition, self-referral, in this case via advertisement in papers, may be a useful tool to increase response rate. When recruiting in primary care, direct access to primary care databases, in a secure and anonymised way, may enable more effective screening. Ultimately, the BRILiANT mood study was shown not to be feasible; this was a useful conclusion from this pilot study.
  
  
  BACKGROUND
  ISRCTN 64524251; UKCRN Portfolio No: 13284.
authors.affiliation: Institute of Neuroscience, Campus for Ageing & Vitality, Newcastle University, Newcastle upon Tyne, NE4 5PL UK.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Olsen
authors.affiliation: Institute of Health & Society, Baddiley-Clark Building, Newcastle University, Newcastle upon Tyne, NE2 4AX UK.
authors.forename: Denise
authors.initials: D
authors.lastname: Howel
authors.affiliation: Northumberland, Tyne & Wear NHS Foundation Trust, Older Peoples Mental Health Services, Centre for the Health of the Elderly, Campus for Ageing & Vitality, Newcastle upon Tyne, NE4 6BE UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Barber
authors.affiliation: Medical Sciences Division, University of Oxford, South Parks Road, Oxford, OX1 3PL UK.
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
authors.affiliation: Institute of Neuroscience & Newcastle Institute for Ageing, Henry Wellcome Building, Framlington Plane, Newcastle University, Newcastle upon Tyne, NE2 4HH UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Gallagher
authors.affiliation: Institute of Neuroscience & Northumberland, Tyne & Wear NHS Foundation Trust, Academic Psychiatry, Wolfson Research Centre, Campus for Ageing & Vitality, Newcastle University, Newcastle upon Tyne, NE5 4LP UK.
authors.forename: R Hamish
authors.initials: RH
authors.lastname: McAllister-Williams
authors.affiliation: Aging Research Centre, Karolinska Institutet & Stockholm University, Gävlegatan 16, SE-113 30 Stockholm, Sweden.
authors.forename: Jonna
authors.initials: J
authors.lastname: Nilsson
authors.affiliation: Department of Psychiatry, University of Cambridge, University of Cambridge School of Clinical Medicine, Level E4, Cambridge Biomedical Campus, Box 189, Cambridge, CB2 0SP UK.
authors.forename: John
authors.initials: J
authors.lastname: O'Brien
authors.affiliation: Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE UK.
authors.forename: Jennie
authors.initials: J
authors.lastname: Parker
authors.affiliation: Institute of Neuroscience & Newcastle University Institute for Ageing, Campus for Ageing & Vitality, Newcastle University, Newcastle upon Tyne, NE4 5PL UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Thomas
keywords: Cognitive; Depression; Hypertension; Mood; Pilot; Randomised controlled trials; Recruitment