title: Feasibility randomised controlled trial of Recovery-focused Cognitive Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA): study protocol.
abstract: BACKGROUND
  Bipolar disorder is a severe and chronic mental health problem that persists into older adulthood. The number of people living with this condition is set to rise as the UK experiences a rapid ageing of its population. To date, there has been very little research or service development with respect to psychological therapies for this group of people.
  
  
  METHODS
  A parallel two-arm randomised controlled trial comparing a 14-session, 6-month Recovery-focused Cognitive-Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA) plus treatment as usual (TAU) versus TAU alone. Participants will be recruited in the North-West of England via primary and secondary mental health services and through self-referral. The primary objective of the study is to evaluate the feasibility and acceptability of RfCBT-OA; therefore, a formal power calculation is not appropriate. It has been estimated that randomising 25 participants per group will be sufficient to be able to reliably determine the primary feasibility outcomes (eg, recruitment and retention rates), in line with recommendations for sample sizes for feasibility/pilot trials. Participants in both arms will complete assessments at baseline and then every 3 months, over the 12-month follow-up period. We will gain an estimate of the likely effect size of RfCBT-OA on a range of clinical outcomes and estimate parameters needed to determine the appropriate sample size for a definitive, larger trial to evaluate the effectiveness and cost-effectiveness of RfCBT-OA. Data analysis is discussed further in the Analysis section in the main paper.
  
  
  BACKGROUND
  This protocol was approved by the UK National Health Service (NHS) Ethics Committee process (REC ref: 15/NW/0330). The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and local, participating NHS trusts.
  
  
  BACKGROUND
  ISRCTN13875321; Pre-results.
authors.affiliation: Division of Health Research, The Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tyler
authors.affiliation: Division of Health Research, The Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Lobban
authors.affiliation: Lancashire Clinical Trials Unit, College of Health and Wellbeing, University of Central Lancashire, Preston, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Sutton
authors.affiliation: Department of Psychiatry, School of Medicine of the University of California, San Diego, San Diego, California, USA.
authors.forename: Colin
authors.initials: C
authors.lastname: Depp
authors.affiliation: Department of Psychology, University of California, Berkeley, Berkeley, California, USA.
authors.forename: Sheri
authors.initials: S
authors.lastname: Johnson
authors.affiliation: Faculty of Medicine and Health Sciences, Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Ken
authors.initials: K
authors.lastname: Laidlaw
authors.affiliation: Division of Health Research, The Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, UK.
authors.forename: Steven H
authors.initials: SH
authors.lastname: Jones
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001714:Bipolar Disorder / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003362:Cost-Benefit Analysis; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D016016:Proportional Hazards Models; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D016896:Treatment Outcome
keywords: Ageing; Bipolar Disorder; Cognitive Behavioural Therapy; Feasibility; Randomised Controlled Trial; Recovery