title: Behavioural Activation Therapy for Depression after Stroke (BEADS): a study protocol for a feasibility randomised controlled pilot trial of a psychological intervention for post-stroke depression.
abstract: BACKGROUND
  There is currently insufficient evidence for the clinical and cost-effectiveness of psychological therapies for treating post-stroke depression.
  
  
  METHODS
  BEADS is a parallel group feasibility multicentre randomised controlled trial with nested qualitative research and economic evaluation. The aim is to evaluate the feasibility of undertaking a full trial comparing behavioural activation (BA) to usual stroke care for 4 months for patients with post-stroke depression. We aim to recruit 72 patients with post-stroke depression over 12 months at three centres, with patients identified from the National Health Service (NHS) community and acute services and from the voluntary sector. They will be randomly allocated to receive behavioural activation in addition to usual care or usual care alone. Outcomes will be measured at 6 months after randomisation for both participants and their carers, to determine their effectiveness. The primary clinical outcome measure for the full trial will be the Patient Health Questionnaire-9 (PHQ-9). Rates of consent, recruitment and follow-up by centre and randomised group will be reported. The acceptability of the intervention to patients, their carers and therapists will also be assessed using qualitative interviews. The economic evaluation will be undertaken from the National Health Service and personal social service perspective, with a supplementary analysis from the societal perspective. A value of information analysis will be completed to identify the areas in which future research will be most valuable.
  
  
  CONCLUSIONS
  The feasibility outcomes from this trial will provide the data needed to inform the design of a definitive multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of behavioural activation for treating post-stroke depression.
  
  
  BACKGROUND
  Current controlled trials ISRCTN12715175.
authors.affiliation: Division of Rehabilitation and Ageing, School of Medicine, B Floor Medical School, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH UK.
authors.forename: Shirley A
authors.initials: SA
authors.lastname: Thomas
authors.affiliation: Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Coates
authors.affiliation: Division of Rehabilitation and Ageing, School of Medicine, B Floor Medical School, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH UK.
authors.forename: Roshan
authors.initials: R
authors.lastname: das Nair
authors.affiliation: Division of Rehabilitation and Ageing, School of Medicine, B Floor Medical School, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH UK.
authors.forename: Nadina B
authors.initials: NB
authors.lastname: Lincoln
authors.affiliation: Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Cindy
authors.initials: C
authors.lastname: Cooper
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Palmer
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Walters
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Nicholas R
authors.initials: NR
authors.lastname: Latimer
authors.affiliation: Vascular Medicine, Division of Medical Sciences and GEM, School of Medicine, Royal Derby Hospital, University of Nottingham, Uttoxeter Road, Derby, DE22 3DT UK.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: England
authors.affiliation: Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Mandefield
authors.affiliation: Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
authors.forename: Timothy
authors.initials: T
authors.lastname: Chater
authors.affiliation: School of Health Sciences, A Floor, South Block, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2HA UK.
authors.forename: Patrick
authors.initials: P
authors.lastname: Callaghan
authors.affiliation: School of Health Sciences, A Floor, South Block, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2HA UK.
authors.forename: Avril E R
authors.initials: AE
authors.lastname: Drummond
keywords: Behavioural activation; Complex intervention; Depression; Feasibility; Post-stroke depression; Psychological intervention; Randomised controlled trial; Stroke