title: The Cognitive Remediation in Bipolar (CRiB) pilot study: study protocol for a randomised controlled trial.
abstract: People with bipolar disorder often show difficulties with cognitive functioning, and though these difficulties are identified as important targets for intervention, few treatment options are available. Preliminary evidence suggests that cognitive remediation therapy (a psychological treatment proven beneficial for people diagnosed as having schizophrenia) is helpful for people with bipolar disorders. We are conducting a pilot trial to determine whether individual, computerised, cognitive remediation therapy (CRT) for people with bipolar disorder 1) increases cognitive function; 2) improves global functioning, goal attainment and mood symptoms; 3) is acceptable and feasible for participants; and 4) can be addressed in a comprehensive, larger, randomised, controlled trial.
  
  
  
  The study is designed as a two-arm, randomised, controlled trial comparing cognitive remediation therapy with treatment-as-usual (TAU) for euthymic bipolar patients. Participants are eligible to take part if aged between 18 and 65 with a diagnosis of bipolar disorder (type I) and currently in euthymic state, and no neurological, substance or personality disorder diagnoses. Sixty participants will be recruited (mainly through secondary and tertiary care) and will be block-randomised to receive either treatment-as-usual alone or in addition to a 12-week course of cognitive remediation therapy totalling 20-40 therapy hours. The intervention will comprise regular sessions with a therapist and computer-based training. Research assessments will take place before and after the intervention period and at a 12-week follow-up, and will include evaluation of neuropsychological, symptom-related, demographic and social factors, as well as collecting qualitative data regarding CRT expectations and satisfaction. Intention-to-treat analyses will examine the efficacy of cognitive remediation therapy primarily on cognition and additionally on functioning, quality of life and mood symptoms. Furthermore, we will examine the acceptability of CRT and undertake a preliminary health economics analysis to ascertain the cost of delivering the intervention.
  
  
  
  The results of this trial will provide valuable information about whether cognitive remediation therapy may be beneficial for people diagnosed with bipolar disorder in a euthymic state.
  
  
  
  ISRCTN registry, ISRCTN32290525 . Registered on 2 March 2016.
authors.affiliation: Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK. Becci.strawbridge@kcl.ac.uk.|The NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Becci.strawbridge@kcl.ac.uk.
authors.forename: Rebecca
authors.identifier: 0000-0002-2984-1124
authors.initials: R
authors.lastname: Strawbridge
authors.affiliation: The NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.|Oliver Zangwill Centre for Neuropsychological Rehabilitation, Cambridgeshire Community Services NHS Trust, Princess of Wales Hospital, Lynn Road, Ely, CB6 1DN, UK.|Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Fish
authors.affiliation: Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.|OPTIMA Mood Disorders Service, Lambeth Hospital, South London and Maudsley NHS Foundation Trust, London, SW9 9NU, UK.
authors.forename: Rozmin
authors.initials: R
authors.lastname: Halari
authors.affiliation: The NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.|Department of Biostatistics, King's Clinical Trials Unit, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.
authors.forename: John
authors.initials: J
authors.lastname: Hodsoll
authors.affiliation: The NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.|Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Reeder
authors.affiliation: Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.|OPTIMA Mood Disorders Service, Lambeth Hospital, South London and Maudsley NHS Foundation Trust, London, SW9 9NU, UK.
authors.forename: Karine
authors.initials: K
authors.lastname: Macritchie
authors.affiliation: Department of Health Services and Population Research, King's Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: The NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.|Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.
authors.forename: Til
authors.initials: T
authors.lastname: Wykes
authors.affiliation: Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.|The NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.|OPTIMA Mood Disorders Service, Lambeth Hospital, South London and Maudsley NHS Foundation Trust, London, SW9 9NU, UK.
authors.forename: Allan H
authors.initials: AH
authors.lastname: Young
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001714:Bipolar Disorder / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D000072466:Cognitive Remediation; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D055815:Young Adult
keywords: Bipolar disorder; Cognitive remediation therapy; Randomised controlled trial; Trial protocol