title: The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been explored.
  
  
  METHODS
  People aged 18 years and above with advanced cancer attending General Practitioner (GP), oncology or hospice outpatients from centres across England will be screened to establish a DSM-IV diagnosis of depression. Self-referral is also accepted. Eligible consenters will be randomised to a single blind, multicentre, randomised controlled trial of the addition to treatment as usual (TAU) of up to 12 one-hour weekly sessions of manualised CBT versus TAU alone. Sessions are delivered in primary care through Increasing Access to Psychological Care (IAPT) service, and the manual includes a focus on issues for people approaching the end of life. The main outcome is the Beck Depression Inventory-II (BDI-II). Subsidiary measures include the Patient Health Questionnaire, quality of life measure EQ-5D, Satisfaction with care, Eastern Cooperative Oncology Group-Performance Status and a modified Client Service Receipt Inventory. At 90 % power, we require 240 participants to enter the trial. Data will be analysed using multi-level (hierarchical) models for data collected at baseline, 6, 12, 18 and 24 weeks. Cost effectiveness analysis will incorporate costs related to the intervention to compare overall healthcare costs and QALYs between the treatment arms. We will conduct qualitative interviews after final follow-up on patient and therapist perspectives of the therapy.
  
  
  CONCLUSIONS
  This trial will provide data on the clinical and cost effectiveness of CBT for people with advanced cancer and depression. We shall gain an understanding of the feasibility of delivering care to this group through IAPT. Our findings will provide evidence for policy-makers, commissioners and clinicians in cancer and palliative care, and in the community.
  
  
  BACKGROUND
  Controlled Trials ISRCTN07622709 , registered 15 July 2011.
authors.affiliation: Division of Psychiatry, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. m.serfaty@ucl.ac.uk.
authors.forename: Marc
authors.initials: M
authors.lastname: Serfaty
authors.affiliation: Division of Psychiatry, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. michael.king@ucl.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: King
authors.affiliation: Research Department of Primary Care & Population Health, UCL Royal Free Site, Rowland Hill Street, London, NW3 2PF, UK. i.nazareth@ucl.ac.uk.
authors.forename: Irwin
authors.initials: I
authors.lastname: Nazareth
authors.affiliation: Marie Curie Hospice, 11 Lyndhurst Gardens, London, NW3 5NS, UK. Adrian.Tookman@mariecurie.org.uk.|Palliative Medicine, Royal Free Hampstead NHS Trust, London, UK. Adrian.Tookman@mariecurie.org.uk.
authors.forename: Adrian
authors.initials: A
authors.lastname: Tookman
authors.affiliation: Research Department of Primary Care & Population Health, UCL Royal Free Site, Rowland Hill Street, London, NW3 2PF, UK. i.nazareth@ucl.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Wood
authors.affiliation: Marie Curie Palliative Care Research Department, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. anna.gola@ucl.ac.uk.
authors.forename: Anna
authors.initials: A
authors.lastname: Gola
authors.affiliation: Division of Psychiatry, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. t.aspden@ucl.ac.uk.
authors.forename: Trefor
authors.initials: T
authors.lastname: Aspden
authors.affiliation: Palliative Medicine, Newcastle upon Tyne Hospital NHS Foundation Trust, Freeman Road, Newcastle upon Tyne, NE7 7DN, UK. kathrynmannix@btinternet.com.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Mannix
authors.affiliation: Marie Curie Palliative Care Research Department, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. s.davis@ucl.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Davis
authors.affiliation: Psychotherapy and CBT, South London and Maudsley NHS Foundation Trust, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK. stirling.moorey@kcl.ac.uk.
authors.forename: Stirling
authors.initials: S
authors.lastname: Moorey
authors.affiliation: Marie Curie Palliative Care Research Department, UCL, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. caroline.jones@ucl.ac.uk.
authors.forename: Louise
authors.initials: L
authors.lastname: Jones
mesh_terms: D000928:Antidepressive Agents / Q000191:economics* / Q000627:therapeutic use*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics*; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D003865:Major Depressive Disorder / Q000191:economics* / Q000523:psychology / Q000628:therapy*; D016527:Drug Costs; D004739:England; D006801:Humans; D009369:Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000191:economics / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents