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

Trials, Feb 2016

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. Discussion 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. Trial registration Controlled Trials ISRCTN07622709, registered 15 July 2011.

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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

Serfaty et al. Trials 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 Marc Serfaty 0 3 Michael King 0 3 Irwin Nazareth 2 3 Adrian Tookman 1 3 7 John Wood 2 3 Anna Gola 3 6 Trefor Aspden 0 3 Kathryn Mannix 3 5 Sarah Davis 3 6 Stirling Moorey 3 4 Louise Jones 3 6 0 Division of Psychiatry, UCL , 6th Floor Maple House, 149 Tottenham Court Road, London W1T 7NF , UK 1 Marie Curie Hospice , 11 Lyndhurst Gardens, London NW3 5NS , UK 2 Research Department of Primary Care & Population Health, UCL Royal Free Site , Rowland Hill Street, London NW3 2PF , UK 3 Authors' information Dr. M. Serfaty, Clinical Reader and Consultant in Psychiatry, Division of Psychiatry. Prof. M. King, Professor of Primary Care Psychiatry, UCL Division of Psychiatry. Prof. Irwin Nazareth, Professor of Primary Care and Population Science, UCL. Dr. A. Tookman, Clinical Director Marie Curie Hospice, Hampstead and Consultant Palliative Medicine. Mr. J. Wood, Senior Statistician, PRIMENT, UCL. Dr. A. Gola, Health Economist, MCPCRD, UCL Division of Psychiatry. Dr. T. Aspden, Senior Research Associate, UCL. Dr. K. Mannix, Consultant in palliative medicine and CB Therapist, Marie Curie Hospice Newcastle; Palliative Care Lead, Newcastle upon Tyne Hospitals NHS FT. Ms. S. Davis, Research Nurse, Marie Curie Palliative Care Research Dept, Division of Psychiatry, UCL. Dr. S. Moorey, Head of Psychotherapy SLAM. Consultant psychiatrist in CBT, Honorary Senior Lecturer, Institute of Psychiatry, King's College London. Dr. L. Jones. Clinical Senior Lecturer, Marie Curie Palliative Care Research Dept, Division of Psychiatry, UCL 4 Psychotherapy and CBT, South London and Maudsley NHS Foundation Trust, Institute of Psychiatry, Psychology and Neuroscience, Kings College London , London , UK 5 Palliative Medicine, Newcastle upon Tyne Hospital NHS Foundation Trust , Freeman Road, Newcastle upon Tyne NE7 7DN , UK 6 Marie Curie Palliative Care Research Department, UCL , 6th Floor Maple House, 149 Tottenham Court Road, London W1T 7NF , UK 7 Palliative Medicine, Royal Free Hampstead NHS Trust , London , UK 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. Discussion: 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. Trial registration: Controlled Trials ISRCTN07622709, registered 15 July 2011. Background Depression is one of the most prevalent mental disorders in people with cancer [ 1 ]. It undermines the quality of life for individuals and those close to them [ 2 ], may reduce adherence to medication, and may prolong episodes of hospitalisation and increase healthcare costs [ 3 ]. Untreated depression is an independent predictor of early death in those with advanced cancer [ 4 ]. The prevalence of depression in people with cancer is around 10 % [ 5 ] and in advanced cancer may be as high as 21 % [ 6 ]. It is possible to treat depression effectively in the genera (...truncated)


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Marc Serfaty, Michael King, Irwin Nazareth, Adrian Tookman, John Wood, Anna Gola, Trefor Aspden, Kathryn Mannix, Sarah Davis, Stirling Moorey, Louise Jones. 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, Trials, 2016, pp. 113, 17, DOI: 10.1186/s13063-016-1223-6