Abstract
BackgroundThe 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.MethodsPeople 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.DiscussionThis 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 registrationControlled Trials ISRCTN07622709, registered 15 July 2011.
Highlights
The prevalence of depressive disorder in adults with advanced cancer is around 20 %
We describe the protocol for a national, single-blind, two-arm, randomised controlled trial of up to 12 sessions of cognitive behavioural therapy (CBT) offered in addition to usual care through the UK Improving Access to Psychological Therapies (IAPT) service available through primary care, versus usual care alone, for people with advanced cancer who have a DSM-IV diagnosis of depression
2) To determine through a randomised controlled trial the cost effectiveness of Cognitive Behavioural Therapy plus treatment as usual compared to treatment as usual for depression in adults with cancer which is no longer amenable to curative treatment
Summary
The prevalence of depressive disorder in adults with advanced cancer is around 20 %. 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]. It is possible to treat depression effectively in the general population using antidepressant medication and psychological treatments such as cognitive behavioural therapy (CBT) and interpersonal therapies [7, 8]. It is not known whether these approaches are beneficial in those people with cancer who experience depression or those whose low mood exceeds what might be expected in the face of life-limiting illness. A recent systematic review of randomized controlled trials of the efficacy of any treatment intended to reduce depression in adults with diagnoses of both cancer and depression found that only seven relatively small trials have been published [9]
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