Abstract
BACKGROUND
With a prevalence of up to 16.5%, depression is one of the commonest mental disorders in people with advanced cancer. Depression reduces the quality of life (QoL) of patients and those close to them. The National Institute for Health and Care Excellence (NICE) guidelines recommend treating depression using antidepressants and/or psychological treatments, such as cognitive-behavioural therapy (CBT). Although CBT has been shown to be effective for people with cancer, it is unclear whether or not this is the case for people with advanced cancer and depression.
OBJECTIVES
To assess the clinical effectiveness and cost-effectiveness of treatment as usual (TAU) plus manualised CBT, delivered by high-level Improving Access to Psychological Therapy (IAPT) practitioners, versus TAU for people with advanced cancer and depression, measured at baseline, 6, 12, 18 and 24 weeks.
DESIGN
Parallel-group, single-blind, randomised trial, stratified by whether or not an antidepressant was prescribed, comparing TAU with CBT plus TAU.
SETTING
Recruitment took place in oncology, hospice and primary care settings. CBT was delivered in IAPT centres or/and over the telephone.
PARTICIPANTS
Patients (N = 230; n = 115 in each arm) with advanced cancer and depression. Inclusion criteria were a diagnosis of cancer not amenable to cure, a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of depressive disorder using the Mini-International Neuropsychiatric Interview, a sufficient understanding of English and eligibility for treatment in an IAPT centre. Exclusion criteria were an estimated survival of < 4 months, being at high risk of suicide and receiving, or having received in the last 2 months, a psychological intervention recommended by NICE for treating depression.
INTERVENTIONS
(1) Up to 12 sessions of manualised individual CBT plus TAU delivered within 16 weeks and (2) TAU.
OUTCOME MEASURES
The primary outcome was the Beck Depression Inventory, version 2 (BDI-II) score at 6, 12, 18 and 24 weeks. Secondary outcomes included scores on the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, satisfaction with care, EuroQol-5 Dimensions and the Client Services Receipt Inventory, at 12 and 24 weeks.
RESULTS
A total of 80% of treatments (185/230) were analysed: CBT (plus TAU) (n = 93) and TAU (n = 92) for the BDI-II score at all time points using multilevel modelling. CBT was not clinically effective [treatment effect -0.84, 95% confidence interval (CI) -2.76 to 1.08; p = 0.39], nor was there any benefit for other measures. A subgroup analysis of those widowed, divorced or separated showed a significant effect of CBT on the BDI-II (treatment effect -7.21, 95% CI -11.15 to -3.28; p < 0.001). Economic analysis revealed that CBT has higher costs but produces more quality-adjusted life-years (QALYs) than TAU. The mean service costs for participants (not including the costs of the interventions) were similar across the two groups. There were no differences in EQ-5D median scores at baseline, nor was there any advantage of CBT over TAU at 12 weeks or 24 weeks. There was no statistically significant improvement in QALYs at 24 weeks.
LIMITATIONS
Although all participants satisfied a diagnosis of depression, for some, this was of less than moderate severity at baseline, which could have attenuated treatment effects. Only 64% (74/115) took up CBT, comparable to the general uptake through IAPT.
CONCLUSIONS
Cognitive-behavioural therapy (delivered through IAPT) does not achieve any clinical benefit in advanced cancer patients with depression. The benefit of CBT for people widowed, divorced or separated is consistent with other studies. Alternative treatment options for people with advanced cancer warrant evaluation. Screening and referring those widowed, divorced or separated to IAPT for CBT may be beneficial. Whether or not improvements in this subgroup are due to non-specific therapeutic effects needs investigation.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN07622709.
FUNDING
This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 19. See the NIHR Journals Library website for further project information.
Plain language summary
There are high rates of depression in people with advanced (cannot-be-cured) cancer. Depression worsens a person’s quality of life (QoL), may become a burden for carers and may prolong a patient’s hospital stay. Cognitive–behavioural therapy (CBT) challenges unhelpful thinking and ways of doing things to help improve mood. CBT is effective for treating depression, but it is unclear if it works for depression in advanced cancer patients. Advanced cancer patients with depression were entered into a research trial to see if the addition of CBT to usual care was better at improving depressive symptoms than usual care alone. We also wished to evaluate whether or not CBT helped to save costs. We enrolled 230 participants from hospital clinics, general practitioner (GP) surgeries and the Marie Curie Hospice, Hampstead. A computer program randomly allocated people to one of two groups: (1) CBT plus usual care or (2) usual care alone. Everyone received usual care from their GPs and oncology teams. Patients who were offered the addition of CBT received up to 12 1-hour sessions delivered through a community service called Improving Access to Psychological Therapies. We measured depression using a questionnaire called the Beck Depression Inventory, version 2 collected at the start of, and at 6, 12, 18 and 24 weeks into, the trial. We also collected other measures, including those relating to health, QoL and resource costs at various times. Overall, there was no improvement in symptoms of low mood or cost savings with the addition of CBT to usual care compared with usual care alone. This means that CBT does not benefit people with depression and advanced cancer, and should not be routinely offered. However, those widowed, divorced or separated appeared to benefit from CBT over and above their usual care. CBT targeted to these people may be helpful and may ensure that resources are allocated in the best way.
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