Abstract
<jats:sec id="abs1-1"><jats:title>Background</jats:title><jats:p>Health anxiety is an under-recognised but frequent cause of distress that is potentially treatable, but there are few studies in secondary care.</jats:p></jats:sec><jats:sec id="abs1-2"><jats:title>Objective</jats:title><jats:p>To determine the clinical effectiveness and cost-effectiveness of a modified form of cognitive–behaviour therapy (CBT) for health anxiety (CBT-HA) compared with standard care in medical outpatients.</jats:p></jats:sec><jats:sec id="abs1-3"><jats:title>Design</jats:title><jats:p>Randomised controlled trial.</jats:p></jats:sec><jats:sec id="abs1-4"><jats:title>Setting</jats:title><jats:p>Five general hospitals in London, Middlesex and Nottinghamshire.</jats:p></jats:sec><jats:sec id="abs1-5"><jats:title>Participants</jats:title><jats:p>A total of 444 patients aged 16–75 years seen in cardiology, endocrinology, gastroenterology, neurology and respiratory medicine clinics who scored ≥ 20 points on the Health Anxiety Inventory (HAI) and satisfied diagnostic requirements for hypochondriasis. Those with current psychiatric disorders were excluded, but those with concurrent medical illnesses were not.</jats:p></jats:sec><jats:sec id="abs1-6"><jats:title>Interventions</jats:title><jats:p>Cognitive–behaviour therapy for health anxiety – between 4 and 10 1-hour sessions of CBT-HA from a health professional or psychologist trained in the treatment. Standard care was normal practice in primary and secondary care.</jats:p></jats:sec><jats:sec id="abs1-7"><jats:title>Main outcome measures</jats:title><jats:p>Primary – researchers masked to allocation assessed patients at baseline, 3, 6, 12, 24 months and 5 years. The primary outcome was change in the HAI score between baseline and 12 months. Main secondary outcomes – costs of care in the two groups after 24 and 60 months, change in health anxiety (HAI), generalised anxiety and depression [Hospital Anxiety and Depression Scale (HADS)] scores, social functioning using the Social Functioning Questionnaire and quality of life using the EuroQol-5 Dimensions (EQ-5D), at 6, 12, 24 and 60 months, and deaths over 5 years.</jats:p></jats:sec><jats:sec id="abs1-8"><jats:title>Results</jats:title><jats:p>Of the 28,991 patients screened over 21 months, 5769 had HAI scores of ≥ 20 points. Improvement in HAI scores at 3 months was significantly greater in the CBT-HA group (mean number of sessions = 6) than in the standard care, and this was maintained over the 5-year period (overall<jats:italic>p</jats:italic> < 0.0001), with no loss of efficacy between 2 and 5 years. Differences in the generalised anxiety (<jats:italic>p</jats:italic> = 0.0018) and depression scores (<jats:italic>p</jats:italic> = 0.0065) on the HADS were similar in both groups over the 5-year period. Gastroenterology and cardiology patients showed the greatest CBT gains. The outcomes for nurses were superior to those of other therapists. Deaths (<jats:italic>n</jats:italic> = 24) were similar in both groups; those in standard care died earlier than those in CBT-HA. Patients with mild personality disturbance and higher dependence levels had the best outcome with CBT-HA. Total costs were similar in both groups over the 5-year period (£12,590.58 for CBT-HA; £13,334.94 for standard care). CBT-HA was not cost-effective in terms of quality-adjusted life-years, as measured using the EQ-5D, but was cost-effective in terms of HAI outcomes, and offset the cost of treatment.</jats:p></jats:sec><jats:sec id="abs1-9"><jats:title>Limitations</jats:title><jats:p>Many eligible patients were not randomised and the population treated may not be representative.</jats:p></jats:sec><jats:sec id="abs1-10"><jats:title>Conclusions</jats:title><jats:p>CBT-HA is a highly effective treatment for pathological health anxiety with lasting benefit over 5 years. It also improves generalised anxiety and depressive symptoms more than standard care. The presence of personality abnormality is not a bar to successful outcome. CBT-HA may also be cost-effective, but the high costs of concurrent medical illnesses obscure potential savings. This treatment deserves further research in medical settings.</jats:p></jats:sec><jats:sec id="abs1-11"><jats:title>Trial registration</jats:title><jats:p>Current Controlled Trials ISRCTN14565822.</jats:p></jats:sec><jats:sec id="abs1-12"><jats:title>Funding</jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment</jats:italic>; Vol. 21, No. 50. See the NIHR Journals Library website for further project information.</jats:p></jats:sec>
Original language | English |
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Pages (from-to) | 1-58 |
Number of pages | 0 |
Journal | Health Technology Assessment |
Volume | 21 |
Issue number | 50 |
DOIs | |
Publication status | E-pub ahead of print - Sept 2017 |