BackgroundComputerised cognitive–behavioural therapy (CCBT) might offer a solution to the current undertreatment of depression.AimsTo determine the clinical effectiveness of online, unsupported CCBT for depression in primary care.MethodThree hundred and three people with depression were randomly allocated to one of three groups: Colour Your Life; treatment as usual (TAU) by a general practitioner; or Colour Your Life and TAU combined. Colour Your Life is an online, multimedia, interactive CCBT programme. No assistance was offered. We had a 6-month follow-up period.ResultsNo significant differences in outcome between the three interventions were found in the intention-to-treat and per protocol analyses.ConclusionsOnline, unsupported CCBT did not outperform usual care, and the combination of both did not have additional effects. Decrease in depressive symptoms in people with moderate to severe depression was moderate in all three interventions. Online CCBT without support is not beneficial for all individuals with depression.

Major depression is a common mental health problem in the general population 1 and is associated with substantial reductions in quality of life.2,3 Cost-of-illness studies reveal that the economic burden of depression is considerable. 4 However, many people with depression attending primary care do not receive the care they need. There is little evidence about the effectiveness of pharmacotherapy in patients with mild to moderate depression 5 and psychological treatments in primary care are scarce and costly. Consequently, effective treatments like cognitive-behavioural therapy (CBT) 6,7 are not offered to all patients and many people with depression in primary care remain untreated. 8 An effective, acceptable and feasible solution for such individuals might be computerised CBT (CCBT). 9 The National Institute for Health and Clinical Excellence (NICE) recommended the use of two CCBT software programs for depression and anxiety, 10 and these programs are now in use in England, Wales and Northern Ireland. In the Netherlands, an online CCBT program is currently being used as part of an ongoing implementation study (www.kleurjeleven.nl/). However, evidence about the costeffectiveness of CCBT is still limited.9 To our knowledge, only one study conducted an economic evaluation of CCBT for depression and it showed that CCBT (delivered on a personal computer in the general practice) can be highly cost-effective compared with usual care by a general practitioner (GP) in the UK setting.11 In a recent study, we compared the clinical effectiveness of unsupported, online CCBT (i.e. Colour Your Life) with treatment as usual (TAU) by a GP and a combination of both CCBT and TAU for depression (CCBT plus TAU). 12 In the present study, we assess the cost-effectiveness of these interventions, focusing on the research question: for mild to moderate depression, is CCBT compared with TAU or CCBT plus TAU preferable in terms of cost-effectiveness from a societal perspective? The Medical and Ethical Committee approved the study protocol. The study is registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236) Method Design and participantsIn a randomised trial, 303 participants were recruited from the general population by means of a large-scale internet-based screening in the South of the Netherlands. Inclusion criteria were: age 18-65; access to the internet at home (for optimal use of the CCBT program, a broad-band connection was required and not dial-up connection); at least mild to moderate depressive complaints (Beck Depression Inventory II (BDI-II) 13 score516); duration of depressive complaints 3 months or more; no current psychological treatment for depression; no continuous antidepressant treatment for at least 3 months prior to entry; fluent in Dutch language; no alcohol and/ or drug dependence; and no severe psychiatric comorbidity (e.g. psychotic disorders). During a 1-year follow-up period, participants were asked to fill in monthly internet questionnaires. 12,14 InterventionsComputeri...

SummaryBackground: The SF-6D is a new health state classification and utility scoring system based on 6 dimensions ('6D') of the Short Form 36, and permits a ''bridging'' transformation between SF-36 responses and utilities. The Health Utilities Index, mark 3 (HUI3) is a valid and reliable multi-attribute health utility scale that is widely used. We assessed within-subject agreement between SF-6D utilities and those from HUI3.Methods: Patients at increased risk of sudden cardiac death and participating in a randomized trial of implantable defibrillator therapy completed both instruments at baseline. Score distributions were inspected by scatterplot and histogram and mean score differences compared by paired t-test. Pearson correlation was computed between instrument scores and also between dimension scores within instruments. Between-instrument agreement was by intra-class correlation coefficient (ICC).Results: SF-6D and HUI3 forms were available from 246 patients. Mean scores for HUI3 and SF-6D were 0.61 (95% CI 0.60-0.63) and 0.58 (95% CI 0.54-0.62) respectively; a difference of 0.03 (p50.03). Score intervals for HUI3 and SF-6D were (-0.21 to 1.0) and (0.30-0.95). Correlation between the instrument scores was 0.58 (95% CI 0.48-0.68) and agreement by ICC was 0.42 (95% CI 0.31-0.52). Correlations between dimensions of SF-6D were higher than for HUI3.Conclusions: Our study casts doubt on the whether utilities and QALYs estimated via SF-6D are comparable with those from HUI3. Utility differences may be due to differences in underlying concepts of health being measured, or different measurement approaches, or both. No gold standard exists for utility measurement and the SF-6D is a valuable addition that permits SF-36 data to be transformed into utilities to estimate QALYs. The challenge is developing a better understanding as to why these classification-based utility instruments differ so markedly in their distributions and point estimates of derived utilities.

BackgroundClinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses.ObjectivesTo develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain.MethodsThe EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously.ResultsTwo overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1–3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5–7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9).ConclusionAdherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.