Using trend arrows in continuous glucose monitoring systems for insulin adjustment in clinical practice: Brazilian Diabetes Society Position Statement.

This manuscript reports the Brazilian Diabetes Society Position Statement for insulin adjustments based on trend arrows observed in continuous glucose monitoring systems. The Brazilian Diabetes Society supports the utilization of trend arrows for insulin dose adjustments in patients with diabetes on basal-bolus insulin therapy, both with multiple daily insulin doses or insulin pumps without closed-loop features. For those on insulin pumps with predictive low-glucose suspend feature, we suggest that only upward trend arrows should be used for adjustments. In this paper, tables for insulin adjustment based on sensitivity factors are provided and strategies to optimize the use of trend arrows in clinical practice are discussed.

Personalising screening of sight-threatening diabetic retinopathy - qualitative evidence to inform effective implementation.

BACKGROUND: Internationally, systematic screening for sight-threatening diabetic retinopathy (STDR) usually includes annual recall. Researchers and policy-makers support extending screening intervals, citing evidence from observational studies with low incidence rates. However, there is little research around the acceptability to people with diabetes (PWD) and health care professionals (HCP) about changing eye screening intervals. METHODS: We conducted a qualitative study to explore issues surrounding acceptability and the barriers and enablers for changing from annual screening, using in-depth, semistructured interviews analysed using the constant comparative method. PWD were recruited from general practices and HCP from eye screening networks and related specialties in North West England using purposive sampling. Interviews were conducted prior to the commencement of and during a randomised controlled trial (RCT) comparing fixed annual with variable (6, 12 or 24 month) interval risk-based screening. RESULTS: Thirty PWD and 21 HCP participants were interviewed prior to and 30 PWD during the parallel RCT. The data suggests that a move to variable screening intervals was generally acceptable in principle, though highlighted significant concerns and challenges to successful implementation. The current annual interval was recognised as unsustainable against a backdrop of increasing diabetes prevalence. There were important caveats attached to acceptability and a need for clear safeguards around: the safety and reliability of calculating screening intervals, capturing all PWD, referral into screening of PWD with diabetic changes regardless of planned interval. For PWD the 6-month interval was perceived positively as medical reassurance, and the 12-month seen as usual treatment. Concerns were expressed by many HCP and PWD that a 2-year interval was too lengthy and was risky for detecting STDR. There were also concerns about a negative effect upon PWD care and increasing non-attendance rates. Amongst PWD, there was considerable conflation and misunderstanding about different eye-related appointments within the health care system. CONCLUSIONS: Implementing variable-interval screening into clinical practice is generally acceptable to PWD and HCP with important caveats, and misconceptions must be addressed. Clear safeguards against increasing non-attendance, loss of diabetes control and alternative referral pathways are required. For risk calculation systems to be safe, reliable monitoring and clear communication is required.

Understanding illness experiences of employees with common mental health disorders.

BACKGROUND: Common mental health disorders (CMHDs) are a leading cause of sickness absence. To address this, a Fit for Work Service (FFWS) was introduced in Greater Manchester, UK, in 2010, offering case-managed and multidisciplinary interventions to early-stage sickness absentees experiencing physical health conditions and/or associated psychosocial problems, to enable a speedy return to work. AIMS: To explore the illness experiences of employees who contacted or were referred to the Greater Manchester FFWS (GM-FFWS). METHODS: A qualitative in-depth study, using narrative interviews with GM-FFWS service users who experienced mental ill-health. Interviews were recorded, transcribed and analysed for key themes. RESULTS: There were 21 interviews available for analysis. Multiple disruptive life events overwhelmed employees' capacity to cope, triggering mental ill-health. For some individuals, the onset of mental ill-health was unexpected and had profound psychological effects on participants' sense of self and personal identity. In certain cases, previous bouts of emotional distress contributed to an underlying psychology of low self-esteem. Mobilizing resources was often a significant factor in supporting recovery. The illness experience led to a process of self-re-evaluation among some participants. CONCLUSIONS: Disruptive events at work have the potential to threaten an individual's sense of self. Employee's experiences of CMHDs can only be fully understood if there is awareness of how these experiences emerge from a person's biography and subsequently inform their responses to contemporary life events. The design of future clinical and non-clinical workplace interventions should take account of these biographical aspects of the illness experience.

Understanding the non-pharmacological correlates of self-reported efficacy of antidepressants.

OBJECTIVE: To explore the non-pharmacological correlates of the perceived effectiveness of antidepressants (ADs), thereby enhancing understanding of the mechanisms involved in recovery from depression while taking ADs. METHOD: An online survey was completed by 1781 New Zealand adults who had taken ADs in the previous 5 years. RESULTS: All 18 psychosocial variables measured were associated with depression reduction, and 16 with improved quality of life (QoL). Logistic regression models revealed that the quality of the relationship with the prescriber was related to both depression reduction and improved QoL. In addition, depression reduction was related to younger age, higher income, being fully informed about ADs by the prescriber, fewer social causal beliefs for depression and not having lost a loved one in the 2 months prior to prescription. Furthermore, both outcome measures were positively related to belief in 'chemical' rather than 'placebo' effects. CONCLUSION: There are multiple non-pharmacological processes involved in recovery while taking ADs. Enhancing them, for example focusing on the prescriber-patient relationship and giving more information, may enhance recovery rates, with or without ADs.

Food for thought: pilot randomized controlled trial of lay health trainers supporting dietary change to reduce cardiovascular disease in deprived communities.

BACKGROUND: Cardiovascular disease (CVD) accounts for 30% of UK deaths. It is associated with modifiable lifestyle factors, including insufficient consumption of fruit and vegetables (F&V). Lay health trainers (LHTs) offer practical support to help people develop healthier behaviour and lifestyles. Our two-group pilot randomized controlled trial (RCT) investigated the effectiveness of LHTs at promoting a heart-healthy lifestyle among adults with at least one risk factor for CVD to inform a full-scale RCT. METHODS: Eligible adults (aged 21-78 years), recruited from five practices serving deprived populations, were randomized to health information leaflets plus LHTs' support for 3 months (n = 76) versus health information leaflets alone (n = 38). RESULTS: We recruited 114 participants, with 60% completing 6 month follow-up. Both groups increased their self-reported F&V consumption and we found no evidence for LHTs' support having significant added impact. Most participants were relatively less deprived, as were the LHTs we were able to recruit and train. CONCLUSIONS: Our pilot demonstrated that an LHT's RCT whilst feasible faces considerable challenges. However, to justify growing investment in LHTs, any behaviour changes and sustained impact on those at greatest need should be demonstrated in an independently evaluated, robust, fully powered RCT.

Serum titres of anti-glutamic acid decarboxylase-65 and anti-IA-2 autoantibodies are associated with different immunoregulatory milieu in newly diagnosed type 1 diabetes patients.

Several studies correlated genetic background and pancreatic islet-cell autoantibody status (type and number) in type 1A diabetes mellitus (T1AD), but there are no data evaluating the relationship among these markers with serum cytokines, regulatory T cells and ß cell function. This characterization has a potential importance with regard to T1AD patients' stratification and follow-up in therapeutic prevention. In this study we showed that peripheral sera cytokines [interleukin (IL)-12, IL-6, II-1ß, tumour necrosis factor (TNF)-α, IL-10] and chemokines (CXCL10, CXCL8, CXCL9, CCL2) measured were significantly higher in newly diagnosed T1AD patients when compared to healthy controls (P < 0·001). Among T1AD, we found a positive correlation between CXCL10 and CCL-2 (r = 0·80; P = 0·000), IL-8 and TNF-α (r = 0·60; P = 0·000); IL-8 and IL-12 (r = 0·57; P = 0·001) and TNF-α and IL-12 (r = 0·93; P = 0·000). Glutamic acid decarboxylase-65 (GAD-65) autoantibodies (GADA) were associated negatively with CXCL10 (r = -0·45; P = 0·011) and CCL2 (r = -0·65; P = 0·000), while IA-2A showed a negative correlation with IL-10 (r = -0·38; P = 0·027). Human leucocyte antigen (HLA) DR3, DR4 or DR3/DR4 and PTPN22 polymorphism did not show any association with pancreatic islet cell antibodies or cytokines studied. In summary, our results revealed that T1AD have a proinflammatory cytokine profile compared to healthy controls and that IA-2A sera titres seem to be associated with a more inflammatory peripheral cytokine/chemokine profile than GADA. A confirmation of these data in the pre-T1AD phase could help to explain the mechanistic of the well-known role of IA-2A as a more specific marker of beta-cell damage than GADA during the natural history of T1AD.

Exploratory review of placebo characteristics reported in randomised placebo controlled antidepressant drug trials.

INTRODUCTION: Systematic reviews of randomised placebo controlled trials of antidepressants have found small and decreasing differences in outcome between pharmacological and placebo arms. Increased knowledge of placebo characteristics may provide greater understanding of antidepressant pharmacological effect. We conducted a systematic review to identify the presence of key placebo characteristics in a sample of antidepressant clinical trials. METHODS: 82 randomised placebo controlled trials of antidepressants, selected in 2 previous systematic reviews (Walsh et al. 2002; NICE 2009), were examined. Presence of placebo characteristics documented using detailed standardised form, with 5 domains: health care environment, practitioner characteristics, patient characteristics, practitioner-patient interaction, and non-pharmaceutical drug characteristics. First authors contacted where possible, and further clarification sought on placebo characteristics within trials. RESULTS: Percentage of trials reporting placebo characteristics within the 5 domains: health care setting 100%, environment 5%; practitioner profession 18%, status 0%, incentives 0%, gender 10%, age 4%, beliefs 6%; patient age 85%, gender 91%, ethnicity 41%, diagnosis and severity 100%, recruitment 16%, incentives 12%, co-morbidity 12%, expectation 0%, beliefs 0%; patient-practitioner interaction type of care 10%, number of visits 94%, empathy and congruence 2%; drug form 45% and frequency 57%. DISCUSSION: Placebo characteristics represent confounding variables which, if not adequately controlled for, could distort findings and conclusions about efficacy. The lack of systematic recording of many placebo characteristics in antidepressant drug trials is a cause for concern. To reduce imprecision and increase generalisability, future antidepressant clinical trials should consider the impact of key placebo characteristics and record their presence when disseminating findings.

Estimating probability of sustained recovery from mild to moderate depression in primary care: evidence from the THREAD study.

BACKGROUND: It is important for doctors and patients to know what factors help recovery from depression. Our objectives were to predict the probability of sustained recovery for patients presenting with mild to moderate depression in primary care and to devise a means of estimating this probability on an individual basis. METHOD: Participants in a randomized controlled trial were identified through general practitioners (GPs) around three academic centres in England. Participants were aged >18 years, with Hamilton Depression Rating Scale (HAMD) scores 12-19 inclusive, and at least one physical symptom on the Bradford Somatic Inventory (BSI). Baseline assessments included demographics, treatment preference, life events and difficulties and health and social care use. The outcome was sustained recovery, defined as HAMD score <8 at both 12 and 26 week follow-up. We produced a predictive model of outcome using logistic regression clustered by GP and created a probability tree to demonstrate estimated probability of recovery at the individual level. RESULTS: Of 220 participants, 74% provided HAMD scores at 12 and 26 weeks. A total of 39 (24%) achieved sustained recovery, associated with being female, married/cohabiting, having a low BSI score and receiving preferred treatment. A linear predictor gives individual probabilities for sustained recovery given specific characteristics and probability trees illustrate the range of probabilities and their uncertainties for some important combinations of factors. CONCLUSIONS: Sustained recovery from mild to moderate depression in primary care appears more likely for women, people who are married or cohabiting, have few somatic symptoms and receive their preferred treatment.

Extreme subcutaneous, intramuscular and inhaled insulin resistance treated by pancreas transplantation alone.

Diabetes mellitus with resistance to insulin administered subcutaneously or intramuscularly (DRIASM) is a rare syndrome and is usually treated with continuous intravenous insulin infusion. We present here two cases of DRIASM in 16 and 18 years female patients that were submitted to pancreas transplantation alone (PTA). Both were diagnosed with type 1 diabetes as young children and had labile glycemic control with recurrent episodes of diabetic ketoacidosis. They had prolonged periods of hospitalization and complications related to their central venous access. Exocrine and endocrine drainages were in the bladder and systemic, respectively. Both presented immediate graft function. In patient 1, enteric conversion was necessary due to reflux pancreatitis. Patient 2 developed mild postoperative hyperglycemia in spite of having normal pancreas allograft biopsy and that was attributed to her immunosuppressive regimen. Patient 1 died 9 months after PTA from septic shock related to pneumonia. In 8 months of follow-up, Patient 2 presented optimal glycemic control without the use of antidiabetic agents. In conclusion, PTA may be an alternative treatment for DRIASM patients.

Motivating patients with shoulder and back pain to self-care: can a videotape of exercise support physiotherapy?

OBJECTIVES: The National Health Service is developing an ethos of self-care. Patients are being encouraged to become proficient in helping themselves. This has long been a philosophy of the physiotherapy profession, where self-care between consultations has been an integral part of the treatment process through encouraging the uptake of self-care skills training. This study explored how patients with shoulder and back pain perceived videotaped exercises and instructions to support their routine physiotherapy, and how the videotape was used. DESIGN: A videotape, developed by physiotherapists for patients with musculoskeletal problems, of exercises to view at home was given to patients by their physiotherapists to support their routine physiotherapy consultations. A qualitative methodology was used to examine how patients responded to being given a videotape of exercises and instructions between consultations. Data were collected through semi-structured interviews. SETTING: The study was based in 26 general practices that had access to practice-based physiotherapists in two primary care trusts in the north-west of England. PARTICIPANTS: Thirty-three patients with shoulder and back pain who received a videotape of exercises and advice were interviewed. RESULTS: Three themes emerged from the data: finding space for exercise; remembering and doing exercises; and supporting the physiotherapy-patient relationship. Patients discussed aspects of motivation, and described how a videotape of exercises might support or inhibit the performance of exercises prescribed by physiotherapists. Patients identified a range of different ways in which they derived support from the videotape. CONCLUSIONS: The videotape supported patients with a variety of different needs as it enhanced their ability to complete exercises correctly. Videotapes (or DVDs) are useful for patients and could be adopted as a tool to support treatment.

Choice and birth method: mixed-method study of caesarean delivery for maternal request.

OBJECTIVE: To explore whether women view decision-making surrounding vaginal or caesarean birth as their choice. DESIGN: Longitudinal cohort study utilising quantitative (questionnaire, routinely collected data) and qualitative (in-depth interviews) methods simultaneously. SETTING: A large hospital providing National Health Service maternity care in the UK. SAMPLE: Four-hundred and fifty-four primigravid women. METHODS: Women completed up to three questionnaires between their antenatal booking appointment and delivery. Amongst these women, 153 were interviewed at least once during pregnancy (between 24 and 36 weeks) and/or after 12 moths after birth. Data were also obtained from women's hospital delivery records. Descriptive statistical analysis was performed (survey and delivery data). Interview data were analysed using a seven-stage sequential form of qualitative analysis. RESULTS: Whilst many women supported the principle of choice, they identified how, in practice their autonomy was limited by individual circumstance and available care provision. All women felt that concerns about their baby's or their own health should take precedence over personal preference. Moreover, expressing a preference for either vaginal or caesarean birth was inherently problematic as choice until the time of delivery was neither static nor final. Women did not have autonomous choice over their actual birth method, but neither did they necessarily want it. CONCLUSIONS: The results of this large exploratory study suggest that choice may not be the best concept through which to approach the current arrangements for birth in the UK. Moreover, they challenge the notion of choice that currently prevails in international debates about caesarean delivery for maternal request.

Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study.

OBJECTIVES: To determine (1) the effectiveness and cost-effectiveness of selective serotonin reuptake inhibitor (SSRI) treatment plus supportive care, versus supportive care alone, for mild to moderate depression in patients with somatic symptoms in primary care; and (2) the impact of the initial severity of depression on effectiveness and relative costs. To investigate the impact of demographic and social variables. DESIGN: The study was a parallel group, open-label, pragmatic randomised controlled trial. SETTING: The study took place in a UK primary care setting. Patients were referred by 177 GPs from 115 practices around three academic centres. PARTICIPANTS: Patients diagnosed with new episodes of depression and potentially in need of treatment. In total, 602 patients were referred to the study team, of whom 220 were randomised. INTERVENTIONS: GPs were asked to provide supportive care to all participants in follow-up consultations 2, 4, 8 and 12 weeks after the baseline assessment, to prescribe an SSRI of their choice to patients in the SSRI plus supportive care arm and to continue treatment for at least 4 months after recovery. They could switch antidepressants during treatment if necessary. They were asked to refrain from prescribing an antidepressant to those in the supportive care alone arm during the first 12 weeks but could prescribe to these patients if treatment became necessary. MAIN OUTCOME MEASURES: The primary outcome measure was Hamilton Depression Rating Scale (HDRS) score at 12-week follow-up. Secondary outcome measures were scores on HDRS at 26-week follow-up, Beck Depression Inventory, Medical Outcomes Study Short Form-36 (SF-36), Medical Interview Satisfaction Scale (MISS), modified Client Service Receipt Inventory and medical record data. RESULTS: SSRIs were received by 87% of patients in the SSRI plus supportive care arm and 20% in the supportive care alone arm. Longitudinal analyses demonstrated statistically significant differences in favour of the SSRI plus supportive care arm in terms of lower HDRS scores and higher scores on the SF-36 and MISS. Significant mean differences in HDRS score adjusted for baseline were found at both follow-up points when analysed separately but were relatively small. The numbers needed to treat for remission (to HDRS > 8) were 6 [95% confidence interval (CI) 4 to 26)] at 12 weeks and 6 (95% CI 3 to 31) at 26 weeks, and for significant improvement (HDRS reduction > or = 50%) were 7 (95% CI 4 to 83) and 5 (95% CI 3 to 13) respectively. Incremental cost-effectiveness ratios and cost-effectiveness planes suggested that adding an SSRI to supportive care was probably cost-effective. The cost-effectiveness acceptability curve for utility suggested that adding an SSRI to supportive care was cost-effective at the values of 20,000 pounds-30,000 pounds per quality-adjusted life-year. A poorer outcome on the HDRS was significantly related to greater severity at baseline, a higher physical symptom score and being unemployed. CONCLUSIONS: Treatment with an SSRI plus supportive care is more effective than supportive care alone for patients with mild to moderate depression, at least for those with symptoms persisting for 8 weeks and an HRDS score of > or = 12. The additional benefit is relatively small, and may be at least in part a placebo effect, but is probably cost-effective at the level used by the National Institute for Health and Clinical Excellence to make judgements about recommending treatments within the National Health Service. However, further research is required.

Synchronization and beam forming in an array of repulsively coupled oscillators.

We study the dynamics of an array of Stuart-Landau oscillators with repulsive coupling. Autonomous network with global repulsive coupling settles on one from a continuum of synchronized regimes characterized by zero mean field. Driving this array by an external oscillatory signal produces a nonzero mean field that follows the driving signal even when the oscillators are not locked to the external signal. At sufficiently large amplitude the external signal synchronizes the oscillators and locks the phases of the array oscillations. Application of this system as a beam-forming element of a phase array antenna is considered. The phase dynamics of the oscillator array synchronization is used to reshape the phases of signals received from the phase array antenna and improve its beam pattern characteristics.

Repulsive synchronization in an array of phase oscillators.

We study the dynamics of a repulsively coupled array of phase oscillators. For an array of globally coupled identical oscillators, repulsive coupling results in a family of synchronized regimes characterized by zero mean field. If the number of oscillators is sufficiently large, phase locking among oscillators is destroyed, independently of the coupling strength, when the oscillators' natural frequencies are not the same. In locally coupled networks, however, phase locking occurs even for nonidentical oscillators when the coupling strength is sufficiently strong.

Patient-practitioner agreement: does it matter?

BACKGROUND: Good communication is a crucial clinical skill. Previous research demonstrated better clinical outcomes when practitioners and patients agree about the nature of patients' core presenting complaints. We investigated the nature of this agreement and its impact on outcome among depressed primary care patients. METHOD: We compared presenting problem formulations completed by patients, GPs and therapists in a primary care randomized controlled trial of cognitive-behavioural therapy and non-directive counselling for depression. Participants compiled formulations from a list of 13 potential problems of self-completed questionnaires. Subjects scored at least 14 on the Beck Depression Inventory (BDI) at baseline. Outcome measure for this study included BDI at 4 and 12 months, failure to attend for therapy when referred, dropout from therapy and patient satisfaction. RESULTS: Among 464 trial patients, 395 received therapy. Patient baseline problem formulations included significantly more items than GPs, who identified significantly more items than therapists. Agreement levels varied according to a range of patient and professional variables. While patients in complete agreement with their therapists about their main problem after assessment had lower average BDI scores at 12 months (9.7 v. 12.8, P=0.03); we found no other significant associations between the extent of agreement and clinical outcome. There were significant (but relatively weak) associations between agreement and aspects of patient satisfaction. CONCLUSION: Our results suggest that detailed mutual understanding of the presenting complaints may be less important than agreement that the core problem is psychological, and that referral for psychological therapy is appropriate.

Accident or suicide? Predictors of Coroners' decisions in suicide and accident verdicts.

OBJECTIVE: To examine the factors used by Coroners to distinguish between suicide and accidental death among young men in Merseyside and Cheshire. DESIGN: Retrospective epidemiological survey of deaths due to external causes. Data sources included Coroner's Inquest, GP and hospital data. Logistic regression was carried out to determine the multiple effect of individual factors on defining Coroner's verdict. SETTING: Merseyside and Cheshire, United Kingdom. SUBJECTS: Males aged 15-39 years who died from unnatural causes during 1995 in Merseyside and Cheshire. MAIN OUTCOME MEASURE: Coroner's verdict. RESULTS: An active mode of death was by far the strongest predictor of a suicide as opposed to an accident verdict. Other significant differentiating factors included expressed intent, behavioural change, deliberate self-harm and psychiatric contact. CONCLUSION: The validity of using method of death as a predictor of intent is questionable. Evidence left by drug users who kill themselves may differ from that left by non-drug users and may need to be sought in less conventional ways. There may be a discrepancy between those factors deemed important by health professionals as indicators of suicide, such as deliberate self-harm, and those given most weight by the Coroner. It may be more pragmatic, in terms of public health policy development, to challenge the concept that self-destructive behaviour can be categorized as being either intentional or unintentional. There is some evidence suggesting that deaths due to suicide and accidents both result from elements of self-destructive behaviour and therefore, the practice of categorizing deaths as either suicides or accidents could be misleading.

Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. I: clinical effectiveness.

OBJECTIVE: To compare the clinical effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients. DESIGN: Prospective, controlled trial with randomised and patient preference allocation arms. SETTING: General practices in London and greater Manchester. PARTICIPANTS: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion. INTERVENTIONS: Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists. MAIN OUTCOME MEASURES: Beck depression inventory scores, other psychiatric symptoms, social functioning, and satisfaction with treatment measured at baseline and at 4 and 12 months. RESULTS: 197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. All groups improved significantly over time. At four months, patients randomised to non-directive counselling or cognitive-behaviour therapy improved more in terms of the Beck depression inventory (mean (SD) scores 12.9 (9.3) and 14.3 (10.8) respectively) than those randomised to usual general practitioner care (18.3 (12.4)). However, there was no significant difference between the two therapies. There were no significant differences between the three treatment groups at 12 months (Beck depression scores 11.8 (9.6), 11.4 (10.8), and 12.1 (10.3) for non-directive counselling, cognitive-behaviour therapy, and general practitioner care). CONCLUSIONS: Psychological therapy was a more effective treatment for depression than usual general practitioner care in the short term, but after one year there was no difference in outcome.

Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. II: cost effectiveness.

OBJECTIVE: To compare the cost effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients. DESIGN: Prospective, controlled trial with randomised and patient preference allocation arms. SETTING: General practices in London and greater Manchester. PARTICIPANTS: 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion. INTERVENTIONS: Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists. MAIN OUTCOME MEASURES: Beck depression inventory scores, EuroQol measure of health related quality of life, direct treatment and non-treatment costs, and cost of lost production. RESULTS: 197 patients were randomly assigned to treatment, 137 chose their treatment, and 130 were randomised only between the two psychological therapies. At four months, both non-directive counselling and cognitive-behaviour therapy reduced depressive symptoms to a significantly greater extent than usual general practitioner care. There was no significant difference in outcome between treatments at 12 months. There were no significant differences in direct costs, production losses, or societal costs between the three treatments at either four or 12 months. Sensitivity analyses did not suggest that the results depended on particular assumptions in the statistical analysis. CONCLUSIONS: Within the constraints of available power, the data suggest that both brief psychological therapies may be significantly more cost effective than usual care in the short term, as benefit was gained with no significant difference in cost. There are no significant differences between treatments in either outcomes or costs at 12 months.