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Background: Effectiveness and cost-effectiveness are increasingly important considerations in determining which mental health services are funded. Questions have been raised concerning the validity of generic health status instruments used in economic evaluation for assessing mental health problems such as depression; measuring capability wellbeing offers a possible alternative. The aim of this study is to assess the validity of the ICECAP-A capability instrument for individuals with depression. Methods: Hypotheses were developed using concept mapping. Validity tests and multivariable regression analysis were applied to data from a cross-sectional dataset to assess the performance of ICECAP-A in individuals who reported having a primary condition of depression. The ICECAP-A was collected alongside instruments used to measure: 1. depression using the depression scale of the Depression, Anxiety and Stress Scale (DASS-D of DASS-21); 2. mental health using the Kessler Psychological Distress Scale (K10); 3. generic health status using a common measure collected for use in economic evaluations, the five level version of EQ-5D (EQ-5D-5L). Results: Hypothesised associations between the ICECAP-A (items and index scores) and depression constructs were fully supported in statistical tests. In the multivariable analysis, instruments designed specifically to measure depression and mental health explained a greater proportion of the variation in ICECAP-A than the EQ-5D-5L. Conclusion: The ICECAP-A instrument appears to be suitable for assessing outcome in adults with depression for resource allocation purposes. Further research is required on its responsiveness and use in economic evaluation. Using a capability perspective when assessing cost-effectiveness could potentially re-orientate resource provision across physical and mental health care services. [ABSTRACT FROM AUTHOR]

Background: Increasing evidence suggests that postnatal paternal depression is associated with adverse emotional, behavioural and cognitive outcomes in children. Despite this, few studies have determined the prevalence of fathers' depressive symptoms during the first few years of their children's lives and explored what factors are related to these symptoms. We estimated the prevalence and examined associated risk factors of paternal depressive symptoms in a nationally representative sample of fathers with children aged between 9 months and 7 years old from the Millennium cohort study. The risk factors examined were maternal depressive symptoms, marital conflict, child temperament, child gender, paternal education, fathers' ethnic background, fathers' employment status, family housing, family income and paternal age.Methods: Secondary data analysis was conducted using the UK Millennium cohort study, which consisted of data from England, Scotland, Wales and Northern Ireland of families with infants born in the year 2000/2001. Data from four sweeps were used from when children in the cohort were aged 9 months, 3, 5 and 7 years old (n = 5155-12,396).Results: The prevalence of paternal depressive symptoms over time was 3.6 % at 9 months, 1.2 % at 3 years old, 1.8 % at 5 years and 2.0 % at 7 years (using Kessler cut-off points to categorise high depressive symptoms vs low depressive symptoms). Linear regression trends (using continuous measures of depressive symptoms) indicated that both paternal and maternal depressive symptoms decreased over time, suggesting similar patterns of parents' depressive symptoms after the birth of a child, but the decrease was more evident for mothers. Paternal depressive symptoms were consistently associated with fathers' unemployment, maternal depressive symptoms and marital conflict. Socioeconomic factors such as rented housing when child was 9 months and low family income when child was 5 and 7 years were also associated with higher paternal depressive symptoms.Conclusions: Paternal depressive symptoms decreased among fathers when their children were aged between 9 months to 3 years old. Paternal unemployment, high maternal depressive symptoms and high marital conflict were important risk factors for paternal depressive symptoms. In light of our findings, we would recommend a more family centred approach to interventions for depression in the postnatal period. [ABSTRACT FROM AUTHOR]

Background: Around 17% of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway.Methods/design: This study tests the uncertainties associated with a large-scale evaluation by conducting an external pilot trial with a nested qualitative study. We aim to recruit and randomise eight comprehensive cardiac rehabilitation teams (clusters) to intervention (embedding enhanced psychological care into routine cardiac rehabilitation programmes) or control (routine cardiac rehabilitation programmes alone) arms. Up to 64 patients (eight per team) identified with depressive symptoms upon initial assessment by the cardiac rehabilitation team will be recruited, and study measures will be administered at baseline (before starting rehabilitation) and at 5 months and 8 months post baseline. Outcomes include depressive symptoms, cardiac mortality and morbidity, anxiety, health-related quality of life and service resource use. Trial data on cardiac team and patient recruitment, and the retention and flow of patients through treatment will be used to assess intervention feasibility and acceptability. Qualitative interviews will be undertaken to explore trial participants' and cardiac rehabilitation nurses' views and experiences of the trial methods and intervention, and to identify reasons why patients declined to take part in the trial. Outcome data will inform a sample size calculation for a definitive trial.Discussion: The pilot trial and qualitative study will inform the design of a fully powered cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the provision of enhanced psychological care within cardiac rehabilitation programmes.Trial Registration: ISRCTN34701576 (Registered 29 May 2014). [ABSTRACT FROM AUTHOR]

Background Stepped care is recommended and implemented as a means to organise depression treatment. Compared with alternative systems, it is assumed to achieve equivalent clinical effects and greater efficiency. However, no trials have examined these assumptions. A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first. Methods/design STEPS (Developing stepped care treatment for depression) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression. We will conduct a pilot randomised controlled trial with an embedded process study. Quantitative trial data on recruitment, retention and the pathway of patients through treatment will be used to assess feasibility. Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial. Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention. A minimum of 60 patients with major depressive disorder will be recruited from an Increasing Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone. All treatments will be delivered at clinic facilities within the University of Exeter. Quantitative patient-related data on depressive symptoms, worry and anxiety and quality of life will be collected at baseline and 6 months. The pilot trial and interviews will be undertaken concurrently. Quantitative and qualitative data will be analysed separately and then integrated. Discussion The outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care. Qualitative data on stepped care will be of immediate interest to patients, clinicians, service managers, policy makers and guideline developers. A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative (or qualitative) design. [ABSTRACT FROM AUTHOR]

Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance antidepressants (m-ADM) can prevent relapse, whereas, r psychological help can help them recover from depression in the longterm. A recently developed treatment, mindfulness-based cognitive therapy (MBCT), shows potential as a brief group program for people with recurring depression.. This trial asks the policy research question; is MBCT with support to taper/discontinue antidepressant medication (MBCT-TS) superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant medication (ADM) usage, (d) (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question also asks whether an increase in mindfulness skills is the key mechanism of change. The design is a single-blind, parallel randomized controlled trial examining MBCT-TS versus m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT-TS with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Results Depressive relapse/recurrence over two years is the primary outcome variable. Analyses will be conducted following CONSORT standards and overseen by the trial's Data Monitoring and Safety Committee. Initial analyses will be conducted on an intention-to-treat basis, with subsequent analyses being per protocol. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre-and post-treatment and a qualitative study of service users' views and experiences. Conclusions If the results of our exploratory trial are extended to this definitive trial, MBCT-TS will be established as an alternative approach to maintenance antidepressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches. [ABSTRACT FROM AUTHOR]

Background Mindfulness-based cognitive therapy (MBCT) is a cost-effective psychosocial prevention programme that helps people with recurrent depression stay well in the long term. It was singled out in the 2009 National Institute for Health and Clinical Excellence (NICE) Depression Guideline as a key priority for implementation. Despite good evidence and guideline recommendations, its roll-out and accessibility across the UK appears to be limited and inequitably distributed. The study aims to describe the current state of MBCT accessibility and implementation across the UK, develop an explanatory framework of what is hindering and facilitating its progress in different areas, and develop an Implementation Plan and related resources to promote better and more equitable availability and use of MBCT within the UK National Health Service. Methods/Design This project is a two-phase qualitative, exploratory and explanatory research study, using an interview survey and in-depth case studies theoretically underpinned by the Promoting Action on Implementation in Health Services (PARIHS) framework. Interviews will be conducted with stakeholders involved in commissioning, managing and implementing MBCT services in each of the four UK countries, and will include areas where MBCT services are being implemented successfully and where implementation is not working well. In-depth case studies will be undertaken on a range of MBCT services to develop a detailed understanding of the barriers and facilitators to implementation. Guided by the study's conceptual framework, data will be synthesized across Phase 1 and Phase 2 to develop a fit for purpose implementation plan. Discussion Promoting the uptake of evidence-based treatments into routine practice and understanding what influences these processes has the potential to support the adoption and spread of nationally recommended interventions like MBCT. This study could inform a larger scale implementation trial and feed into future implementation of MBCT with other long-term conditions and associated co-morbidities. It could also inform the implementation of interventions that are acceptable and effective, but are not widely accessible or implemented. [ABSTRACT FROM AUTHOR]

Background Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. Methods COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Costeffectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. Discussion The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a firstline treatment of depression. Trial registration Current Controlled Trials ISRCTN27473954. [ABSTRACT FROM AUTHOR]

Background: Depression is a common psychiatric disorder characterized by a high rate of relapse and recurrence. The most commonly used strategy to prevent relapse/recurrence is maintenance treatment with antidepressant medication (mADM). Recently, it has been shown that Mindfulness-Based Cognitive Therapy (MBCT) is at least as effective as mADM in reducing the relapse/recurrence risk. However, it is not yet known whether combination treatment of MBCT and mADM is more effective than either of these treatments alone. Given the fact that most patients have a preference for either mADM or for MBCT, the aim of the present study is to answer the following questions. First, what is the effectiveness of MBCT in addition to mADM? Second, how large is the risk of relapse/recurrence in patients withdrawing from mADM after participating in MBCT, compared to those who continue to use mADM after MBCT? Methods/design: Two parallel-group, multi-center randomized controlled trials are conducted. Adult patients with a history of depression (3 or more episodes), currently either in full or partial remission and currently treated with mADM (6 months or longer) are recruited. In the first trial, we compare mADM on its own with mADM plus MBCT. In the second trial, we compare MBCT on its own, including tapering of mADM, with mADM plus MBCT. Follow-up assessments are administered at 3-month intervals for 15 months. Primary outcome is relapse/recurrence. Secondary outcomes are time to, duration and severity of relapse/recurrence, quality of life, personality, several process variables, and incremental cost-effectiveness ratio. Discussion: Taking into account patient preferences, this study will provide information about a) the clinical and cost-effectiveness of mADM only compared with mADM plus MBCT, in patients with a preference for mADM, and b) the clinical and cost-effectiveness of withdrawing from mADM after MBCT, compared with mADM plus MBCT, in patients with a preference for MBCT.Trial registration: ClinicalTrials.gov: NCT00928980 [ABSTRACT FROM AUTHOR]

Background: Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk) shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design: The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences. Discussion: If the results of our exploratory trial are extended to this definitive trial, MBCT will be established as an alternative approach to maintenance anti-depressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches. Trial registration number: ISRCTN26666654 [ABSTRACT FROM AUTHOR]