Digital health literacy and digital engagement for people with severe mental ill health across the course of the COVID-19 pandemic in England.

BACKGROUND: An unprecedented acceleration in digital mental health services happened during the COVID-19 pandemic. However, people with severe mental ill health (SMI) might be at risk of digital exclusion, partly because of a lack of digital skills, such as digital health literacy. The study seeks to examine how the use of the Internet has changed during the pandemic for people with SMI, and explore digital exclusion, symptomatic/health related barriers to internet engagement, and digital health literacy. METHODS: Over the period from July 2020 to February 2022, n = 177 people with an SMI diagnosis (psychosis-spectrum disorder or bipolar affective disorder) in England completed three surveys providing sociodemographic information and answering questions regarding their health, use of the Internet, and digital health literacy. RESULTS: 42.5% of participants reported experiences of digital exclusion. Cochrane-Q analysis showed that there was significantly more use of the Internet at the last two assessments (80.8%, and 82.2%) compared to that at the beginning of the pandemic (65.8%; ps < 0.001). Although 34.2% of participants reported that their digital skills had improved during the pandemic, 54.4% still rated their Internet knowledge as being fair or worse than fair. Concentration difficulties (62.6%) and depression (56.1%) were among the most frequently reported symptomatic barriers to use the Internet. The sample was found to have generally moderate levels of digital health literacy (M = 26.0, SD = 9.6). Multiple regression analysis showed that higher literacy was associated with having outstanding/good self-reported knowledge of the Internet (ES = 6.00; 95% CI: 3.18-8.82; p < .001), a diagnosis of bipolar disorder (compared to psychosis spectrum disorder - ES = 5.14; 95% CI: 2.47-7.81; p < .001), and being female (ES = 3.18; 95% CI: 0.59-5.76; p = .016). CONCLUSIONS: These findings underline the need for training and support among people with SMI to increase digital skills, facilitate digital engagement, and reduce digital engagement, as well as offering non-digital engagement options to service users with SMI.

Predicting prognosis for adults with depression using individual symptom data: a comparison of modelling approaches.

BACKGROUND: This study aimed to develop, validate and compare the performance of models predicting post-treatment outcomes for depressed adults based on pre-treatment data. METHODS: Individual patient data from all six eligible randomised controlled trials were used to develop (k = 3, n = 1722) and test (k = 3, n = 918) nine models. Predictors included depressive and anxiety symptoms, social support, life events and alcohol use. Weighted sum scores were developed using coefficient weights derived from network centrality statistics (models 1-3) and factor loadings from a confirmatory factor analysis (model 4). Unweighted sum score models were tested using elastic net regularised (ENR) and ordinary least squares (OLS) regression (models 5 and 6). Individual items were then included in ENR and OLS (models 7 and 8). All models were compared to one another and to a null model (mean post-baseline Beck Depression Inventory Second Edition (BDI-II) score in the training data: model 9). Primary outcome: BDI-II scores at 3-4 months. RESULTS: Models 1-7 all outperformed the null model and model 8. Model performance was very similar across models 1-6, meaning that differential weights applied to the baseline sum scores had little impact. CONCLUSIONS: Any of the modelling techniques (models 1-7) could be used to inform prognostic predictions for depressed adults with differences in the proportions of patients reaching remission based on the predicted severity of depressive symptoms post-treatment. However, the majority of variance in prognosis remained unexplained. It may be necessary to include a broader range of biopsychosocial variables to better adjudicate between competing models, and to derive models with greater clinical utility for treatment-seeking adults with depression.

Measuring the digital divide among people with severe mental ill health using the essential digital skills framework.

AIMS: Amid the vast digitalisation of health and other services during the pandemic, people with no digital skills are at risk of digital exclusion. This risk might not abate by the end of the pandemic. This article seeks to understand whether people with severe mental ill health (SMI) have the necessary digital skills to adapt to these changes and avoid digital exclusion. METHODS: Two hundred and forty-nine adults with SMI across England completed a survey online or offline. They provided information on their digital skills based on the Essential Digital Skills (EDS) framework, sociodemographic information, and digital access. This is the first time that the EDS is benchmarked in people with SMI. RESULTS: 42.2% had no Foundation Skills, and 46.2% lacked skills for daily life (lacking Foundation or Life Skills). 23.0% of those working lacked skills for professional life (lacking Foundation or Work Skills). The most commonly missing skills were handling passwords and using the device settings (Foundation Skills) and online problem solving (Skills for Life). People were interested in learning more about approximately half of the skills they did not have. People were more likely to lack Foundation Skills if they were older, not in employment, had a psychosis-spectrum disorder, or had no Internet access at home. CONCLUSION: A significant portion of people with SMI lacked Foundation Skills in this objective and benchmarked survey. This points to a high risk for digital exclusion and the need for focused policy and tailored health sector support to ensure people retain access to key services and develop digital skills and confidence. To our knowledge, this is the first time this has been described using the EDS framework. Services, including the National Health Service (NHS), need to be aware of and mitigate the risks.

The lived experience of severe mental illness and long-term conditions: a qualitative exploration of service user, carer, and healthcare professional perspectives on self-managing co-existing mental and physical conditions.

BACKGROUND: People with severe mental illness (SMI), such as schizophrenia, have higher rates of physical long-term conditions (LTCs), poorer health outcomes, and shorter life expectancy compared with the general population. Previous research exploring SMI and diabetes highlights that people with SMI experience barriers to self-management, a key component of care in long-term conditions; however, this has not been investigated in the context of other LTCs. The aim of this study was to explore the lived experience of co-existing SMI and LTCs for service users, carers, and healthcare professionals. METHODS: A qualitative study with people with SMI and LTCs, their carers, and healthcare professionals, using semi-structured interviews, focused observations, and focus groups across the UK. Forty-one interviews and five focus groups were conducted between December 2018 and April 2019. Transcripts were coded by two authors and analysed thematically. RESULTS: Three themes were identified, 1) the precarious nature of living with SMI, 2) the circularity of life with SMI and LTCs, and 3) the constellation of support for self-management. People with co-existing SMI and LTCs often experience substantial difficulties with self-management of their health due to the competing demands of their psychiatric symptoms and treatment, social circumstances, and access to support. Multiple long-term conditions add to the burden of self-management. Social support, alongside person-centred professional care, is a key facilitator for managing health. An integrated approach to both mental and physical healthcare was suggested to meet service user and carer needs. CONCLUSION: The demands of living with SMI present a substantial barrier to self-management for multiple co-existing LTCs. It is important that people with SMI can access person-centred, tailored support for their LTCs that takes into consideration individual circumstances and priorities.

Role of age, gender and marital status in prognosis for adults with depression: An individual patient data meta-analysis.

AIMS: To determine whether age, gender and marital status are associated with prognosis for adults with depression who sought treatment in primary care. METHODS: Medline, Embase, PsycINFO and Cochrane Central were searched from inception to 1st December 2020 for randomised controlled trials (RCTs) of adults seeking treatment for depression from their general practitioners, that used the Revised Clinical Interview Schedule so that there was uniformity in the measurement of clinical prognostic factors, and that reported on age, gender and marital status. Individual participant data were gathered from all nine eligible RCTs (N = 4864). Two-stage random-effects meta-analyses were conducted to ascertain the independent association between: (i) age, (ii) gender and (iii) marital status, and depressive symptoms at 3-4, 6-8, and 9-12 months post-baseline and remission at 3-4 months. Risk of bias was evaluated using QUIPS and quality was assessed using GRADE. PROSPERO registration: CRD42019129512. Pre-registered protocol https://osf.io/e5zup/. RESULTS: There was no evidence of an association between age and prognosis before or after adjusting for depressive 'disorder characteristics' that are associated with prognosis (symptom severity, durations of depression and anxiety, comorbid panic disorderand a history of antidepressant treatment). Difference in mean depressive symptom score at 3-4 months post-baseline per-5-year increase in age = 0(95% CI: -0.02 to 0.02). There was no evidence for a difference in prognoses for men and women at 3-4 months or 9-12 months post-baseline, but men had worse prognoses at 6-8 months (percentage difference in depressive symptoms for men compared to women: 15.08% (95% CI: 4.82 to 26.35)). However, this was largely driven by a single study that contributed data at 6-8 months and not the other time points. Further, there was little evidence for an association after adjusting for depressive 'disorder characteristics' and employment status (12.23% (-1.69 to 28.12)). Participants that were either single (percentage difference in depressive symptoms for single participants: 9.25% (95% CI: 2.78 to 16.13) or no longer married (8.02% (95% CI: 1.31 to 15.18)) had worse prognoses than those that were married, even after adjusting for depressive 'disorder characteristics' and all available confounders. CONCLUSION: Clinicians and researchers will continue to routinely record age and gender, but despite their importance for incidence and prevalence of depression, they appear to offer little information regarding prognosis. Patients that are single or no longer married may be expected to have slightly worse prognoses than those that are married. Ensuring this is recorded routinely alongside depressive 'disorder characteristics' in clinic may be important.

The importance of transdiagnostic symptom level assessment to understanding prognosis for depressed adults: analysis of data from six randomised control trials.

BACKGROUND: Depression is commonly perceived as a single underlying disease with a number of potential treatment options. However, patients with major depression differ dramatically in their symptom presentation and comorbidities, e.g. with anxiety disorders. There are also large variations in treatment outcomes and associations of some anxiety comorbidities with poorer prognoses, but limited understanding as to why, and little information to inform the clinical management of depression. There is a need to improve our understanding of depression, incorporating anxiety comorbidity, and consider the association of a wide range of symptoms with treatment outcomes. METHOD: Individual patient data from six RCTs of depressed patients (total n = 2858) were used to estimate the differential impact symptoms have on outcomes at three post intervention time points using individual items and sum scores. Symptom networks (graphical Gaussian model) were estimated to explore the functional relations among symptoms of depression and anxiety and compare networks for treatment remitters and those with persistent symptoms to identify potential prognostic indicators. RESULTS: Item-level prediction performed similarly to sum scores when predicting outcomes at 3 to 4 months and 6 to 8 months, but outperformed sum scores for 9 to 12 months. Pessimism emerged as the most important predictive symptom (relative to all other symptoms), across these time points. In the network structure at study entry, symptoms clustered into physical symptoms, cognitive symptoms, and anxiety symptoms. Sadness, pessimism, and indecision acted as bridges between communities, with sadness and failure/worthlessness being the most central (i.e. interconnected) symptoms. Connectivity of networks at study entry did not differ for future remitters vs. those with persistent symptoms. CONCLUSION: The relative importance of specific symptoms in association with outcomes and the interactions within the network highlight the value of transdiagnostic assessment and formulation of symptoms to both treatment and prognosis. We discuss the potential for complementary statistical approaches to improve our understanding of psychopathology.

Cost-effectiveness of computerized cognitive-behavioural therapy for the treatment of depression in primary care: findings from the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial.

BACKGROUND: Computerized cognitive-behavioural therapy (cCBT) forms a core component of stepped psychological care for depression. Existing evidence for cCBT has been informed by developer-led trials. This is the first study based on a large independent pragmatic trial to assess the cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care compared with usual GP care alone and to establish the differential cost-effectiveness of a free-to-use cCBT programme (MoodGYM) in comparison with a commercial programme (Beating the Blues) in primary care. METHOD: Costs were estimated from a healthcare perspective and outcomes measured using quality-adjusted life years (QALYs) over 2 years. The incremental cost-effectiveness of each cCBT programme was compared with usual GP care. Uncertainty was estimated using probabilistic sensitivity analysis and scenario analyses were performed to assess the robustness of results. RESULTS: Neither cCBT programme was found to be cost-effective compared with usual GP care alone. At a £20 000 per QALY threshold, usual GP care alone had the highest probability of being cost-effective (0.55) followed by MoodGYM (0.42) and Beating the Blues (0.04). Usual GP care alone was also the cost-effective intervention in the majority of scenario analyses. However, the magnitude of the differences in costs and QALYs between all groups appeared minor (and non-significant). CONCLUSIONS: Technically supported cCBT programmes do not appear any more cost-effective than usual GP care alone. No cost-effective advantage of the commercially developed cCBT programme was evident compared with the free-to-use cCBT programme. Current UK practice recommendations for cCBT may need to be reconsidered in the light of the results.

Fathers' views and experiences of their own mental health during pregnancy and the first postnatal year: a qualitative interview study of men participating in the UK Born and Bred in Yorkshire (BaBY) cohort.

BACKGROUND: The prevalence of fathers' depression and anxiety in the perinatal period (i.e. from conception to 1 year after birth) is approximately 5-10%, and 5-15%, respectively; their children face increased risk of adverse emotional and behavioural outcomes, independent of maternal mental health. Critically, fathers can be protective against the development of maternal perinatal mental health problems and their effects on child outcomes. Preventing and treating paternal mental health problems and promoting paternal psychological wellbeing may therefore benefit the family as a whole. This study examined fathers' views and direct experiences of paternal perinatal mental health. METHODS: Men in the Born and Bred in Yorkshire (BaBY) epidemiological prospective cohort who met eligibility criteria (baby born <12 months; completed Mental Health and Wellbeing [MHWB] questionnaires) were invited to participate. Those expressing interest (n = 42) were purposively sampled to ensure diversity of MHWB scores. In-depth interviews were conducted at 5-10 months postpartum with 19 men aged 25-44 years. The majority were first-time fathers and UK born; all lived with their partner. Data were analysed using thematic analysis. RESULTS: Four themes were identified: 'legitimacy of paternal stress and entitlement to health professionals' support', 'protecting the partnership', 'navigating fatherhood', and, 'diversity of men's support networks'. Men largely described their 'stress' with reference to exhaustion, poor concentration and irritability. Despite feeling excluded by maternity services, fathers questioned their entitlement to support, noting that services are pressured and 'should' be focused on mothers. Men emphasised the need to support their partner and protect their partnership as central to the successfully navigation of fatherhood; they used existing support networks where available but noted the paucity of tailored support for fathers. CONCLUSIONS: Fathers experience psychological distress in the perinatal period but question the legitimacy of their experiences. Men may thus be reluctant to express their support needs or seek help amid concerns that to do so would detract from their partner's needs. Resources are needed that are tailored to men, framed around fatherhood, rather than mental health or mental illness, and align men's self-care with their role as supporter and protector. Further research is needed to inform how best to identify and manage both parents' mental health needs and promote their psychological wellbeing, in the context of achievable models of service delivery.

Exploring why people with SMI smoke and why they may want to quit: baseline data from the SCIMITAR RCT.

ACCESSIBLE SUMMARY: People with severe mental ill health are up to three times more likely to smoke than other members of the general population. Life expectancy in this client group is reduced by up to 30 years, and smoking is the single most important cause of premature death. The aim of this study was to explore why people with severe mental ill health smoked and why they might want to stop smoking or cut down on the amount of cigarettes that they smoked. The study found that people with severe mental ill health are motivated to cut down or stop smoking, and this is mainly due to concerns about their own health. The reasons people gave for smoking were to relieve stress, to help relax and for something to do when they are bored. Health professionals should offer evidence supported smoking cessation therapy to people with severe mental ill health. In addition to standard National Health Service smoking cessation treatments such as pharmacotherapy and behavioural support. Practitioners should help people with serious mental ill health to identify meaningful activities to relieve boredom and challenge any incorrect beliefs they hold that smoking helps relaxation and relieves stress. ABSTRACT: Smoking is the single most preventable cause of premature mortality for people with serious mental ill health (SMI). Yet little is known about the reasons why service users smoke or what their motivations for quitting might be. The aim of this paper is to explore smoking behaviours, reasons for smoking and motivations for cutting down/stopping smoking in individuals with SMI who expressed an interest in cutting down or stopping smoking. Prior to randomization, the smoking behaviours and motivations for wanting to cut down or stop smoking of participants in a randomized trial were systematically assessed. Participant's primary reasons for continuing to smoke were that they believed it helped them to cope with stress, to relax and relieve boredom. Participant's main motivations for wanting to cut down or stop smoking were related to concerns for their own health. Previous attempts to stop smoking had often been made alone without access to evidence supported smoking cessation therapy. Future recommendations include helping people with SMI to increase their activity levels to relieve boredom and inspire confidence in their ability to stop smoking and challenging beliefs that smoking aids relaxation and relieves stress.

Evidence-based guidelines for treating depressive disorders with antidepressants: A revision of the 2008 British Association for Psychopharmacology guidelines.

A revision of the 2008 British Association for Psychopharmacology evidence-based guidelines for treating depressive disorders with antidepressants was undertaken in order to incorporate new evidence and to update the recommendations where appropriate. A consensus meeting involving experts in depressive disorders and their management was held in September 2012. Key areas in treating depression were reviewed and the strength of evidence and clinical implications were considered. The guidelines were then revised after extensive feedback from participants and interested parties. A literature review is provided which identifies the quality of evidence upon which the recommendations are made. These guidelines cover the nature and detection of depressive disorders, acute treatment with antidepressant drugs, choice of drug versus alternative treatment, practical issues in prescribing and management, next-step treatment, relapse prevention, treatment of relapse and stopping treatment. Significant changes since the last guidelines were published in 2008 include the availability of new antidepressant treatment options, improved evidence supporting certain augmentation strategies (drug and non-drug), management of potential long-term side effects, updated guidance for prescribing in elderly and adolescent populations and updated guidance for optimal prescribing. Suggestions for future research priorities are also made.

Cost-effectiveness of combining systematic identification and treatment of co-morbid major depression for people with chronic diseases: the example of cancer.

BACKGROUND: Co-morbid major depression occurs in approximately 10% of people suffering from a chronic medical condition such as cancer. Systematic integrated management that includes both identification and treatment has been advocated. However, we lack information on the cost-effectiveness of this combined approach, as published evaluations have focused solely on the systematic (collaborative care) treatment stage. We therefore aimed to use the best available evidence to estimate the cost-effectiveness of systematic integrated management (both identification and treatment) compared with usual practice, for patients attending specialist cancer clinics. METHOD: We conducted a cost-effectiveness analysis using a decision analytic model structured to reflect both the identification and treatment processes. Evidence was taken from reviews of relevant clinical trials and from observational studies, together with data from a large depression screening service. Sensitivity and scenario analyses were undertaken to determine the effects of variations in depression incidence rates, time horizons and patient characteristics. RESULTS: Systematic integrated depression management generated more costs than usual practice, but also more quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) was £11,765 per QALY. This finding was robust to tests of uncertainty and variation in key model parameters. CONCLUSIONS: Systematic integrated management of co-morbid major depression in cancer patients is likely to be cost-effective at widely accepted threshold values and may be a better way of generating QALYs for cancer patients than some existing medical and surgical treatments. It could usefully be applied to other chronic medical conditions.

Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis.

OBJECTIVES: To provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. DATA SOURCES: Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. REVIEW METHODS: A generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. RESULTS: The Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. CONCLUSIONS: In light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify postnatal depression. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.

Is it clinically and cost effective to screen for postnatal depression: a systematic review of controlled clinical trials and economic evidence.

BACKGROUND: Postnatal depression (PND) is a common mental health problem, which is associated with adverse consequences beyond the individual with depression. It is not known whether using formal methods to identify PND are clinically and cost effective in improving maternal and infant outcomes. OBJECTIVES: To evaluate the clinical and cost effectiveness of antenatal and postnatal identification of depressive symptoms. SEARCH STRATEGY: Twenty electronic databases were searched to retrieve English and non-English language articles published until February 2007. SELECTION CRITERIA: Randomised controlled trials or controlled trials comparing the use of formal methods to identify PND, with or without enhancement of care, or feedback of scores with not using formal methods to identify PND or usual care. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for inclusion and extracted data. Results from the trials were combined to calculate odds ratios and 95% confidence intervals for dichotomous outcomes. MAIN RESULTS: Five studies were identified that compared formal use of a method to identify PND, with or without enhancement of care, or feedback of scores with not using a formal method or usual care. All of the studies used the Edinburgh Postnatal Depression Scale (EPDS) to identify women with PND. The results of the studies indicated beneficial effects of using the EPDS in reducing EPDS scores (OR = 0.61; 95% CI 0.48-0.76). AUTHOR'S CONCLUSIONS: Despite some apparent beneficial effects of using formal methods to identify PND, it is difficult to disentangle the effects of the screening component alone from interventions linked to a positive screen as some of the studies included enhancements of care and/or an intervention.

Barriers to the uptake of computerized cognitive behavioural therapy: a systematic review of the quantitative and qualitative evidence.

BACKGROUND: Studies of cognitive behavioural therapy delivered by computer (cCBT) show clinical efficacy for treating anxiety and depression, but have not focused on barriers to uptake. Potential barriers include adverse consequences, accessibility and acceptability. METHOD: An integrated systematic review was conducted of quantitative and qualitative studies and surveys from multiple electronic databases where computers delivered cCBT for anxiety or depression. RESULTS: Substantial numbers of potential participants are lost prior to trials commencing with little explanation. Among trial participants, drop-outs may be higher in the cCBT groups (odds ratio 2.03, 95% confidence interval 0.81-5.09). Only a median of 56% completed a full course of cCBT and personal circumstance was a more common cause of drop-out than difficulties with the technology or social background. Risk was rarely assessed in the majority of programs. Significant staff time was needed to support clients. Therapists were more negative about cCBT than clients. CONCLUSIONS: While cCBT is likely to be an effective and acceptable intervention for some people, there are barriers to its uptake that will substantially limit its impact if not addressed. These included investigating the outcome and attitudes of those who do not make it as far as cCBT trials and why so few finish a full course of cCBT.

A review and critical appraisal of measures of therapist-patient interactions in mental health settings.

OBJECTIVES: To assemble and to appraise critically the current literature on tests and measures of therapist-patient interactions in order to make recommendations for practice, training and research, and to establish benchmarks for standardisation, acceptability and routine use of such measures. DATA SOURCES: Major electronic databases (including PsycINFO) were searched from inception to 2002. REVIEW METHODS: A comprehensive conceptual map of the subject area of therapist-patient interactions was developed through data extraction from, and analysis of, studies selected from the literature searches. The results of these searches were assessed and appraised to produce a set of possible therapist-patient measures. These measures were then evaluated. RESULTS: The contextual map included the various concepts and domains that had been used in the context of the literature on therapist-patient interactions, and was used to guide the successive stages of the review. Three developmental processes were identified as necessary for the provision of an effective therapeutic relationship: 'establishing a relationship', 'developing a relationship' and 'maintaining a relationship'. Eighty-three therapist-patient measures having basic information on reliability and validity were identified for critical appraisal. The areas of the conceptual map that received most coverage (i.e. over 50% measures associated with them) were framework, therapist and patient engagement, roles, therapeutic techniques and threats to the relationship. These areas relate to the three key developmental processes outlined above. Of the 83 measures matching the content domain, 43 met the minimum standard. A total of 30 measures displayed adequate responsiveness or precision. None of the 43 measures that met the minimum standard was fully addressed in terms of acceptability and feasibility evidence. The majority of these measures had three or fewer components described. Therefore, out of a total of 83 measures matching the content domain, no measure could be said to have met an industry standard. CONCLUSIONS: The findings indicate that the therapist-patient interaction can be measured using a wide range of instruments of varying value. However, due care should be taken in ensuring that the measure is suitable for the context in which it is to be used. Following on from this work, it is suggested that specific research networks for the development of therapist-patient measures should be established, that research activity should prioritise investment in increasing the evidence base of existing measures rather than attempting to develop new ones, and that research activity should focus on improving these existing measures in terms of acceptability and feasibility issues.

A meta-analysis of randomized trials of behavioural treatment of depression.

BACKGROUND: Depression is a common, disabling condition for which psychological treatments, in particular cognitive behavioural therapies are recommended. Promising results in recent randomized trials have renewed interest in behavioural therapy. This systematic review sought to identify all randomized trials of behavioural therapy for depression, determine the effect of such interventions and examine any moderators of such effect. METHOD: Randomized trials of behavioural treatments of depression versus controls or other psychotherapies were identified using electronic database searches, previous reviews and reference lists. Data on symptom-level, recovery/dropout rate and study-level moderators (study quality, number of sessions, severity and level of training) were extracted and analysed using meta-analysis and meta-regression respectively. RESULTS: Seventeen randomized controlled trials including 1109 subjects were included in this meta-analysis. A random-effects meta-analysis of symptom-level post-treatment showed behavioural therapies were superior to controls [standardized mean difference (SMD) -0.70, 95% CI -1.00 to -0.39, k=12, n=459], brief psychotherapy (SMD -0.56, 95% CI -1.0 to -0.12, k=3, n=166), supportive therapy (SMD -0.75, 95% CI -1.37 to -0.14, k=2, n=45) and equal to cognitive behavioural therapy (SMD 0.08, 95% CI -0.14 to 0.30, k=12, n=476). CONCLUSIONS: The results in this study indicate behavioural therapy is an effective treatment for depression with outcomes equal to that of the current recommended psychological intervention. Future research needs to address issues of parsimony of such interventions.

Collaborative care for depression in UK primary care: a randomized controlled trial.

BACKGROUND: Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial. METHOD: We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9). RESULTS: We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32). CONCLUSIONS: Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.

A systematic review and economic model of the clinical effectiveness and cost-effectiveness of interventions for preventing relapse in people with bipolar disorder.

OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of pharmacological and/or psychosocial interventions for the prevention of relapse in people with bipolar disorder. DATA SOURCES: Major electronic databases were searched up to September 2005. REVIEW METHODS: Systematic reviews were undertaken on the clinical and economic effectiveness of treatments. An analysis was performed using the methods of mixed treatment comparison (MTC) to enable indirect comparisons to be made between the treatments. An economic model of treatments for the prevention of relapse in bipolar disorder was developed. RESULTS: Forty-five trials were included in the clinical effectiveness review; all but one studied adults. This review found that for the prevention of all relapses, lithium, valproate, lamotrigine and olanzapine performed better than placebo, with lithium and lamotrigine having the strongest evidence. For depressive relapse prevention, valproate, lamotrigine and imipramine performed better than placebo, with evidence strongest for lamotrigine and weakest for imipramine. For manic relapses, lithium and olanzapine performed significantly better than placebo. The MTC found that the best treatment for bipolar I patients with mainly depressive symptoms was valproate, followed by lithium plus imipramine. For bipolar I patients with mainly manic symptoms, olanzapine was the best treatment. From the studies investigating psychosocial interventions, there were few data for each comparison and outcome. The evidence suggests that cognitive behaviour therapy (CBT), in combination with usual treatment, is effective for the prevention of relapse. Group psychoeducation and possibly family therapy may also have roles as adjunctive therapy for preventing relapse. The results from the decision analytic model developed on the cost-effectiveness of long-term maintenance treatments of bipolar I patients suggest that the choice of treatment is dependent upon a number of factors: the previous episode history of a patient and the mortality benefit assumed for lithium strategies. The results from the base-case analysis for patients with a recent history of depression suggest that valproate, lithium and the combination of lithium and imipramine are potentially cost-effective depending upon the amount that a decision-maker is willing to pay for additional health gain. Using conventional amounts that the NHS is prepared to pay for health gain, then the lithium-based strategies appear to be potentially cost-effective for this group. For patients with a recent history of mania, the choice of pharmacological intervention appears to be between olanzapine and lithium monotherapy. Again using conventional threshold as a reference point, the results suggest that lithium is the most cost-effective therapy. Excluding the additional mortality benefit associated with lithium-based strategies resulted in all treatments for patients with a recent history of a depressive episode being dominated by valproate and, in the case of patients with a recent history of a manic episode, by olanzapine. CONCLUSIONS: Lithium, valproate, lamotrigine and olanzapine are effective as maintenance therapy for the prevention of relapse in bipolar disorder. Olanzapine and lithium are efficacious for the prevention of manic relapses and valproate, lamotrigine and imipramine for the prevention of depressive relapse. There is some evidence that CBT, group psychoeducation and family therapy might be beneficial as adjuncts to pharmacological maintenance treatments. Insufficient information is available regarding the relative tolerability of the treatments or their relative effects on suicide rate and mortality. For patients with a recent depressive episode, valproate, lithium monotherapy and the combination of lithium and imipramine are potentially cost-effective. For patients with a recent manic episode, olanzapine and lithium monotherapy are potentially cost-effective. The cost-effectiveness estimates in both groups of patients were shown to be sensitive to the assumption of a reduced suicidal risk associated with lithium-based strategies. Further research is needed into the adverse effects of all treatments and the differential effects of agents. Good-quality trials of valproate, of combination therapy, e.g. lithium plus a selective serotonin reuptake inhibitor antidepressant, of psychosocial interventions and of the disorder in children are also required.

A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines.

OBJECTIVES: To establish the role and value of written information available to patients about individual medicines from the perspective of patients, carers and professionals. To determine how effective this information is in improving patients' knowledge and understanding of treatment and health outcomes. DATA SOURCES: Electronic databases searched to late 2004, experts in information design, and stakeholder workshops (including patients and patient organisations). REVIEW METHODS: Data from selected studies were tabulated and the results were qualitatively synthesised along with findings from the information design and stakeholder workshop strands. RESULTS: Most people do not value the written information they receive. They had concerns about the use of complex language and poor visual presentation and in most cases the research showed that the information did not increase knowledge. The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information. Most patients wanted to know about any adverse effects that could arise. Patients require information to help decision-making about whether to take a medicine or not and (once taking a medicine) with ongoing decisions about the management of the medicine and interpreting symptoms. Patients did not want written information to be a substitute for spoken information from their prescriber. While not everyone wanted written information, those who did wanted sufficient detail to meet their need. Some health professionals thought that written information for patients should be brief and simple, with concerns about providing side-effect information. They saw increasing compliance as a prime function, in contrast to patients who saw an informed decision not to take a medicine as an acceptable outcome. CONCLUSIONS: The combination of a quantitative and qualitative review, an exploration of best practice in information design, plus the input of patients at stakeholder workshops, allowed this review to look at all perspectives. There is a gap between currently provided leaflets and information which patients would value and find more useful. The challenge is to develop methods of provision flexible enough to allow uptake of varying amounts and types of information, depending on needs at different times in an illness. This review has identified a number of areas where future research could be improved in terms of the robustness of its design and conduct, and the use of patient-focused outcomes. The scope for this research includes determining the content, delivery and layout of statutory leaflets that best meet patients' needs, and providing individualised information, which includes both benefit and harm information. In particular, studies of the effectiveness and role and value of Internet-based medicines information are needed.