Search

SummaryUse of cost-effectiveness acceptability curves, as a method for summarising information on uncertainty cost-effectiveness, has become widespread within applied studies. This includes several studies in the mental health field. This editorial uses examples from recent papers to illustrate how cost effectiveness acceptability curves are constructed, what they represent and how they should be interpreted.

Restricted and repetitive behaviors (RRBs) are characteristic of autism spectrum disorders (ASD). However, compared to social and communicative impairments, less is known about their development, trajectory and etiology. This study explored RRBs in young children with ASD matched to typically developing (TD) children on non-verbal development. RRBs were coded from direct observation at three time points within 13 months of development. Children with ASD displayed higher frequency and greater diversity of RRBs at all time points, however RRBs were not unique to ASD and evident in the TD control group albeit at a reduced frequency. RRBs did not correlate with social and communicative impairments in the ASD group, suggesting dissociation between these domains.

BackgroundDespite evidence of the effectiveness of injectable opioid treatment compared with oral methadone for chronic heroin addiction, the additional cost of injectable treatment is considerable, and cost-effectiveness uncertain.AimsTo compare the cost-effectiveness of supervised injectable heroin and injectable methadone with optimised oral methadone for chronic refractory heroin addiction.MethodMultisite, open-label, randomised controlled trial. Outcomes were assessed in terms of quality-adjusted life-years (QALYs). Economic perspective included health, social services and criminal justice resources.ResultsIntervention costs over 26 weeks were significantly higher for injectable heroin (mean £8995 v. £4674 injectable methadone and £2596 oral methadone; PP =n.s.) due to higher costs of criminal activity. In cost-effectiveness analysis, oral methadone was dominated by injectable heroin and injectable methadone (more expensive and less effective). At willingness to pay of £30 000 per QALY, there is a higher probability of injectable methadone being more cost-effective (80%) than injectable heroin.ConclusionsInjectable opioid treatments are more cost-effective than optimised oral methadone for chronic refractory heroin addiction. The choice between supervised injectable heroin and injectable methadone is less clear. There is currently evidence to suggest superior effectiveness of injectable heroin but at a cost that policy makers may find unacceptable. Future research should consider the use of decision analytic techniques to model expected costs and benefits of the treatments over the longer term.

Despite a preference for economic evaluations to measure outcomes in terms of quality-adjusted life years, generic measures of outcome are rarely used in mental health research involving young people.To explore the validity and responsiveness of the EQ-5D measure of health-related quality of life in adolescents with major depression.Data came from a clinical trial involving adolescents with persistent major depression (n = 199). Construct validity was tested using socio-demographic constructs and baseline clinical outcome scores. To assess convergent validity, correlation between EQ-5D and clinical outcome scores was tested. To assess responsiveness, the mean change in EQ-5D scores of participants categorised as improved versus not improved on clinical outcome measures was tested.Significant differences in mean EQ-5D score were found for co-morbidity and three of four severity measures but not gender, age, treatment history or suicide attempts. Mean EQ-5D scores were significantly correlated with all clinical outcome measures, although relationships were moderate or weak. A change in mean EQ-5D score was significantly related to clinical assessments of improvement on all outcome measures.Results provide initial evidence to support the relevance of the EQ-5D in adolescents with major depression, but this evidence is weak. Replication studies are needed to assess the generalisability of these findings.

Summary Background The CRIMSON (CRisis plan IMpact: Subjective and Objective coercion and eNgagement) study is an individual level, randomised controlled trial that compared the effectiveness of Joint Crisis Plans (JCPs) with treatment as usual for people with severe mental illness. The JCP is a negotiated statement by a patient of treatment preferences for any future psychiatric emergency, when he or she might be unable to express clear views. We assessed whether the additional use of JCPs improved patient outcomes compared with treatment as usual. Methods Patients were eligible if they had at least one psychiatric admission in the previous 2 years and were on the Enhanced Care Programme Approach register. The study was done with 64 generic and specialist community mental health teams in four English mental health care provider organisations (trusts). Hypotheses tested were that, compared with the control group, the intervention group would experience: fewer compulsory admissions (primary outcome); fewer psychiatric admissions; shorter psychiatric stays; lower perceived coercion; improved therapeutic relationships; and improved engagement. We stratified participants by centre. The research team but not participants nor clinical staff were masked to allocation. This study is registered with ClinicalTrials.gov, number ISRCTN11501328. Findings 569 participants were randomly assigned (285 to the intervention group and 284 to the control group). No significant treatment effect was seen for the primary outcome (56 [20%] sectioned in the control group and 49 [18%] in the JCP group; odds ratio 0·90 [95% CI 0·58–1·39, p=0·63]) or any secondary outcomes, with the exception of an improved secondary outcome of therapeutic relationships (17·3 [7·6] vs 16·0 [7·1]; adjusted difference −1·28 [95% CI −2·56 to −0·01, p=0·049]). Qualitative data supported this finding. Interpretation Our findings are inconsistent with two earlier JCP studies, and show that the JCP is not significantly more effective than treatment as usual. There is evidence to suggest the JCPs were not fully implemented in all study sites, and were combined with routine clinical review meetings which did not actively incorporate patients' preferences. The study therefore raises important questions about implementing new interventions in routine clinical practice. Funding Medical Research Council UK and the National Institute for Health Research.

OBJECTIVE: To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN: A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING: Study participants were recruited from secondary care mental health and social services in four UK centres. PARTICIPANTS: Potential participants were aged 18 years or over, had a clinical diagnosis of schizophrenia, confirmed by an examination of case notes, and provided written informed consent. We excluded those who were unable to speak sufficient English to complete the baseline assessment, those with severe cognitive impairment and those already receiving arts therapy. INTERVENTIONS: Group art therapy was delivered by registered art therapists according to nationally agreed standards. Groups had up to eight members, lasted for 90 minutes and ran for 12 months. Members were given access to a range of art materials and encouraged to use these to express themselves freely. Activity groups were designed to control for the non-specific effects of group art therapy. Group facilitators offered various activities and encouraged participants to collectively select those they wanted to pursue. Standard care involved follow-up from secondary care mental health services and the option of referral to other services, except arts therapies, as required. MAIN OUTCOME MEASURES: Our co-primary outcomes were global functioning (measured using the Global Assessment of Functioning Scale - GAF) and mental health symptoms (measured using the Positive and Negative Syndrome Scale - PANSS) at 24 months. The main secondary outcomes were level of group attendance, social functioning, well-being, health-related quality of life, service utilisation and other costs measured 12 and 24 months after randomisation. RESULTS: Four hundred and seventeen people were recruited, of whom 355 (85%) were followed up at 2 years. Eighty-six (61%) of those randomised to art therapy and 73 (52%) of those randomised to activity groups attended at least one group. No differences in primary outcomes were found between the three study arms. The adjusted mean difference between art therapy and standard care at 24 months was -0.9 [95% confidence interval (CI) -3.8 to 2.1] on the GAF Scale and 0.7 (95% CI -3.1 to 4.6) on the PANSS Scale. Differences in secondary outcomes were not found, except that those referred to an activity group had fewer positive symptoms of schizophrenia at 24 months than those randomised to art therapy. Secondary analysis indicated that attendance at art therapy groups was not associated with improvements in global functioning or mental health. Although the total cost of the art therapy group was lower than the cost of the two comparison groups, referral to group art therapy did not appear to provide a cost-effective use of resources. CONCLUSIONS: Referring people with established schizophrenia to group art therapy as delivered in this randomised trial does not appear to improve global functioning or mental health of patients or provide a more cost-effective use of resources than standard care alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 46150447. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 8. See the HTA programme website for further project information.

OBJECTIVES: To evaluate the clinical effectiveness of group art therapy for people with schizophrenia and to test whether any benefits exceed those of an active control treatment.DESIGN: Three arm, rater blinded, pragmatic, randomised controlled trial.SETTING: Secondary care services across 15 sites in the United Kingdom.PARTICIPANTS: 417 people aged 18 or over, who had a diagnosis of schizophrenia and provided written informed consent to take part in the study.INTERVENTIONS: Participants, stratified by site, were randomised to 12 months of weekly group art therapy plus standard care, 12 months of weekly activity groups plus standard care, or standard care alone. Art therapy and activity groups had up to eight members and lasted for 90 minutes. In art therapy, members were given access to a range of art materials and encouraged to use these to express themselves freely. Members of activity groups were offered various activities that did not involve use of art or craft materials and were encouraged to collectively select those they wanted to pursue.MAIN OUTCOME MEASURES: The primary outcomes were global functioning, measured using the global assessment of functioning scale, and mental health symptoms, measured using the positive and negative syndrome scale, 24 months after randomisation. Main secondary outcomes were levels of group attendance, social functioning, and satisfaction with care at 12 and 24 months.RESULTS: 417 participants were assigned to either art therapy (n=140), activity groups (n=140), or standard care alone (n=137). Primary outcomes between the three study arms did not differ. The adjusted mean difference between art therapy and standard care at 24 months on the global assessment of functioning scale was -0.9 (95% confidence interval -3.8 to 2.1), and on the positive and negative syndrome scale was 0.7 (-3.1 to 4.6). Secondary outcomes did not differ between those referred to art therapy or those referred to standard care at 12 or 24 months.CONCLUSIONS: Referring people with established schizophrenia to group art therapy as delivered in this trial did not improve global functioning, mental health, or other health related outcomes.TRIAL REGISTRATION: Current Controlled Trials ISRCTN46150447.

BackgroundThe dangerous severe personality disorder programme was developed in high secure prisons and hospitals at great expense to identify and treat the most dangerous offenders with personality disorders.AimsTo evaluate whether the long-term costs of the programme are greater or less than the long-term outcomes.MethodWe used a Markov decision model with a cost-effectiveness analysis to determine the incremental cost of the programme per serious offence prevented and a cost-offset analysis to consider whether monetary benefits were greater than costs.ResultsCosts were consistently higher for the intervention programme and the cost per serious offence prevented was over £2 million, although there was some evidence that adjustments to the programme could lead to similar interventions becoming cost-effective.ConclusionsLittle evidence was found to support the cost-effectiveness of the intervention programme for offenders with personality disorders, although delivery of the programme in a lower-cost prison would probably yield greater benefits than costs. There are frequent calls for mentally disordered offenders to be detained in secure hospitals rather than prisons; however, if reoffending remains the outcome of interest for policy makers, it is likely that the costs of detention in hospital will remain greater than the benefits for dangerous offenders with a personality disorder.

Autism spectrum disorders (ASD) are associated with a substantial economic burden, but there is little evidence of the costs in the early years; the period in which children are increasingly likely to be diagnosed. We describe the services used by 152 children aged 24–60 months with autism, report family out-of-pocket expenses and productivity losses, and explore the relationship between family characteristics and costs. Children received a wide range of hospital and community services including relatively high levels of contact with speech and language therapists and paediatricians. Total service costs varied greatly (mean £430 per month; range £53 to £1,116), with some families receiving little statutory support. Higher costs were associated with increasing age and symptom severity.

Background Conduct disorders are the most common psychiatric disorders in children and may persist into adulthood in about 50% of cases. The costs to society are high and impact many public sector agencies. Parenting programmes have been shown to positively affect child behaviour, but little is known about their potential long-term cost-effectiveness. We therefore estimate the costs of and longer-term savings from evidence-based parenting programmes for the prevention of persistent conduct disorder. Methods A decision-analytic Markov model compares two scenarios: 1) a 5-year old with clinical conduct disorder receives an evidence-based parenting programme; 2) the same 5-year old does not receive the programme. Cost-savings analysis is performed by comparing the probability that conduct disorder persists over time in each scenario, adopting both a public sector and a societal perspective. If the intervention is successful in reducing persistent conduct disorder, cost savings may arise from reduced use of health services, education support, social care, voluntary agencies and from crimes averted. Results Results strongly suggest that parenting programmes reduce the chance that conduct disorder persists into adulthood and are cost-saving to the public sector within 5-8 years under base case conditions. Total savings to society over 25 years are estimated at £16,435 per family, which compares with an intervention cost in the range of £952-£2,078 (2008/09 prices). Conclusions Effective implementation of evidence-based parenting programmes is likely to yield cost savings to the public sector and society. More research is needed to address evidence gaps regarding the current level of provision, longer-term effectiveness and questions of implementation, engagement and equity.

Background Abnormal health anxiety, also called hypochondriasis, has been successfully treated by cognitive behaviour therapy (CBT) in patients recruited from primary care, but only one pilot trial has been carried out among those attending secondary medical clinics where health anxiety is likely to be more common and have a greater impact on services. The CHAMP study extends this work to examine both the clinical and cost effectiveness of CBT in this population. Method/Design The study is a randomized controlled trial with two parallel arms and equal randomization of 466 eligible patients (assuming a 20% drop-out) to an active treatment group of 5-10 sessions of cognitive behaviour therapy and to a control group. The aim at baseline, after completion of all assessments but before randomization, was to give a standard simple explanation of the nature of health anxiety for all participants. Subsequently the control group was to receive whatever care might usually be available in the clinics, which is normally a combination of clinical assessment, appropriate tests and reassurance. Those allocated to the active treatment group were planned to receive between 5 and 10 sessions of an adapted form of cognitive behaviour therapy based on the Salkovskis/Warwick model, in which a set of treatment strategies are chosen aimed at helping patients understand the factors that drive and maintain health anxiety. The therapy was planned to be given by graduate research workers, nurses or other health professionals trained for this intervention whom would also have their competence assessed independently during the course of treatment. The primary outcome is reduction in health anxiety symptoms after one year and the main secondary outcome is the cost of care after two years. Discussion This represents the first trial of adapted cognitive behaviour therapy in health anxiety that is large enough to test not only the clinical benefits of treatment but also whether the cost of treatment is offset by savings from reduced use of other health services in comparison to the control group. Cognitive behaviour therapy for Health Anxiety in Medical Patients (CHAMP) Trial registration Current Controlled Trials ISRCTN14565822

BackgroundAlternatives to traditional in-patient services may be associated with a better experience of admission.AimsTo compare patient satisfaction, ward atmosphere and perceived coercion in the two types of service, using validated measures.MethodThe experience of 314 patients in four residential alternatives and four standard services were compared using the Client Satisfaction Questionnaire (CSQ), the Service Satisfaction Scale – Residential form (SSS–Res), the Ward Atmosphere Scale (WAS) and the Admission Experience Scale (AES).ResultsCompared with standard wards, service users from alternative services reported greater levels of satisfaction (mean difference CSQ 3.3, 95% CI 1.8 to 4.9; SSS–Res 11.4, 95% CI 5.0 to 17.7). On the AES, service users in alternatives perceived less coercion (mean difference –1.3, 95% CI –1.8 to –0.8) and having more ‘voice’ (mean difference 0.9, 95% CI 0.6 to 1.2). Greater autonomy, more support and less anger and aggression were revealed by WAS scores. Differences in CSQ and AES scores remained significant after multivariable adjustment, but SSS–Res results were attenuated, mainly by detention status.ConclusionsCommunity alternatives were associated with greater service user satisfaction and less negative experiences. Some but not all of these differences were explained by differences in the two populations, particularly in involuntary admission.

BackgroundKey questions regarding residential alternatives to standard acute psychiatric care, such as crisis houses and short-stay in-patient units, concern the role that they fulfil within local acute care systems, and whether they manage people with needs and illnesses of comparable severity to those admitted to standard acute wards.AimsTo study the extent to which people admitted to residential alternatives and to standard acute services are similar, and the role within local acute care systems of admission to an alternative service. Method Our approach combined quantitative and qualitative methods. Consecutive cohorts of patients in six residential alternatives across England and six standard acute wards in the same areas were identified, and clinical and demographic characteristics, severity of symptoms, impairments and risks compared. Semi-structured interviews with key stakeholders in each local service.MethodOur approach combined quantitative and qualitative methods. Consecutive cohorts of patients in six residential alternatives across England and six standard acute wards in the same areas were identified, and clinical and demographic characteristics, severity of symptoms, impairments and risks compared. Semi-structured interviews with key stakeholders in each local service system were used to explore the role and functioning of each alternative.ResultsBeing already known to services (OR =2.6, 95% CI 1.3-5.2), posing a lower risk to others (OR=0.49, 95% CI 0.31-0.78) and having initiated help-seeking in the current crisis (OR=2.2, 95% CI 1.2-4.3) were associated with being admitted to an alternative rather than a standard service. Stakeholder interviews suggested that alternatives have a role that is similar but not identical to standard hospital services. They can divert some, but not all, patients from acute admission.ConclusionsResidential alternatives are integrated into catchment area mental health systems. They serve similar, but not identical, clinical populations to standard acute wards and provide some, but not all, of the functions of these wards.

In the last 10 years a sum in excess of £200 million has been spent in developing a new programme of treatment for those deemed to have dangerous and severe personality disorder (DSPD) in England. This proto-diagnosis is a new concept in forensic psychiatric practice and, although its conception was bold, it carried considerable risks in implementation as so little was known about the effective management of this group of disorders. We review the successes and failures of this pioneering programme a decade after its introduction and conclude that although much has been gained from the experiment – particularly in developing services for those with personality disorder in general – it has been less effective in managing those whom it was primarily targeting and may not have been cost-effective.

Mindfulness-based cognitive therapy (MBCT) is an efficacious psychosocial intervention for recurrent depression (Kuyken et al., 2008; Ma & Teasdale, 2004; Teasdale et al., 2000). To date, no compelling research addresses MBCT's mechanisms of change. This study determines whether MBCT's treatment effects are mediated by enhancement of mindfulness and self-compassion across treatment, and/or by alterations in post-treatment cognitive reactivity. The study was embedded in a randomized controlled trial comparing MBCT with maintenance antidepressants (mADM) with 15-month follow-up (Kuyken et al., 2008). Mindfulness and self-compassion were assessed before and after MBCT treatment (or at equivalent time points in the mADM group). Post-treatment reactivity was assessed one month after the MBCT group sessions or at the equivalent time point in the mADM group. One hundred and twenty-three patients with � 3 prior depressive episodes, and successfully treated with antidepres- sants, were randomized either to mADM or MBCT. The MBCT arm involved participation in MBCT, a group-based psychosocial intervention that teaches mindfulness skills, and discontinuation of ADM. The mADM arm involved maintenance on a therapeutic ADM dose for the duration of follow-up. Interviewer-administered outcome measures assessed depressive symptoms and relapse/recurrence across 15-month follow-up. Mindfulness and self-compassion were measured using self-report questionnaire. Cognitive reactivity was operationalized as change in depressive thinking during a laboratory mood induction. MBCT's effects were mediated by enhancement of mindfulness and self-compassion across treatment. MBCT also changed the nature of the relationship between post-treatment cognitive reactivity and outcome. Greater reactivity predicted worse outcome for mADM participants but this relationship was not evident in the MBCT group. MBCT's treatment effects are mediated by augmented self-compassion and mindfulness, along with a decoupling of the relationship between reactivity of depressive thinking and poor outcome. This decoupling is associated with the cultivation of self-compassion across treatment.

Background: In early typical language development, children understand words before they are able to use them in speech. Children with autism spectrum disorders (ASD) generally show impairments in both the comprehension and the production of language. However, the relative degree of delay or impairment in each of these sub-domains may also be atypical and remains less well-understood. Aims: Relative delay in receptive and expressive language skills was examined within a large sample of preschoolers with autism. Children’s language abilities varied from pre-verbal to fluent speech. Method & Procedures: Scores on one direct clinician assessment and two parent-report measures of language were obtained for 152 preschoolers with core autism. Outcomes & Results: As expected, on average, the language ability of the children with autism was lower than typical age norms, albeit with substantial individual variability. On all three language measures, receptive ability was relatively more impaired than expressive ability. Higher non-verbal ability was associated with such an atypical language profile. Conclusions & Implications: Recognition of the marked receptive language impairment relative to expressive language, found to affect at least one-third of preschoolers with autism in this sample, has important implications for interacting with these children and for informing appropriate targets in language and communication intervention.

Objectives: To determine if street triage is effective at reducing the total number of people with mental health needs detained under section 136, and is associated with cost savings compared to usual police response. Design: Routine data from a 6-month period in the year before and after the implementation of a street triage scheme were used to explore detentions under section 136, and to populate a decision analytic model to explore the impact of street triage on the cost to the NHS and the criminal justice sector of supporting people with a mental health need. Setting: A predefined area of Sussex, South East England, UK. Participants: All people who were detained under section 136 within the predefined area or had contact with the street triage team. Interventions: The street triage model used here was based on a psychiatric nurse attending incidents with a police constable. Primary and secondary outcome measures: The primary outcome was change in the total number of detentions under section 136 between the before and after periods assessed. Secondary analysis focused on whether the additional costs of street triage were offset by cost savings as a result of changes in detentions under section 136. Results: Detentions under section 136 in the street triage period were significantly lower than in the usual response period (118 vs 194 incidents, respectively; χ2 (1df) 18.542, p

BackgroundMajor depression is an important and costly problem among adolescents, yet evidence to support the provision of cost-effective treatments is lacking.AimsTo assess the short-term cost-effectiveness of combined selective serotonin reuptake inhibitors (SSRIs) and cognitive–behavioural therapy (CBT) together with clinical care compared with SSRIs and clinical care alone in adolescents with major depression.MethodPragmatic randomised controlled trial in the UK. Outcomes and costs were assessed at baseline, 12 and 28 weeks.ResultsThe trial comprised 208 adolescents, aged 11–17 years, with major or probable major depression who had not responded to a brief initial psychosocial intervention. There were no significant differences in outcome between the groups with and without CBT. Costs were higher in the group with CBT, although not significantly so (P=0.057). Cost-effectiveness analysis and exploration of the associated uncertainty suggest there is less than a 30% probability that CBT plus SSRIs is more cost-effective than SSRIs alone.ConclusionsA combination of CBT plus SSRIs is not more cost-effective in the short-term than SSRIs alone for treating adolescents with major depression in receipt of routine specialist clinical care.

BackgroundYoung people with anorexia nervosa are often admitted to hospital for treatment. As well as being disruptive to school, family and social life, in-patient treatment is expensive, yet cost-effectiveness evidence is lacking.AimsCost-effectiveness analysis of three treatment strategies for adolescents with anorexia nervosa.MethodUK multicentre randomised, controlled trial comparing in-patient psychiatric treatment, specialist out-patient treatment and general out-patient treatment. Outcomes and costs assessed at baseline, 1 and 2 years.ResultsThere were 167 young people in the trial. There were no statistically significant differences in clinical outcome between the three groups at 2 years. The specialist out-patient group was less costly over the 2-year follow-up (mean total cost £26 738) than the in-patient (£34 531) and general out-patient treatment (£40 794) groups, but this result was not statistically significant. Exploration of the uncertainty associated with the costs and effects of the three treatments suggests that specialist out-patient treatment has the highest probability of being cost-effective.ConclusionsOn the basis of cost-effectiveness, these results support the provision of specialist out-patient services for adolescents with anorexia nervosa.

Economic evaluation of health care interventions usually requires the collection of service use data to estimate the total cost of participants in an evaluation. There are a number of methods available to measure the quantity of services used but little is known about the relative accuracy of alternative methods. In a multicentre randomised controlled trial of interventions for the treatment of adults with recurrent episodes of deliberate self-harm (the POPMACT trial), health service data were collected by patient self-report after six and twelve months and also from GP records by independent investigators. Agreement for overall costs was relatively high. However, this hides substantial variation in agreement between the two sources of information for different services. The results suggest that GP records provide more accurate data on the use of general practice-based contacts than patient report, but less reliable information on contacts with other health services. Thus reliance on GP records for data on hospital services and other community health services based outside of general practice surgeries is not recommended. Future research should explore the level of agreement between patient report and other providing sector records, such as hospital records.

Background A Joint Crisis Plan (JCP) aims to empower patients whilst facilitating early detection and treatment of relapse. Two studies have suggested that JCPs might reduce compulsory treatment and improve therapeutic relationships. Aim The CRIMSON randomised controlled trial compared JCPs with treatment as usual for people with severe mental illness. Methods Eligibility criteria were: at least one psychiatric admission in the previous two years and on Enhanced Care Programme Approach register. The settings were 64 community mental health teams. The intervention was the JCP, a negotiated statement by a patient of treatment preferences for any future psychiatric emergency. Hypotheses tested were that, compared to the control group, the intervention group would experience: (1) fewer compulsory admissions; (2) fewer psychiatric admissions; (3) shorter psychiatric stays; (4) lower perceived coercion; (5) improved therapeutic relationships; and (6) improved engagement. Results 569 participants were randomised (285 experimental, 284 control group). No significant treatment effect was seen for the primary outcome (56 (20%) in the control arm and 49 (18%) in the JCP arm; odds ratio 0.90 (95% CI 0.58 to 1.39, p = 0.63) or admissions outcomes, however there was evidence for improved therapeutic relationships (17.3 (7.6) v 16.0 (7.1); adjusted difference –1.28 (95% CI –2.56 to –0.01, p = 0.049). Qualitative data supported this finding. Discussion The results contrast with two earlier studies. There is evidence to suggest the JCPs were not fully implemented in all sites. Conclusion The study raises important questions about implementing new interventions in routine practice.

Introduction: Only 30–40% of depressed patients treated with medication achieve full remission. Studies that change medication or augment it by psychotherapy achieve only limited benefits, in part because current treatments are not designed for chronic and complex patients. Previous trials have excluded high-risk patients and those with comorbid personality disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a novel, transdiagnostic treatment for disorders of emotional over-control. The REFRAMED trial aims to evaluate the effectiveness and cost-effectiveness of RO-DBT for patients with treatment-resistant depression. Methods and analysis: REFRAMED is a multicentre randomised controlled trial, comparing 7 months of individual and group RO-DBT treatment with treatment as usual (TAU). Our primary outcome measure is depressive symptoms 12 months after randomisation. We shall estimate the cost-effectiveness of RO-DBT by cost per quality-adjusted life year. Causal analyses will explore the mechanisms by which RO-DBT is effective. Ethics and dissemination: The National Research Ethics Service (NRES) Committee South Central – Southampton A first granted ethical approval on 20 June 2011, reference number 11/SC/0146. Trial registration number: ISRCTN85784627.

Objective To investigate the cost effectiveness of joint crisis plans, a form of advance agreement for people with severe mental illness. Design Single blind randomised controlled trial. Setting Eight community mental health teams in southern England. Participants 160 people with a diagnosis of psychotic illness or non-psychotic bipolar disorder who had been admitted to hospital at least once within the previous two years. Intervention Joint crisis plan formulated by the patient, care coordinator, psychiatrist, and project worker containing contact information, details of illnesses, treatments, relapse indicators, and advance statements of preferences for care for future relapses. Control group was standardised service information. Main outcome measures Admission to hospital; service use over 15 months. Results Use of a joint crisis plan was associated with less service use and lower costs on average than in the standardised service information group, but differences were not significant. Total costs during follow-up were £7264 (€10 616, $13 560) for each participant with a joint crisis plan and £8359 (€12 217, $15 609) for each participant with standardised service information (mean difference £1095; 95% confidence interval −2814 to 5004). Cost effectiveness acceptability curves, used to explore uncertainty in estimates of costs and effects, suggest there is a greater than 78% probability that joint crisis plans are more cost effective than standardised service information in reducing the proportion of patients admitted to hospital. Conclusion Joint crisis plans produced a non-significant decrease in admissions and total costs. Though the cost estimates had wide confidence intervals, the associated uncertainty suggests there is a relatively high probability of the plans being more cost effective than standardised service information for people with psychotic disorders.

Purpose.Data on the process of mental health care is scant. Most studies focus on services at their inception when activity may be atypical and then usually present data only mean values for the reported variables over the whole study period. We aimed to test whether care delivery changes over time, and to describe any changes at the individual patient and team levels.Methods.Process data on 272 patients in three new intensive case management (ICM) teams were collected over 2 years. Interventions were prospectively recorded using clinician-derived categories. Changes over time are described at both patient and team level.Results.The number of contacts and the proportion of face-to-face activity were remarkably constant after the first month at the patient level. The proportion of ‘psychiatric’ interventions (main focus on medication or a specific ‘mental health’ intervention performed) increased greatly after the first 6 months. The care activity received by individual patients varied considerably. Overall, teams varied significantly in the extent to which their activity rates were sustained over time.Conclusions.New ICM teams deliver highly individualised care with more marked differences in treatment patterns between patients in the same team than mean differences between teams. The early ‘engagement’ period is marked by a greater focus on social care. There is evidence of differences in sustainability of the services by site.

We present the cost and cost-effectiveness of referral to an alcohol health worker (AHW) and information only control in alcohol misusing patients. The study was a pragmatic randomised controlled trial conducted from April 2001 to March 2003 in an accident and emergency department (AED) in a general hospital in London, England. A total of 599 adults identified as drinking hazardously according to the Paddington Alcohol Test were randomised to referral to an alcohol health worker who delivered a brief intervention (n = 287) or to an information only control (n = 312). Total societal costs, including health and social services costs, criminal justice costs and productivity losses, and clinical measures of alcohol consumption were measured. Levels of drinking were observably lower in those referred to an AHW at 12 months follow-up and statistically significantly lower at 6 months follow-up. Total costs were not significantly different at either follow-up. Referral to AHWs in an AED produces favourable clinical outcomes and does not generate a significant increase in cost. A decision-making approach revealed that there is at least a 65% probability that referral to an AHW is more cost-effective than the information only control in reducing alcohol consumption among AED attendees with a hazardous level of drinking.

Background: Recognition has grown over recent years of the need for economic information on the impacts of child and adolescent mental health problems and the cost‐effectiveness of interventions. Methods: A range of electronic databases were examined using a predefined search strategy to identify economic studies which focused on services, pharmacological interventions and other treatments for children and adolescents with a diagnosed mental health problem or identified as at risk of mental illness. Published studies were included in the review if they assessed both costs and outcomes, with cost‐effectiveness being the primary interest. Studies meeting the criteria for inclusion were assessed for quality. Results: There are still relatively few economic evaluations in this field. Behavioural disorders have been given relatively greater attention in economic evaluations of child and adolescent mental health. These studies tentatively suggest child behavioural gains and parent satisfaction from parent and child training programmes, although the cost‐effectiveness of the location of delivery for behavioural therapies is less clear. In general, the quality of economic evaluations was limited by small sample sizes, constrained measurement of costs, narrow perspectives and over‐simple statistical and econometric methods. Conclusion: Economic evaluations in the field of child and adolescent mental health interventions are few in number and generally poor in quality, although the number of studies being undertaken now appears to be rising.

Background High levels of public spending, rising costs of treatments and scarcity of mental health resources have intensified the need for information on the cost-effectiveness of interventions for depression. There have been few reviews that consider the cost-effectiveness of all treatments for depression together. Methods Systematic review of published economic evaluations of interventions for depression to identify where evidence of cost-effectiveness exists and where ambiguity remains. Results Fifty-eight papers met the criteria and were included in the review. The quality of the evaluations varied greatly. Evidence establishing the cost-effectiveness of interventions for depression is accumulating; selective serotonin reuptake inhibitors (SSRI) and the newer antidepressants venlafaxine, mirtazepine and nefazodone appear cost-effective compared with older drugs. Despite the availability of high quality economic evaluations of psychological therapies compared to usual care, there is limited evidence of their cost-effectiveness particularly when compared directly to pharmacotherapies. Changes to health systems have been found to be cost-effective in some patient groups, but there is no evidence that screening in primary care populations is a cost-effective strategy. Limitations Vastly different interventions, outcome measures and cost perspectives meant a meta-analysis of costs and effects was not considered possible. Conclusions On the basis of available evidence, it is not possible to identify the most cost-effective strategy for alleviating the symptoms of depression, although the SSRIs and newer antidepressants consistently appear more cost-effective than tricyclic antidepressants in many patient groups. Better quality economic evidence is needed.

Background. We carried out a large randomized trial of a brief form of cognitive therapy, manual-assisted cognitive behaviour therapy (MACT) versus treatment as usual (TAU) for deliberate self-harm.Method. Patients presenting with recurrent deliberate self-harm in five centres were randomized to either MACT or (TAU) and followed up over 1 year. MACT patients received a booklet based on cognitive behaviour therapy (CBT) principles and were offered up to five plus two booster sessions of CBT from a therapist in the first 3 months of the study. Ratings of parasuicide risk, anxiety, depression, social functioning and global function, positive and negative thinking, and quality of life were measured at baseline and after 6 and 12 months.Results. Four hundred and eighty patients were randomized. Sixty per cent of the MACT group had both the booklet and CBT sessions. There were seven suicides, five in the TAU group. The main outcome measure, the proportion of those repeating deliberate self-harm in the 12 months of the study, showed no significant difference between those treated with MACT (39%) and treatment as usual (46%) (OR 0·78, 95% CI 0·53 to 1·14, P=0·20).Conclusion. Brief cognitive behaviour therapy is of limited efficacy in reducing self-harm repetition, but the findings taken in conjunctin with the economic evaluation (Byford et al. 2003) indicate superiority of MACT over TAU in terms of cost and effectiveness combined.

OBJECTIVE: To assess the feasibility of overcoming sample size limitations in economic analyses of clinical trials through meta-analysis of data on individual patients from multiple trials.\ud \ud DESIGN: Meta-analysis of individual patient data from trials of counselling in primary care compared with usual care by a general practitioner.\ud \ud SETTING: Primary care.\ud \ud PATIENTS: People with mental health problems.\ud \ud MAIN OUTCOME MEASURES: Direct treatment costs, depressive symptoms, and cost effectiveness.\ud \ud RESULTS: Meta-analysis of individual patient data proved feasible. The results showed that the previous analyses of individual trials were underpowered to provide useful conclusions about the cost comparisons. The results are sensitive to assumptions made about the costs of sessions with a counsellor and the management of patients by a general practitioner.\ud \ud CONCLUSIONS: Meta-analysis of individual patient data may assist in overcoming sample size limitations in economic analyses. Although feasible, such analysis has shortcomings that may limit the validity of the results. The relative costs and benefits of this method, as opposed to further collection of primary data, are as yet unclear.

BackgroundTrials in community psychiatry must balance rigour with generalisability. The UK700 trial failed to find a significant effect on hospitalisation, but its sample population contained significant heterogeneity of exposure to case management in the two groups.AimsTo test whether patients successfully exposed to a minimum of 12 months' intensive case management over the 2-year follow-up period achieved reduced hospitalisation.MethodOf 679 participants with hospitalisation data, 84 were identified as having < 12 months' exposure owing to prolonged hospitalisation, imprisonment or a combination of the two. These patients were excluded and outcomes tested for the remaining 595 patients.ResultsOverall reduced case-load size did not reduce hospitalisation or treatment costs over 2 years despite elimination of outliers. Age, previous hospitalisation and source of recruitment to the study all correlated with outcome.ConclusionsCase-load reduction is not in itself enough to reduce the need for hospital care in psychosis. Baseline patient characteristics (in particular length of previous hospitalisation and recruitment from in-patient care) have a significant influence and should be allowed for in power calculations. Identifying the optimal clinical profile for patients likely to benefit from intensive case management remains a pressing need for further studies.

SummaryKnowledge of the cost of pharmaceuticals is an important step towards cost-effective prescribing, yet evidence presented by Singh and colleagues highlights a lack of awareness of the cost of psychotropic medication among doctors in one NHS foundation trust and failures in the dissemination of cost data. These findings support the existence of substantial barriers to the success of cost-effective prescribing strategies in the UK. The next, and more challenging step, is to explore knowledge of the relative cost-effectiveness of pharmaceuticals, since knowledge of cost alone is inadequate to ensure prescribing practices make a meaningful constribution to the efficient use of scarce health service resources.

Background Studies of intensive case management (ICM) for patients with psychotic illnesses have produced conflicting results in terms of outcome. Negative results have sometimes been attributed to a failure to deliver differing patterns of care. Aims To test whether the actual care delivered in a randomised clinical trial of ICM v. standard case management (the UK700 trial) differed significantly. Method Data on 545 patients' care were collected over 2 years. All patient contacts and all other patient-centred interventions (e.g. telephone calls, carer contacts) of over 15 minutes were prospectively recorded. Rates and distributions of these interventions were compared. Results Contact frequency was more than doubled in the ICM group. There were proportionately more failed contacts and carer contacts but there was no difference in the average length of individual contacts or the proportion of contacts in the patients' homes. Conclusions The failure to demonstrate outcome differences in the UK700 study is not due to a failure to vary the treatment process. UK standard care contains many of the characteristics of assertive outreach services and differences in outcome may require that greater attention be paid to delivering evidence-based interventions. Declaration of interest None.

Objective: To test the hypothesis that a community based intervention by secondary child and adolescent mental health services would be significantly more effective and less costly than a hospital based intervention. Design: Open study with two randomised parallel groups. Setting: Two health districts in the north of England. Participants: Parents of 3 to 10 year old children with behavioural disorder who had been referred to child and adolescent mental health services. Intervention: Parental education groups. Main outcome measures: Parents9 and teachers9 reports of the child9s behaviour, parental depression, parental criticism of the child, impact of the child9s behaviour on the family. Results: 141 subjects were randomised to community (n=72) or hospital (n=69) treatment. Primary outcome data were obtained on 115 (82%) cases a year later. Intention to treat analyses showed no significant differences between the community and hospital based groups on any of the outcome measures, or on costs. Parental depression was common and predicted the child9s outcome. Conclusions: Location of child mental health services may be less important than the range of services that they provide, which should include effective treatment for parents9 mental health problems.

OBJECTIVES: The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive-behaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting. DESIGN: The design was principally a pragmatic randomised controlled trial, but was accompanied by two additional allocation methods allowing patient preference: the option of a specific choice of treatment (preference allocation) and the option to be randomised between the psychological therapies only. Of the 464 patients allocated to the three treatments, 197 were randomised between the three treatments, 137 chose a specific treatment, and 130 were randomised between the psychological therapies only. The patients underwent follow-up assessments at 4 and 12 months. SETTING: The study was conducted in 24 general practices in Greater Manchester and London. SUBJECTS: A total of 464 eligible patients, aged 18 years and over, were referred by 73 GPs and allocated to one of the psychological therapies or usual GP care for depressive symptoms. INTERVENTIONS: The interventions consisted of brief psychological therapy (12 sessions maximum) or usual GP care. Non-directive counselling was provided by counsellors who were qualified for accreditation by the British Association for Counselling. Cognitive-behaviour therapy was provided by clinical psychologists who were qualified for accreditation by the British Association for Behavioural and Cognitive Psychotherapies. Usual GP care included discussions with patients and the prescription of medication, but GPs were asked to refrain from referring patients for psychological intervention for at least 4 months. Most therapy sessions took place on a weekly basis in the general practices. By the 12-month follow-up, GP care in some cases did include referral to mental healthcare specialists. MAIN OUTCOME MEASURES: The clinical outcomes included depressive symptoms, general psychiatric symptoms, social function and patient satisfaction. The economic outcomes included direct and indirect costs and quality of life. Assessments were carried out at baseline during face-to-face interviews as well as at 4 and 12 months in person or by post. RESULTS: At 4 months, both psychological therapies had reduced depressive symptoms to a significantly greater extent than usual GP care. Patients in the psychological therapy groups exhibited mean scores on the Beck Depression Inventory that were 4-5 points lower than the mean score of patients in the usual GP care group, a difference that was also clinically significant. These differences did not generalize to other measures of outcome. There was no significant difference in outcome between the two psychological therapies when they were compared directly using all 260 patients randomised to a psychological therapy by either randomised allocation method. At 12 months, the patients in all three groups had improved to the same extent. The lack of a significant difference between the treatment groups at this point resulted from greater improvement of the patients in the GP care group between the 4- and 12-month follow-ups. At 4 months, patients in both psychological therapy groups were more satisfied with their treatment than those in the usual GP care group. However, by 12 months, patients who had received non-directive counselling were more satisfied than those in either of the other two groups. There were few differences in the baseline characteristics of patients who were randomised or expressed a treatment preference, and no differences in outcome between these patients. Similar outcomes were found for patients who chose either psychological therapy. Again, there were no significant differences between the two groups at 4 or 12 months. Patients who chose counselling were more satisfied with treatment than those who chose c

Background There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement. Methods/Design The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1:1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes depending on whether the outcome is time-to-event or continuous. Discussion The START trial is a pragmatic national trial of sufficient size to evaluate multisystemic therapy, to inform policymakers, service commissioners, professionals, service users and their families about its potential in the UK. It will also provide data on the clinical and cost-effectiveness of usual services provided to youth with serious antisocial behaviour problems. Trial registration ISRCTN77132214

Objective To compare the impact of endometrial resection and abdominal hysterectomy on a range of health outcomes and health service costs, based on longer term follow up of patients randomised to a clinical trial. Design A parallel group randomised control trial. Setting The gynaecology department of a teaching hospital. Participants 196 women requiring surgical treatment for menorrhagia were randomised and received surgery (88 underwent resection and 97 hysterectomy). Longer term follow up was undertaken using a postal questionnaire sent to all 196 women. Main outcome measures Longer term assessment was on the basis of menstrual symptoms, health related quality of life using the Short Form 36 (SF36) and the EuroQo1 visual analogue scale, patient satisfaction and health service resource cost. Results Of 196 women who were sent a questionnaire, 155 (79%) responded at an average interval of 2.8 years after initial surgery. All aspects of health outcomes were as good or better in patients randomised to hysterectomy. Among patients randomised to resection, 57% had experienced no improvement in premenstrual symptoms following surgery and 23% had taken time off work due to menstrual problems; among hysterectomy patients, these rates were 23% and YO, respectively. Women randomised to hysterectomy had better mean scores on seven of the eight dimensions of the SF36 health related quality of life instrument, with the greatest difference being on the pain dimension (P= 0.01). Women randomised to hysterectomy were generally more satisfied with treatment (P= 0.002). By two years after initial surgery, women randomised to resection had a 12% probability of having had a repeat resection and a 16% chance of having had a hysterectomy. As a percentage of the mean total cost associated with women randomised to hysterectomy, the mean total cost of resection was 53% based on four months follow up; this proportion had increased to 71 YO, based on an average overall follow up of 2.2 years. Conclusions These results show that, at an average follow up of 28 years among responders to a questionnaire, women randomised to hysterectomy experienced more of an improvement in menstrual symptoms and higher rates of satisfaction with treatment. There is also some evidence of superior health related quality of life amongst hysterectomy patients. However, the health service cost of endometrial resection remains lower than that of hysterectomy. An assessment of the relative cost effectiveness of the two procedures awaits further research.

BACKGROUND: The early detection and referral to specialized services of young people at ultra-high risk (UHR) for psychosis may reduce the duration of untreated psychosis and, therefore, improve prognosis. General practitioners (GPs) are usually the healthcare professionals contacted first on the help-seeking pathway of these individuals. METHODS/DESIGN: This is a cluster randomized controlled trial (cRCT) of primary care practices in Cambridgeshire and Peterborough, UK. Practices are randomly allocated into two groups in order to establish which is the most effective and cost-effective way to identify people at UHR for psychosis. One group will receive postal information about the local early intervention in psychosis service, including how to identify young people who may be in the early stages of a psychotic illness. The second group will receive the same information plus an additional, ongoing theory-based educational intervention with dedicated liaison practitioners to train clinical staff at each site. The primary outcome of this trial is count data over a 2-year period: the yield - number of UHR for psychosis referrals to a specialist early intervention in psychosis service - per primary care practice. DISCUSSION: There is little guidance on the essential components of effective and cost-effective educational interventions in primary mental health care. Furthermore, no study has demonstrated an effect of a theory-based intervention to help GPs identify young people at UHR for psychosis. This study protocol is underpinned by a robust scientific rationale that intends to address these limitations. TRIAL REGISTRATION: Current Controlled Trials ISRCTN70185866.

The Leeds Stroke Rehabilitation Placement Scheme (SRPS) provides short-term intensive support for vulnerable stroke patients on discharge from hospital. A previous study at one year post stroke established the benefits of this community support, demonstrating that patients involved in the scheme were more likely to maintain their three-month post stroke functional ability than patients discharged directly at home, as is conventional. Given the scarcity of resources, however, it is important to demonstrate not only the effectiveness of an intervention but also the cost-effectiveness, in order to ensure that resources are allocated efficiently. The aim of this study was to combine the previously reported effectiveness data with newly gathered cost information, to carry out a cost-effectiveness analysis of the SRPS. The results show that the SRPS attained a unit increase in functional ability, as given by the Barthel Activities of Daily Living Index, at lower cost (£586.85) than the alternative of discharging patients directly home (£5859.48). Although methodological problems and limitations in the data allow only tentative conclusions to be made, the study does highlight the practical problems encountered in the field of cost-effectiveness analysis and makes a number of recommendations to guide future evaluations of stroke rehabilitation services.

IntroductionEvidence from previous small trials has suggested the effectiveness of early social communication interventions for autism.ObjectivesThe Preschool Autism Communication Trial (PACT) investigated the efficacy of such an intervention in the largest psychosocial autism trial to date.AimsTo provide a stringent test of a pre-school communication intervention for autism.Methods152 children with core autism aged 2 years - 4 years 11 months in a 3 site 2 arm single (assessor) blinded randomised controlled trial of the parent-mediated communication-focused intervention added to treatment as usual (TAU) against TAU alone. Primary outcome; severity of autism symptoms (modified social communication algorithm from Autism Diagnostic Observation Schedule-Generic, ADOS-G). Secondary outcomes; blinded measures of parent-child interaction, child language, and adaptation in school.ResultsAt 13 month endpoint the treatment resulted in strong improvement in parental synchronous response to child (adjusted between-group effect size 1.22 (95% CI 0.85, 1.59) and child initiations with parent (ES 0.41 (0.08, 0.74) but small effect on autism symptomatology (ADOS-G, ES -0.24 (95% CI -0.59, 0.11) ns). Parents (not blind to allocation) reported strong treatment effects on child language and social adaptation but effects on blinded research assessed language and school adaptation were small.ConclusionsAddition of the PACT intervention showed clear benefit in improving parent-child dyadic social communication but no substantive benefit over TAU in modifying objectively rated autism symptoms. This attenuation on generalisation from ‘proximal’ intervention effects to wider symptom change in other contexts remains a significant challenge for autism treatment and measurement methodology.