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Objective:The authors examined whether lamotrigine is a clinically effective and cost-effective treatment for people with borderline personality disorder.Method:This was a multicenter, double-blind, placebo-controlled randomized trial. Between July 2013 and November 2016, the authors recruited 276 people age 18 or over who met diagnostic criteria for borderline personality disorder. Individuals with coexisting bipolar affective disorder or psychosis, those already taking a mood stabilizer, and women at risk of pregnancy were excluded. A web-based randomization service was used to allocate participants randomly in a 1:1 ratio to receive either an inert placebo or up to 400 mg/day of lamotrigine. The primary outcome measure was score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at 52 weeks. Secondary outcome measures included depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, and adverse events.Results:A total of 195 (70.6%) participants were followed up at 52 weeks, at which point 49 (36%) of those in the lamotrigine group and 58 (42%) of those in the placebo group were taking study medication. The mean ZAN-BPD score was 11.3 (SD=6.6) among those in the lamotrigine group and 11.5 (SD=7.7) among those in the placebo group (adjusted difference in means=0.1, 95% CI=−1.8, 2.0). There was no evidence of any differences in secondary outcomes. Costs of direct care were similar in the two groups.Conclusions:The results suggest that treating people with borderline personality disorder with lamotrigine is not a clinically effective or cost-effective use of resources.

Background and aims Despite recent gains in the amount and quality of early autism intervention research, identifying what works for whom remains an ongoing challenge. Exploiting data from the Preschool Autism Communication Trial (PACT), we undertook secondary analysis to explore prognostic indicators and predictors of response to one year of PACT therapy versus treatment as usual within this large and rigorously characterised cohort recruited across three UK trial sites. Methods In this secondary analysis of variability in child gains on the primary trial outcome measure – social-communication symptom severity – we used a pragmatic and data-driven approach to identify a subgroup of children who showed reliable improvement and a subgroup showing clear lack thereof. We then tested which among several baseline child and family factors – including measures routinely collected in research trials and clinical practice – varied as a function of child outcome status and treatment group. Results Greater baseline child non-verbal ability was a significant prognostic indicator of symptom reduction over time (i.e. irrespective of treatment group). By contrast, parent synchrony presented as marginal predictor, and trial recruitment site as a significant predictor, of differential outcome by treatment group. Specifically, lower parent synchrony showed some association with poorer outcomes for children from families assigned to treatment as usual (but with no such effect for those assigned to PACT). Similarly, children at one recruitment site were more likely to have poorer outcomes if assigned to treatment as usual, compared to children at the same site assigned to PACT. Conclusions The current data contribute to an evidence base indicting that early non-verbal ability is a robust indicator of generally better prognosis for young children with autism. Lower parent synchrony and a broadly more deprived socio-geographical context may inform the appropriate targeting of PACT. That is, given that the former factors predicted poorer outcome in children from families assigned to treatment as usual, the receipt of a relatively low-dose, parent-mediated and communication-focused therapy might be developmentally protective for young children with autism. Nevertheless, results from this study also highlight the paucity of meaningful predictors of outcome among routine clinical characterisation measures such as those investigated here. Implications Understanding the factors associated with differential treatment outcomes is critical if we are to individualise treatment decisions for children with autism. Inherently tied to this objective is a need to delineate those factors which specifically predict positive response (or lack of response) to one or other treatment option, versus those that indicate generally better (or poorer) prognosis, irrespective of treatment.

Supplemental material, Appendix for Predictors of reliable symptom change: Secondary analysis of the Preschool Autism Communication Trial by Kristelle Hudry, Helen McConachie, Ann Le Couteur, Patricia Howlin, Barbara Barrett, Vicky Slonims and The PACT Consortium in Autism & Developmental Language Impairments

Background: Non-cardiac chest pain is very common and generally managed inappropriately. Psychological interventions need more attention. Methods: We tested the effectiveness and cost-effectiveness of a modified form of cognitive behaviour therapy for chest pain (CBT-CP)(4-10 sessions) in patients who attended cardiology clinics or emergency medical services repeatedly. We planned to recruit 96 patients. Participants were randomised using a remote web-based system to CBT-CP or to standard care in the clinic. Assessments were made at baseline and at six and 12 months. The primary outcome was the change in the Health Anxiety Inventory score at six months. Other clinical measures, social functioning, quality of life, and costs of services were also recorded. Findings: 68 patients were randomised with low attrition rates at 6 and 12 months with 81% of all possible assessments completed at 6 and 12 months. Many more patients who were eligible were not referred. The Although there were no significant group differences between any of the outcome measures at either 6 or 12 months, patients receiving CBT-CP had between two and three times fewer hospital bed days, outpatient appointments, and A&E attendances than those allocated to standard care and total costs per patient were £1496.49 lower, though the differences in costs were not significant. There was a small non- significant gain in quality adjusted life years (QALY's) in those allocated to CBT-CP compared with standard care (0.76 vs 0.74). Interpretation: It is concluded that CBT-CP in the context of current hospital structures is not a feasible or viable treatment, but is worthy of further research as a potentially cost-effective treatment for non-cardiac chest pain.

Three principles of the enterprising approach to counseling the poor black family are: (1) sensitizing the counselor to the attitudes, values, interests, living conditions, etc. of poor blacks; (2) creating opportunities for poor blacks to succeed in some of their endeavors; and, (3) training the counselor as an intervening agent. (Author)

This document considers the final statistical and health economic analyses for the IMPACT trial. The IMPACT Study investigated whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care in adolescents with moderate to severe unipolar major depression.The purpose of the SAP is to document the confirmatory statistical analyses of the trial thereby controlling for statistical analyses bias. The statistical analyses follow the principles of ICH E9.The protocol of the paper is published in Goodyer IM et al Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial. Trials. 2011 Jul 13;12:175. doi: 10.1186/1745-6215-12-175.PROTOCOL PAPER ABSTRACTBACKGROUND:Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg) with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated.METHODS/DESIGN:Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry.DISCUSSION:The objective of this clinical trial is to determine whether there are specific effects of specialist psychotherapy that reduce relapse in unipolar major depression in adolescents and thereby costs of treatment to society. We also anticipate being able to utilise psychotherapy experience, neuroimaging, genetic and hormone measures to reveal what techniques and their protocols may work best for which patients.TRIAL REGISTRATION:Current Controlled Trials ISRCTN83033550.

This document considers the final statistical and health economic analyses for the IMPACT trial. Note Version 3 contains Health Economic addendum previously omitted.The IMPACT Study investigated whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care in adolescents with moderate to severe unipolar major depression.The purpose of the SAP is to document the confirmatory statistical analyses of the trial thereby controlling for statistical analyses bias. The statistical analyses follow the principles of ICH E9.The protocol of the paper is published in Goodyer IM et al Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial. Trials. 2011 Jul 13;12:175. doi: 10.1186/1745-6215-12-175.PROTOCOL PAPER ABSTRACTBACKGROUND:Up to 70% of adolescents with moderate to severe unipolar major depression respond to psychological treatment plus Fluoxetine (20-50 mg) with symptom reduction and improved social function reported by 24 weeks after beginning treatment. Around 20% of non responders appear treatment resistant and 30% of responders relapse within 2 years. The specific efficacy of different psychological therapies and the moderators and mediators that influence risk for relapse are unclear. The cost-effectiveness and safety of psychological treatments remain poorly evaluated.METHODS/DESIGN:Improving Mood with Psychoanalytic and Cognitive Therapies, the IMPACT Study, will determine whether Cognitive Behavioural Therapy or Short Term Psychoanalytic Therapy is superior in reducing relapse compared with Specialist Clinical Care. The study is a multicentre pragmatic effectiveness superiority randomised clinical trial: Cognitive Behavioural Therapy consists of 20 sessions over 30 weeks, Short Term Psychoanalytic Psychotherapy 30 sessions over 30 weeks and Specialist Clinical Care 12 sessions over 20 weeks. We will recruit 540 patients with 180 randomised to each arm. Patients will be reassessed at 6, 12, 36, 52 and 86 weeks. Methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, research assessors independent of treatment team and blind to randomization, analysis by intention to treat, data management using remote data entry, measures of quality assurance, advanced statistical analysis, manualised treatment protocols, checks of adherence and competence of therapists and assessment of cost-effectiveness. We will also determine whether time to recovery and/or relapse are moderated by variations in brain structure and function and selected genetic and hormone biomarkers taken at entry.DISCUSSION:The objective of this clinical trial is to determine whether there are specific effects of specialist psychotherapy that reduce relapse in unipolar major depression in adolescents and thereby costs of treatment to society. We also anticipate being able to utilise psychotherapy experience, neuroimaging, genetic and hormone measures to reveal what techniques and their protocols may work best for which patients.TRIAL REGISTRATION:Current Controlled Trials ISRCTN83033550.

CONSORT 2010 checklist. (DOCX 209 kb)

Unadjusted mean EDE and ZAN score by treatment group for all post randomisation time points and baseline (time 0). Lowest score if best. Error bars show 95Â % CI. EDE Eating Disorder Examination, ZAN Zanarini Rating Scale. (DOCX 74 kb)

Background: Traditionally, classical test theory (CTT) has been used for instrument development and various methods have since been proposed for reducing outcome measures to shorter versions. These reduction methods have not previously been compared in mental or physical health. Aim: To identify and compare the various methods used to develop brief versions of outcome measures from existing measures in mental health. Method: A systematic review of the literature in Embase, Medline, PsychInfo and from a grey literature was done. Search strategies were developed in each database to identify all relevant literature based on the inclusion criteria. Each paper identified was briefly described and then assessed using a bespoke assessment checklist developed by the authors. Methods for reducing outcome measures found across all studies were compared. Results: Ten papers were identified. Five methods were used for scale reduction: Rasch analysis (RA), exploratory factor analysis (EFA), graded response models (GRMs), all-subset regression, and regression. RA was the most widely used process. Conclusion: The Rasch model (RM) is the only model where “‘specific objectivity”‘ is a defining property of the model. This property is necessary for constructing scales in line with the fundamental principles of measurement.

Background: Existing research identified substantial gaps between NHS mental health services and the criminal justice system for individuals with enduring moderate to severe mental health needs (EMHN). A pilot study in Cornwall echoed these findings, identifying deficiencies in provision at the interface ofpolice and mental health services. Aim: To explore the interagency management of individuals with EMHN as they come into contact with the police. Design: A mixed-methods approach within a community psychology framework to enhance the implementation of findings. Stage 1: policy review and clinical audit to identify a sample of mental health service users who were in contact with the police. Stage 2: case-linkage study of 80 service user journeys through services at the time of three types of police contact (Section 136 detention; arrest for criminal offence and contact that did not result in detention); and a health economics component including analysis of the actual cost of 55 service user journeys and enhanced service scenarios. Stage 3: local stakeholder consultation to validate and contextualise case-linkage findings, including a national event. Setting: The research site was the county of Cornwall within the organisational contexts of Cornwall Partnership NHS Foundation Trust and Devon & Cornwall Police. Sample: Proportionate stratified random sampling identified a sample of 80 cases examined in the case-linkage study from the 538 linked cases identified by the clinical audit. Data sources: Case-linkage and health economics data involved individuals’ police and mental health records; stakeholder consultation data involved focus groups and interviews. Results: Of the sample of 80 cases examined, 23 individuals had been detained under Section 136 of the Mental Health Act (1983: Great Britain. Mental Health Act 1983. Chapter 20. London: The Stationery Office; 1983) (accounting for 32 detentions), 52 had been detained in custody on suspicion of an offence(accounting for 126 arrests) and 15 had non-detention contact with the police. Findings showed that where police were aware of mental health needs and individuals were on caseload of a Mental Health Team, there was increased interaction and enhanced outcomes for service users and organisations. Thehealth economics scenario modelling suggests that enhancing services has minimal effects on individual level costs compared with current practice. Conclusions: The research revealed discrepancy in police and mental health professionals’ assessment of risk and interpretation of protocol and highlighted the need for joint interagency protocols and training to improve information sharing between agencies to enhance the management of individuals with enduring moderate to severe mental health needs. Funding: The National Institute for Health Research Health Services and Delivery Research programme.