Humanistic counselling plus pastoral care as usual versus pastoral care as usual for the treatment of psychological distress in adolescents in UK state schools (ETHOS): a randomised controlled trial.

BACKGROUND: About one in seven adolescents have a mental health disorder in England, UK. School counselling is one of the most common means of trying to address such a problem. We aimed to determine the effectiveness and cost-effectiveness of school-based humanistic counselling (SBHC) for the treatment of psychological distress in young people in England, UK. METHODS: We did a two-arm, individually randomised trial in 18 secondary state-funded schools across the Greater London area of the UK. Participants were randomly assigned (1:1) using a centrally secure randomisation procedure with random permuted blocks to either SBHC plus schools' pastoral care as usual (PCAU), or PCAU alone. Participants were pupils aged 13-16 years who had moderate-to-severe levels of emotional symptoms (measured by a score of ≥5 on the Strengths and Difficulties Questionnaire Emotional Symptoms scale) and were assessed as competent to consent to participate in the trial. Participants, providers, and assessors (who initially assessed and enrolled participants) were not masked but testers (who measured outcomes) were masked to treatment allocation. The primary outcome was psychological distress at 12 weeks (Young Person's Clinical Outcomes in Routine Evaluation measure [YP-CORE]; range 0-40), analysed on an intention-to-treat basis (with missing data imputed). Costs were assessed at 24 weeks (Client Service Receipt Inventory and service logs). The trial was registered with ISRCTN, number ISRCTN10460622. FINDINGS: 329 participants were recruited between Sept 29, 2016, and Feb 8, 2018, with 167 (51%) randomly assigned to SBHC plus PCAU and 162 (49%) to PCAU. 315 (96%) of 329 participants provided data at 12 weeks and scores were imputed for 14 participants (4%). At baseline, the mean YP-CORE scores were 20·86 (SD 6·38) for the SBHC plus PCAU group and 20·98 (6·41) for the PCAU group. Mean YP-CORE scores at 12 weeks were 16·41 (SD 7·59) for the SBHC plus PCAU group and 18·34 (7·84) for the PCAU group (difference 1·87, 95% CI 0·37-3·36; p=0·015), with a small effect size (0·25, 0·03-0·47). Overall costs at 24 weeks were £995·20 (SD 769·86) per pupil for the SBHC plus PCAU group and £612·89 (1224·56) for the PCAU group (unadjusted difference £382·31, 95% CI £148·18-616·44; p=0·0015). The probability of SBHC being more cost-effective reached 80% at a willingness to pay of £390 for a 1-point improvement on the YP-CORE. Five serious adverse events occurred for four participants in the SBHC plus PCAU group, all involving suicidal intent. Two serious adverse events occurred for two participants in the PCAU group, one involving suicidal intent. INTERPRETATION: The addition of SBHC to PCAU leads to small reductions in psychological distress, but at an additional economic cost. SBHC is a viable treatment option but there is a need for equally rigorous evaluation of alternative interventions. FUNDING: This work was supported by the Economic and Social Research Council (grant reference ES/M011933/1).

Prevalence and clinical correlates of self-injurious behavior in Tourette syndrome.

Tourette syndrome (TS) is a neurodevelopmental condition characterized by the presence of multiple tics. In addition to common behavioral co-morbidities such as obsessive-compulsive disorder and attention-deficit and hyperactivity disorder, patients with TS can present with self-injurious behavior (SIB): deliberate, non-accidental, repetitive infliction of self-harm without suicidal intent. In order to determine the prevalence and clinical correlates of SIB in TS, we conducted a systematic literature review in accordance to the methodology described in the MOOSE Guidelines for Meta-Analysis and Systematic Reviews of Observational Studies in Epidemiology. The literature search yielded 20 cohort studies that were suitable for quantitative synthesis. Combined results showed that SIB is present in 35 % of patients with TS. Obsessive-compulsive behaviors appear to be associated with SIB in patients with TS, and their presence should alert clinicians to the possible co-occurrence of SIB, particularly if the patient has multiple behavioral co-morbidities. Since the reviewed studies were methodologically heterogeneous and were conducted in specialist clinics, our findings cannot be generalized to patients with TS in the wider community.

Results of a Community-based, Randomized Study Comparing a Clear Liquid Diet With a Low-residue Diet Using a Magnesium Citrate Preparation for Screening and Surveillance Colonoscopies.

BACKGROUND: Current bowel preparations for colonoscopy include a clear liquid diet (CLD) along with consumption of a laxative. This dietary restriction along with large volume bowel preparations are barriers to compliance and willingness among patients in scheduling screening examinations. The aim of our study was to compare the efficacy and tolerability of a low-volume split dose magnesium citrate bowel preparation in patients on a low-residue diet (LRD) with those on a CLD. METHODS: In this single center, single blinded, randomized controlled trial, patients scheduled for outpatient colonoscopies were assigned to either a CLD or a LRD 1 day before the examination. Both groups received a split dose magnesium citrate preparation. The quality of the preparation was rated using the Boston Bowel Preparation Scale (BBPS). Patient satisfaction and side effects were evaluated using a questionnaire. RESULTS: We were unable to detect a significant difference in the BBPS scores between the LRD and CLD groups (P=0.581). A significantly higher percentage of patients in the LRD group rated the diet as easy compared with the CLD group (P<0.001). Satisfaction scores were significantly higher in the LRD group, compared with the CLD group (P<0.001). The side effect profiles of both arms were similar. CONCLUSIONS: There was no significant difference between LRD and CLD in patients using a magnesium citrate bowel preparation for screening and surveillance colonoscopies. Patient satisfaction scores were higher with a LRD compared with a CLD. We believe the LRD should be the recommended diet in patients using a standard bowel preparation for screening and surveillance colonoscopy.

Effectiveness and cost-effectiveness of humanistic counselling in schools for young people with emotional distress (ETHOS): study protocol for a randomised controlled trial.

BACKGROUND: One in ten children in Britain have been identified as experiencing a diagnosable mental health disorder. School-based humanistic counselling (SBHC) may help young people identify, address, and overcome psychological distress. Data from four pilot trials suggest that SBHC may be clinically effective. However, a fully powered randomised controlled trial (RCT) is needed to provide a robust test of its effectiveness, to assess its cost-effectiveness, and to determine the process of change. METHODS/DESIGN: The Effectiveness and Cost-effectiveness Trial of Humanistic Counselling in Schools (ETHOS) is a two-arm, parallel-group RCT comparing the clinical and cost-effectiveness of SBHC with Pastoral Care as Usual (PCAU) in school settings. Eligibility criteria for young people include being between 13 and 16 years of age and experiencing moderate to severe levels of emotional distress. Participants are randomised to receive either SBHC or PCAU. SBHC is delivered in up to 10 weekly, individual sessions in their school with a qualified, experienced counsellor who has also received training using a clinical practice manual. Adherence to the SBHC model is assessed by a sub-team of auditors and in clinical supervision. PCAU consists of the schools' pre-existing systems for supporting the emotional health and well-being of students. The primary outcomes are psychological distress measured using the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) and costs evaluated using the Client Service Receipt Inventory (CSRI). Secondary outcomes include psychological difficulties, levels of depression, anxiety and self-esteem, well-being, school engagement, educational outcomes and achievement of personal goals. Qualitative interviews with participants, parents and school staff will look to identify the mechanisms of change in SBHC. Researchers administering the measures are blind to allocation. The trial requires n = 306 participants (n = 153 in each group), with 90% power to detect a standardised mean difference (SMD) of 0.5. An intention-to-treat analysis will be undertaken. DISCUSSION: This RCT is powered to detect clinically meaningful differences, and will make a major contribution to the evidence base for mental health provision for adolescents. It will have implications for all stakeholders, including policy-makers, statutory advisory bodies for child welfare, head teachers, children and young people practitioners, child welfare and parenting organisations, and young people. TRIAL REGISTRATION: Controlled Trials International Standard Randomised Controlled Trial Number (ISRCTN) Registry, ID: ISRCTN10460622 . Registered on 11 May 2016.

Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis.

BACKGROUND: Studies report contrasting results regarding the efficacy and safety of pharmacological, psychological, and combined interventions in psychosis and schizophrenia in children, adolescents and young adults. METHODS: Systematic review and meta-analysis. Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to July 2013 without restriction to publication status. Randomised trials comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults were included. Studies were assessed for bias, and GRADE criteria were used to describe the quality of the results. RESULTS: Twenty-seven trials including 3067 participants were identified. Meta-analyses were performed for 12 comparisons: symptoms, relapse, global state, psychosocial functioning, depression, weight and discontinuation. Low quality evidence demonstrated that antipsychotics have small beneficial effects on psychotic symptoms (SMD = -0.42, 95% CI -0.58 to -0.26), and a medium adverse effect on weight gain (WMD = 1.61, 95% CI 0.61 to 2.60) and discontinuation due to side effects (RR = 2.44, 95% CI, 1.12 to 5.31). There were no trials of psychological treatments in under-18 year olds. There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate, but low quality evidence of a large effect for family plus individual CBT on the number of days to relapse (WMD = 32.25, 95% CI -36.52 to -27.98). CONCLUSIONS: For children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults. Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population.

Early interventions to prevent psychosis: systematic review and meta-analysis.

OBJECTIVE: To determine whether any psychological, pharmacological, or nutritional interventions can prevent or delay transition to psychotic disorders for people at high risk. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to November 2011 without restriction to publication status. REVIEW METHODS: Randomised trials comparing any psychological, pharmacological, nutritional, or combined intervention with usual services or another treatment. Studies of participants with a formal diagnosis of schizophrenia or bipolar disorder were excluded. Studies were assessed for bias, and relevant limitations were considered in summarising the results. RESULTS: 11 trials including 1246 participants and eight comparisons were included. Median sample size of included trials was 81 (range 51-288). Meta-analyses were performed for transition to psychosis, symptoms of psychosis, depression, and mania; quality of life; weight; and discontinuation of treatment. Evidence of moderate quality showed an effect for cognitive behavioural therapy on reducing transition to psychosis at 12 months (risk ratio 0.54 (95% confidence interval 0.34 to 0.86); risk difference -0.07 (-0.14 to -0.01). Very low quality evidence for omega-3 fatty acids and low to very low quality evidence for integrated psychotherapy also indicated that these interventions were associated with reductions in transition to psychosis at 12 months. CONCLUSIONS: Although evidence of benefits for any specific intervention is not conclusive, these findings suggest that it might be possible to delay or prevent transition to psychosis. Further research should be undertaken to establish conclusively the potential for benefit of psychological interventions in the treatment of people at high risk of psychosis.

EQ-5D™-derived utility values for different levels of migraine severity from a UK sample of migraineurs.

BACKGROUND: To estimate utility values for different levels of migraine pain severity from a United Kingdom (UK) sample of migraineurs. METHODS: One hundred and six migraineurs completed the EQ-5D to evaluate their health status for mild, moderate and severe levels of migraine pain severity for a recent migraine attack, and for current health defined as health status within seven days post-migraine attack. Statistical tests were used to evaluate differences in mean utility scores by migraine severity. RESULTS: Utility scores for each health state were significantly different from 1.0 (no problems on any EQ-5D dimension) (p < 0.0001) and one another (p < 0.0001). The lowest mean utility, - 0.20 (95% confidence interval [CI]: -0.27 - -0.13), was for severe migraine pain. The smallest difference in mean utility was between mild and moderate migraine pain (0.13) and the largest difference in mean utility was between current health (without migraine) and severe migraine pain (1.07). CONCLUSIONS: Results indicate that all levels of migraine pain are associated with significantly reduced utility values. As severity worsened, utility decreased and severe migraine pain was considered a health state worse than death. Results can be used in cost-utility models examining the relative economic value of therapeutic strategies for migraine in the UK.

Health state utilities for non small cell lung cancer.

BACKGROUND: Existing reports of utility values for metastatic non-small cell lung cancer (NSCLC) vary quite widely and are not all suitable for use in submissions in the UK. The aim of this study was to elicit UK societal based utility values for different stages of NSCLC and different grade III-IV toxicities commonly associated with chemotherapy treatments. Toxicities included neutropenia, febrile neutropenia, fatigue, diarrhoea, nausea and vomiting, rash and hair loss. METHODS: Existing health state descriptions of metastatic breast cancer were revised to make them suitable as descriptions of metastatic NSCLC patients on second-line treatment. The existing health states were used in cognitive debrief interviews with oncologists (n = 5) and oncology specialist nurses (n = 5). Changes were made as suggested by the clinical experts. The resulting health states (n = 17) were piloted and used in a societal based valuation study (n = 100). Participants rated half of the total health states in a standard gamble interview to derive health state utility scores. Data were analysed using a mixed model analysis. RESULTS: Each health state described the symptom burden of disease and impact on different levels of functioning (physical, emotional, sexual, and social). The disutility related to each disease state and toxicity was estimated and were combined to give health state values. All disease states and toxicities were independent significant predictors of utility (p < 0.001). Stable disease with no toxicity (our base state) had a utility value of 0.653. Utility scores ranged from 0.673 (responding disease with no toxicity) to 0.473 for progressive disease. CONCLUSION: This study reflects the value that society place on the avoidance of disease progression and severe toxicities in NSCLC.

Patient-reported outcomes measurements in epilepsy.

This review was designed to explore and review the range of patient-reported outcomes used to assess people with epilepsy. Literature searches were conducted through EMBASE.com and supplemented with hand searching of relevant articles. References obtained through hand searches were compared with EMBASE.com citations until we were confident that the review had reached a point of saturation. The search included English language papers published between January 1997 and March 2007. Searching through EMBASE.com yielded a total of 110 hits and the hand searches identified 35 potentially relevant studies. A total of 61 studies were considered relevant to the current review and were included in the study. Several instruments that have been designed and validated to measure patient-reported outcomes in an epilepsy population are currently being used, including the Quality of Life in Epilepsy (QOLIE)-89 and -31, the Liverpool Seizure Severity Scale and the Washington Psychosocial Seizure Inventory. In addition, the QOLIE-adolescent (QOLIE-AD)-48 and the Adolescent Psychosocial Seizure Inventory have been designed for use with adolescent epileptic patients. We found a paucity of valid condition-specific instruments assessing patient preference and patient satisfaction in this population. Several condition-specific instruments exist to measure patient-reported outcomes in epilepsy, specifically in the areas of health-related quality of life, patient-reported symptoms and psychosocial functioning. However, measures designed to assess other areas of patient-reported outcomes, such as patient preference and satisfaction, are poorly developed.