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PURPOSE OF REVIEW: Mirogabalin is a novel gabapentinoid medication for the treatment of neuropathic pain. The purpose of this review is to discuss current evidence for its use. Gabapentinoids are widely prescribed for neuropathic pain. Mirogabalin offers theoretical advantages over traditional gabapentinoids due to its specificity for the α2δ-1 subunit of voltage-gated calcium channels. It is theorised that this specificity may reduce adverse drug reactions by minimising binding to the α2δ-2 subunit which is responsible for many of the gabapentinoid side effects. RECENT FINDINGS: Mirogabalin's slower dissociation from the α2δ-1 compared with α2δ-2, and its higher potency may also impart an efficacy benefit over traditional gabapentinoids. These theoretical advantages of mirogabalin remain inconclusive in clinical practice, with mixed evidence regarding mirogabalin versus traditional gabapentinoids. Some studies suggest a reduced side effect profile yet, others fail to demonstrate significant differences. Regarding efficacy, mirogabalin may be superior to placebo for several neuropathic pain syndromes, but evidence of widespread benefit over traditional gabapentinoids is currently lacking. SUMMARY: Mirogabalin offers theoretical promise, but large, independent studies are required to further assess its performance versus traditional gabapentinoids.
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Analgésicos , Compuestos Bicíclicos con Puentes , Neuralgia , Humanos , Neuralgia/tratamiento farmacológico , Analgésicos/uso terapéutico , Compuestos Bicíclicos con Puentes/uso terapéutico , Compuestos Bicíclicos con Puentes/farmacología , Gabapentina/uso terapéutico , Canales de Calcio/efectos de los fármacos , Ácido gamma-Aminobutírico/uso terapéuticoRESUMEN
Background: Increases in high-intensity locomotor activity of match play have been recorded in elite soccer. This places an onus on academy practitioners to develop players for the future demands of the game. At an academy level, locomotor data are not available for analysis over a longitudinal period, and thus changes can only be assessed with physical attribute assessment. The aim of the present study is to establish if changes in physical capacity were observed in a professional Scottish soccer academy over a ten-year period. Methods: A retrospective analysis was completed where linear mixed effect (LME) models were individually fitted to explain variation across each measure of physical capacity. Model selection was undertaken with likelihood ratio tests where the initial complex models were compared to simpler nested models to arrive at the final model by maximum likelihood. Results: The main findings were that most recent players' sprint test data revealed a significant improvement in 5m, 10m and 20m sprint performance, greater increases in CMJ performance in older age groups, and greater increases in YYIR1 performance at U13 and U14. Most physical results showed increased performance with greater relative height and weight. Conclusion: Players recruited more recently to academies are fitter than they were previously. Reference values within clubs that establish first team requirements will contribute to appropriate planning and implementation of training.
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Aim: There is growing interest in tailoring psychological interventions for distressing voices and a need for reliable tools to assess phenomenological features which might influence treatment response. This study examines the reliability and internal consistency of the Voice Characterisation Checklist (VoCC), a novel 10-item tool which assesses degree of voice characterisation, identified as relevant to a new wave of relational approaches. Methods: The sample comprised participants experiencing distressing voices, recruited at baseline on the AVATAR2 trial between January 2021 and July 2022 (n = 170). Inter-rater reliability (IRR) and internal consistency analyses (Cronbach's alpha) were conducted. Results: The majority of participants reported some degree of voice personification (94%) with high endorsement of voices as distinct auditory experiences (87%) with basic attributes of gender and age (82%). While most identified a voice intention (75%) and personality (76%), attribution of mental states (35%) to the voice ('What are they thinking?') and a known historical relationship (36%) were less common. The internal consistency of the VoCC was acceptable (10 items, α = 0.71). IRR analysis indicated acceptable to excellent reliability at the item-level for 9/10 items and moderate agreement between raters' global (binary) classification of more vs. less highly characterised voices, κ = 0.549 (95% CI, 0.240-0.859), p < 0.05. Conclusion: The VoCC is a reliable and internally consistent tool for assessing voice characterisation and will be used to test whether voice characterisation moderates treatment outcome to AVATAR therapy. There is potential wider utility within clinical trials of other relational therapies as well as routine clinical practice.
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Background: Disrupted circadian rhythms can have a major effect on human physiology and healthcare outcomes, with proven increases in ICU morbidity, mortality and length of stay. Methods: We performed a multicentre observational study to study the nocturnal lux exposure of patients in 3 intensive care units. Results: The median light intensity recorded was 1 lux over the 6-hour recording period; however, this is deceptive as it hides short periods of high lux. When looked at in shorter time segments of 30 minutes, there were significant periods of lux higher than a crude median, especially in higher acuity patients. There was a positive correlation between acuity (as estimated by SOFA score) and maximum lux (R = 0.479, p = .0001), median lux (R = 0.35, p = .006) and cumulative lux (R = 0.55, p = .000001). There was no relationship between neighbouring patient acuity and lux. Conclusions: Clinicians should practice vigilance at night to provide optimal environmental conditions for patients to minimise potential harm.
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ABSTRACT: Hall, AJ, Aspe, RR, Craig, TP, Kavaliauskas, M, Babraj, J, and Swinton, PA. The effects of sprint interval training on physical performance: a systematic review and meta-analysis. J Strength Cond Res 37(2): 457-481, 2023-The present study aimed to synthesize findings from published research and through meta-analysis quantify the effect of sprint interval training (SIT) and potential moderators on physical performance outcomes (categorized as aerobic, anaerobic, mixed aerobic-anaerobic, or muscular force) with healthy adults, in addition to assessing the methodological quality of included studies and the existence of small study effects. Fifty-five studies were included (50% moderate methodological quality, 42% low methodological quality), with 58% comprising an intervention duration of ≤4 weeks and an array of different training protocols. Bayesian's meta-analysis of standardized mean differences (SMD) identified a medium effect of improved physical performance with SIT (ES 0.5 = 0.52; 95% credible intervals [CrI]: 0.42-0.62). Moderator analyses identified overlap between outcome types with the largest effects estimated for anaerobic outcomes (ES 0.5 = 0.61; 95% CrI: 0.48-0.75). Moderator effects were identified for intervention duration, sprint length, and number of sprints performed per session, with larger effects obtained for greater values of each moderator. A substantive number of very large effect sizes (41 SMDs > 2) were identified with additional evidence of extensive small study effects. This meta-analysis demonstrates that short-term SIT interventions are effective for developing moderate improvements in physical performance outcomes. However, extensive small study effects, likely influenced by researchers analyzing many outcomes, suggest potential overestimation of reported effects. Future research should analyze fewer a priori selected outcomes and investigate models to progress SIT interventions for longer-term performance improvements.
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Entrenamiento de Intervalos de Alta Intensidad , Adulto , Humanos , Entrenamiento de Intervalos de Alta Intensidad/métodos , Teorema de Bayes , Fuerza Muscular , Rendimiento Físico FuncionalRESUMEN
Background 'Open Dialogue' is a social network model of crisis and continuing mental healthcare which involves elements of service delivery such as immediate response and a style of therapeutic meeting called network meetings. Although there are indications from non-randomised studies that it may help people in their recovery from severe mental health crises and improve long-term outcomes, this has yet to be tested in a randomised controlled trial. Methods This paper outlines the protocol for a multi-site cluster-randomised control trial assessing the clinical and cost-effectiveness of Open Dialogue compared to treatment as usual (TAU) for individuals presenting in crisis to six mental health services in England. The primary outcome is time to relapse, with secondary outcomes including measures of recovery and service use. Participants will be followed-up for two years, with data collected from electronic medical records and researcher-led interviews. The analysis will compare outcomes between treatment groups as well as investigating potential mediators of effect: shared decision-making and social network quality and size. Carers of a subsample of participants will be asked about their experiences of shared decision-making, carer burden, and satisfaction. Discussion This trial will provide evidence of whether Open Dialogue services implemented in the English mental health system is an effective alternative to current care and may have important implications for the organization of community mental health services. Trial registration: retrospectively registered (108 participants recruited of 570 target) on 20/12/2019, ISRCTN52653325.
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Servicios de Salud Mental , Salud Mental , Adulto , Cuidadores/psicología , Análisis Costo-Beneficio , Humanos , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Although the World Health Organization has called for mental health services to be integrated into primary care, mental health remains in most countries, and especially in low- and middle-income countries, one of the most neglected topics in the training curriculum of frontline health workers. As a result, primary healthcare professionals leave medical and nursing schools with insufficient knowledge, and often with negative attitudes towards mental disorders. AIM: We investigated the effect of a brief training intervention on schizophrenia and depression conducted among general practitioners and nurses in Armenia. METHODS: Training interventions were one-day, face-to-face, interactive workshops, including didactic presentations and discussions of case studies. We used a quasi-experimental design of the before/after type, to compare data on knowledge, attitudes and practices collected before and after the training sessions. RESULTS: Mean scores for knowledge, attitudes and practices increased significantly (p < 0.001) among both nurses and GPs for both schizophrenia (111 GPs and 167 nurses) and depression (459 GPs and 197 nurses). CONCLUSIONS: Our experience suggests that a brief training intervention can result in significant improvements in knowledge, attitudes and practices among primary healthcare workers and could help improve mental health services.
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Conocimientos, Actitudes y Práctica en Salud , Esquizofrenia , Armenia , Depresión/terapia , Personal de Salud , Humanos , Atención Primaria de Salud , Esquizofrenia/terapiaRESUMEN
PURPOSE: Although participation is key to community mental health, the concept remains elusive. The study explored a conceptualization of participation in the community-based mental health agencies context from a first-person perspective, using the Clubhouse model as an example. METHODS: Qualitative data, collected from 21 Clubhouse service users through three focus groups (1 UK and 2 US) for primary analysis and secondary data from 104 individual interviews, were analysed using a grounded theory approach. RESULTS: Focus group narratives revealed three main domains of what may be named everyday participation process, Making Decisions, Doing Work, and Locating Oneself in Community, blended with each other rather than forming clear-cut stages. Sixty-six extracted primary codes, with two underlying interrelated core categories identified, named Autonomy and Egalitarian Connection, were organized by domain and by category. CONCLUSIONS: The findings suggest a 3 × 2 axial model of participation that participation signifies a behaviour, comprised of three blended activity domains, entailing actions and interactions that concern Autonomy and Egalitarian Connection, which, dynamically interacting with each other, appear to condition meaningful participation the next day. Egalitarian relationship skills development appears critical for training practitioners to help promote service users' quality everyday participation and getting-a-life-back experiences towards well-being, or meaningful life.
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Trastornos Mentales , Salud Mental , Teoría Fundamentada , Humanos , Apoyo SocialRESUMEN
A 3 yr experiment was conducted to evaluate the influence of diet and feeding location on animal performance, carcass characteristics, whole blood counts, and internal parasite burden of lambs assigned to 1 of 4 treatments: 1) confinement fed 71% alfalfa, 18% barley pellet, 5% molasses, 0.013% Bovatec, 6.1% vitamin/mineral package diet (CALF), 2) confinement fed 60% barley, 26% alfalfa pellet, 4% molasses, 2.5% soybean-hi pro, 0.016% Bovatec, 7.4% vitamin/mineral package diet (CBAR), 3) field fed 71% alfalfa, 18% barley pellet, 5% molasses, 0.013% Bovatec, 6.1% vitamin/mineral package diet (FALF), and 4) field fed 60% barley, 26% alfalfa pellet, 4% molasses, 2.5% soybean-hi pro, 0.016% Bovatec, 7.4% vitamin/mineral package diet (FBAR). A year × location interaction was detected for ending body weight (BW), average daily gain (ADG), and dry matter intake (DMI); therefore results are presented by year. In all years, cost of gain and DMI were greater for CALF and FALF than for CBAR and FBAR feed treatments (p ≤ 0.03). In yr 2 and 3 field treatments had greater ending BW and ADG than confinement treatments. For all years, diet did not affect ending BW or ADG. In yr 1 dressing percent and rib eye area were greater for field finished lambs than confinement finished (p ≤ 0.02) and Warner-Bratzler shear force was greater for CALF and FALF (p = 0.03). In yr 2 lambs in FALF and FBAR treatments had greater leg scores and conformation than CALF and CBAR (p = 0.09). In yr 1, FALF had a greater small intestine total worm count than all other treatments. In yr 1, ending Trichostrongyle type egg counts were greater for FALF (p = 0.05). In yr 2, ending Nematodirus spp. egg counts were greater for FALF and lowest for CBAR (p < 0.01). Abomasum Teladorsagia circumcinta worm burden was greater in CALF than all other treatments (p = 0.07) in yr 2. While field finishing lambs with a grain- or forage-based diet we conclude that it is possible to produce a quality lamb product without adverse effects to animal performance, carcass quality or increasing parasite burdens.
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BACKGROUND: AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth 'voices'). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU). METHODS: This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued. DISCUSSION: This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings. TRIAL REGISTRATION: ISRCTN registry ISRCTN55682735 . Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).
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Trastornos Psicóticos , Esquizofrenia , Voz , Alucinaciones/diagnóstico , Alucinaciones/terapia , Humanos , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Esquizofrenia/diagnóstico , Esquizofrenia/terapia , Resultado del TratamientoRESUMEN
AbstractThe purpose of this long-term retrospective analysis was to determine whether anthropometric and physical performance data could predict success in elite youth Scottish soccer players. Stature, body mass, sprint, jump and aerobic performance were collected from 512 players (U10 to U17) across a 10-year period. Players participated in an average of four profiling sessions (range: 1-14) and up to a maximum of three per year (August, December, and May) with standardisation applied to the surface, test order, time and protocols. One hundred players were awarded professional contracts. Associations between variables were quantified with mixed-effects linear models. Prediction was assessed with least absolute shrinkage and selection operator (LASSO) regression developed on a training set (2/3 data) and tested with proportion of error on a leave-out (1/3 data) test set. Confidence intervals were obtained through bootstrap LASSO samples. A strong relative age bias was identified with 50% of successful players born in the first quarter of the year. Successful players were on average taller and performed better in sprint and jump tests (p < 0.05). However, effects were small and even when variables were combined, proportion of errors identified were similar to random guessing (0.45[95%CI:0.41-0.49]). The results indicate that whilst successful players as youths demonstrate on average distinct anthropometric and physical profiles, these differences are unlikely to provide a reliable source to predict success within an already talented group. Practitioners should use data collected to guide exercise prescription but be aware of its substantive limitations in predicting success in isolation.
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Antropometría , Rendimiento Atlético/fisiología , Contratos , Fútbol/fisiología , Adolescente , Factores de Edad , Aptitud , Estatura , Índice de Masa Corporal , Niño , Humanos , Masculino , Destreza Motora/fisiología , Análisis de Regresión , Estudios Retrospectivos , Escocia , Maduración SexualRESUMEN
BACKGROUND: A growing body of research suggests that childhood adversities are associated with later psychosis, broadly defined. However, there remain several gaps and unanswered questions. Most studies are of low-level psychotic experiences and findings cannot necessarily be extrapolated to psychotic disorders. Further, few studies have examined the effects of more fine-grained dimensions of adversity such as type, timing and severity. AIMS: Using detailed data from the Childhood Adversity and Psychosis (CAPsy) study, we sought to address these gaps and examine in detail associations between a range of childhood adversities and psychotic disorder. METHOD: CAPsy is population-based first-episode psychosis case-control study in the UK. In a sample of 374 cases and 301 controls, we collected extensive data on childhood adversities, in particular household discord, various forms of abuse and bullying, and putative confounders, including family history of psychotic disorder, using validated, semi-structured instruments. RESULTS: We found strong evidence that all forms of childhood adversity were associated with around a two- to fourfold increased odds of psychotic disorder and that exposure to multiple adversities was associated with a linear increase in odds. We further found that severe forms of adversity, i.e. involving threat, hostility and violence, were most strongly associated with increased odds of disorder. More tentatively, we found that some adversities (e.g. bullying, sexual abuse) were more strongly associated with psychotic disorder if first occurrence was in adolescence. CONCLUSIONS: Our findings extend previous research on childhood adversity and suggest a degree of specificity for severe adversities involving threat, hostility and violence.
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Adultos Sobrevivientes del Maltrato a los Niños/estadística & datos numéricos , Experiencias Adversas de la Infancia/estadística & datos numéricos , Maltrato a los Niños/estadística & datos numéricos , Hostilidad , Trastornos Psicóticos/epidemiología , Trastornos Psicóticos/etiología , Adolescente , Adulto , Estudios de Casos y Controles , Niño , Femenino , Humanos , MasculinoRESUMEN
Pathogenic E. coli remains undigested upon phagocytosis by Tetrahymena and is egested from the ciliate as viable cells in its fecal pellets. Factors that are involved in the survival of Shiga toxin-producing E. coli serovar O157: H7 (EcO157) from digestion by Tetrahymena were identified by microarray analysis of its transcriptome in the protozoan phagosome. Numerous genes belonging to anaerobic metabolism and various stress responses were upregulated significantly ≥ 2-fold in EcO157 cells in the food vacuoles compared with in planktonic cells that remained uningested by the protist. Among these were the oxidative stress response genes, ahpF and katG. Fluorescence microscopy and staining with CellROX® Orange confirmed the presence of reactive oxygen species in food vacuoles containing EcO157 cells. Frequency distribution analysis of the percentage of EcO157 viable cells in Tetrahymena fecal pellets revealed that the ΔahpCF and ΔahpCFΔkatG mutants were less fit than the wild type strain and ΔkatG mutant after passage through the protist. Given the broad use of oxidants as sanitizers in the food industry, our observation of the oxidative stress response in EcO157 during its interaction with Tetrahymena emphasizes the importance of furthering our knowledge of the physiology of this human pathogen in environments relevant to its ecology and to food safety.
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Escherichia coli O157 , Tetrahymena , Escherichia coli O157/genética , Inocuidad de los Alimentos , Humanos , Estrés Oxidativo , Tetrahymena/genética , TranscriptomaRESUMEN
OBJECTIVE: Stressful life events have been implicated in the onset of psychotic disorders, but there are few robust studies. We sought to examine the nature and magnitude of associations between adult life events and difficulties and first-episode psychoses, particularly focusing on contextual characteristics, including threat, intrusiveness, and independence. METHOD: This study forms part of the Childhood Adversity and Psychosis Study (CAPsy), an epidemiological case-control study in London, United Kingdom. Data on life events and difficulties (problems lasting 4 wk or more) during 1 year prior to onset (cases) or interview (controls) were assessed using the semi-structured Life Events and Difficulties Schedule (LEDS). Data were available on 253 individuals with a first episode of psychosis and 301 population-based controls. RESULTS: We found strong evidence that odds of exposure to threatening and intrusive events in the 1 year prior to onset were substantially higher among cases compared with controls, independent of age, gender, ethnicity, and social class (ORs > 3). This was consistent across diagnostic categories. We found further evidence that the effect of threatening events and difficulties was cumulative (1 event odds ratio [OR] 2.69 [95% confidence interval (CI) 1.51-4.79]; 2 events OR 4.87 [95% CI 2.34-10.16]; ≥3 events OR 5.27 [95% CI 1.83-15.19]; 1 difficulty OR 3.02 [95% CI 1.79-5.09]; 2 difficulties OR 9.71 [95% CI 4.20-22.40]; ≥3 difficulties OR 12.84 [95% CI 3.18-51.85]). CONCLUSIONS: Threatening and intrusive life events and difficulties are common in the year pre-onset among individuals with a first episode of psychosis. Such experiences may contribute to the development of psychotic disorders.
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Experiencias Adversas de la Infancia/estadística & datos numéricos , Acontecimientos que Cambian la Vida , Síntomas Prodrómicos , Trastornos Psicóticos/epidemiología , Adolescente , Adulto , Estudios de Casos y Controles , Femenino , Humanos , Londres/epidemiología , Masculino , Persona de Mediana Edad , Trastornos Psicóticos/etiología , Adulto JovenRESUMEN
The typical reliance on self-report questionnaires in retrospective case-control studies of childhood abuse and psychotic disorders has been criticised, due to the potential for recall bias associated with, amongst other factors, cognitive impairments and detachment from reality, among individuals with psychosis. One way to establish if any substantial bias may exist is to examine whether the concordance of reports of childhood abuse established from retrospective self-report methods versus more comprehensive interviewer-rated assessments differ between individuals with psychosis and controls. Data from the Childhood Adversity and Psychosis (CAPsy) study were used to examine the accuracy, strength of agreement, and convergent validity of two distinct retrospective measures of childhood abuse: a self-report questionnaire (the Childhood Trauma Questionnaire; CTQ) and a comprehensive interview (the Childhood Experiences of Care and Abuse schedule; CECA). In a sample of 234 cases with first-episode psychosis and 293 controls, we found no strong evidence that the validity of the two measures differed between cases and controls. For reports of sexual and emotional abuse, we found fair levels of agreement between CECA and CTQ ratings in both groups (kappa coefficients 0.43-0.53), moderate to high sensitivity and specificity, and reasonably high convergent validity (tetrachoric correlations of 0.78-0.80). For physical abuse, convergent validity was slightly lower in cases compared with controls. Both measures can be used in future studies to retrospectively assess associations between childhood abuse and psychotic phenomena, but time-permitting, the CECA is preferable as it provides additional important contextual details of abuse exposure.
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Maltrato a los Niños , Trastornos Psicóticos , Niño , Humanos , Trastornos Psicóticos/epidemiología , Estudios Retrospectivos , Autoinforme , Encuestas y CuestionariosRESUMEN
BACKGROUND: Cannabis is the most prevalent illicit substance among people with psychosis, and its use is associated with poorer clinical and social outcomes. However, so far, there has been limited evidence that any treatment is effective for reducing use. Contingency management (CM) is an incentive-based intervention for substance misuse that has a substantial evidence base across a range of substances and cohorts. However, to date there have been no randomised controlled trials (RCTs) of CM as a treatment for cannabis use specifically in psychosis. OBJECTIVE: To conduct a RCT investigating the clinical effectiveness and cost-effectiveness of CM in reducing cannabis use among Early Intervention in Psychosis (EIP) service users. DESIGN: The CIRCLE (Contingency Intervention for Reduction of Cannabis in Early Psychosis) trial was a rater-blinded, multicentre RCT with two arms. Participants were randomised 1 : 1 to either an CM arm, in which participants received CM for cannabis use alongside an optimised treatment-as-usual programme including structured psychoeducation, or a control arm in which participants received the treatment as usual only. SETTING: EIP services across the Midlands and the south-east of England. PARTICIPANTS: The main eligibility criteria were EIP service users with a history of psychosis, aged 18-36 years, and having used cannabis at least once per week during 12 of the previous 24 weeks. INTERVENTION: The CM intervention offered financial incentives (i.e. shopping vouchers) for cannabis abstinence over 12 once-weekly sessions, confirmed using urinalysis. The maximum value in vouchers that participants could receive was £240. MAIN OUTCOME MEASURES: The main outcome was time to relapse, operationalised as admission to an acute mental health service or hospital. The primary outcome was assessed at 18 months post inclusion using electronic patient records. Secondary outcomes assessed the clinical effectiveness and cost-effectiveness of the intervention, for which data were collected at 3 and 18 months. RESULTS: A total of 278 participants were randomised to the CM arm and 273 were randomised to the control arm. In total, 530 (96%) participants were followed up for the primary outcome. There was no significant difference in time to admission between trial arms by 18 months following consent (hazard ratio 1.03, 95% confidence interval 0.76 to 1.40). There were no statistically significant differences in most secondary outcomes, including cannabis use, at either follow-up assessment. There were 58 serious adverse events, comprising 52 inpatient episodes, five deaths and one arrest. LIMITATIONS: Participant retention was low at 18 months, limiting the assessment of secondary outcomes. A different CM intervention design or reward level may have been effective. CONCLUSIONS: The CM intervention did not appear to be effective in reducing cannabis use and acute relapse among people with early psychosis and problematic cannabis use. FUTURE WORK: Cannabis use is still a significant clinical concern in this population. A pressing need remains to identify suitable treatments. A wider perspective on the social circumstances of young people with psychosis may be needed for a successful intervention to be found. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33576045. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 45. See the NIHR Journals Library website for further project information.
A large proportion of people with psychosis use cannabis, despite the negative impact that it has on their recovery. So far, a clearly effective way of helping young people in the early stages of psychosis to cut down their cannabis use has not been found. The CIRCLE trial investigated if an approach known as contingency management (CM) would be beneficial for this group. This approach involves offering voucher rewards for not using cannabis. It has been effective in addressing drug use problems in general, but there is not much evidence about its effects on cannabis use in those with psychosis. A total of 551 service users with psychosis who used cannabis agreed to enter the trial. Half of the sample group was chosen by a chance method to receive CM. The other half formed a comparison group. The CM group received shopping vouchers if urine samples showed that they had not used cannabis for the previous week, measured over 12 weekly sessions. Participants could obtain £240-worth of vouchers if they did not use cannabis during the treatment period. The participants in both groups were also offered a six-session psychoeducation programme about the pros and cons of cannabis use and ways to reduce use of it. The main comparison in the trial was the average length of time in each group before a relapse of psychosis occurred, which was recorded for each participant over 18 months after they joined the trial. The results found no difference between the two trial groups in this measure. Furthermore, there were no differences found between the groups in terms of the levels of cannabis use, clinical symptoms, or engagement with work or education. However, a cost-effectiveness analysis found an 85% chance of CM being more effective than the treatment-as-usual psychoeducation package, which appears to be because of the lower use of inpatient services by those receiving CM. However, it is difficult to understand why this was, because there was no drop in cannabis use. The results suggest that CM is unlikely to be clinically effective and that alternative treatments are still needed.
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Terapia Conductista/economía , Cannabis/efectos adversos , Trastornos Psicóticos/terapia , Recurrencia , Adolescente , Adulto , Análisis Costo-Beneficio/economía , Inglaterra , Femenino , Humanos , Masculino , Motivación , Trastornos Relacionados con Sustancias/terapia , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Cannabis is the most commonly used illicit substance amongst people with psychosis. Continued cannabis use following the onset of psychosis is associated with poorer functional and clinical outcomes. However, finding effective ways of intervening has been very challenging. We examined the clinical and cost-effectiveness of adjunctive contingency management (CM), which involves incentives for abstinence from cannabis use, in people with a recent diagnosis of psychosis. METHODS: CIRCLE was a pragmatic multi-centre randomised controlled trial. Participants were recruited via Early Intervention in Psychosis (EIP) services across the Midlands and South East of England. They had had at least one episode of clinically diagnosed psychosis (affective or non-affective); were aged 18 to 36; reported cannabis use in at least 12 out of the previous 24 weeks; and were not currently receiving treatment for cannabis misuse, or subject to a legal requirement for cannabis testing. Participants were randomised via a secure web-based service 1:1 to either an experimental arm, involving 12 weeks of CM plus a six-session psychoeducation package, or a control arm receiving the psychoeducation package only. The total potential voucher reward in the CM intervention was £240. The primary outcome was time to acute psychiatric care, operationalised as admission to an acute mental health service (including community alternatives to admission). Primary outcome data were collected from patient records at 18 months post-consent by assessors masked to allocation. The trial was registered with the ISRCTN registry, number ISRCTN33576045. RESULTS: Five hundred fifty-one participants were recruited between June 2012 and April 2016. Primary outcome data were obtained for 272 (98%) in the CM (experimental) group and 259 (95%) in the control group. There was no statistically significant difference in time to acute psychiatric care (the primary outcome) (HR 1.03, 95% CI 0.76, 1.40) between groups. By 18 months, 90 (33%) of participants in the CM group, and 85 (30%) of the control groups had been admitted at least once to an acute psychiatric service. Amongst those who had experienced an acute psychiatric admission, the median time to admission was 196 days (IQR 82, 364) in the CM group and 245 days (IQR 99, 382) in the control group. Cost-effectiveness analyses suggest that there is an 81% likelihood that the intervention was cost-effective, mainly resulting from higher mean inpatient costs for the control group compared with the CM group; however, the cost difference between groups was not statistically significant. There were 58 adverse events, 27 in the CM group and 31 in the control group. CONCLUSIONS: Overall, these results suggest that CM is not an effective intervention for improving the time to acute psychiatric admission or reducing cannabis use in psychosis, at least at the level of voucher reward offered.
Asunto(s)
Terapia Conductista/métodos , Cannabis , Trastornos Psicóticos/terapia , Trastornos Relacionados con Sustancias/rehabilitación , Adolescente , Adulto , Terapia Conductista/economía , Cannabis/efectos adversos , Condicionamiento Operante , Análisis Costo-Beneficio , Inglaterra , Femenino , Humanos , Masculino , Motivación , Adulto JovenRESUMEN
AIM: Looking after someone in the early stages of psychosis can have a negative impact on caregivers, but there is little clarity about which interventions, if any, caregivers should be offered. This study investigated sleep disturbances in early psychosis caregivers and the relationship between their sleep quality and distress. METHOD: In all, 79 caregivers of patients with a recent first episode of psychosis completed self-report measures including the Pittsburgh Sleep Quality Index (PSQI), the RAND 36-item Health Survey 1.0 (SF-36) and the Experiences of Caregiving Inventory (ECI). RESULTS: All caregivers were living with their relatives with psychosis and had been providing support since the onset of illness (mean duration = 92.5 weeks, SD = 84.0); 60% (47/79) obtained a global PSQI score that exceeded the established cut-off score for clinically significant sleep problems (>5). Low "sleep duration" and "sleep disturbances" contributed the most to elevated PSQI scores, with 17.7% of participants reporting regular wakening at night due to "stress" or "worries." When predicting psychological distress (SF-36) from negative appraisals of caregiving (ECI) and poor sleep (PSQI), a significant unadjusted regression model was obtained, F(2,73) = 29.440, P = .000, R2 of .447. An estimation of the indirect effect of negative thoughts about caregiving on mental distress through poor sleep was also significant (ab = -.05, 95% CI [-.09, -.02], PM = .39). CONCLUSION: Caregivers of people with psychosis may have significant problems with sleep, which relates to distress and negative appraisals about caregiving. Health services need to ask caregivers directly about such issues and consider offering brief interventions to improve sleep quality.