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Background: Sleep problems are common in mental health service users, but few non-pharmacological therapies are offered. Therapies are being developed and tested, but there may be barriers to these therapies reaching those who need them. Methods: Light-Dark and Activity Rhythm Therapy (L-DART), is a new sleep therapy delivered by an occupational therapist, which has been feasibility tested in people with schizophrenia spectrum diagnoses. This paper presents two surveys, conducted with mental health staff and service users, on sleep problems, treatment wishes; and barriers and facilitators to uptake of L-DART or similar therapies. Descriptive statistics, single-level and multi-level ordinal logistic regression were used to examine factors associated with sleep problems and referral intentions. Findings: Sleep problems were commonly identified by staff and service users, there was demand for non-pharmacological intervention across diagnostic and demographic categories, but staff readiness to refer differed according to NHS Trust and service user diagnosis. Staff and service user reports differed in awareness of sleep disordered breathing and parasomnias, and wish for referral. Staff were more confident identifying sleep problems than addressing them, but more training was associated with greater confidence concerning both assessment and treatment. Conclusions: A range of sleep problems are prevalent and recognised in mental health service users, and there is an unmet need for non-pharmacological sleep interventions. Improving suitable resources to support self-management in this group may help; Staff and service users also reported a high readiness to refer or be referred for sleep interventions. Staff training to improve identification of sleep problems, and differentiation between types of sleep problems, would support access to the most appropriate treatments. Highlights: Self-reported or staff reported sleep problems are common in mental health service users. Staff are less aware of sleep disordered breathing and parasomnias than are service users. There is demand for non-pharmacological sleep interventions and wish to refer/be referred. Staff have had limited training regarding sleep, but more training is associated with greater confidence to assess and address sleep. [ABSTRACT FROM AUTHOR]

Introduction: People with schizophrenia spectrum disorder diagnoses commonly have poor sleep, which predicts various negative outcomes. The problems are diverse, including substantial circadian dysregulation, sleep-wake timing issues, hypersomnia (excessive sleep), and more classic insomnia. Methods: This paper reports on a mixed methods expert opinion study based on the principles of Delphi methodology. The study examines and explores opinion on the optimal contents and format for an occupational therapy intervention to improve poor sleep in this population. Views of clinical and academic topic experts (n = 56), were elicited, examined and explored in three rounds, views from previous rounds being presented back to participants in subsequent rounds. Participants with relevant personal experience (n = 26) then rated and commented on suggestions, with a focus on acceptability. Descriptive statistics and graphs of ratings were triangulated with qualitative content analysis of free-text. Results: Participants emphasised the central importance of intervention personalisation, although the manner and extent of personalisation suggested varied. Many components and domains were acknowledged as important, with the challenge being how to keep such an intervention simple, brief, and feasible for end-users, for sustainable implementation. The strongest consensus was to address evening routine, daytime activity, and environmental interventions. Relaxation, mindfulness, thermoregulation, sensory factors, and cognitive or psychological approaches were rated as less important. There was disagreement on whether to include time in bed restriction, and how to address napping, as well as how far to address medication timing. Clinicians and researchers advocated some version of stimulus control, but participants with personal experience reported low levels of acceptability for this, describing entirely negative experiences using 'the 15-minute rule' (part of stimulus control). Conclusion: These results are informative for clinicians treating sleep problems in people with schizophrenia and related conditions, as well as for decision makers considering the potential contribution of the profession of occupational therapy toward sleep treatment. [ABSTRACT FROM AUTHOR]

Background Transition to psychotic disorder has been the traditional outcome of interest for research in the at-risk mental state (ARMS). However, there is growing recognition that individuals with ARMS may function poorly regardless of whether they develop psychosis. We aimed to review the literature to determine whether there are specific factors associated with, or predictive of, functional impairment in the ARMS population. Method An electronic database search of MEDLINE, PsycINFO and Embase from inception until May 2014 was conducted using keyword search terms synonymous with the at-risk mental state and functioning. Eligible studies were original peer-reviewed English language research articles with populations that met validated at-risk diagnostic criteria and examined the cross-sectional or longitudinal association between any variable and a measure of functioning. Results Seventy-two eligible studies were identified. Negative symptoms and neurocognitive impairment were associated with poor functioning in cross-sectional studies. Negative and disorganised symptoms, neurocognitive deficits and poor functioning at baseline were predictive of poor functional outcome in longitudinal studies. Positive symptoms were unrelated to functioning in both cross-sectional and longitudinal studies. Functional disability was persistent and resistant to current treatments. Conclusions Negative and disorganised symptoms and cognitive deficits pre-date frank psychotic symptoms and are risk factors for poor functioning. This is consistent with a subgroup of ARMS individuals potentially having neurodevelopmental schizophrenia. Treatments aimed at improving functioning must be considered a priority on par with preventing transition to psychosis in the development of future interventions in the ARMS group. [ABSTRACT FROM AUTHOR]

We used UK CUtLASS RCT data to establish that patients’ rating of mental health improvement (baseline to week 12) correlated significantly with percentage symptom improvement (PANSS). In a regression analysis predictors of the patient’s week 12 mental health rating were percentage change in positive symptoms (PANSS), DAI score and the patient's rating of side effects. Patients in an RCT were able to subjectively rate their mental health status, validated by objective improvement on the PANSS. [ABSTRACT FROM AUTHOR]

Background: People with schizophrenia have a higher premature mortality risk compared with the general population mainly due to cardiovascular disease (CVD). Despite this, people with schizophrenia are less likely to access physical health services or have their physical health investigated and monitored.Aims: To examine the beliefs and actions of mental health professionals regarding the physical health of people with schizophrenia.Method: Two hundred and fifty-five healthcare professionals who support people with schizophrenia within Greater Manchester Mental Health NHS Foundation Trust (GMMH), United Kingdom and Pennine Care NHS Foundation Trust (PCFT), United Kingdom took part. Beliefs and actions were assessed using a self-administered questionnaire, which was constructed around two primary domains (1) CVD risk factors; and (2) physical health interventions. Descriptive statistics were reported and responses between different healthcare professional groups were compared.Results: The overwhelming majority of participants were aware of established CVD risk factors with 98% identifying family history of CVD, 98% for smoking and 96% for high blood pressure. Most participants believed nearly all healthcare professionals were responsible for monitoring the physical health of people with schizophrenia, regardless of job speciality. There were 67% of participants who reported delivering an intervention to improve sedentary behaviour for people with schizophrenia. However, awareness of government and NHS recommended lifestyle interventions were low.Conclusions: This study found good knowledge regarding many established CVD risk factors but little clarity regarding who is responsible for monitoring the physical health of people with schizophrenia and how often brief lifestyle interventions are being implemented. [ABSTRACT FROM AUTHOR]

Aim: Many young people at ultra‐high risk (UHR) of developing psychosis exhibit marked and persistent impairments in social and occupational functioning. We aimed to explore UHR patients' subjective experiences of these difficulties and their causes. Methods: We conducted semi‐structured interviews with 20 UHR individuals recruited from Early Detection and Intervention Teams in Northwest England. Topics covered included how participants spent their time, their interpersonal relationships, academic and occupational performance, premorbid functioning and clinical treatment. Thematic analysis was used to examine the prevailing themes. Results: The sample included individuals with varying degrees of functional impairment, ranging from mild to severe difficulties in functioning. Analysis of the qualitative data elicited themes around 2 topics: breadth of functional difficulties and subjective reasons for poor functioning. Participants reported a range of impairments in their social and occupational functioning which they attributed to a combination of clinical, cognitive and psychological factors. These included variables previously identified in the quantitative literature such as psychiatric symptoms, adverse life experiences and cognitive deficits. However, our findings also included other factors which have received comparably little attention such as self‐stigmatizing attitudes and dysfunctional metacognitive beliefs. Conclusions: We propose a model that attempts to explain how these variables interact to drive and sustain functional impairment in the UHR population. This will assist in the development of clinical interventions aimed at promoting functional recovery among UHR individuals. [ABSTRACT FROM AUTHOR]

Background: Psychotic disorders are associated with high rates of sustained unemployment, however, little is known about the long-term employment outcome of people at ultra-high risk (UHR) of developing psychosis. We sought to investigate the long-term unemployment rate and baseline predictors of employment status at follow-up in a large UHR cohort.Method: 268 UHR patients recruited from the Personal Assessment and Crisis Evaluation clinic in Melbourne, Australia were followed-up over 2-14years after initial presentation to the service. Individuals in no form of employment or education were classed as unemployed. Logistic regression analyses were used to examine predictors of employment outcome.Results: A high rate of unemployment was present at follow-up in this UHR sample (23%). At baseline, those who were unemployed at follow-up had a longer duration of untreated illness, more severe negative symptoms, lower IQ, poorer social and occupational functioning and reported more childhood trauma than the employed group. At follow-up, unemployed individuals exhibited significantly more severe symptoms on all measures and were more likely to have been diagnosed with a mood, anxiety, psychotic or substance use disorder. Childhood trauma and the duration of untreated illness at baseline were significant independent predictors of employment status at follow-up in the multivariate analyses.Conclusions: Nearly a quarter of this UHR sample was unemployed at long-term follow-up. The duration of untreated illness and the effects of childhood trauma are potentially modifiable risk factors for long-term employment outcome in this group. Vocational support may be beneficial for many UHR patients presenting to services. [ABSTRACT FROM AUTHOR]

Several efforts to develop pharmacological treatments with a beneficial effect on cognition in schizophrenia are underway, while cognitive remediation has shown modest effects on cognitive performance. Our goal was to test if pharmacological augmentation of cognitive training would result in enhancement of training-induced learning. We chose modafinil as the pharmacological augmenting agent, as it is known to have beneficial effects on learning and cognition. 49 participants with chronic schizophrenia were enroled in a double-blind, placebo-controlled study across two sites and were randomised to either modafinil (200 mg/day) or placebo. All participants engaged in a cognitive training program for 10 consecutive weekdays. The primary outcome measure was the performance on the trained tasks and secondary outcome measures included MATRICS cognitive battery, proxy measures of everyday functioning and symptom measures. 84% of the participants completed all study visits. Both groups showed significant improvement in the performance of the trained tasks suggesting potential for further learning. Modafinil did not induce differential enhancement on the performance of the trained tasks or any differential enhancement of the neuropsychological and functional measures compared to placebo. Modafinil showed no significant effects on symptom severity. Our study demonstrated that combining pharmacological compounds with cognitive training is acceptable to patients and can be implemented in large double-blind randomised controlled trials. The lack of differential enhancement of training-induced learning raises questions, such as choice and optimal dose of drug, cognitive domains to be trained, type of cognitive training, intervention duration and chronicity of illness that require systematic investigation in future studies. [ABSTRACT FROM AUTHOR]

Background: There is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based psychological therapies which are strongly advised by NICE guidance for severe mental health problems. The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme (which is complete) aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes). Methods: The study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up. Discussion: The key output will be a potentially effective and cost-effective ward-based psychological intervention that increases patient access to psychological therapy in inpatient settings, is feasible to deliver in inpatient settings and is acceptable to patients. Trial Registration number: ClinicalTrials.gov Identifier: NCT03950388. Registered 15th May 2019. https://clinicaltrials.gov/ct2/show/NCT03950388 [ABSTRACT FROM AUTHOR]

Objectives. The aim of the study was to investigate sexual function in patients with schizophrenia receiving treatment with a first-generation antipsychotic (FGA) or a second-generation antipsychotic (SGA) drug. Sexual function is an important aspect of human experience, which can be affected by antipsychotic drug treatment. Sexual dysfunction in patients with schizophrenia may be less prevalent with SGA than with FGA drug treatment. Methods. A cross-sectional prevalence study assessed sexual function in a sample of 144 patients with DSM-IV schizophrenia aged between 18 and 65, using the Derogatis Interview for Sexual Functioning (self-report version: DISF-SR). Two equal-sized groups ( N = 72) received treatment with an FGA or an SGA drug for at least 12 weeks. Results. No significant differences were seen on DISF-SR total score or subscale score between the two treatment groups. Conclusions. There are no differences in measured sexual function of non-randomised patients with schizophrenia treated with an FGA compared with SGA-treated patients. [ABSTRACT FROM AUTHOR]

The impact of antipsychotic drug treatment on sexual function was investigated during a randomised trial comparing first generation antipsychotics (FGAs) to (nonclozapine) second generation antipsychotics (SGAs). Sexual function and quality of life were (rater-blind) assessed in 42 patients with DSM-IV schizophrenia (aged 18-65) using the self-report version of the Derogatis Interview for Sexual Function (DISF-SR) and the Heinrichs Quality of Life Scale (QLS), prior to, and 12 weeks following, a change in medication from an FGA drug to either an FGA or SGA drug. SGAs significantly improved sexual function compared to FGAs. Change in sexual function was associated with change in quality of life. Where impaired sexual functioning is a distressing adverse effect of treatment with an FGA agent, consideration should be given to switching to an SGA. [ABSTRACT FROM AUTHOR]

Dysfunctional metacognitive beliefs are common among people with psychosis. In this meta-analysis we examined whether these are also present in people meeting at-risk mental state (ARMS) criteria. We also explored the relationship between metacognitive beliefs and symptoms in the ARMS group. An electronic database search of Ovid MEDLINE, PsycINFO and Embase from inception until August 2016 was conducted using keyword search terms synonymous with ARMS and metacognition. Eligible studies were original research articles that examined metacognitive beliefs using the Metacognitions Questionnaire (MCQ) among people meeting ARMS criteria. Studies included in the meta-analyses also reported comparison MCQ data acquired from healthy controls, help-seeking individuals, or people with psychotic disorders. Eleven eligible studies were identified, reporting data from six unique ARMS samples. People with ARMS did not differ from those with established psychotic disorders on any MCQ subscale, but they reported significantly more dysfunctional metacognitive beliefs than healthy or help-seeking controls. Maladaptive metacognitive beliefs were associated with a range of symptoms in ARMS individuals, but evidence for associations with specific subthreshold psychotic phenomena was inconsistent. This evidence indicates how valuable assessment and treatment of dysfunctional metacognitive beliefs may be but suggests that specific aspects of methodology should be addressed. [ABSTRACT FROM AUTHOR]

Objective: Research and clinical translation in schizophrenia is limited by inconsistent definitions of treatment resistance and response. To address this issue, the authors evaluated current approaches and then developed consensus criteria and guidelines.Method: A systematic review of randomized antipsychotic clinical trials in treatment-resistant schizophrenia was performed, and definitions of treatment resistance were extracted. Subsequently, consensus operationalized criteria were developed through 1) a multiphase, mixed methods approach, 2) identification of key criteria via an online survey, and 3) meetings to achieve consensus.Results: Of 2,808 studies identified, 42 met inclusion criteria. Of these, 21 studies (50%) did not provide operationalized criteria. In the remaining studies, criteria varied considerably, particularly regarding symptom severity, prior treatment duration, and antipsychotic dosage thresholds; only two studies (5%) utilized the same criteria. The consensus group identified minimum and optimal criteria, employing the following principles: 1) current symptoms of a minimum duration and severity determined by a standardized rating scale; 2) moderate or worse functional impairment; 3) prior treatment consisting of at least two different antipsychotic trials, each for a minimum duration and dosage; 4) systematic monitoring of adherence and meeting of minimum adherence criteria; 5) ideally at least one prospective treatment trial; and 6) criteria that clearly separate responsive from treatment-resistant patients.Conclusions: There is considerable variation in current approaches to defining treatment resistance in schizophrenia. The authors present consensus guidelines that operationalize criteria for determining and reporting treatment resistance, adequate treatment, and treatment response, providing a benchmark for research and clinical translation. [ABSTRACT FROM AUTHOR]

Objective: The authors developed and validated a clozapine-specific side-effects scale capable of eliciting the subjectively unpleasant side-effects of clozapine.Methods: Questions from the original Glasgow Antipsychotic Side-effects Scale (GASS) were compared to a list of the most commonly reported clozapine side-effects and those with a significant subjective burden were included in the GASS for Clozapine (GASS-C). The original authors of the GASS and a group of mental health professionals from the UK and Ireland were enlisted to comment on the questions in the GASS-C based on their clinical experience. 110 clozapine outpatients from two sites completed the GASS-C, the original GASS and a repeat GASS-C. Statistical analyses were performed using SPSS for Windows version 19.Results: The GASS-C was shown to have construct validity, in that Spearman's correlation coefficient was 0.816 (p<0.001) with the original GASS, whilst Cohen's kappa coefficient was >0.77 (p<0.001) for one question and >0.81 (p<0.001) for remaining relevant questions. GASS-C was also shown to have strong test-retest reliability, in that Cronbach's alpha coefficient was >0.907 (p<0.001), whilst Cohen's kappa coefficient was >0.81 (p<0.001) for 12 questions and >0.61 (p<0.001) for the remaining four questions.Conclusion: The GASS-C is a valid and reliable clinical tool to enable a systematic assessment of the subjectively unpleasant side-effects of clozapine. Future research should focus on how the scale can be utilised as a clinical tool to improve real-world outcomes such as adherence to clozapine therapy and quality of life. [ABSTRACT FROM AUTHOR]

Neurocognitive impairment predicts disability in schizophrenia, making intervention theoretically attractive as a means to minimise chronic disability. Many trials confirm that cognitive remediation (CR) produces meaningful, durable improvements in cognition and functioning but fewer focus on the early stages. We systematically reviewed CR trials in early schizophrenia to determine its efficacy on global cognition, functioning and symptoms. Two reviewers independently searched electronic databases to identify randomised controlled trials investigating CR following a first episode of psychosis. Eleven trials with 615 participants were identified. Random effect models revealed a non-significant effect of CR on global cognition (effect size=0.13, 95% CI -0.04, 0.31; p0.14), p<0.05 in sensitivity analysis (effect size 0.19; CI 0.00, 0.38). One of seven neurocognitive domains showed a significant positive effect (verbal learning and memory) and five others showed borderline significant benefits. There was a significant effect on functioning (0.18; CI 0.01, 0.36; p<0.05) and symptoms (0.19; CI 0.02, 0.36; p<0.05). CR's effect on functioning and symptoms was larger in trials with adjunctive psychiatric rehabilitation and small group interventions. CR's effect sizes in early illness were smaller than those in chronic schizophrenia, perhaps because of participants' reduced scope for improvement, though trials' small number and size produces uncertain estimates of effect. However, significant benefits were seen in functioning and symptoms and moderator analyses indicate factors that may increase CR's effect. Findings here, theoretical considerations and trials in chronic schizophrenia suggest that targeting social cognition might also enhance its efficacy. [ABSTRACT FROM AUTHOR]

Background Quality of life (QoL) is considered an important outcome in health research. It can be rated by the patient, or by an external assessor. We wished to identify the predictors of any discrepancies between these two approaches in people with schizophrenia. Methods Patients with DSM schizophrenia and related disorders (N = 80) completed both patient-rated (Lancashire Quality of Life Profile; LQOLP) and assessor-rated (Heinrich's Quality of Life Scale; QLS) measures of QoL. Results Patient-rated (LQOLP) and assessor-rated (QLS) measures showed a modest correlation (r = 0.38). In a regression analysis, independent predictors of subjectively-rated QoL being higher than objectively-assessed QoL in the same patient, were low insight score (BIS), negative symptoms (PANSS), absence of depression (CDSS), and less positive attitude toward prescribed treatment (DAI). Conclusions In people with schizophrenia, scores on objectively- and subjectively-rated measures of quality of life can differ markedly. When comparing subjective to objective assessments, patients with depressive symptoms will value their QoL lower, and those with low insight will value their QoL higher. This has important implications for the utility and interpretation of QoL measures in schizophrenia. [ABSTRACT FROM AUTHOR]

Background: Clozapine is the only medication licensed for the treatment of resistant schizophrenia in the UK. Although efficacious, a common and unpopular side effect of clozapine treatment is clozapine-induced hypersalivation (CIH), which can contribute to non-adherence. The standard treatment for CIH in the UK is hyoscine hydrobromide but this may aggravate cognitive deficits in patients with schizophrenia while glycopyrrolate may be an effective alternative with a more tolerable side effect profile. There is currently no convincing evidence for hyoscine, or any other medication, as an effective treatment for CIH.Methods/design: This is a multicentre randomised, double-blind, placebo-controlled feasibility study of glycopyrronium bromide (glycopyrrolate) and hyoscine hydrobromide (hyoscine) in patients with clozapine-induced hypersalivation. We aim to recruit 42 patients who have been prescribed clozapine and are experiencing hypersalivation, and randomise them to one of three study arms (either hyoscine, glycopyrrolate or placebo). The primary outcome measures will be the participant recruitment and attrition rates, and the secondary outcome will be the metrics of the daytime hypersalivation measure. After a 1-week washout period (discontinuing CIH medication, if any), there will be a 4-week treatment period where participants will be titrated up to the maximum tolerated dose of hyoscine, glycopyrrolate or placebo. Measurements of daytime salivation, nocturnal salivation, cognition and side effects will be taken during home visits in week 2 and week 5. Information on salivation and side effects will also be taken through telephone calls in week 3 and week 4. To gather information on the experience of study participants, exit interviews will also be requested with all participants who drop out of the study and a sample of participants who complete the study.Discussion: There is currently no convincing evidence for hyoscine, or any other medication, as an effective treatment for CIH. There is promising evidence that glycopyrrolate may be more successful in the treatment of CIH causing fewer cognitive side effects. We propose to conduct a randomised placebo-controlled feasibility study of glycopyrrolate and hyoscine in the treatment of clozapine-induced hypersalivation to inform the design of a future efficacy trial.Trial Registration: Clinicaltrials.gov NCT02613494 , 23 November 2015. [ABSTRACT FROM AUTHOR]