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Bucci S.,University of Manchester | Barrowclough C.,University of Manchester | Ainsworth J.,University of Manchester | Ainsworth J.,Health eResearch Centre | | And 10 more authors.
Trials | Year: 2015

Background: Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. Methods/Design: We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. Discussion: To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care. Trial registration:ISRCTN34966555 . Date of first registration: 12 June 2014. © 2015 Bucci et al.

Macdonald G.,Queens University of Belfast | Lewis J.,The Colebrooke Center for Evidence and Implementation | Macdonald K.,Nuffield College | Gardner E.,Northern Ireland Clinical Trials Unit | And 5 more authors.
Trials | Year: 2014

Background: Serious case reviews and research studies have indicated weaknesses in risk assessments conducted by child protection social workers. Social workers are adept at gathering information but struggle with analysis and assessment of risk. The Department for Education wants to know if the use of a structured decision-making tool can improve child protection assessments of risk. Methods/design: This multi-site, cluster-randomised trial will assess the effectiveness of the Safeguarding Children Assessment and Analysis Framework (SAAF). This structured decision-making tool aims to improve social workers' assessments of harm, of future risk and parents' capacity to change. The comparison is management as usual. Inclusion criteria: Children's Services Departments (CSDs) in England willing to make elevant teams available to be randomised, and willing to meet the trial's training and data collection requirements. Exclusion criteria: CSDs where there were concerns about performance; where a major organisational restructuring was planned or under way; or where other risk assessment tools were in use.Six CSDs are participating in this study. Social workers in the experimental arm will receive 2 days training in SAAF together with a range of support materials, and access to limited telephone consultation post-training. The primary outcome is child maltreatment. This will be assessed using data collected nationally on two key performance indicators: the first is the number of children in a year who have been subject to a second Child Protection Plan (CPP); the second is the number of re-referrals of children because of related concerns about maltreatment. Secondary outcomes are: i) the quality of assessments judged against a schedule of quality criteria and ii) the relationship between the three assessments required by the structured decision-making tool (level of harm, risk of (re)abuse and prospects for successful intervention). Discussion: This is the first study to examine the effectiveness of SAAF. It will contribute to a very limited literature on the contribution that structured decision-making tools can make to improving risk assessment and case planning in child protection and on what is involved in their effective implementation. Trial registration: ISRCTN 45137562 15 July 2014. © 2014 Macdonald et al.

For young adults who have experienced severe mental health disorders, exercise may help reduce the severity of their symptoms, a new, small study suggests. In the study, researchers looked at 38 adults, ages 18 to 35, who had experienced an episode of psychosis — a serious mental disorder in which a person loses touch with reality and may experience delusions and hallucinations. All of the people were receiving antipsychotic medications and mental health care through early-intervention mental health services in England. The researchers assigned 31 of the people to participate in a 10-week exercise program. The remaining seven were not assigned to participate in such a program. (The groups were uneven in size because the researchers originally set up the study to assess how practical it would be to run an exercise program for people with psychosis; the added the control group later when they decided to look at the effectiveness of the program by comparing people who were exercising with those who were not.) The researchers found that the people who participated in the exercise program experienced a 27 percent decrease in the overall severity and frequency of their symptoms over the 10 weeks, on average. In comparison, the severity and frequency of symptoms among the people in the control group decreased by nearly 8 percent, on average, over the same period of time, they found. [5 Controversial Mental Health Treatments] "I would highly recommend exercise as an intervention for early psychosis," said lead study author Joseph Firth, a postgraduate research student in the Institute of Brain, Behavior and Mental Health at the University of Manchester in England. "It can help with both the physical health and psychosocial recovery of the patient," which are aspects of psychosis that are often left untreated, or can even be worsened, by antipsychotic medications, he said. In the study, the people in the exercise intervention group were assigned to work out for at least 90 minutes per week for 10 weeks, but they ended up exercising for 107 minutes per week, on average, the researchers found. When the researchers analyzed the severity of various types of psychosis symptoms after the 10 weeks, they found that the greatest improvement occurred in symptoms such as social withdrawal and low motivation — the severity and frequency of these symptoms decreased by 33 percent in the exercise intervention group. In comparison, the severity and frequency of these symptoms decreased by 11.5 percent in the control group over the same period. It is not clear why exercise may benefit young people with early psychosis, but several potential mechanisms may be involved, the researchers said. In a previous study, for example, the same researchers found that exercise helped young people with psychosis re-direct their attention from the disturbing thoughts and voices that might have usually troubled them, Firth told Live Science. "Exercise was also said to produce an energizing, 'feel good' effect for the young people, helping them to overcome the motivational deficits associated with psychosis," he said. But Firth stressed that merely telling young people with psychosis to exercise more often is not enough to increase their activity, or allow them to experience the benefits shown in the new study. [How to Stick to an Exercise Routine] Instead, the patients should exercise with specially trained professionals, similar to the ways in which other forms of therapy are delivered, he said. The new study was published Monday (March 14) in the journal Early Intervention in Psychiatry. Copyright 2016 LiveScience, a Purch company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Drake R.J.,Institute of Brain | Addington J.,University Institute of Mental Health | Viswanathan A.C.,University College London | Lewis S.W.,Institute of Brain | And 5 more authors.
Journal of Clinical Psychiatry | Year: 2016

Objective: Male gender and young age at onset of schizophrenia are traditionally associated with poor treatment outcome and often used to determine prognosis. However, many studies use nonincident samples and fail to adjust for symptom severity at onset. We hypothesized that age and gender would influence severity of presentation but would not predict outcome after adjustment for symptoms at presentation. Method: 628 people with first-episode ICD-9 and DSM-IV nonaffective psychosis from 2 historical cohorts recruited from sequential presentations in Canada and the United Kingdom (1996-1998) were assessed prospectively at presentation and over 12-18 months using the Positive and Negative Syndrome Scale (PANSS). Results: Models of the age-at-onset distributions with 2 underlying modes at similar ages in women (ages 23 years and 47 years) and men (ages 22 years and 46 years) had relatively good fits compared to single-mode models (χ2 1 better by 9.2 for females, 8.0 for males, both P <.05). At presentation, scores for negative symptoms were 1.84 points worse for males (95% CI, 1.05 to 2.58; P <.001) in a mixed effects model. Younger age also predicted higher negative scores at presentation (partial correlation r =-0.18, P <.01; P <.001 in the mixed effects model). Findings were similar for cognitive-disorganized symptoms. However, after controlling for baseline symptoms, age at onset and gender did not significantly predict subsequent symptom course in the mixed effects models. Conclusions: Gender and age at onset are independently associated with symptoms at presentation but not with medium-term course of schizophrenia. This finding reinforces the importance of early identification and prevention of severe negative symptoms at first episode, whatever an individual's age and gender. © 2016 Physicians Postgraduate Press, Inc.

Marshall A.,University of St. Andrews | Nazroo J.,University of Manchester | Feeney K.,RAND Corporation | Feeney K.,University of California at Berkeley | And 4 more authors.
Journal of Epidemiology and Community Health | Year: 2016

Background The USA and England have very different health systems. Comparing hypertension care outcomes in each country enables an evaluation of the effectiveness of each system. Method The English Longitudinal Study of Ageing and the Health and Retirement Survey are used to compare the prevalence of controlled, uncontrolled and undiagnosed hypertension within the hypertensive population (diagnosed or measured within the survey data used) aged 50 years and above in the USA and in England. Results Controlled hypertension is more prevalent within the hypertensive population in the USA (age 50-64: 0.53 (0.50 to 0.57) and age 65+: 0.51 (0.49 to 0.53)) than in England (age 50-64: 0.45 (0.42 to 0.48) and age 65+: 0.42 (0.40 to 0.45)). This difference is driven by lower undiagnosed hypertension in the USA (age 50-64: 0.18 (0.15-0.21) and age 65+: 0.13 (0.12 to 0.14)) relative to England (age 50-64: 0.26 (0.24 to 0.29) and age 65+: 0.22 (0.20 to 0.24)). The prevalence of uncontrolled hypertension within the hypertensive population is very similar in the USA (age 50-64: 0.29 (0.26 to 0.32) and age 65+: 0.36 (0.34 to 0.38)) and England (age 50-64: 0.29 (0.26 to 0.32) and age 65+: 0.36 (0.34 to 0.39)). Hypertension care outcomes are comparable across US insurance categories. In both countries, undiagnosed hypertension is positively correlated with wealth (ages 50-64). Uncontrolled hypertension declines with rising wealth in the USA. Conclusions Different diagnostic practices are likely to drive the cross-country differences in undiagnosed hypertension. US government health systems perform at least as well as private healthcare and are more equitable in the distribution of care outcomes. Higher undiagnosed hypertension among the affluent may reflect less frequent medical contact.

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