Barriers to the management of sexual dysfunction among people with psychosis: analysis of qualitative data from the REMEDY trial.

BACKGROUND: More than half of people who use antipsychotic medication for psychosis report having sexual dysfunction. The REMEDY trial aimed to find out if switching antipsychotic medication provides an effective way to reduce sexual dysfunction among people with psychosis. We set out to recruit 216 participants over a two-year period, but recruitment was stopped after an extended 12-month pilot phase, during which we recruited only 10 participants. As part of a nested process evaluation, we conducted qualitative interviews with front-line clinicians to examine barriers to recruitment to the trial. METHODS: We developed a semi-structured interview schedule to explore staff views on factors that influenced whether they referred potential participants to the study. We interviewed a purposive sample of 51 staff from four National Health Service (NHS) Trusts in England, ensuring a range of different backgrounds, seniority, and levels of involvement in the trial. Audio recordings of interviews were transcribed for verbatim, and data were analysed using an inductive approach to thematic analysis. RESULTS: Nine interconnected themes were generated. Six themes concerned barriers to recruitment; including; prioritising patients' mental stability, mutual discomfort and embarrassment about discussing a "taboo" subject, and concerns about unintended consequences of asking people with psychosis about their sexual functioning. Three themes, including the quality of treatment relationships and strategies for opening dialogue suggested ways to improve recognition of these "hidden" side effects. CONCLUSION: The identification and management of sexual dysfunction among people with psychosis are not priorities for mental health services in England at this time. Many staff working in front-line services feel unprepared and uncomfortable asking people with psychosis about these problems. While greater use of screening tools may improve the identification of sexual dysfunction among people with psychosis, the evaluation and implementation of interventions to manage them will continue to be challenging unless NHS leaders and senior clinicians demonstrate greater commitment to changing current clinical practice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12307891.

Observations of community-based multidisciplinary team meetings in health and social care for older people with long term conditions in England.

BACKGROUND: Community-based multi-disciplinary teams (MDTs) are the most common means to encourage health and social care service integration in England yet are rarely studied or directly observed. This paper reports on two rounds of non-participant observations of community-based multi-disciplinary team (MDT) meetings in two localities, as part of an evaluation of the Integrated Care and Support Pioneers Programme. We sought to understand how MDT meetings coordinate care and identify their 'added value' over bilateral discussions. METHODS: Two rounds of structured non-participant observations of 11 MDTs (28 meetings) in an inner city and mixed urban-rural area in England (June 2019-February 2020), using a group analysis approach. RESULTS: Despite diverse settings, attendance and caseloads, MDTs adopted similar processes of case management: presentation; information seeking/sharing; narrative construction; solution seeking; decision-making and task allocation. Patient-centredness was evident but scope to strengthen 'patient-voice' exists. MDTs were hampered by information governance rules and lack of interoperability between patient databases. Meetings were characterised by mutual respect and collegiality with little challenge. Decision-making appeared non-hierarchical, often involving dyads or triads of professionals. 'Added value' lay in: rapid patient information sharing; better understanding of contributing agencies' services; planning strategies for patients that providers had struggled to find the right way to engage satisfactorily; and managing risk and providing mutual support in stressful cases. CONCLUSIONS: More attention needs to be given to removing barriers to information sharing, creating scope for constructive challenge between staff and deciding when to remove cases from the caseload.

Switching antipsychotic medication to reduce sexual dysfunction in people with psychosis: the REMEDY RCT.

BACKGROUND: Sexual dysfunction is common among people who are prescribed antipsychotic medication for psychosis. Sexual dysfunction can impair quality of life and reduce treatment adherence. Switching antipsychotic medication may help, but the clinical effectiveness and cost-effectiveness of this approach is unclear. OBJECTIVE: To examine whether or not switching antipsychotic medication provides a clinically effective and cost-effective method to reduce sexual dysfunction in people with psychosis. DESIGN: A two-arm, researcher-blind, pilot randomised trial with a parallel qualitative study and an internal pilot phase. Study participants were randomised to enhanced standard care plus a switch of antipsychotic medication or enhanced standard care alone in a 1 : 1 ratio. Randomisation was via an independent and remote web-based service using dynamic adaptive allocation, stratified by age, gender, Trust and relationship status. SETTING: NHS secondary care mental health services in England. PARTICIPANTS: Potential participants had to be aged ≥ 18 years, have schizophrenia or related psychoses and experience sexual dysfunction associated with the use of antipsychotic medication. We recruited only people for whom reduction in medication dosage was ineffective or inappropriate. We excluded those who were acutely unwell, had had a change in antipsychotic medication in the last 6 weeks, were currently prescribed clozapine or whose sexual dysfunction was believed to be due to a coexisting physical or mental disorder. INTERVENTIONS: Switching to an equivalent dose of one of three antipsychotic medications that are considered to have a relatively low propensity for sexual side effects (i.e. quetiapine, aripiprazole or olanzapine). All participants were offered brief psychoeducation and support to discuss their sexual health and functioning. MAIN OUTCOME MEASURES: The primary outcome was patient-reported sexual dysfunction, measured using the Arizona Sexual Experience Scale. Secondary outcomes were researcher-rated sexual functioning, mental health, side effects of medication, health-related quality of life and service utilisation. Outcomes were assessed 3 and 6 months after randomisation. Qualitative data were collected from a purposive sample of patients and clinicians to explore barriers to recruitment. SAMPLE SIZE: Allowing for a 20% loss to follow-up, we needed to recruit 216 participants to have 90% power to detect a 3-point difference in total Arizona Sexual Experience Scale score (standard deviation 6.0 points) using a 0.05 significance level. RESULTS: The internal pilot was discontinued after 12 months because of low recruitment. Ninety-eight patients were referred to the study between 1 July 2018 and 30 June 2019, of whom 10 were randomised. Eight (80%) participants were followed up 3 months later. Barriers to referral and recruitment included staff apprehensions about discussing side effects, reluctance among patients to switch medication and reticence of both staff and patients to talk about sex. LIMITATIONS: Insufficient numbers of participants were recruited to examine the study hypotheses. CONCLUSIONS: It may not be possible to conduct a successful randomised trial of switching antipsychotic medication for sexual functioning in people with psychosis in the NHS at this time. FUTURE WORK: Research examining the acceptability and effectiveness of adjuvant phosphodiesterase inhibitors should be considered. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12307891. 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. 24, No. 44. See the NIHR Journals Library website for further project information.

Antipsychotic medications can improve the mental health of people with psychosis but may also cause side effects. These include sexual side effects, such as reduced desire for sex or less pleasure from having sex. One way to try to tackle this problem is to switch the medicine people take to one that is thought less likely to cause these problems. However, it is unclear if this helps, and switching medication could potentially harm mental health or cause new side effects. We conducted a study to compare the effect of switching with not switching the medication of people with psychosis experiencing sexual side effects. We collected information about sexual functioning, mental health, quality of life and use of services at the start of the study and 6 months later. We also interviewed nurses, doctors and patients to get their views about the study. We recruited 10 patients over a 12-month period and conducted interviews with 51 clinicians and four patients. Many clinicians said that they found it difficult to talk to their patients about sex. Some thought that these problems occurred rarely and that other side effects mattered more to patients. Many patients were concerned about switching their medication, especially when it had improved their mental health. Others felt that these side effects were not very important, and some were not prepared to take part in a trial that could delay a change being made to their medication. We did not collect enough information to be able to find out if switching medication helps people who experience sexual side effects of antipsychotic drugs. It is important that clinicians ask about sexual side effects of antipsychotic medication and that further efforts are made to find ways to help patients who experience them.

Structured Psychological Support for people with personality disorder: feasibility randomised controlled trial of a low-intensity intervention.

BACKGROUND: National guidance cautions against low-intensity interventions for people with personality disorder, but evidence from trials is lacking. AIMS: To test the feasibility of conducting a randomised trial of a low-intensity intervention for people with personality disorder. METHOD: Single-blind, feasibility trial (trial registration: ISRCTN14994755). We recruited people aged 18 or over with a clinical diagnosis of personality disorder from mental health services, excluding those with a coexisting organic or psychotic mental disorder. We randomly allocated participants via a remote system on a 1:1 ratio to six to ten sessions of Structured Psychological Support (SPS) or to treatment as usual. We assessed social functioning, mental health, health-related quality of life, satisfaction with care and resource use and costs at baseline and 24 weeks after randomisation. RESULTS: A total of 63 participants were randomly assigned to either SPS (n = 33) or treatment as usual (n = 30). Twenty-nine (88%) of those in the active arm of the trial received one or more session (median 7). Among 46 (73%) who were followed up at 24 weeks, social dysfunction was lower (-6.3, 95% CI -12.0 to -0.6, P = 0.03) and satisfaction with care was higher (6.5, 95% CI 2.5 to 10.4; P = 0.002) in those allocated to SPS. Statistically significant differences were not found in other outcomes. The cost of the intervention was low and total costs over 24 weeks were similar in both groups. CONCLUSIONS: SPS may provide an effective low-intensity intervention for people with personality disorder and should be tested in fully powered clinical trials.

Psychological Support for Personality (PSP) versus treatment as usual: study protocol for a feasibility randomized controlled trial of a low intensity intervention for people with personality disorder.

BACKGROUND: Previous research has demonstrated the clinical effectiveness of long-term psychological treatment for people with some types of personality disorder. However, the high intensity and cost of these interventions limit their availability. Lower-intensity interventions are increasingly being offered to people with personality disorder, but their clinical and cost effectiveness have not been properly tested in experimental studies. We therefore set out to develop a low intensity intervention for people with personality disorder and to test the feasibility of conducting a randomized controlled trial to compare the clinical effectiveness of this intervention with that of treatment as usual (TAU). METHODS: A two-arm, parallel-group, single-blind, randomized controlled trial of Psychological Support for Personality (PSP) versus TAU for people aged over 18 years, who are using secondary care mental health services and have personality disorder. We will exclude people with co-existing organic or psychotic mental disorders (dementia, bipolar affective disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizotypal disorder), those with cognitive or language difficulties that would preclude them from providing informed consent or compromise participation in study procedures, and those who are already receiving psychological treatment for personality disorder. Participants will be randomized via a remote system in a ratio of PSP to TAU of 1:1. Randomization will be stratified according to the referring team and gender of the participant. A single follow-up assessment will be conducted by masked researchers 24 weeks after randomization to assess mental health (using the Warwick and Edinburgh Well-Being Schedule), social functioning (using the Work and Social Adjustment Scale), health-related quality of life (EQ-5D-5 L), incidence of suicidal behavior, satisfaction with care (Client Satisfaction Questionnaire), and resource use and costs using a modified version of the Adult Service Use Schedule. In addition to this, each participant will be asked to complete the patient version of the Clinical Global Impression Scale. Feasibility and acceptability will primarily be judged by study recruitment rate and engagement and retention in treatment. The analysis will focus principally on descriptive data on the rate of recruitment, characteristics of participants, attrition, adherence to therapy, and follow-up. We will explore the distribution of study outcomes to investigate assumptions of normality in order to plan the analysis and sample size of a future definitive trial. DISCUSSION: Most people with personality disorder do not currently receive evidence-based interventions. While a number of high intensity psychological treatments have been shown to be effective, there is an urgent need to develop effective low intensity approaches to help people unable to use existing treatments. PSP is a low intensity intervention for individuals, which was developed following extensive consultation with users and providers of services for people with personality disorder. This study aims to examine the feasibility of a randomized trial of PSP compared to TAU for people with personality disorder. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN14994755 . Registered on 18 July 2017.

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

BACKGROUND: Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). OBJECTIVES: To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. DESIGN: International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. SETTING: Schools and private, voluntary and state-funded health-care services. PARTICIPANTS: Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. INTERVENTIONS: All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. MAIN OUTCOME MEASURES: The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). RESULTS: A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS social affect decreased from 14.1 to 13.3 in music therapy and from 13.5 to 12.4 in standard care [mean difference: music therapy vs. standard care = 0.06, 95% confidence interval (CI) -0.70 to 0.81], with no significant difference in improvement. There were also no differences in the parent-rated social responsiveness score, which decreased from 96.0 to 89.2 in the music therapy group and from 96.1 to 93.3 in the standard care group over this period (mean difference: music therapy vs. standard care = -3.32, 95% CI -7.56 to 0.91). There were seven admissions to hospital that were unrelated to the study interventions in the two IMT arms compared with 10 unrelated admissions in the ESC group. CONCLUSIONS: Adding IMT to the treatment received by children with ASD did not improve social affect or parent-assessed social responsiveness. FUTURE WORK: Other methods for delivering music-focused interventions for children with ASD should be explored. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78923965. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 59. See the NIHR Journals Library website for further project information.

A prospective, quantitative study of mental health act assessments in England following the 2007 amendments to the 1983 act: did the changes fulfill their promise?

BACKGROUND: In 2008, the Mental Health Act (MHA) 2007 amendments to the MHA 1983 were implemented in England and Wales. The amendments were intended to remove perceived obstacles to the detention of high risk patients with personality disorders (PDs), sexual deviance and learning disabilities (LDs). The AMEND study aimed to test the hypothesis that the implementation of these changes would lead to an increase in numbers or proportions of patients with these conditions who would be assessed and detained under the MHA 2007. METHOD: A prospective, quantitative study of MHA assessments undertaken between July-October 2008-11 at three English sites. Data were collected from local forms used for MHA assessment documentation and patient electronic databases. RESULTS: The total number of assessments in each four month period of data collection varied: 1034 in 2008, 1042 in 2009, 1242 in 2010 and 1010 in 2011 (n = 4415). Of the assessments 65.6% resulted in detention in 2008, 71.3% in 2009, 64.7% in 2010 and 63.5% in 2011. There was no significant change in the odds ratio of detention when comparing the 2008 assessments against the combined 2009, 2010 and 2011 data (OR = 1.025, Fisher's exact Χ 2 p = 0.735). Only patients with LD and 'any other disorder or disability of the mind' were significantly more likely to be assessed under the MHA post implementation (Χ2 = 5.485, P = 0.018; Χ2 = 24.962, P > 0.001 respectively). There was no significant change post implementation in terms of the diagnostic category of detained patients. CONCLUSIONS: In the first three years post implementation, the 2007 Act did not facilitate the compulsory care of patients with PDs, sexual deviance and LDs.

Likelihood and predictors of detention in patients with personality disorder compared with other mental disorders: A retrospective, quantitative study of Mental Health Act assessments.

BACKGROUND: The UK guidelines on the treatment of personality disorder recommend avoiding compulsory treatment except in extreme situations. Little is known about how often patients with personality disorder are detained or how this compares with the treatment of other mental disorders. OBJECTIVES: Our aim is to test the hypothesis that people with personality disorder are infrequently detained under the Mental Health Act (MHA) and that risk factors associated with detention are the same as those for people with other mental disorders. METHOD: We used a retrospective, quantitative study of MHA assessments. RESULTS: Of the 2 087 assessments undertaken, 204 (9.8%) patients had a diagnosis of personality disorder; 40.7% of assessments in the personality disorder group resulted in detention, as did 69.7% of patients with other mental disorders. A higher proportion of people with personality disorder received no intervention following assessment compared with those with other mental disorders (20.6% vs. 4.7%, p < 0.001). Study centre and a history of admission were risk factors for detention in both groups. Risk was a predictor of detention in those with other mental disorders. CONCLUSIONS: Detention rates in patients with personality disorder are lower than those for other disorders but are still substantial. Risk factors for detention in patients with personality disorder differ from those with other mental disorders. Copyright © 2016 John Wiley & Sons, Ltd.

Patient experience of negative effects of psychological treatment: results of a national survey†.

BACKGROUND: To make informed choices, patients need information about negative as well as positive effects of treatments. There is little information about negative effects of psychological interventions. AIMS: To determine the prevalence of and risk factors for perceived negative effects of psychological treatment for common mental disorders. METHOD: Cross-sectional survey of people receiving psychological treatment from 184 services in England and Wales. Respondents were asked whether they had experienced lasting bad effects from the treatment they received. RESULTS: Of 14 587 respondents, 763 (5.2%) reported experiencing lasting bad effects. People aged over 65 were less likely to report such effects and sexual and ethnic minorities were more likely to report them. People who were unsure what type of therapy they received were more likely to report negative effects (odds ratio (OR) = 1.51, 95% CI 1.22-1.87), and those that stated that they were given enough information about therapy before it started were less likely to report them (OR = 0.65, 95% CI 0.54-0.79). CONCLUSIONS: One in 20 people responding to this survey reported lasting bad effects from psychological treatment. Clinicians should discuss the potential for both the positive and negative effects of therapy before it starts.

Selecting outcome measures in mental health: the views of service users.

BACKGROUND: Little is known about service users' views of measures used to evaluate treatments in mental health. AIMS: To identify the views of people with psychosis and affective disorder about the relevance and acceptability of commonly used outcome measures. METHODS: Twenty-four widely used outcome measures were presented to expert groups of service users. Nominal group methods were used to develop consensus about the appropriateness of each measure. Comments made by service users about how outcomes should be assessed were also recorded. RESULTS: Group members expressed concern about the ability of some outcome measures to capture their experiences. Patient-rated measures were assessed as more relevant and appropriate than staff-rated measures, and the need to examine negative as well as the positive effects of treatments was emphasised. Specific concerns were raised about some widely used measures including the Global Assessment of Functioning and the European Quality of Life scale. CONCLUSIONS: We consider it essential that service users' views are taken into account when selecting measures to evaluate treatment outcomes. Providing insight into views of users of mental health services, our findings serve as a starting point for discussion.

Impact of screening for risk of suicide: randomised controlled trial.

BACKGROUND: Concerns have been expressed about the impact that screening for risk of suicide may have on a person's mental health. AIMS: To examine whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living. METHOD: In a multicentre, single-blind, randomised controlled trial, 443 patients in four general practices were randomised to screening for suicidal ideation or control questions on health and lifestyle (trial registration: ISRCTN84692657). The primary outcome was thinking that life is not worth living measured 10-14 days after randomisation. Secondary outcome measures comprised other aspects of suicidal ideation and behaviour. RESULTS: A total of 443 participants were randomised to early (n = 230) or delayed screening (n = 213). Their mean age was 48.5 years (s.d. = 18.4, range 16-92) and 137 (30.9%) were male. The adjusted odds of experiencing thoughts that life was not worth living at follow-up among those randomised to early compared with delayed screening was 0.88 (95% CI 0.66-1.18). Differences in secondary outcomes between the two groups were not seen. Among those randomised to early screening, 37 people (22.3%) reported thinking about taking their life at baseline and 24 (14.6%) that they had this thought 2 weeks later. CONCLUSIONS: Screening for suicidal ideation in primary care among people who have signs of depression does not appear to induce feelings that life is not worth living.

A study of cardiovascular risk in overweight and obese people in England.

OBJECTIVES: To report current levels of obesity and associated cardiac risk using routinely collected primary care computer data. METHODS: 67 practices took part in an educational intervention to improve computer data quality and care in cardiovascular disease. Data were extracted from 435,102 general practice computer records. 64.3% (229,108/362,861) of people age 15 y and older had a body mass index (BMI) recording or a valid height and weight record that enabled BMI to be derived. Data about cardiovascular disease and risk factors were also extracted. The prevalence of disease and the control of risk factors in the overweight and obese population were compared with those of normal body weight. RESULTS: 56.8% of men and 69.3% of women aged over 15 y had a BMI record. 22% of men and 32.3% of women aged 15 to 24 y were overweight or obese; rising each decade to a peak of 65.6% of men and 57.5% of women aged 55 to 64 y. Thereafter, the proportion who were overweight or obese declined. The prevalence of ischaemic heart disease, diabetes mellitus and hypertension rose with increasing levels of obesity; their prevalence in those who are moderately obese was between two and three times that of the general population. Systolic and diastolic blood pressure, blood glucose even in non-diabetics, cholesterol and triglycerides were all elevated in the overweight and obese population. CONCLUSION: Based on the recorded data over half of men and nearly half of women are overweight or obese. They have increased cardiovascular risk, which is not adequately controlled by current practice.

Preventing stroke in people with atrial fibrillation: a cross-sectional study.

BACKGROUND: The annual stroke rate in atrial fibrillation is around 5 per cent with increased risk in those with hypertension, diabetes, left ventricular dysfunction and other cardiovascular risk factors. This study set out to identify the patients with atrial fibrillation and modifiable risk factors for stroke. METHOD: Analysis of practice computer data taken from eight general practices (81 811 patients) in the south of England. 944 patients with a diagnosis of atrial fibrillation, of whom 782 (82.8 percent) were aged 65 years and over. RESULTS: The age standardised prevalence of diagnosed atrial fibrillation was 1.23 per cent (1.28 percent for men and 1.18 percent for women). It was much more prevalent in the older population, 8.28 percent and 6.66 percent for males and females over 65, respectively. Cardiovascular co-morbidities were more frequent with increasing age. Blood pressure (BP) was recorded in over 95 per cent of patients with atrial fibrillation though there was scope for improving control; 25 per cent of men and 31 per cent women had a BP over 150/90. Inconsistent recording of ECG and echocardiography made it hard to identify patients with left ventricular dysfunction. Forty six percent of men and 37 percent of women were either being prescribed Warfarin, or had contraindications to its use; of those on Warfarin 75.9 percent have an international normalized ratio in range. Forty four per cent were treated with aspirin. People at high risk of stroke were no more likely to be treated with Warfarin or aspirin than those at moderate risk. CONCLUSIONS: The rate of use of Warfarin remains low, and there is scope for better recording and management of risk factors particularly BP.