Structured psychological support for people with personality disorder: feasibility randomised controlled trial of a low-intensity intervention

National guidance cautions against low-intensity interventions for people with personality disorder, but evidence from trials is lacking. To test the feasibility of conducting a randomised trial of a low-intensity intervention for people with personality disorder. 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. 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. SPS may provide an effective low-intensity intervention for people with personality disorder and should be tested in fully powered clinical trials

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

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

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

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

BackgroundSexual 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.ObjectiveTo examine whether or not switching antipsychotic medication provides a clinically effective and cost-effective method to reduce sexual dysfunction in people with psychosis.DesignA 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.SettingNHS secondary care mental health services in England.ParticipantsPotential 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.InterventionsSwitching 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 measuresThe 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 sizeAllowing 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.ResultsThe 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.LimitationsInsufficient numbers of participants were recruited to examine the study hypotheses.ConclusionsIt 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 workResearch examining the acceptability and effectiveness of adjuvant phosphodiesterase inhibitors should be considered.Trial registrationCurrent Controlled Trials ISRCTN12307891.FundingThis 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

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

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