The potential for medicinal cannabis to help manage challenging behaviour in people with intellectual disability: A perspective review

Background: Around 2% of the population have intellectual disabilities. Over one-third people with intellectual disabilities (PwID) present with ‘challenging behaviour’, which nosologically and diagnostically is an abstract concept. Challenging behaviour is influenced by a range of bio-psycho-social factors in a population, which is unable to suitably comprehend and/or communicate concerns. This predisposes to poor health and social outcomes. There is no evidence-based treatments for managing challenging behaviour. Cannabidiol (CBD) and tetrahydrocannabinol (THC) are being trialled for a range of disorders, which are over-represented in PwID and provoke challenging behaviours, such as severe epilepsy, spasticity, post-traumatic stress disorder, social phobia, pain, etc.// Methods: This perspective review explores the different conditions, which benefit from medicinal CBD/THC preparations, by analysing recent literature from neurobiological, pre-clinical and clinical studies related to the topic. The evidence is synthesised to build an argument of the therapeutic benefits and challenges of medicinal cannabis to manage severe challenging behaviour in PwID.// Results: There is developing evidence of medicinal CBD/THC improving psychiatric and behavioural presentations in general. In particular, there is emergent proof in certain key areas of influence of medicinal CBD/THC positively supporting challenging behaviour, for example in children with neurodevelopmental disorders. However, there are significant challenges in employing such treatments in vulnerable populations such as PwID.// Conclusion: Further clinical research for the considered use of medicinal CBD/THC for challenging behaviour management in PwID is needed. Strong co-production with experts with lived experience is needed for further testing to be done in this exciting new area

Collaborative care intervention for individuals with severe mental illness: the PARTNERS2 programme including complex intervention development and cluster RCT

Background and aims: Individuals living with severe mental illness such as schizophrenia and bipolar can have significant emotional, cognitive, physical and social challenges. Most people with severe mental illness in the United Kingdom do not receive specialist mental health care. Collaborative care is a system of support that combines clinical and organisational components to provide integrated and person-centred care. It has not been tested for severe mental illness in the United Kingdom. We aimed to develop and evaluate a primary care-based collaborative care model (PARTNERS) designed to improve quality of life for people with diagnoses of schizophrenia, bipolar or other psychoses when compared with usual care. Methods: Phase 1 included studies to (1) understand context: an observational retrospective study of primary and secondary care medical records and an update of the Cochrane review ‘Collaborative care approaches for people with severe mental illness’; (2) develop and formatively evaluate the PARTNERS intervention: a review of literature on collaborative care and recovery, interviews with key leaders in collaborative care and recovery, focus groups with service users and a formative evaluation of a prototype intervention model; and (3) develop trial science work in this area: a core outcome set for bipolar and recruitment methods. In phase 2 we conducted a cluster randomised controlled trial measuring quality of life using the Manchester Short Assessment of Quality of Life and secondary outcomes including time use, recovery and mental well-being; a cost-effectiveness study; and a mixed-methods process evaluation. Public involvement underpinned all of the workstream activity through the study Lived Experience Advisory Panel and the employment of service user researchers in the project team. Results phase 1: The study of records showed that care for individuals under secondary care is variable and substantial and that people are seen every 2 weeks on average. The updated Cochrane review showed that collaborative care interventions were highly variable, and no reliable conclusions can be drawn about effectiveness. The PARTNERS model incorporated change at organisational, practitioner and individual levels. Coaching was selected as the main form of support for individuals’ personal goals. In the formative evaluation, we showed that more intensive supervision and ‘top-up’ training were needed to achieve the desired shifts in practice. A core outcome set was developed for bipolar, and measures were selected for the trial. We developed a stepped approach to recruitment including initial approach and appointment. Results phase 2: The trial was conducted in four areas. In total, 198 participants were recruited from 39 practices randomised. Participants received either the PARTNERS intervention or usual care. The follow-up rate was 86% at 9–12 months. The mean change in overall Manchester Short Assessment Quality of Life score did not differ between the groups [0.25 (standard deviation 0.73) for intervention vs. 0.21 (standard deviation 0.86) for control]. We also found no difference for any secondary measures. Safety outcomes (e.g. crises) did not differ between those receiving and those not receiving the intervention. Although the costs of intervention and usual care were similar, there is insufficient evidence to draw conclusions about the overall cost-effectiveness of PARTNERS. The mixed-methods process evaluation demonstrated that a significant proportion of individuals did not receive the full intervention. This was partly due to care partner absence and participant choice. The in-depth realist informed case studies showed that participants generally appreciated the support, with some describing having a ‘professional friend’ as very important. For some people there was evidence that delivery of the intervention had led to specific personal changes. Strengths and limitations: The phase 1 records study provided insights into usual care that had not been previously documented. The realist informed complex intervention development was both theoretical and pragmatic. The trial continued through the COVID-19 pandemic with high levels of follow-up. The process evaluation had the depth to explore individual changes in participants’ response to the intervention. Weaknesses in the trial methodology included suboptimal implementation, outcome measures that may not have been sensitive to changes patients most appreciated and difficulties collecting some outcomes. Conclusions: While PARTNERS was not shown to be superior to usual care, the change to PARTNERS care was not shown to be unsafe. Full intervention implementation was challenging, but this is to be expected in studies of care that include those with psychosis. Some individuals responded well to the intervention when psychological support in the form of individualised goal setting was flexibly deployed, with evidence that having access to a ‘professional friend’ was experienced as particularly helpful for some individuals. Future work: Key components of the PARTNERS model could be developed further and tested, along with improved supervision in the context of ongoing community mental health care change. Trial registration: This trial is registered as ISRCTN95702682

Steps to prevent SUDEP: the validity of risk factors in the SUDEP and seizure safety checklist: a case control study

Our objectives were to compare people with epilepsy (PWE) who died of sudden unexpected death in epilepsy (SUDEP) with live controls using the risk factor items of the SUDEP and Seizure Safety Checklist. All 48 SUDEPs of 93 epilepsy deaths which occurred in Cornwall UK 2004–2012 were compared to 220 live controls using the SUDEP and Seizure Safety Checklist, an evidenced based tool used to communicate person centered risk of SUDEP to PWE. The odds ratio for having a specific factor in those who died was compared to controls and ranked according to P value using a sequential Bonferroni correction for multiple comparisons. Of the 17 modifiable and non-modifiable risk factors analyzed 9 were statistically significant of which 7 are potentially modifiable. Well known modifiable factors such as nocturnal monitoring, compliance and sleeping position featured prominently in the risk association. This is the first case control study exploring the risk factors for SUDEP since 2009. The findings are compared to the current considered risk factors as identified in a major recent review. The study further validates certain SUDEP risk factors. It highlights that the majority of risk factors strongly associated with SUDEP are potentially modifiable. There is an emerging profile to rank the risk factors. It furthers the evidence to use structured risk assessment and communication tools such as the SUDEP and Seizure Safety Checklist in daily clinical practice. It highlights key areas for a person centered discussion to empower PWE to mitigate risk

Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial

Background Obesity is a major challenge for people with schizophrenia. Aims We assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. Method In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. Results Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI-1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. Conclusions Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia