The development of a novel sexual health promotion intervention for young people with mental ill-health: the PROSPEct project.

BACKGROUND: Young people with mental ill-health experience higher rates of high-risk sexual behaviour, have poorer sexual health outcomes, and lower satisfaction with their sexual wellbeing compared to their peers. Ensuring good sexual health in this cohort is a public health concern, but best practice intervention in the area remains under-researched. This study aimed to co-design a novel intervention to address the sexual health needs of young people with mental ill-health to test its effectiveness in a future trial undertaken in youth mental health services in Melbourne, Australia. METHODS: We followed the 2022 Medical Research Council (MRC) guidelines for developing and evaluating complex interventions. This involved synthesising evidence from the 'top down' (published evidence) and 'bottom up' (stakeholder views). We combined systematic review findings with data elicited from qualitative interviews and focus groups with young people, carers, and clinicians and identified critical cultural issues to inform the development of our intervention. RESULTS: Existing evidence in the field of sexual health in youth mental health was limited but suggested the need to address sexual wellbeing as a concept broader than an absence of negative health outcomes. The Information-Motivation-Belief (IMB) model was chosen as the theoretical Framework on which to base the intervention. Interviews/focus groups were conducted with 29 stakeholders (18 clinicians, three carers, and eight young people). Synthesis of the evidence gathered resulted in the co-design of a novel intervention consisting of an initial consultation and four 60-90-minute sessions delivered individually by a young 'sex-positive' clinician with additional training in sexual health. Barriers and supports to intervention success were also identified. CONCLUSIONS: Using the MRC Framework has guided the co-design of a potentially promising intervention that addresses the sexual health needs of young people with mental ill-health. The next step is to test the intervention in a one-arm feasibility trial.

Prevalence and Correlates of Tobacco Use in Young People Presenting to Australian Primary Mental Health Services.

INTRODUCTION: In Australian youth primary mental health settings it is unclear as to the rates and correlates of tobacco use at service entry. AIMS AND METHODS: We aimed to delineate the prevalence and correlates of recent tobacco use (eg, cigarettes, chewing tobacco, cigars, etc) in the past 3 months in young people at their first presentation to primary mental health services as a function of age. Cross-sectional self-report measures were collected using a tablet device from young people presenting to one of five Australian primary mental health (headspace) services. Logistic regression assessed correlates of past 3-month tobacco use in adolescents (12-17 years) and young adults (18-25 years). RESULTS: Regular (at least monthly) tobacco use in the past 3 months was found in 23.4% (n = 247, N = 1055) of the sample. Increasing age (odds ratio [OR] =1.47 per year; 95% confidence interval [CI]: 1.15 to 1.89), male sex (OR = 1.98; 95% CI: 1.02 to 3.83), being in a relationship (OR = 1.96; 95% CI: 1.01 to 3.82), and poorer functioning (OR = 0.95 per unit Social and Occupational Functioning Assessment Scale increase; 95% CI: 0.91 to 0.99) predicted regular tobacco use in adolescents, but not in young adults. Living in a regional location (OR = 2.10; 95% CI: 1.40 to 3.13) and not studying (OR = 0.47; 95% CI: 0.31 to 0.73) predicted tobacco use in young adults. Having a diagnosed mental illness other than depression and/or anxiety predicted tobacco use in both groups (adolescents OR = 2.49; 95% CI: 1.26 to 4.94; young adults OR = 1.80; 95% CI: 1.13 to 2.89). CONCLUSIONS: Nearly a quarter of young people with mental illness are using tobacco, supporting the need for early intervention approaches. Adapting treatment targets by age could improve the impact of interventions in adolescents versus young adults. Poor functioning and lack of engagement in education were associated with tobacco use in both age groups, respectively; however, more research is needed to determine the direction of these relationships. IMPLICATIONS: Young people with mental illness have a high prevalence of recent tobacco use and this is evident when they first present to youth primary mental health services. Youth-oriented mental health settings may provide a unique window for tobacco use prevention and early intervention to reduce smoking in people with mental illness, a priority population. Age-specific targeted approaches might be needed in adolescents and young adults.

The effectiveness of peer support from a person with lived experience of mental health challenges for young people with anxiety and depression: a systematic review.

BACKGROUND: Peer workers support individuals experiencing mental health challenges by drawing on their shared lived experience. Peer support has become increasingly popular for young people with anxiety and depression, but the evidence base is unclear. This systematic review aimed to understand the effectiveness of peer support for youth depression and anxiety (either primary or comorbid), and to understand in which contexts, for whom, and why peer support works. METHODS: A systematic search was conducted with the Orygen Evidence Finder, Embase, MEDLINE, and PsycInfo from January 1980 to July 2022. Controlled trials of interventions to improve mental health in young people (mean age 14-24), delivered by a peer worker with lived experienced of mental health challenges were included. Outcomes related to depression or anxiety were extracted and descriptive synthesis was undertaken due to the heterogeneity of studies. Study quality was rated using the Critical Appraisal Skills Programme; reporting adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RESULTS: Nine randomised controlled trials with 2,003 participants were included, with seven undertaken in high income countries. One targeted depression and anxiety, two stigma-distress (any mental disorder), one first episode psychosis, four studies preventing eating disorders and one drug misuse. One study successfully reduced anxiety and depression, another reduced depression only, four reported reductions in negative affect, with the final three measuring, but not having a significant impact on depression. Study quality was rated as 'good' overall. DISCUSSION: Despite the uptake of youth peer support globally, there is limited evidence from controlled trials of the effect of peer support-related interventions on anxiety and depression. There is some effect on negative affect, especially for university students. Further rigorously designed trials of peer delivered interventions for young people need to be conducted with a focus on understanding the mechanisms of action underpinning peer support.

Discharge destinations for young people with a first episode of psychosis after attending an early intervention for psychosis service.

OBJECTIVE: Early intervention for psychosis services result in superior outcomes in the domains of symptomatic and functional recovery, hospitalisation and employment compared to standard services; however, the optimal duration of care with these services is unknown. Knowledge on the discharge destinations, specifically the proportion discharged to high- and low-intensity services, could provide insights into the proportion of who may require a longer tenure of care. This study aimed to determine (1) the discharge destinations from early intervention for psychosis services and (2) baseline and intra-episode factors associated with discharge to the secondary care/adult mental health service. METHODOLOGY: This study was conducted at the Early Psychosis Prevention and Intervention Centre in Melbourne and included all young people treated by the service with a first episode of psychosis over a 6-year period. Discharge destinations were categorised according to high-intensity services, namely, secondary mental health care, or lower intensity services, such as private practitioners or primary care. RESULTS: A total of 1101 young people with a first episode of psychosis were included in the study, of whom 58.8% were male and the median age was 20.0 years (interquartile range: 17-22). After a median of 95.4 weeks (interquartile range: 66.7-105.7), 36.6% were discharged to the adult mental health services, which was associated with being not in employment, education or training at presentation (odds ratio = 1.71, 95% confidence interval [1.23, 2.37]); experiencing a relapse (odds ratio = 1.76, 95% confidence interval [1.24, 2.49]); and being admitted to a mental health unit (odds ratio = 3.98, 95% confidence interval [2.61, 6.09]). Young people who lived with their parents were less likely to be discharged to secondary care services (odds ratio = 0.52, 95% confidence interval [0.37, 0.73]), as were those who were achieving symptomatic remission within 12 weeks (odds ratio = 0.60, 95% confidence interval [0.43, 0.83]). Migrant status and the duration of untreated psychosis were not associated with discharge destination. CONCLUSION: These findings indicate that there is a sizable, identifiable minority who may benefit from a longer episode of care with early intervention for psychosis services.

Correlates of substance use in a large naturalistic cohort of young people with early and emerging psychosis.

BACKGROUND: Substance use remains a barrier to recovery for young people accessing early intervention services for psychosis. While correlates of use have been explored in populations experiencing a first episode of psychosis (FEP), sample sizes have been small and less research assesses cohorts at ultrahigh risk of psychosis (UHR). METHODS: This study uses data from a naturalistic cohort including UHR and FEP participants (N = 1252) to elucidate clinical correlates of use in the past 3 months of any illicit substance, amphetamine-type stimulants (ATS), cannabis, and tobacco. Moreover, network analysis based on use of these substances and additionally alcohol, cocaine, hallucinogens, sedatives, inhalants, and opioids was completed. RESULTS: Young people with FEP used substances at significantly higher rates than those at UHR. High concurrence of use was seen between substances. In the FEP group, participants who had used any illicit substance, ATS, and/or tobacco had increased positive symptoms and decreased negative symptoms. Young people with FEP who used cannabis had increased positive symptoms. In the UHR group, participants who had used any illicit substance, ATS, and/or cannabis in the past 3 months showed decreased negative symptoms compared to those who had not. CONCLUSION: A distinct clinical picture of more florid positive symptoms and alleviated negative symptoms seen in those who use substances in the FEP group appears muted in the UHR cohort. Treating young people at UHR in early intervention services represents the earliest opportunity to address substance use early to improve outcomes.

Understanding the complexity, patterns, and correlates of alcohol and other substance use among young people seeking help for mental ill-health.

PURPOSE: Use of alcohol and other substances is a multifaceted issue impacting young people across multiple life domains. This paper aims to elucidate patterns of substance use and associated demographic and clinical factors among young people seeking treatment for their mental health. METHODS: Young people (12-25 years old) were recruited from five youth-specific primary mental health ("headspace") services in Australia. Self-reported substance use and harms in the past 3 months were measured using WHO-ASSIST. Network analyses were conducted to evaluate interrelationships between use and harms associated with different substances. Subgroups were then identified based on whether participants reported using high centrality substances, and associated demographic and clinical factors were assessed with multinomial logistic regression. RESULTS: 1107 youth participated. 70% reported use of at least one substance in the past 3 months, with around 30% of those reporting related health, social, legal or financial problems. Network analysis highlighted substantial interconnections between use and harm indicators for all substances, with amphetamine-type stimulants (ATS) and cannabis being high central substances. Higher levels of substance use and harms were reported in subgroups with ATS or cannabis use and different risk factors were associated with these subgroups. CONCLUSIONS: Findings highlight the importance of screening for substance use in youth primary mental healthcare settings, offering a key opportunity for early intervention. Clinicians should be aware of the inner connections of use and harms of different drugs and the role of cannabis and amphetamine use as a marker for more substance use profiles.

Co-designing a peer-led model of delivering behavioural activation for people living with depression or low mood in Australian farming communities.

INTRODUCTION: Farmers face a range of factors that negatively influence their mental health and suicide risk, yet have limited access to appropriate support. Behavioural activation (BA) is an evidence-based therapy that can be effectively delivered by nonclinical workers. Working with members of farming communities to deliver BA to their peers has the potential to overcome many well-established barriers to mental health help-seeking and improve outcomes for this at-risk group. OBJECTIVE: This paper describes the findings of a co-design phase informing the development of a peer (farmer)-led approach for delivering BA for farmers living with depression or low mood. DESIGN: This qualitative study used a co-design approach involving members of the target community. Focus groups were transcribed and analysed using Thematic Analysis and the Framework approach. FINDINGS: Ten online focus groups with 22 participants were held over 3 months. Four overarching, interlinked themes were identified: (i) filling the gap in rural mental health support; (ii) alignment with the farming context-tailoring how, where and when we engage about mental health; (iii) the 'messenger' is as important as the message; and (iv) sustainability, governance and support. DISCUSSION: Findings suggest BA could be a contextually appropriate model of support for the farming community-given its practical and solution-focused approach-and could help improve access to support. Having peer workers deliver the intervention was viewed as appropriate. Ensuring governance structures are developed to support peers to deliver the intervention will be essential to facilitate effectiveness, safety and sustainability. CONCLUSION: Insights gained through co-design have been critical to the success of developing this new model of support for members of farming communities experiencing depression or low mood.

The clinical and functional outcomes of a large naturalistic cohort of young people accessing national early psychosis services.

AIMS: Services for individuals with a first episode of psychosis or at ultra-high risk of psychosis have become a treatment model of choice in mental health care. The longitudinal changes in clinical and functional outcomes as a result of real-world treatment remain under-reported. METHODS: We analysed data from first episode of psychosis and ultra-high risk services delivered across Australian primary youth mental health care services known as headspace between 19 June 2017 and 30 September 2019. Outcome measures were completed and entered into a minimum dataset every 90 days a participant was receiving treatment and included psychiatric symptomatology (Brief Psychiatric Rating Scale and psychological distress, K10) and psychosocial functioning (Social and Occupational Functioning Assessment Scale and My Life Tracker). Linear mixed-effects models were used to evaluate changes in outcome over time. RESULTS: Outcome data from a total of 1252 young people were evaluated (643 first episode of psychosis, 609 ultra-high risk). Of those who entered ultra-high risk services, 11.8% transitioned to first episode of psychosis services. Overall, substantial improvement in clinical (Brief Psychiatric Rating Scale, K10) and functional (Social and Occupational Functioning Assessment Scale, My Life Tracker) outcomes were seen across groups and outcomes. Ultra-high risk patients showed a greater reduction in distress symptoms, while first episode of psychosis patients experienced a greater reduction in positive psychosis symptoms. Although clinical outcomes showed a plateau effect after approximately 3 months of care, improvement in functional outcomes (Social and Occupational Functioning Assessment Scale, My Life Tracker) continued later in treatment. CONCLUSION: These findings support the use of real-time, real-world and low-cost administrative data to rigorously evaluate symptomatic and functional outcomes in early psychosis treatment settings. Findings that functional outcomes improve past the remittance of clinical outcomes also support the functional recovery focus of early psychosis services and remaining high levels of distress suggest the need for ultra-high risk services to extend beyond 6 months of care.

The incidence and admission rate for first-episode psychosis in young people before and during the COVID-19 pandemic in Melbourne, Australia.

OBJECTIVE: The COVID-19 pandemic has had a profound effect on global mental health, with one-third of infected individuals developing a psychiatric or neurological disorder 6 months after infection. The risk of infection and the associated restrictions introduced to reduce the spread of the virus have also impacted help-seeking behaviours. Therefore, this study aimed to determine whether there was a difference during the COVID-19 pandemic in the treated incidence of psychotic disorders and rates of admission to hospital for psychosis (including involuntary admission). METHODS: Incident cases of first-episode psychosis in young people, aged 15 to 24, at an early intervention service in Melbourne from an 8-month period before the pandemic were compared with rates during the pandemic. Hospital admission rates for these periods were also compared. RESULTS: Before the pandemic, the annual incidence of first-episode psychosis was 104.5 cases per 100,000 at-risk population, and during the pandemic it was 121.9 (incidence rate ratio = 1.14, 95% confidence interval = [0.92, 1.42], p = 0.24). Immediately after the implementation of restrictions, there was a non-significant reduction in the treated incidence (incidence rate ratio = 0.80, 95% confidence interval = [0.58, 1.09]), which was followed by a significant increase in the treated incidence in later months (incidence rate ratio = 1.94, 95% confidence interval = [1.52, 2.49]; incidence rate ratio = 1.64, 95% confidence interval = [1.25, 2.16]). Before the pandemic, 37.3% of young people with first-episode psychosis were admitted to hospital, compared to 61.7% during the pandemic (odds ratio = 2.71, 95% confidence interval = [1.73, 4.24]). Concerning the legal status of the admissions, before the pandemic, 27.3% were admitted involuntarily to hospital, compared to 42.5% during the pandemic (odds ratio = 1.97, 95% confidence interval = [1.23, 3.14]). CONCLUSION: There was a mild increase, which did not reach statistical significance, in the overall incidence of first-episode psychosis; however, the pattern of presentations changed significantly, with nearly twice as many cases presenting in the later months of the restrictions. There was a significant increase in both voluntary and involuntary admissions, and the possible explanations for these findings are discussed.

What impact does illness severity have on the sexual health of young people affected by mental health disorders? A comparison of inpatients and outpatients.

OBJECTIVE: Young people affected by mental health disorders have greater sexual health needs compared to their peers. Less is known about this need across illness severity. METHOD: A cross-sectional survey of the sexual health of those attending outpatients or inpatients within a youth mental health service was conducted. Statistical differences between groups were explored. RESULTS: One hundred and seven young people (18-25 years) participated and of these, 37.7% were inpatients who had more severe psychiatric symptoms than outpatients. While inpatients were as likely to be sexually active as outpatients, they were significantly less likely to have a regular sexual partner (25% vs 64.5%). Additionally, they used amphetamines more frequently during sex (28.6% vs 5.8%). Sexual dysfunction was experienced by 55.6% of inpatients and 37.9% of outpatients. CONCLUSIONS: High-risk sexual behaviours and sexual dysfunction were highly prevalent in both groups. For some behaviours and dysfunction, this prevalence was higher in the inpatient population. Holistic clinical services that address the mental, physical and sexual health needs of consumers are needed both within inpatient and outpatient settings.

A novel way to quantify schizophrenia symptoms in clinical trials.

BACKGROUND: A major problem in quantifying symptoms of schizophrenia is establishing a reliable distinction between enduring and dynamic aspects of psychopathology. This is critical for accurate diagnosis, monitoring and evaluating treatment effects in both clinical practice and trials. MATERIALS AND METHODS: We applied Generalizability Theory, a robust novel method to distinguish between dynamic and stable aspects of schizophrenia symptoms in the widely used Positive and Negative Symptom Scale (PANSS) using a longitudinal measurement design. The sample included 107 patients with chronic schizophrenia assessed using the PANSS at five time points over a 24-week period during a multi-site clinical trial of N-Acetylcysteine as an add-on to maintenance medication for the treatment of chronic schizophrenia. RESULTS: The original PANSS and its three subscales demonstrated good reliability and generalizability of scores (G = 0.77-0.93) across sample population and occasions making them suitable for assessment of psychosis risks and long-lasting change following a treatment, while subscales of the five-factor models appeared less reliable. The most enduring symptoms represented by the PANSS were poor attention, delusions, blunted affect and poor rapport. More dynamic symptoms with 40%-50% of variance explained by patient transient state including grandiosity, preoccupation, somatic concerns, guilt feeling and hallucinatory behaviour. CONCLUSIONS: Identified dynamic symptoms are more amendable to change and should be the primary target of interventions aiming at effectively treating schizophrenia. Separating out the dynamic symptoms would increase assay sensitivity in trials, reduce the signal to noise ratio and increase the potential to detect the effects of novel therapies in clinical trials.

Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d'appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d'efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo.

OBJECTIVES: Garcinia mangostana Linn. ("mangosteen") pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. METHODS: People diagnosed with schizophrenia or schizoaffective disorder (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. RESULTS: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. CONCLUSION: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

Novel Genetic Locus Influencing Retinal Venular Tortuosity Is Also Associated With Risk of Coronary Artery Disease.

OBJECTIVE: The retina may provide readily accessible imaging biomarkers of global cardiovascular health. Increasing evidence suggests variation in retinal vascular traits is highly heritable. This study aimed to identify the genetic determinants of retinal vascular traits. Approach and Results: We conducted a meta-analysis of genome-wide association studies for quantitative retinal vascular traits derived using semi-automatic image analysis of digital retinal photographs from the GoDARTS (Genetics of Diabetes Audit and Research in Tayside; N=1736) and ORCADES (Orkney Complex Disease Study; N=1358) cohorts. We identified a novel genome-wide significant locus at 19q13 (ACTN4/CAPN12) for retinal venular tortuosity (TortV), and one at 13q34 (COL4A2) for retinal arteriolar tortuosity (TortA); these 2 loci were subsequently confirmed in 3 independent cohorts (Ntotal=1413). In the combined analysis of discovery and replication cohorts, the lead single-nucleotide polymorphism in ACTN4/CAPN12 was rs1808382 (ßs.d.=-0.109; SE=0.015; P=2.39×10-13) and in COL4A2 was rs7991229 (ßs.d.=0.103; SE=0.015; P=4.66×10-12). Notably, the ACTN4/CAPN12 locus associated with TortV is also associated with coronary artery disease, heart rate, and atrial fibrillation. CONCLUSIONS: Genetic determinants of retinal vascular tortuosity are also linked to cardiovascular health. These findings provide a molecular pathophysiological foundation for the use of retinal vascular traits as biomarkers for cardiovascular diseases.

Defining disengagement from mental health services for individuals experiencing first episode psychosis: a systematic review.

BACKGROUND: Individuals affected by psychotic disorders frequently disengage from mental health services, although reports of this rate in the literature have ranged from 6 to 60%. One of the potential explanations for the large variation is that studies have adopted different definitions. Without a universal definition it is challenging to compare rates and factors leading to disengagement across studies. This systematic review aims to identify and compare how disengagement from psychosis services has been defined, measured and operationalised in the literature to date. METHODS: A systemic literature search of the PubMed, PsycINFO and CINAHL databases was completed following the PRISMA guidelines for systematic reviews. RESULTS: 1506 Studies were identified, of which 30 were eligible to be included. It was found that disengagement was operationalized as either a categorical or continuous variable across studies, with 18 studies classifying it as a categorical, binary variable. Only four studies applied a time period over which disengagement was said to occur, and only four studies used an instrument to measure or predict disengagement. Few studies considered similar factors in their definition, when this occurred it was because the papers came from the same research group. DISCUSSION: To truly understand the phenomenon of disengagement, studies need to have a comparable outcome variable. The need for consensus on a gold standard definition of disengagement that considers the full breadth of its complexity remains. A potential process for establishing a definition that includes set parameters, agreed upon terminology and time periods of assessment is discussed.

The rates and determinants of disengagement and subsequent re-engagement in young people with first-episode psychosis.

BACKGROUND: A core component of treatment provided by early intervention for psychosis (EI) services is ensuring individuals remain successfully engaged with the service. This ensures they can receive the care they may need at this critical early stage of illness. Unfortunately, rates of disengagement are high in individuals with a first episode of psychosis (FEP), representing a major barrier to effective treatment. This study aimed to ascertain the rates and determinants of disengagement and subsequent re-engagement of young people with FEP in a well-established EI service in Melbourne, Australia. METHOD: This cohort study involved all young people, aged 15-24, who presented to the Early Psychosis Prevention and Intervention Centre (EPPIC) service with FEP between 1st January 2011 and 1st September 2014. Data were collected retrospectively from clinical files and electronic records. Cox regression analysis was used to identify determinants of disengagement and re-engagement. RESULTS: A total of 707 young people presented with FEP during the study period, of which complete data were available for 700. Over half of the cohort (56.3%, N = 394) disengaged at least once during their treatment period, however, the majority of these individuals (85.5%, N = 337) subsequently re-engaged following the initial episode of disengagement. Of those who disengaged from the service, 54 never re-engaged, representing 7.6% of the total cohort. Not being in employment, education or training, not having a family history of psychosis in second degree relatives and using cannabis were found to be significant predictors of disengagement. No significant predictors of re-engagement were identified. CONCLUSION: In this study, the rate of disengagement in young people with first-episode psychosis was higher than found previously. Encouragingly, rates of re-engagement were also high. The concept of disengagement from services might be more complex than previously thought with individuals disengaging and re-engaging a number of times during their episode of care. What prompts individuals to re-engage with services needs to be better understood.

A review of prospective registration of trials published in nursing science journals in 2017.

AIM: To determine the proportion of trials published in nursing science journals in 2017 that were prospectively registered. DESIGN: A review of randomized controlled trials published in a Journal Citation Report nursing science journal in 2017. DATA SOURCE: Table of contents of included journals. REVIEW METHODS: Randomized controlled trials were identified by manually reviewing the title of all papers published in included journals. Included trials were classified as: (a) Prospectively registered; (b) Retrospectively registered; (c) Registered but registration not reported in the manuscript; (d) Indeterminate registration; and (e) Not registered. Additionally, we recorded if the trial registration number was reported in the manuscript abstract. RESULTS: Of 151 randomized controlled trials published in nursing science journals in 2017, 17 (11%) were prospectively registered. Thirty-six (24%) trials were retrospectively and 93 (62%) not registered. We could not determine the registration status of five (3%) trials. The registration number was included in the abstract of two prospectively and eight retrospectively registered studies. Compared with the rest of the world, trial registration rates were significantly lower in Asian countries. CONCLUSION: Two included trials were prospectively registered and reported a registration number in the abstract. Compared with other disciplines, rates of prospective trial registration are low. Nurse trialists must ensure that they prospectively register all trials. IMPACT: We intended to replicate this review in subsequent years with a view to reporting improvements in prospective registration rates over time.

Development of a measure of model fidelity for mental health Crisis Resolution Teams.

BACKGROUND: Crisis Resolution Teams (CRTs) provide short-term intensive home treatment to people experiencing mental health crisis. Trial evidence suggests CRTs can be effective at reducing hospital admissions and increasing satisfaction with acute care. When scaled up to national level however, CRT implementation and outcomes have been variable. We aimed to develop and test a fidelity scale to assess adherence to a model of best practice for CRTs, based on best available evidence. METHODS: A concept mapping process was used to develop a CRT fidelity scale. Participants (n = 68) from a range of stakeholder groups prioritised and grouped statements (n = 72) about important components of the CRT model, generated from a literature review, national survey and qualitative interviews. These data were analysed using Ariadne software and the resultant cluster solution informed item selection for a CRT fidelity scale. Operational criteria and scoring anchor points were developed for each item. The CORE CRT fidelity scale was then piloted in 75 CRTs in the UK to assess the range of scores achieved and feasibility for use in a 1-day fidelity review process. Trained reviewers (n = 16) rated CRT service fidelity in a vignette exercise to test the scale's inter-rater reliability. RESULTS: There were high levels of agreement within and between stakeholder groups regarding the most important components of the CRT model. A 39-item measure of CRT model fidelity was developed. Piloting indicated that the scale was feasible for use to assess CRT model fidelity and had good face validity. The wide range of item scores and total scores across CRT services in the pilot demonstrate the measure can distinguish lower and higher fidelity services. Moderately good inter-rater reliability was found, with an estimated correlation between individual ratings of 0.65 (95% CI: 0.54 to 0.76). CONCLUSIONS: The CORE CRT Fidelity Scale has been developed through a rigorous and systematic process. Promising initial testing indicates its value in assessing adherence to a model of CRT best practice and to support service improvement monitoring and planning. Further research is required to establish its psychometric properties and international applicability.