The effectiveness of a primary care-based collaborative care model to improve quality of life in people with severe mental illness: PARTNERS2 cluster randomised controlled trial.

BACKGROUND: Individuals living with severe mental illness can have significant emotional, physical and social challenges. Collaborative care combines clinical and organisational components. AIMS: We tested whether a primary care-based collaborative care model (PARTNERS) would improve quality of life for people with diagnoses of schizophrenia, bipolar disorder or other psychoses, compared with usual care. METHOD: We conducted a general practice-based, cluster randomised controlled superiority trial. Practices were recruited from four English regions and allocated (1:1) to intervention or control. Individuals receiving limited input in secondary care or who were under primary care only were eligible. The 12-month PARTNERS intervention incorporated person-centred coaching support and liaison work. The primary outcome was quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). RESULTS: We allocated 39 general practices, with 198 participants, to the PARTNERS intervention (20 practices, 116 participants) or control (19 practices, 82 participants). Primary outcome data were available for 99 (85.3%) intervention and 71 (86.6%) control participants. Mean change in overall MANSA score did not differ between the groups (intervention: 0.25, s.d. 0.73; control: 0.21, s.d. 0.86; estimated fully adjusted between-group difference 0.03, 95% CI -0.25 to 0.31; P = 0.819). Acute mental health episodes (safety outcome) included three crises in the intervention group and four in the control group. CONCLUSIONS: There was no evidence of a difference in quality of life, as measured with the MANSA, between those receiving the PARTNERS intervention and usual care. Shifting care to primary care was not associated with increased adverse outcomes.

Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT.

BACKGROUND: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. OBJECTIVE: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? DESIGN: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. SETTINGS: Glasgow, UK, and Melbourne, Australia. PARTICIPANTS: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. INTERVENTIONS: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. MAIN OUTCOME MEASURES: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. RESULTS: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference -4.29, 95% confidence interval -7.29 to -1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. LIMITATIONS: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. CONCLUSIONS: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. FUTURE WORK: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3-0.4). TRIAL REGISTRATION: This trial is registered as ISRCTN99559262. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).

WHAT WAS THE PROBLEM?: Relapse is a considerable problem for people with a diagnosis of schizophrenia. Relapse can be predicted by early warning signs that are unique to the person. They include withdrawal, fear and paranoia. WHAT WAS THE QUESTION?: Is it possible to investigate the effectiveness of an intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? WHAT DID WE DO?: We spoke with 88 mental health staff, 40 carers and 21 service users before we designed a system that used a mobile phone to help people monitor early warning signs. We included peer support to help people using the system reflect on their experiences. We hoped the overall system, called EMPOWER, would help people to be more in charge of their mental health. After consenting 86 people to the study, we were able to randomly assign 73 people either to use the EMPOWER system (42 people) or to receive their normal treatment alone (31 people). We used research measures over 1 year to help us better understand people's experiences. We also involved carers (for example family or friends) and mental health service providers in the research. WHAT DID WE FIND?: We found that it was possible to recruit people to the study and to gather research data. We also found that people used the EMPOWER system and found it acceptable. We found that those who used EMPOWER had a lower rate of relapse over 12 months than people who did not. They were also less likely to be fearful of relapse. We found that EMPOWER was likely to be cost-effective. WHAT DOES THIS MEAN?: This means that a study to investigate the effectiveness of a system to recognise and respond to early warning signs of relapse in schizophrenia is possible.

The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia.

BACKGROUND: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. METHODS: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). FINDINGS: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference -7·53 (95% CI -14·45 to 0·60; Cohen's d -0·53). INTERPRETATION: A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited. FUNDING: UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

Adapting, updating and translating the Social Functioning Scale to assess social, recreational and independent functioning among youth with psychosis in diverse sociocultural contexts.

AIM: To compare social, recreational and independent functioning among persons with psychosis across two geo-cultural contexts, we adapted the well-established Social Functioning Scale (SFS) and translated it into French and Tamil. We present the development and psychometric testing of this adaptation, the SFS-Early Intervention. METHODS: Sixteen items were added to reflect contemporary youth activities (e.g., online games) and 31 items adapted to enhance applicability and/or include context-specific examples (e.g., 'church activity' replaced with 'religious/spiritual activity'). Psychometric properties and participant feedback were evaluated. RESULTS: Test-retest reliability (ICCs) ranged from 0.813 to 0.964. Internal consistency (Cronbach's α) ranged from .749 to .936 across sites and languages. Correlations with original subscales were high. The scale was rated easy to complete and understand. CONCLUSIONS: The SFS-Early Intervention is a promising patient-reported measure of social, recreational and independent functioning. Our approach shows that conceptually sound existing measures are adaptable to different times and contexts.

Development of a core outcome set for use in community-based bipolar trials-A qualitative study and modified Delphi.

BACKGROUND: A core outcome set (COS) is a standardised collection of outcomes to be collected and reported in all trials within a research area. A COS can reduce reporting bias and facilitate evidence synthesis. This is currently unavailable for use in community-based bipolar trials. This research aimed to develop such a COS, with input from a full range of stakeholders. METHODS: A co-production approach was used throughout. A longlist of outcomes was derived from focus groups with people with a bipolar diagnosis and carers, interviews with healthcare professionals and a rapid review of outcomes listed in bipolar trials on the Cochrane database. An expert panel with personal and/or professional experience of bipolar participated in a modified Delphi process and the COS was finalised at a consensus meeting. RESULTS: Fifty participants rated the importance of each outcome. Sixty-six outcomes were included in Round 1 of the questionnaire; 13 outcomes were added by Round 1 participants and were rated in Round 2. Seventy-six percent of participants (n = 38) returned to Round 2 and 60 outcomes, including 4 outcomes added by participants in Round 1, received a rating of 7-9 by >70% and 1-3 by <25% of the sample. Fourteen participants finalised a COS containing 11 outcomes at the consensus meeting: personal recovery; connectedness; clinical recovery of bipolar symptoms; mental health and wellbeing; physical health; self-monitoring and management; medication effects; quality of life; service outcomes; experience of care; and use of coercion. CONCLUSIONS: This COS is recommended for use in community-based bipolar trials to ensure stakeholder-relevant outcomes, facilitate data synthesis, and transparent reporting. The COS includes guidance notes for each outcome to allow the identification of suitable measurement instruments. Further validation is recommended for use with a wide range of communities and to achieve standardised measurement.

Short-term outcome of first episode delusional disorder in an early intervention population.

BACKGROUND: Previous evidence suggests that delusional disorder has a later onset and better functional outcomes compared to schizophrenia. However, studies have not examined longitudinal outcomes in a first episode population, where confounding factors may be adjusted for. METHODS: A nested case control study was designed within the National EDEN study; a cohort of 1027 first episode psychosis patients. Patients with a baseline diagnosis of delusional disorder (n = 48) were compared with schizophrenia (n = 262) at 6 and 12 months with respect to symptomatic and functional outcomes. Regression analysis was used to adjust for possible confounders. RESULTS: Delusional disorder patients had a shorter duration of untreated psychosis compared to schizophrenia but were similar in other baseline characteristics. At baseline, delusional disorder patients had lower symptom scores but higher function scores compared to those with schizophrenia. At 12 months the differences persisted for symptoms scores but not overall function scores. After adjusting for baseline score, age and duration of untreated psychosis, differences between the groups remained significant only for Positive and Negative Syndrome Scale (PANNS) negative, general and total scores and recovery rates. There were no differences in changes in outcomes scores. CONCLUSIONS: Delusional disorder in a first episode psychosis population presents with less severe symptoms, higher recovery rates and better functioning than schizophrenia, but at 12 months differences are ameliorated when adjusting for baseline differences.

Fidelity scales and performance measures to support implementation and quality assurance for first episode psychosis services.

AIM: The purpose of this paper is to review fidelity and outcome measures which can be used to support broad implementation of first episode psychosis services and ensure quality of existing services. First episode psychosis services use a combination of evidence-based practices to improve the outcome of a first episode of psychosis and the early stages of schizophrenia. Now that there is an established international evidence base to show that they are effective, efforts are being made to make such services widely available as a routine part of health care. METHODS: We provide an overview of the literature from the perspective of an expert task force that was commissioned to report to the board of the International Early Psychosis Association IEPA. First, we examined the evidence-based components that underpin first episode psychosis services and identified common elements. Next, we reviewed the availability of fidelity measures and outcome indicators, finally we reviewed how broadly these services are delivered internationally, and the barriers to ensuring broad access to quality services. RESULTS: There is a growing consensus about the elements required to deliver effective services. Fidelity scales and performance measures are available to assess quality, access, and outcome. First episode psychosis services are variably offered in high-income countries and rarely with attention to access and quality of services. Several strategies to promote implementation are identified. CONCLUSIONS: Fidelity scales and outcome measure are valuable resources to support widespread implementation and quality assurance for first episode psychosis services.

Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets.

BACKGROUND: In the general population the prevalence of bipolar and schizophrenia is 0.24% and 1.4% respectively. People with schizophrenia and bipolar disorder have a significantly reduced life expectancy, increased rates of unemployment and a fear of stigma leading to reduced self-confidence. A core outcome set is a standardised collection of items that should be reported in all controlled trials within a research area. There are currently no core outcome sets available for use in effectiveness trials involving bipolar or schizophrenia service users managed in a community setting. METHODS: A three-step approach is to be used to concurrently develop two core outcome sets, one for bipolar and one for schizophrenia. First, a comprehensive list of outcomes will be compiled through qualitative research and systematic searching of trial databases. Focus groups and one-to-one interviews will be completed with service users, carers and healthcare professionals. Second, a Delphi study will be used to reduce the lists to a core set. The three-round Delphi study will ask service users to score the outcome list for relevance. In round two stakeholders will only see the results of their group, while in round three stakeholders will see the results of all stakeholder group by stakeholder group. Third, a consensus meeting with stakeholders will be used to confirm outcomes to be included in the core set. Following the development of the core set a systematic literature review of existing measures will allow recommendations for how the core outcomes should be measured and a stated preference survey will explore the strength of people's preferences and estimate weights for the outcomes that comprise the core set. DISCUSSION: A core outcome set represents the minimum measurement requirement for a research area. We aim to develop core outcome sets for use in research involving service users with schizophrenia or bipolar managed in a community setting. This will inform the wider PARTNERS2 study aims and objectives of developing an innovative primary care-based model of collaborative care for people with a diagnosis of bipolar or schizophrenia.

Prevalence of psychotic-like experiences in young adults with social anxiety disorder and correlation with affective dysregulation.

Social anxiety disorder (SAD) is associated with psychotic-like experiences (PLEs) and is a frequent diagnosis in the prodromal phases of psychosis. We investigated whether psychopathological factors could discriminate which subjects with SAD are more likely to develop PLEs. A sample of 128 young adults with SAD was split into two subsamples according to the presence of clinically relevant PLEs. Correlations between PLEs and other psychopathological markers were explored. The SAD with PLEs group showed higher level of anxiety, depression, and intolerance of uncertainty (IU) compared with the SAD without PLEs group. A limitation of this study is that the cross-sectional design precluded the analysis of causality. In our sample, the presence of PLEs is related to higher levels of depression, anxiety, and IU. The current findings are consistent with hypotheses suggesting that cognitive disturbances, together with social anxiety, may result in PLEs.

From environment to therapy in psychosis: a real-world momentary assessment approach.

The current article discusses how momentary assessment may fundamentally contribute to identifying environmental risk factors and symptom patterns, as well as provide new opportunities for treatment. A new prototype device, the "PsyMate," was specifically developed to implement momentary assessment in clinical practice. It was shown that self-monitoring of both positive and negative psychotic symptoms (a) is feasible, (b) provides a much more detailed and fine-grained picture of symptoms, and (c) reveals patterns of behavior that may be relevant for treatment. Furthermore, the PsyMate could be instrumental for real-time and real-world delivery of psychological interventions. With PsyMate, patients can become active partners in the therapeutic process, resulting in greater patient ownership and empowerment as well as understanding of their symptoms and the environment.

Collaborating to provide early-intervention services to persons in England with first-episode psychosis.

OBJECTIVE: This qualitative study explores the experiences of stakeholders in implementing the guidance for early-intervention services (EIS) for first-episode psychosis in England. One important challenge in implementing early-intervention policy is to develop workable, integrated partnership across a number of diverse organizational boundaries, particularly with child and adolescent mental health services (CAMHS). METHODS: A series of 142 semistructured interviews and six focus groups involving 31 people were undertaken between February 2004 and September 2007. A broad range of individuals were interviewed from different strategic, managerial, and operational levels of the health service. RESULTS: A main finding was the challenge experienced by a majority of EIS agencies in developing partnerships with CAMHS. Elements that led to more successful partnership development included joint learning and training, senior-level "champions" of the partnership, joint operational policy or protocol development, and use of specific CAMHS-EIS link workers. The most successful approach was to develop a separate youth-focused service that placed multiple teams and organizations responsive to younger people's needs (including education, employment guidance, social activities, pregnancy services, and peer support) under one roof. CONCLUSIONS: This study highlights that traditional hierarchical models of policy implementation may be less successful in achieving the goal of collaborative partnerships at the interface between CAMHS and EIS. The most successful model of working between CAMHS and EIS required an innovative approach to commissioning, policy implementation, and service development. The findings from this study may help determine the best model of partnership development for EIS and CAMHS in England.