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Background: Depressive episodes are common after first-episode psychosis (FEP), affecting more than 40% of people, adding to individual burden, poor outcomes, and healthcare costs. If the risks of developing depression were lower, this could have a beneficial effect on morbidity and mortality, as well as improving outcomes. Sertraline is a selective serotonin reuptake inhibitor and a common first-line medication for the treatment of depression in adults. It has been shown to be safe when co-prescribed with antipsychotic medication, and there is evidence that it is an effective treatment for depression in established schizophrenia. We present a protocol for a multi-centre, double-blind, randomised, placebo-controlled clinical trial called ADEPP that aims to investigate the efficacy and cost-effectiveness of sertraline in preventing depression after FEP., Methods: The recruitment target is 452 participants between the ages of 18 and 65 years who are within 12 months of treatment initiation for FEP. Having provided informed consent, participants will be randomised to receive either 50 mg of sertraline daily or matched placebo for 6 months, in addition to treatment as usual. The primary outcome measure will be a comparison of the number of new cases of depression between the treatment and placebo arms over the 6-month intervention phase. Secondary outcomes include suicidal behaviour, anxiety, rates of relapse, functional outcome, quality of life, and resource use., Discussion: The ADEPP trial will test whether the addition of sertraline following FEP is a clinically useful, acceptable, and cost-effective way of improving outcomes following FEP., Trial Registration: ISRCTN12682719 registration date 24/11/2020., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Adolescent-onset psychosis is associated with more severe symptoms and poorer outcomes than adult-onset psychosis. The National Institute for Clinical Excellence (NICE) recommend that adolescents with first episode psychosis (FEP) should be offered a combination of antipsychotic medication (APs), cognitive behavioural therapy (CBT) and family intervention (FI). The evidence for APs in treating psychosis is limited in adolescents compared to adults. Nevertheless, it indicates that APs can reduce overall symptoms in adolescents but may cause more severe side effects, including cardiovascular and metabolic effects, than in adults. CBT and FI can improve outcomes in adults, but there are no studies of psychological interventions (PI) in patients under 18 years old. Given this limited evidence base, NICE made a specific research recommendation for determining the clinical and cost effectiveness of APs versus PI versus both treatments for adolescent FEP., Methods/design: The current study aimed to establish the feasibility and acceptability of conducting such a trial by recruiting 14-18-year-olds with a first episode of psychosis into a feasibility prospective randomised open blinded evaluation (PROBE) design, three-arm, randomised controlled trial of APs alone versus PI alone versus a combination of both treatments. We aimed to recruit 90 participants from Early Intervention and Child and Adolescent Mental Health Teams in seven UK sites. APs were prescribed by participants' usual psychiatrists. PI comprised standardised cognitive behavioural therapy and family intervention sessions., Discussion: This is the first study to compare APs to PI in an adolescent population with FEP. Recruitment finished on 31 October 2018. The study faced difficulties with recruitment across most sites due to factors including clinician and service-user treatment preferences., Trial Registration: Current controlled trial with ISRCTN, ISRCTN80567433 . Registered on 27 February 2017.

Background: Many people diagnosed with schizophrenia, bipolar or other psychoses in England receive the majority of their healthcare from primary care. Primary care practitioners may not be well equipped to meet their needs and there is often poor communication with secondary care. Collaborative care is a promising alternative model but has not been trialled specifically with this service user group in England. Collaborative care for other mental health conditions has not been widely implemented despite evidence of its effectiveness. We carried out a formative evaluation of the PARTNERS model of collaborative care, with the aim of establishing barriers and facilitators to delivery, identifying implementation support requirements and testing the initial programme theory., Methods: The PARTNERS intervention was delivered on a small scale in three sites. Qualitative data was collected from primary and secondary care practitioners, service users and family carers, using semi-structured interviews, session recordings and tape-assisted recall. Deductive and inductive thematic analysis was carried out; themes were compared to the programme theory and used to inform an implementation support strategy., Results: Key components of the intervention that were not consistently delivered as intended were: interaction with primary care teams, the use of coaching, and supervision. Barriers and facilitators identified were related to service commitment, care partner skills, supervisor understanding and service user motivation. An implementation support strategy was developed, with researcher facilitation of communication and supervision and additional training for practitioners. Some components of the intervention were not experienced as intended; this appeared to reflect difficulties with operationalising the intervention. Analysis of data relating to the intended outcomes of the intervention indicated that the mechanisms proposed in the programme theory had operated as expected., Conclusions: Additional implementation support is likely to be required for the PARTNERS model to be delivered; the effectiveness of such support may be affected by practitioner and service user readiness to change. There is also a need to test the programme theory more fully. These issues will be addressed in the process evaluation of our full trial., Trial Registration: ISRCTN95702682 , 26 October 2017.

Background: Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT., Methods: This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms., Discussion: It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience., Trial Registration: ISRCTN, ISRCTN14678860 , Registered on 6 June 2016.

Background: In the UK, crisis planning for mental health care should acknowledge the right to make an informed advance treatment refusal under the Mental Capacity Act 2005. Our aims were to estimate the demand for such treatment refusals within a sample of service users who had had a recent hospital admission for psychosis or bipolar disorder, and to examine the relationship between refusals, and service user characteristics., Methods: To identify refusals we conducted content analysis of Joint Crisis Plans, which are plans formulated by service users and their clinical team with involvement from an external facilitator, and routine care plans in sub-samples from a multi-centre randomised controlled trial of Joint Crisis Plans (plus routine mental health care) versus routine care alone (CRIMSON) in England. Factors hypothesised to be associated with refusals were identified using the trial data collected through baseline interviews of service users and clinicians and collection of routine clinical data., Results: Ninety-nine of 221 (45%) of the Joint Crisis Plans contained a treatment refusal compared to 10 of 424 (2.4%) baseline routine care plans. No Joint Crisis Plans recorded disagreement with refusals on the part of clinicians. Among those with completed Joint Crisis Plans, adjusted analyses indicated a significant association between treatment refusals and perceived coercion at baseline (odds ratio = 1.21, 95% CI 1.02-1.43), but not with baseline working alliance or a past history of involuntary admission., Conclusions: We demonstrated significant demand for written treatment refusals in line with the Mental Capacity Act 2005, which had not previously been elicited by the process of treatment planning. Future treatment/crisis plans should incorporate the opportunity for service users to record a treatment refusal during the drafting of such plans., Trial Registration: ISRCTN11501328 Registered 13th March 2008.

Background: No evidence based approach to reduce duration of untreated psychosis (DUP) has been effective in the UK. Existing interventions have many components and have been difficult to replicate. The majority of DUP in Birmingham, UK is accounted for by delays within mental health services (MHS) followed by help-seeking delay and, we hypothesise, these require explicit targeting. This study examined the feasibility and impact of an intervention to reduce DUP, targeting help-seeking and MHSs delays., Methods: A dual-component intervention, comprising a direct care pathway, for 16-25 year olds, and a community psychosis awareness campaign, using our youth-friendly website as the central hub, was implemented, targeting the primary sources of care pathway delays experienced by those with long DUP. Evaluation, using a quasi-experimental, design compared DUP of cases in two areas of the city receiving early detection vs detection as usual, controlling for baseline DUP in each area., Results: DUP in the intervention area was reduced from a median 71 days (mean 285) to 39 days (mean 104) following the intervention, with no change in the control area. Relative risk for the reduction in DUP was 0.74 (95% CI 0.35 to 0.89; p = .004). Delays in MHSs and help-seeking were also reduced., Conclusions: Our targeted approach appears to be successful in reducing DUP and could provide a generalizable methodology applicable in a variety of healthcare contexts with differing sources of delay. More research is needed, however, to establish whether our approach is truly effective., Trial Registration: ISRCTN45058713 - 30 December 2012.

Background: Studies demonstrate ethnic variations in pathways to care during first episode psychosis (FEP). There are no extant studies, however, that have statistically examined the influence of culturally mediated illness attributions on these variations., Methods: We conducted an observational study of 123 (45 White; 35 Black; 43 Asian) patients recruited over a two-year period from an Early Intervention Service (EIS) in Birmingham, UK. Sociodemographic factors (age; sex; education; country of birth; religious practice; marital status; living alone), duration of untreated psychosis (DUP), service contacts (general practitioner; emergency services; faith-based; compulsory detention; criminal justice) and illness attributions ("individual;" "natural;" "social;" "supernatural;" "no attribution") were assessed., Results: Ethnic groups did not differ in DUP (p = 0.86). Asian patients were more likely to report supernatural illness attributions in comparison to White (Odds Ratio: 4.02; 95 % Confidence Intervals: 1.52, 10.62) and Black (OR: 3.48; 95 % CI: 1.25, 9.67) patients. In logistic regressions controlling for confounders and illness attributions, Black (OR: 14.00; 95 % CI: 1.30, 151.11) and Asian (OR: 13.29; 95 % CI: 1.26, 140.47) patients were more likely to consult faith-based institutions than White patients. Black patients were more likely to be compulsorily detained than White patients (OR: 4.56; 95 % CI: 1.40, 14.85)., Conclusion: Illness attributions and sociodemographic confounders do not fully explain the ethnic tendency to seek out faith-based institutions. While Asian and Black patients are more likely to seek help from faith-based organisations, this does not appear to lead to a delay in contact with mental health services.

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.

Background: Substance misuse in those with severe mental health problems is common and associated with poor engagement in treatment and treatment outcomes. Up to 44% of those admitted into psychiatric inpatient facilities have coexisting substance-misuse problems. However, this is not routinely addressed as part of their treatment plan. A mental health admission may present a window of opportunity for inpatients to reevaluate the impact of their substance use. This study will aim to evaluate the effectiveness of a targeted brief motivational intervention in improving engagement in treatment and to assess how feasible and acceptable this intervention is to inpatients and staff as a routine intervention., Methods/design: This randomized controlled trial will use concealed randomization; blind, independent assessment of outcome at 3 months; characterization of refusers and dropouts; and be analyzed according to the intention-to-treat principle. After baseline assessments, eligible participants will be randomized either to the Brief Integrated Motivational Intervention plus Treatment As Usual, or Treatment as Usual alone. Eligible participants will be those who are new admissions; >18 years; ICD-10 diagnosis of -schizophrenia or related disorder, bipolar affective disorder, recurrent depressive disorder, and DSM-IV diagnosis of substance abuse or dependence over the last 3 months. The primary outcome is engagement in treatment for substance misuse, and secondary outcomes include readiness to change substance misuse together with a cost-effectiveness analysis. Qualitative interviews with staff and participants will assess the acceptability of the intervention., Discussion: This pilot randomized trial will provide the first robust evidence base for inpatient care of people with severe mental health problems and co-morbid substance misuse and provide the groundwork for confirmatory trials to evaluate a potentially feasible, cost-effective, and easy-to-implement treatment option that may be readily integrated into standard inpatient and community-based care., Trial Registration: ISRCTN43548483 Date of ISRCTN assignation: 4/17/2014.

Background: Social anxiety is among the most prevalent and debilitating affective disturbances manifest in people with psychosis. It is usually accompanied by high levels of depression and leads to significant social disability, lower quality of life and poorer prognosis as it raises the possibility of an early relapse. Despite its elevated prevalence and severity in psychosis, social anxiety remains under-recognized and under-treated. Cognitive-behavioural therapy is recommended for the treatment of people with psychosis. However, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms, and not for co-morbid affective disturbances such as social anxiety. There is lack of evidence on the clinical effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in psychosis., Methods/design: Electronic databases will be systematically searched for randomised controlled trials and quasi-experimental studies investigating the effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in people with psychosis. Grey literature will also be searched by screening trial registers. Only studies published in English will be included in the review. Date restrictions will not be applied. Eligible studies will have as the primary outcome social anxiety (continuous data) measured using any psychometrically validated scale both self-reported and clinician administered. Secondary outcomes will include general anxiety symptoms, distress, depression, positive and negative symptoms of schizophrenia, and quality of life measured using any psychometrically validated scale, both self-reported and clinician administered, and the cost of cognitive-behaviour therapy (CBT) intervention (with another treatment or treatment-as-usual)., Conclusions: This review will provide an evidence synthesis of the effectiveness and cost-effectiveness of cognitive-behavioural interventions for the treatment of social anxiety disorder in people with psychosis. The review will identify the specific intervention components associated with effectiveness which will facilitate the translation of the existing evidence to the development of new, targeted interventions optimising these components. In doing so, this review will provide recommendations for the treatment of social anxiety and associated distress in psychosis and will further inform the development of future interventions in this area., Trial Registration: PROSPERO registration numberCRD42014009052.

Background: Reducing the duration of untreated psychosis (DUP) is an aspiration of international guidelines for first episode psychosis; however, public health initiatives have met with mixed results. Systematic reviews suggest that greater focus on the sources of delay within care pathways, (which will vary between healthcare settings) is needed to achieve sustainable reductions in DUP (BJP 198: 256-263; 2011)., Methods/design: A quasi-experimental trial, comparing a targeted intervention area with a 'detection as usual' area in the same city. A proof-of-principle trial, no a priori assumptions are made regarding effect size; key outcome will be an estimate of the potential effect size for a definitive trial. DUP and number of new cases will be collected over an 18-month period in target and control areas and compared; historical data on DUP collected in both areas over the previous three years, will serve as a benchmark. The intervention will focus on reducing two significant DUP component delays within the overall care pathway: delays within the mental health service and help-seeking delay., Discussion: This pragmatic trial will be the first to target known delays within the care pathway for those with a first episode of psychosis. If successful, this will provide a generalizable methodology that can be implemented in a variety of healthcare contexts with differing sources of delay.

Background: With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive., Methods/design: A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up., Discussion: The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a reliable and cost-effective method to reduce stigma in young people, whilst increasing mental health literacy, and emotional well-being., Trial Registration: ISRCTN: ISRCTN07406026.

Background: Command hallucinations are among the most distressing, high risk and treatment resistant symptoms for people with psychosis; however, currently, there are no evidence-based treatment options available for this group. A cognitive therapy grounded in the principles of the Social Rank Theory, is being evaluated in terms of its effectiveness in reducing harmful compliance with command hallucinations., Methods/design: This is a single blind, intention-to-treat, multi-centre, randomized controlled trial comparing Cognitive Therapy for Command Hallucinations + Treatment as Usual with Treatment as Usual alone. Eligible participants have to fulfil the following inclusion criteria: i) ≥16 years; ii) ICD-10 diagnosis of schizophrenia or related disorder; iii) command hallucinations for at least 6 months leading to risk of harm to self or others. Following the completion of baseline assessments, eligible participants will be randomly allocated to either the Cognitive Therapy for Command Hallucinations + Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at 9 and 18 months post randomization with assessors blind to treatment allocation. The primary outcome is compliance behaviour and secondary outcomes include beliefs about voices' power, distress, psychotic symptoms together with a health economic evaluation. Qualitative interviews with services users will explore the acceptability of Cognitive Therapy for Command Hallucinations., Discussion: Cognitive behaviour therapy is recommended for people with psychosis; however, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms. In this trial, however, the focus of the cognitive behavioural intervention is on individuals' appraisals, behaviour and affect and not necessarily symptoms; this is also reflected in the outcome measures used. If successful, the results will mark a significant breakthrough in the evidence base for service users and clinicians and will provide a treatment option for this group where none currently exist. The trial will open the way for further breakthrough work with the 'high risk' population of individuals with psychosis, which we would intend to pursue., Trial Registration: ISRCTN: ISRCTN62304114.

Background: The use of compulsory treatment under the Mental Health Act (MHA) has continued to rise in the UK and in other countries. The Joint Crisis Plan (JCP) is a statement of service users' wishes for treatment in the event of a future mental health crisis. It is developed with the clinical team and an independent facilitator. A recent pilot RCT showed a reduction in the use of the MHA amongst service users with a JCP. The JCP is the only intervention that has been shown to reduce compulsory treatment in this way. The CRIMSON trial aims to determine if JCPs, compared with treatment as usual, are effective in reducing the use of the MHA in a range of treatment settings across the UK., Methods/design: This is a 3 centre, individual-level, single-blind, randomised controlled trial of the JCP compared with treatment as usual for people with a history of relapsing psychotic illness in Birmingham, London and Lancashire/Manchester. 540 service users will be recruited across the three sites. Eligible service users will be adults with a diagnosis of a psychotic disorder (including bipolar disorder), treated in the community under the Care Programme Approach with at least one admission to a psychiatric inpatient ward in the previous two years. Current inpatients and those subject to a community treatment order will be excluded to avoid any potential perceived pressure to participate. Research assessments will be conducted at baseline and 18 months. Following the baseline assessment, eligible service users will be randomly allocated to either develop a Joint Crisis Plan or continue with treatment as usual. Outcome will be assessed at 18 months with assessors blind to treatment allocation. The primary outcome is the proportion of service users treated or otherwise detained under an order of the Mental Health Act (MHA) during the follow-up period, compared across randomisation groups. Secondary outcomes include overall costs, service user engagement, perceived coercion and therapeutic relationships. Sub-analyses will explore the effectiveness of the JCP in reducing use of the MHA specifically for Black Caribbean and Black African service users (combined). Qualitative investigations with staff and service users will explore the acceptability of the JCPs., Discussion: JCPs offer a potential solution to the rise of compulsory treatment for individuals with psychotic disorders and, if shown to be effective in this trial, they are likely to be of interest to mental health service providers worldwide., Trial Registration: Current Controlled Trials ISRCTN11501328.

Background: Treatment delay in first episode psychosis is common. As general practitioners are the first point of contact for many individuals with first episode psychosis, they are well placed to detect the early symptoms and make urgent referrals to specialist secondary care services. However, early psychosis is often difficult to detect. The primary objective of the Redirect trial is to estimate whether an educational intervention targeted at general practitioners increases the general practitioner referral rate of young people with first episode psychosis to Early Intervention Services., Methods/design: This paper describes the design of a stratified-cluster randomised controlled trial of an educational intervention on first episode psychosis in primary care. The primary outcome is the number of general practitioner referrals of young people with first episode psychosis to Early Intervention Services. Secondary outcomes are duration of untreated psychosis, time to recovery, use of the Mental Health Act, and general practitioner consultation rate. Young people with first episode psychosis referred to Early Intervention Services will be recruited over a two-year period from 1 March 2004. Seventy-eight out of 89 eligible general practices were recruited. The educational intervention has been implemented and evaluated by general practitioners. The education was well received and considered relevant to clinical practice by the general practitioners., Discussion: The results suggest that the recruitment strategy and implementation of the educational intervention are feasible and acceptable in a primary care setting. The Redirect trial will provide robust information about the efficacy of an evidence-based complex educational intervention targeted at general practitioners on referral rates of young people with first episode psychosis to Early Intervention Services.