Identifying types of problems and relative priorities in the problem lists of participants in CBT for psychosis trials.

BACKGROUND: There is wide variation in the problems prioritised by people with psychosis in cognitive behavioural therapy for psychosis (CBTp). While research trials and mental health services have often prioritised reduction in psychiatric symptoms, service users may prioritise issues not directly related to psychosis. This discrepancy suggests potential challenges in treatment outcome research. AIMS: The present study aimed to examine the types of problems that were recorded on problem lists generated in CBTp trials. METHOD: Problem and goals lists for 110 participants were extracted from CBTp therapy notes. Subsequently, problems were coded into 23 distinct categories by pooling together items that appeared thematically related. RESULTS: More than half of participants (59.62%) listed a non-psychosis-related priority problem, and 22.12% did not list any psychosis related problems. Chi-square tests indicated there was no difference between participants from early intervention (EI) and other services in terms of priority problem (χ2 = 0.06, p = .804), but that those from EI were more likely to include any psychosis-related problems in their lists (χ2 = 6.66, p = .010). CONCLUSIONS: The findings of this study suggest that psychiatric symptom reduction is not the primary goal of CBTp for most service users, particularly those who are not under the care of EI services. The implications for future research and clinical practice are discussed.

The effect of thought importance on stress responses: a test of the metacognitive model.

Negative metacognitive beliefs are central determinants of distress in the metacognitive model of psychological vulnerability to stress. The current study tested this assertion in 75 undergraduate students assigned to either experimental (metacognitive belief manipulation) or control (no metacognitive belief manipulation) condition. All participants underwent a fake EEG, where they were told that the EEG would detect negative thoughts. The experimental subjects were informed that if they had a negative thought they may be exposed to a contingent burst of loud noise, while the control condition was told that they may be exposed to a burst of loud noise at random. Participants also underwent the Trier Social Stress Test. The results showed that on physiological measures (skin conductance level) there were no significant differences between groups. However, on self-report measures (positive and negative affect) participants in the experimental condition reported greater levels of negative affect and lower levels of positive affect in response to stress and maintained low positive affect at recovery. The results are consistent with the metacognitive model and suggest that metacognitive beliefs impact on positive and negative affect in reaction to and recovery from stress exposure.

Are experiences of psychosis associated with unhelpful metacognitive coping strategies? A systematic review of the evidence.

This review investigated whether unhelpful metacognitive coping strategies, such as attentional biases, worry, rumination, and thought control, are associated with experiences of psychosis. These processes, known collectively as the Cognitive Attentional Syndrome (CAS), form a central tenet of the Self-Regulatory Executive Function model. Three research questions based on assumptions underlying the CAS were addressed. It was predicted that processes of (a) self-focused processing, (b) negative perseverative thinking (worry and rumination), and (c) counterproductive thought control would be associated with experiences of psychosis. A comprehensive search of the literature identified 51 eligible studies: 17 investigated self-focused attention, 25 investigated perseverative processing (worry: n = 18; rumination: n = 10), and 9 investigated thought control strategies. Findings indicated that unhelpful metacognitive coping strategies associated with the CAS are related to experiences of psychosis and appear to share important relationships with distress. Implications for future research and clinical practice are discussed.

Assessment of metacognitive beliefs in an at risk mental state for psychosis: A validation study of the Metacognitions Questionnaire-30.

AIM: The Metacognitions Questionnaire-30 (MCQ-30) has been used to assess metacognitive beliefs in a range of mental health problems. The aim of this study is to assess the validity of the MCQ-30 in people at risk for psychosis. METHODS: One hundred eighty-five participants meeting criteria for an at risk mental state completed the MCQ-30 as part of their involvement in a randomized controlled trial. Confirmatory and exploratory factor analyses were conducted to assess factor structure and construct validity. RESULTS: Confirmatory factor analyses confirmed the original five-factor structure of the MCQ-30. Examination of principal component analysis and parallel analysis outputs also suggested a five-factor structure. Correlation analyses including measures of depression, social anxiety, and beliefs about paranoia showed evidence of convergent validity. Discriminant validity was supported using the normalizing subscale of the beliefs about paranoia tool. CONCLUSIONS: The MCQ-30 demonstrated good fit using the original five-factor model, acceptable to very good internal consistency of items was evident and clinical usefulness in those at risk for psychosis was demonstrated.

Delivery of cognitive-behaviour therapy for psychosis: a service user preference trial.

BACKGROUND: Clinical guidelines recommend cognitive behaviour therapy (CBT) for people with psychosis, however, implementation is poor and not everyone wishes to engage with therapy. Understanding service user (SU) preferences for receiving such treatments is a priority for services. AIMS: To explore SU preferences and outcomes of different methods of delivering CBT for psychosis. METHOD: SUs experiencing psychosis could choose between treatment as usual (TAU); TAU plus telephone-delivered CBT with self-help, CBT recovery manual (TS); high support CBT (HS - TAU plus TS plus group sessions) or randomisation. Participants received their option of choice and were followed-up on several outcomes over 9 and 15 months. RESULTS: Of 89 people recruited, three chose to be randomised and 86 expressed a treatment preference (32 chose TAU, 34 chose TS, 23 chose HS). There were few differences between those who chose therapy compared to those who chose TAU. Those who had more positive impacts from their symptoms were significantly more likely to choose TAU. CONCLUSIONS: Most people had strong preferences about treatment delivery and a substantial number did not wish to receive additional therapy. These findings have to be considered when planning and allocating resources for people with psychosis.

An Integrative Cognitive Model of Internalized Stigma in Psychosis.

BACKGROUND: Internalized stigma is a significant difficulty for those who experience psychosis, but it has never been conceptualized using cognitive theory. AIMS: The aim of this paper is to outline a cognitive model conceptualizing internalized stigma experienced by people who also experience psychosis. METHOD: Previous literature is reviewed, critiqued and synthesized to develop the model. It draws upon previous social cognitive models of internalized stigma and integrates cognitive behavioural theory and social mentality theory. RESULTS: This paper identifies key cognitive, behavioural and emotional processes that contribute to the development and maintenance of internalized stigma, whilst also recognizing the central importance of cultural context in creating negative stereotypes of psychosis. Moreover, therapeutic strategies to alleviate internalized stigma are identified. A case example is explored and a formulation and brief intervention plan was developed in order to illustrate the model in practice. CONCLUSION: An integrative cognitive model is presented, which can be used to develop individualized case formulations, which can guide cognitive behavioural interventions targeting internalized stigma in those who experience psychosis. More research is required to examine the efficacy of such interventions. In addition, it is imperative to continue to research interventions that create change in stigma at a societal level.

An exploration of the relationship between use of safety-seeking behaviours and psychosis: A systematic review and meta-analysis.

Safety-seeking behaviours are responses employed to protect against perceived threat. In relation to anxiety disorders, safety-seeking behaviours have been implicated in both the formation and maintenance of distress. Several studies have highlighted similar findings in relation to psychosis; however, this literature has not yet been synthesized. This review is, therefore, being conducted in order to synthesize the literature on safety seeking in people with psychosis to increase the understanding of this relationship. A systematic search identified and included 43 studies comprising 2,592 participants, published between 1995 and 2015. The results indicated that people experiencing psychosis commonly respond to their experiences with behavioural and cognitive strategies intended to manage their difficulties. In relation to safety seeking, avoidance, and resistance, there was a pattern that these responses are associated with increased distress and appraisals of threat. The results relating to engagement response styles showed the opposite pattern. These results provide support for cognitive models of safety seeking and psychosis with many of the meta-analyses reported here showing a clear pattern of association between behavioural responses and distress. However, the results reported within individual studies are mixed. This appears to be particularly true with the response style of distraction, with our analyses unable to clarify this relationship. It is possible that the mixed results could reflect the complexities in defining safety seeking and distinguishing it from coping in this population. The clinical implications of this are discussed.

The Impact of Causal Explanations on Outcome in People Experiencing Psychosis: A Systematic Review.

Findings suggest that the way an individual understands their experiences has important consequences on subsequent health behaviour. One aspect of an individual's understanding is what they believe has caused their experiences. This has been associated with treatment outcome and attitudes towards mental health problems. The aim of this systematic review was to examine the impact of causal beliefs on treatment outcome and stigma in people experiencing psychosis. Three main databases were searched and 21 articles that investigated various aspects of treatment outcome, and stigma in relation to causal beliefs was included in the review. Overall, there were a small number of replicated findings which limits the interpretation of results. There is an indication that causal explanations are associated with various treatment outcomes, including attitudes towards treatment and satisfaction with therapeutic relationships as well as internalized stigma. Spiritual beliefs appeared to be adopted as a coping mechanism and a way to reduce stigma but did not appear to be associated with treatment outcome. Individuals with psychosis do appear to develop causal beliefs that may be associated with engagement with services and treatment, as well as impacting on their attitudes towards themselves and others with mental illness. This may have important implications for clinical practice. Copyright © 2016 John Wiley & Sons, Ltd. KEY PRACTITIONER MESSAGE: Individuals who have experience of psychosis develop their own subjective causal explanations, and these can be complex and contradictory. An individual's causal explanation may influence how they engage with services and treatment, as well as providing a way of coming to terms with their difficulties. Causal explanations may also contribute to the experience of stigma, which is often a significant barrier to recovery for this client group.

Longitudinal predictors of subjective recovery in psychosis.

BACKGROUND: Research has highlighted the importance of recovery as defined by the service user, and suggests a link to negative emotion, although little is known about the role of negative emotion in predicting subjective recovery. AIMS: To investigate longitudinal predictors of variability in recovery scores with a focus on the role of negative emotion. METHOD: Participants (n = 110) with experience of psychosis completed measures of psychiatric symptoms, social functioning, subjective recovery, depression, hopelessness and self-esteem at baseline and 6 months later. Path analysis was used to examine predictive factors for recovery and negative emotion. RESULTS: Subjective recovery scores were predicted by negative emotion, positive self-esteem and hopelessness, and to a lesser extent by symptoms and functioning. Current recovery score was not predicted by past recovery score after accounting for past symptoms, current hopelessness and current positive self-esteem. CONCLUSIONS: Psychosocial factors and negative emotion appear to be the strongest longitudinal predictors of variation in subjective recovery, rather than psychiatric symptoms.

Shared treatment decision-making and empowerment-related outcomes in psychosis: systematic review and meta-analysis.

BACKGROUND: In the UK almost 60% of people with a diagnosis of schizophrenia who use mental health services say they are not involved in decisions about their treatment. Guidelines and policy documents recommend that shared decision-making should be implemented, yet whether it leads to greater treatment-related empowerment for this group has not been systematically assessed. AIMS: To examine the effects of shared decision-making on indices of treatment-related empowerment of people with psychosis. METHOD: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) of shared decision-making concerning current or future treatment for psychosis (PROSPERO registration CRD42013006161). Primary outcomes were indices of treatment-related empowerment and objective coercion (compulsory treatment). Secondary outcomes were treatment decision-making ability and the quality of the therapeutic relationship. RESULTS: We identified 11 RCTs. Small beneficial effects of increased shared decision-making were found on indices of treatment-related empowerment (6 RCTs; g = 0.30, 95% CI 0.09-0.51), although the effect was smaller if trials with >25% missing data were excluded. There was a trend towards shared decision-making for future care leading to reduced use of compulsory treatment over 15-18 months (3 RCTs; RR = 0.59, 95% CI 0.35-1.02), with a number needed to treat of approximately 10 (95% CI 5-∞). No clear effect on treatment decision-making ability (3 RCTs) or the quality of the therapeutic relationship (8 RCTs) was found, but data were heterogeneous. CONCLUSIONS: For people with psychosis the implementation of shared treatment decision-making appears to have small beneficial effects on indices of treatment-related empowerment, but more direct evidence is required.

NICE v. SIGN on psychosis and schizophrenia: same roots, similar guidelines, different interpretations.

A recent editorial claimed that the 2014 National Institute for Health and Care Excellence (NICE) guideline on psychosis and schizophrenia, unlike its equivalent 2013 Scottish Intercollegiate Guidelines Network (SIGN) guideline, is biased towards psychosocial treatments and against drug treatments. In this paper we underline that the NICE and SIGN guidelines recommend similar interventions, but that the NICE guideline has more rigorous methodology. Our analysis suggests that the authors of the editorial appear to have succumbed to bias themselves.

Design and protocol for the Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial.

BACKGROUND: For around a third of people with a diagnosis of schizophrenia, the condition proves to respond poorly to treatment with many typical and atypical antipsychotics. This is commonly referred to as treatment-resistant schizophrenia. Clozapine is the only antipsychotic with convincing efficacy for people whose symptoms are considered treatment-resistant to antipsychotic medication. However, 30-40 % of such conditions will have an insufficient response to the drug. Cognitive behavioural therapy has been shown to be an effective treatment for schizophrenia when delivered in combination with antipsychotic medication, with several meta-analyses showing robust support for this approach. However, the evidence for the effectiveness of cognitive behavioural therapy for people with a schizophrenia diagnosis whose symptoms are treatment-resistant to antipsychotic medication is limited. There is a clinical and economic need to evaluate treatments to improve outcomes for people with such conditions. METHODS/DESIGN: A parallel group, prospective randomised, open, blinded evaluation of outcomes design will be used to compare a standardised cognitive behavioural therapy intervention added to treatment as usual versus treatment as usual alone (the comparator group) for individuals with a diagnosis of schizophrenia for whom an adequate trial of clozapine has either not been possible due to tolerability problems or was not associated with a sufficient therapeutic response. The trial will be conducted across five sites in the United Kingdom. DISCUSSION: The recruitment target of 485 was achieved, with a final recruitment total of 487. This trial is the largest definitive, pragmatic clinical and cost-effectiveness trial of cognitive behavioural therapy for people with schizophrenia whose symptoms have failed to show an adequate response to clozapine treatment. Using a prognostic risk model, baseline information will be used to explore whether there are identifiable subgroups for which the treatment effect is greatest. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99672552 . Registered 29(th) November 2012.

Experiential avoidance and appraisals of voices as predictors of voice-related distress.

OBJECTIVES: Research has suggested that the extent to which voices (i.e., auditory verbal hallucinations) are experienced as distressing might be influenced by negative beliefs about voices as well as maladaptive metacognitive styles involving the negative appraisal and maladaptive control of mental experiences. This cross-sectional study examined the contribution of both specific appraisals of voices and a metacognitive factor (i.e., experiential avoidance) to voice-related distress. METHODS: Self-report measurers of voice characteristics (voice frequency, duration as well as amount and intensity of voice-related distress), experiential avoidance, and appraisals of voices were collected in a sample of 101 voice-hearers. RESULTS: Experiential avoidance and negative beliefs about voices were associated with higher levels of voice-related distress, but not to measures of voice frequency and duration. Experiential avoidance and negative 'metaphysical' beliefs about voices were significant predictors of voice-related distress even after accounting for the effect of frequency and duration of voices, and explained similar proportions of unique variance in distress. CONCLUSIONS: These findings suggest that the appraisals of voices and experiential avoidance are predictive of voice-related distress and that cognitive-behavioural interventions targeting both voice-specific appraisals and general maladaptive metacognitive processes could prove useful treatment approaches for clients with distressing voices. PRACTITIONER POINTS: Experiential avoidance (EA) and negative appraisals predict voice-related distress caused by voices, but not their frequency and duration. Interventions for voices should consider targeting EA and negative appraisals (e.g., cognitive-behavioural therapy, Acceptance and Commitment Therapy) to ameliorate distress.

Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial.

BACKGROUND: Antipsychotic drugs are usually the first line of treatment for schizophrenia; however, many patients refuse or discontinue their pharmacological treatment. We aimed to establish whether cognitive therapy was effective in reducing psychiatric symptoms in people with schizophrenia spectrum disorders who had chosen not to take antipsychotic drugs. METHODS: We did a single-blind randomised controlled trial at two UK centres between Feb 15, 2010, and May 30, 2013. Participants aged 16-65 years with schizophrenia spectrum disorders, who had chosen not to take antipsychotic drugs for psychosis, were randomly assigned (1:1), by a computerised system with permuted block sizes of four or six, to receive cognitive therapy plus treatment as usual, or treatment as usual alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. Our primary outcome was total score on the positive and negative syndrome scale (PANSS), which we assessed at baseline, and at months 3, 6, 9, 12, 15, and 18. Analysis was by intention to treat, with an ANCOVA model adjusted for site, age, sex, and baseline symptoms. This study is registered as an International Standard Randomised Controlled Trial, number 29607432. FINDINGS: 74 individuals were randomly assigned to receive either cognitive therapy plus treatment as usual (n=37), or treatment as usual alone (n=37). Mean PANSS total scores were consistently lower in the cognitive therapy group than in the treatment as usual group, with an estimated between-group effect size of -6.52 (95% CI -10.79 to -2.25; p=0.003). We recorded eight serious adverse events: two in patients in the cognitive therapy group (one attempted overdose and one patient presenting risk to others, both after therapy), and six in those in the treatment as usual group (two deaths, both of which were deemed unrelated to trial participation or mental health; three compulsory admissions to hospital for treatment under the mental health act; and one attempted overdose). INTERPRETATION: Cognitive therapy significantly reduced psychiatric symptoms and seems to be a safe and acceptable alternative for people with schizophrenia spectrum disorders who have chosen not to take antipsychotic drugs. Evidence-based treatments should be available to these individuals. A larger, definitive trial is needed. FUNDING: National Institute for Health Research.

Components of therapy as mechanisms of change in cognitive therapy for people at risk of psychosis: analysis of the EDIE-2 trial.

BACKGROUND: Research suggests that the way in which cognitive therapy is delivered is an important factor in determining outcomes. We test the hypotheses in which the development of a shared problem list, use of case formulation, homework tasks and active intervention strategies will act as process variables. METHOD: Presence of these components during therapy is taken from therapist notes. The direct and indirect effect of the intervention is estimated by an instrumental variable analysis. RESULTS: A significant decrease in the symptom score for case formulation (coefficient = -23, 95% CI -44 to -1.7, P = 0.036) and homework (coefficient = -0.26, 95% CI -0.51 to -0.001, P = 0.049) is found. Improvement with the inclusion of active change strategies is of borderline significance (coefficient = -0.23, 95% CI -0.47 to 0.005, P = 0.056). CONCLUSIONS: There is a greater treatment effect if formulation and homework are involved in therapy. However, high correlation between components means that these may be indicators of overall treatment fidelity.

Recovery-focused cognitive-behavioural therapy for recent-onset bipolar disorder: randomised controlled pilot trial.

BACKGROUND: Despite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder. AIMS: A pilot study to assess the feasibility and effectiveness of a new intervention, recovery-focused cognitive-behavioural therapy (CBT), designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes. METHOD: A single, blind randomised controlled trial compared treatment as usual (TAU) with recovery-focused CBT plus TAU (n = 67). RESULTS: Recruitment and follow-up rates within 10% of pre-planned targets to 12-month follow-up were achieved. An average of 14.15 h (s.d. = 4.21) of recovery-focused CBT were attended out of a potential maximum of 18 h. Compared with TAU, recovery-focused CBT significantly improved personal recovery up to 12-month follow-up (Bipolar Recovery Questionnaire mean score 310.87, 95% CI 75.00-546.74 (s.e. = 120.34), P = 0.010, d = 0.62) and increased time to any mood relapse during up to 15 months follow-up (χ2 = 7.64, P<0.006, estimated hazard ratio (HR) = 0.38, 95% CI 0.18-0.78). Groups did not differ with respect to medication adherence. CONCLUSIONS: Recovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness. Clinical- and cost-effectiveness now need to be reliably estimated in a definitive trial.

Metacognitive therapy in treatment-resistant psychosis: a multiple-baseline study.

BACKGROUND: More effective psychological treatments for psychosis are required. Case series data and pilot trials suggest metacognitive therapy (MCT) is a promising treatment for anxiety and depression. Other research has found negative metacognitive beliefs and thought-control strategies may be involved in the development and maintenance of hallucinations and delusions. The potential of MCT in treating psychosis has yet to be investigated. AIMS: Our aim was to find out whether a short number of MCT sessions would be associated with clinically significant and sustained improvements in delusions, hallucinations, anxiety, depression and subjective recovery in patients with treatment-resistant long-standing psychosis. METHOD: Three consecutively referred patients, each with a diagnosis of paranoid schizophrenia and continuing symptoms, completed a series of multiple baseline assessments. Each then received between 11 and 13 sessions of MCT and completed regular assessments of progress, during therapy, post-therapy and at 3-month follow-up. RESULTS: Two out of 3 participants achieved clinically significant reductions across a range of symptom-based outcomes at end-of-therapy. Improvement was sustained at 3-month follow-up for one participant. CONCLUSIONS: Our study demonstrates the feasibility of using MCT with people with medication-resistant psychosis. MCT was acceptable to the participants and associated with meaningful change. Some modifications may be required for this population, after which a controlled trial may be warranted.

Core schemas across the continuum of psychosis: a comparison of clinical and non-clinical groups.

BACKGROUND: Research suggests that core schemas are important in both the development and maintenance of psychosis. AIMS: The aim of the study was to investigate and compare core schemas in four groups along the continuum of psychosis and examine the relationships between schemas and positive psychotic symptomatology. METHOD: A measure of core schemas was distributed to 20 individuals experiencing first-episode psychosis (FEP), 113 individuals with "at risk mental states" (ARMS), 28 participants forming a help-seeking clinical group (HSC), and 30 non-help-seeking individuals who endorse some psychotic-like experiences (NH). RESULTS: The clinical groups scored significantly higher than the NH group for negative beliefs about self and about others. No significant effects of group on positive beliefs about others were found. For positive beliefs about the self, the NH group scored significantly higher than the clinical groups. Furthermore, negative beliefs about self and others were related to positive psychotic symptomatology and to distress related to those experiences. CONCLUSIONS: Negative evaluations of the self and others appear to be characteristic of the appraisals of people seeking help for psychosis and psychosis-like experiences. The results support the literature that suggests that self-esteem should be a target for intervention. Future research would benefit from including comparison groups of people experiencing chronic psychosis and people who do not have any psychotic-like experiences.

Group Cohesion and Necessary Adaptations in Online Hearing Voices Peer Support Groups: Qualitative Study With Group Facilitators.

BACKGROUND: Face-to-face hearing voices peer support groups (HVGs), a survivor-led initiative that enables individuals who hear voices to engage with the support of peers, have a long-standing history in community settings. HVGs are premised on the notion that forming authentic, mutual relationships enables the exploration of one's voice hearing experiences and, in turn, reduces subjective distress. As such, group cohesion is assumed to be a central mechanism of change in HVGs. The rise of digital mental health support, coupled with the COVID-19 pandemic, has resulted in many HVGs adapting to online delivery. However, to date no studies have examined the implementation of these online groups and the adaptations necessary to foster cohesion. OBJECTIVE: This study aims to understand the experience of group cohesion among HVG facilitators in online groups compared with face-to-face groups. Specifically, we examined the ways in which the medium through which groups run (online or face-to-face) impacts group cohesion and how facilitators adapted HVGs to foster group cohesion online. METHODS: Semistructured qualitative interviews were conducted with 11 facilitators with varied experience of facilitating online and face-to-face HVGs. Data were analyzed using reflexive thematic analysis. RESULTS: The findings are organized into 3 themes and associated subthemes: nonverbal challenges to cohesion (lack of differentiation, transitional space, inability to see the whole picture, and expressions of empathy); discursive challenges to cohesion (topic-based conversation and depth of disclosure); and necessary adaptations for online groups (fostering shared experience and using the unique context to demonstrate investment in others). Despite challenges in both the setting and content of online groups, facilitators felt that group cohesion was still possible to achieve online but that it had to be facilitated intentionally. CONCLUSIONS: This study is the first to specifically investigate group cohesion in online HVGs. Participants noted numerous challenges to group cohesion when adapting groups to run online, including the unnaturally linear narrative flow of dialogue in online settings; lack of transitional spaces, and associated small talk before and after the session; ease of disengagement online; inhibited sharing; and absence of shared physical presence online. Although these challenges were significant, facilitators nevertheless emphasized that the benefits provided by the accessibility of online groups outweighed these challenges. Necessary adaptations for cultivating group cohesion online are outlined and include capitalizing on moments of humor and spontaneity, using group activities, encouraging information sharing between participants using the chat and screen-sharing features, and using objects from participants' environments to gain deeper insight into their subjective worlds.

Study protocol for an adaptive, multi-arm, multi-stage (MAMS) randomised controlled trial of brief remotely delivered psychosocial interventions for people with serious mental health problems who have experienced a recent suicidal crisis: Remote Approaches to Psychosocial Intervention Delivery (RAPID).

BACKGROUND: People with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Admissions can have significant personal costs, be traumatic and are the most expensive form of mental health care. There is an urgent need for treatments to reduce suicidal thoughts and behaviours and reduce avoidable psychiatric admissions. METHODS: A multi-stage, multi-arm (MAMS) randomised controlled trial (RCT) with four arms conducted over two stages to determine the clinical and cost effectiveness of three psychosocial treatments, compared to treatment as usual (TAU), for people with SMHP who have had recent suicidal crisis. Primary outcome is any psychiatric hospital admissions over a 6-month period. We will assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression. The remote treatments delivered over 3 months are structured peer support (PREVAIL); a safety planning approach (SAFETEL) delivered by assistant psychologists; and a CBT-based suicide prevention app accessed via a smartphone (BrighterSide). Recruitment is at five UK sites. Stage 1 includes an internal pilot with a priori progression criteria. In stage 1, the randomisation ratio was 1:1:1:2 in favour of TAU. This has been amended to 2:2:3 in favour of TAU following an unplanned change to remove the BrighterSide arm following the release of efficacy data from an independent RCT. Randomisation is via an independent remote web-based randomisation system using randomly permuted blocks, stratified by site. An interim analysis will be performed using data from the first 385 participants from PREVAIL, SAFETEL and TAU with outcome data at 6 months. If one arm is dropped for lack of benefit in stage 2, the allocation ratio of future participants will be 1:1. The expected total sample size is 1064 participants (1118 inclusive of BrighterSide participants). DISCUSSION: There is a need for evidence-based interventions to reduce psychiatric admissions, via reduction of suicidality. Our focus on remote delivery of established brief psychosocial interventions, utilisation of different modalities of delivery that can provide sustainable and scalable solutions, which are also suitable for a pandemic or national crisis context, will significantly advance treatment options. TRIAL REGISTRATION: ISRCTN33079589. Registered on June 20, 2022.