Investigating the relationship between specific negative symptoms and metacognitive functioning in psychosis: A systematic review.

BACKGROUND: Disrupted metacognition is implicated in development and maintenance of negative symptoms, but more fine-grained analyses would inform precise treatment targeting for individual negative symptoms. AIMS: This systematic review identifies and examines datasets that test whether specific metacognitive capacities distinctly influence negative symptoms. MATERIALS & METHODS: PsycINFO, EMBASE, Medline and Cochrane Library databases plus hand searching of relevant articles, journals and grey literature identified quantitative research investigating negative symptoms and metacognition in adults aged 16+ with psychosis. Authors of included articles were contacted to identify unique datasets and missing information. Data were extracted for a risk of bias assessment using the Quality in Prognostic Studies tool. RESULTS: 85 published reports met criteria and are estimated to reflect 32 distinct datasets and 1623 unique participants. The data indicated uncertainty about the relationship between summed scores of negative symptoms and domains of metacognition, with significant findings indicating correlation coefficients from 0.88 to -0.23. Only eight studies investigated the relationship between metacognition and individual negative symptoms, with mixed findings. Studies were mostly moderate-to-low risk of bias. DISCUSSION: The relationship between negative symptoms and metacognition is rarely the focus of studies reviewed here, and negative symptom scores are often summed. This approach may obscure relationships between metacognitive domains and individual negative symptoms which may be important for understanding how negative symptoms are developed and maintained. CONLCLUSION: Methodological challenges around overlapping participants, variation in aggregation of negative symptom items and types of analyses used, make a strong case for use of Individual Participant Data Meta-Analysis to further elucidate these relationships.

Using EMPOWER in daily life: a qualitative investigation of implementation experiences.

BACKGROUND: Digital self-management tools blended with clinical triage and peer support have the potential to improve access to early warning signs (EWS) based relapse prevention in schizophrenia care. However, the implementation of digital interventions in psychosis can be poor. Traditionally, research focused on understanding how people implement interventions has focused on the perspectives of mental health staff. Digital interventions are becoming more commonly used by patients within the context of daily life, which means there is a need to understand implementation from the perspectives of patients and carers. METHODS: Semi-structured one-on-one interviews with 16 patients who had access to the EMPOWER digital self-management intervention during their participation in a feasibility trial, six mental health staff members who supported the patients and were enrolled in the trial, and one carer participant. Interviews focused on understanding implementation, including barriers and facilitators. Data were coded using thematic analysis. RESULTS: The intervention was well implemented, and EMPOWER was typically perceived positively by patients, mental health staff and the carer we spoke to. However, some patients reported negative views and reported ideas for intervention improvement. Patients reported valuing that the app afforded them access to things like information or increased social contact from peer support workers that went above and beyond that offered in routine care. Patients seemed motivated to continue implementing EMPOWER in daily life when they perceived it was creating positive change to their wellbeing, but seemed less motivated if this did not occur. Mental health staff and carer views suggest they developed increased confidence patients could self-manage and valued using the fact that people they support were using the EMPOWER intervention to open up conversations about self-management and wellbeing. CONCLUSIONS: The findings from this study suggest peer worker supported digital self-management like EMPOWER has the potential to be implemented. Further evaluations of these interventions are warranted, and conducting qualitative research on the feasibility gives insight into implementation barriers and facilitators, improving the likelihood of interventions being usable. In particular, the views of patients who demonstrated low usage levels would be valuable.

Investigating the relationship between negative symptoms and metacognitive functioning in psychosis: An individual participant data meta-analysis.

PURPOSE: Negative symptoms are a persistent, yet under-explored problem in psychosis. Disturbances in metacognition are a potential causal factor in negative symptom development and maintenance. This meta-analysis uses individual participant data (IPD) from existing research to assess the relationship between negative symptoms and metacognition treated as summed scores and domains. METHODS: Data sets containing individuals with negative symptoms and metacognition data, aged 16+ with psychosis, were identified according to pre-specific parameters. IPD integrity and completeness were checked and data were synthesized in two-stage meta-analyses of each negative symptoms cluster compared with metacognition in seemingly unrelated regression using restricted maximum likelihood estimation. Planned and exploratory sensitivity analyses were also conducted. RESULTS: Thirty-three eligible data sets were identified with 21 with sufficient similarity and availability to be included in meta-analyses, corresponding to 1301 participants. The strongest relationships observed were between summed scores of negative symptoms and metacognition. Metacognitive domains of self-reflectivity and understanding others' minds, and expressive negative symptoms emerged as significant in some meta-analyses. The uncertainty of several effect estimates increased significantly when controlling for covariates. CONCLUSIONS: This robust meta-analysis highlights the impact of using summed versus domain-specific scores of metacognition and negative symptoms, and relationships are not as clear-cut as once believed. Findings support arguments for further differentiation of negative symptom profiles and continued granular exploration of the relationship between metacognition and negative symptoms.

The voice characterisation checklist: psychometric properties of a brief clinical assessment of voices as social agents.

Aim: There is growing interest in tailoring psychological interventions for distressing voices and a need for reliable tools to assess phenomenological features which might influence treatment response. This study examines the reliability and internal consistency of the Voice Characterisation Checklist (VoCC), a novel 10-item tool which assesses degree of voice characterisation, identified as relevant to a new wave of relational approaches. Methods: The sample comprised participants experiencing distressing voices, recruited at baseline on the AVATAR2 trial between January 2021 and July 2022 (n = 170). Inter-rater reliability (IRR) and internal consistency analyses (Cronbach's alpha) were conducted. Results: The majority of participants reported some degree of voice personification (94%) with high endorsement of voices as distinct auditory experiences (87%) with basic attributes of gender and age (82%). While most identified a voice intention (75%) and personality (76%), attribution of mental states (35%) to the voice ('What are they thinking?') and a known historical relationship (36%) were less common. The internal consistency of the VoCC was acceptable (10 items, α = 0.71). IRR analysis indicated acceptable to excellent reliability at the item-level for 9/10 items and moderate agreement between raters' global (binary) classification of more vs. less highly characterised voices, κ = 0.549 (95% CI, 0.240-0.859), p < 0.05. Conclusion: The VoCC is a reliable and internally consistent tool for assessing voice characterisation and will be used to test whether voice characterisation moderates treatment outcome to AVATAR therapy. There is potential wider utility within clinical trials of other relational therapies as well as routine clinical practice.

Acceptance and Commitment Therapy for people living with motor neuron disease: an uncontrolled feasibility study.

BACKGROUND: Motor neuron disease (MND) is a fatal, progressive neurodegenerative disease that causes progressive weakening and wasting of limb, bulbar, thoracic and abdominal muscles. Clear evidence-based guidance on how psychological distress should be managed in people living with MND (plwMND) is lacking. Acceptance and Commitment Therapy (ACT) is a form of psychological therapy that may be particularly suitable for this population. However, to the authors' knowledge, no study to date has evaluated ACT for plwMND. Consequently, the primary aim of this uncontrolled feasibility study was to examine the feasibility and acceptability of ACT for improving the psychological health of plwMND. METHODS: PlwMND aged ≥ 18 years were recruited from 10 UK MND Care Centres/Clinics. Participants received up to 8 one-to-one ACT sessions, developed specifically for plwMND, plus usual care. Co-primary feasibility and acceptability outcomes were uptake (≥ 80% of the target sample [N = 28] recruited) and initial engagement with the intervention (≥ 70% completing ≥ 2 sessions). Secondary outcomes included measures of quality of life, anxiety, depression, disease-related functioning, health status and psychological flexibility in plwMND and quality of life and burden in caregivers. Outcomes were assessed at baseline and 6 months. RESULTS: Both a priori indicators of success were met: 29 plwMND (104%) were recruited and 76% (22/29) attended ≥ 2 sessions. Attrition at 6-months was higher than anticipated (8/29, 28%), but only two dropouts were due to lack of acceptability of the intervention. Acceptability was further supported by good satisfaction with therapy and session attendance. Data were possibly suggestive of small improvements in anxiety and psychological quality of life from baseline to 6 months in plwMND, despite a small but expected deterioration in disease-related functioning and health status. CONCLUSIONS: There was good evidence of acceptability and feasibility. Limitations included the lack of a control group and small sample size, which complicate interpretation of findings. A fully powered RCT to evaluate the clinical and cost-effectiveness of ACT for plwMND is underway. TRIAL REGISTRATION: The study was pre-registered with the ISRCTN Registry (ISRCTN12655391).

An examination of the potential benefits of expert guided physical activity for supporting recovery from extreme social withdrawal: Two case reports focused on the treatment of Hikikomori.

Extreme and long-term social withdrawal, first described in Japan as Hikikomori, has now become a globally recognized mental health problem. Intervention studies severely lag behind epidemiological and phenomenological research. We present two descriptive case reports of Japanese university students with Hikikomori who participated in an early phase test of a structured intervention involving physical activities that was developed and facilitated by clinicians and physical education specialists-Human Movement Consultation (HMC). The two recipients (19- and 29-years old at the start of treatment) completed approximately 40 consultation sessions delivered over 3 years consisting of a combination of outdoor workouts (i.e., walking, running, and cycling) and interpersonal sports (e.g., table tennis, badminton, and tennis). Changes in social withdrawal behavior were independently rated from clinical health records using a structured scale (the Glasgow Hikikomori Scale; GHS). Behavioral observations and scale data for both cases indicated improvements from pre-treatment levels of social withdrawal. At the end of the intervention, both had returned to normative levels of functioning. Case A returned to university and Case B secured a new job upon the completion of HMC. To help advance our understanding of treatment options, these case descriptions analyze potential change mechanisms in order to understand how HMC can support recovery from extreme social withdrawal. One key observation is that both outdoor workouts and interpersonal sports offer a non-threatening method of enabling Hikikomori to engage in interpersonal interactions. Such connections via structured activities may allow the reinstatement of social skills in a graded manner. In addition, an initial focus on physical experiences may help promote psychological and social connectedness without triggering the social fears and challenges that underlie the Hikikomori state. The findings from these two cases offer a framework to guide further research and the development of exercise-based interventions for this hidden and often neglected group.

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.

Splitting Things Apart to Put Them Back Together Again: A Targeted Review and Analysis of Psychological Therapy RCTs Addressing Recovery From Negative Symptoms.

Negative symptoms have attracted growing attention as a psychological treatment target and the past 10 years has seen an expansion of mechanistic studies and clinical trials aimed at improving treatment options for this frequently neglected sub-group of people diagnosed with schizophrenia. The recent publication of several randomized controlled trials of psychological treatments that pre-specified negative symptoms as a primary outcome warrants a carefully targeted review and analysis, not least because these treatments have generally returned disappointing therapeutic benefits. This mini-review dissects these trials and offers an account of why we continue to have significant gaps in our understanding of how to support recovery in people troubled by persistent negative symptoms. Possible explanations for mixed trial results include a failure to separate the negative symptom phenotype into the clinically relevant sub-types that will respond to mechanistically targeted treatments. For example, the distinction between experiential and expressive deficits as separate components of the wider negative symptom construct points to potentially different treatment needs and techniques. The 10 negative symptom-focused RCTs chosen for analysis in this mini-review present over 16 different categories of treatment techniques spanning a range of cognitive, emotional, behavioral, interpersonal, and metacognitive domains of functioning. The argument is made that treatment development will advance more rapidly with the use of more precisely targeted psychological treatments that match interventions to a focused range of negative symptom maintenance processes.

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.

Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial.

BACKGROUND: AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth 'voices'). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU). METHODS: This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued. DISCUSSION: This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings. TRIAL REGISTRATION: ISRCTN registry ISRCTN55682735 . Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).

Candidate Factors Maintaining Social Anxiety in the Context of Psychotic Experiences: A Systematic Review.

Social anxiety is common in psychosis and associated with impaired functioning, poorer quality of life, and higher symptom severity. This study systematically reviewed factors maintaining social anxiety in people with attenuated, transient, or persistent psychotic experiences. Other correlates of social anxiety were also examined. MEDLINE, Embase, CENTRAL, and PsycINFO were searched for relevant literature up to October 19, 2020. Forty-eight articles were eligible for narrative synthesis: 38 cross-sectional studies, 8 prospective studies, 1 uncontrolled trial, and 1 qualitative study. From 12060 participants, the majority was general population (n = 8771), followed by psychosis samples (n = 2532) and those at high risk of psychosis (n = 757). The methodological quality and risk of bias were assessed using the Mixed Methods Appraisal Tool. Ninety percent of studies were rated as high to very-high quality. Poorer quality studies typically failed to adequately control for confounds and provided insufficient information on the measurement validity and reliability. Prominent psychological factors maintaining social anxiety included self-perceptions of stigma and shame. Common correlates of social anxiety included poorer functioning and lower quality of life. In conclusion, stigma and shame could be targeted as a causal mechanism in future interventional studies. The integration of findings from this review lead us to propose a new theoretical model to guide future intervention research.

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial.

BACKGROUND: Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. OBJECTIVE: The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. METHODS: We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app-based intervention for people diagnosed with schizophrenia. RESULTS: Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. CONCLUSIONS: Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

Development and testing of a checklist to assess compliance with the faculty of pain medicine's core standards for pain management services: experience in a new national tertiary pain service.

INTRODUCTION: The Faculty of Pain Medicine recently published the first UK-focused Core Standards for Pain Management Services (CSPMS). We present an audit checklist tool developed to map compliance to the CSPMS, which offers a practical method of auditing any pain management service against the standards. METHODS: The checklist tool was developed and its utility was field-tested in the Scottish National Residential Pain Management Programme (SNRPMP), a newly established service offering residential service to people in Scotland. RESULTS: The checklist tool developed provides an easy and practical approach to evaluating any pain service against the national standards. Its application to evaluate the SNRPMP indicates that the service meets the majority of CSPMS standards and highlights aspects of the service requiring improvement. CONCLUSION: The layout of the developed checklist tool offers an alternative format for the structuring of the national standards in possible future revisions. The audit checklist tool enables evaluation of services with a numerical score, enabling monitoring of their compliance with national standards as well as comparisons between pain services.

Jamaican adolescents' receptiveness to digital mental health services: A cross-sectional survey from rural and urban communities.

BACKGROUND: Improving access to mental health resources for young people is an urgent healthcare challenge. As the majority of youth live in low and middle-income countries (LMICs) mental ill health can exert substantial adverse impacts on societies that can least afford it. Digital mental health technologies might help close the treatment gap but we need to understand barriers to implementing these strategies, especially in resource constrained contexts such as LMICs. METHODS: We surveyed adolescents (N = 107; aged 10-19 years) from Jamaican communities using questionnaires adopted from previous studies conducted in LMICs. The questions addressed mental health help-seeking preferences, expectations of help-seeking effectiveness, and practical and attitudinal barriers to using mobile-phone-based mental health resources. We present descriptive data alongside exploratory analyses of differences in attitudes and preferences expressed by subgroups of respondents. RESULTS: Adolescents reported very few practical or infrastructure barriers to accessing digital mental health resources. >90% of the sample had access to a smartphone, 78% expected that digital solutions could benefit adolescents with symptoms of mental distress, and 56% were interested in using mental health apps to monitor their own mental health. Stigma, shame, and embarrassment were major barriers to help-seeking and formal professional help was only preferred for more severe conditions such as psychosis and substance abuse. CONCLUSIONS: Practical barriers are unlikely to impede the uptake of digital mental health resources by Jamaican adolescents. Our data suggest that mental health literacy, stigma, and embarrassment pose more serious blocks to help-seeking.

Metacognition and Intersubjectivity: Reconsidering Their Relationship Following Advances From the Study of Persons With Psychosis.

As research on metacognition has progressed a significant array of definitions, methodologies and therapeutic applications have emerged. Some of this work has primarily framed metacognition as an activity carried out by one person in order to know, monitor, and adjust their beliefs, memories, and behaviors. Accordingly, problems with metacognition have often been characterized as issues related to cognition. This, however, risks neglecting how metacognition is also a fundamentally intersubjective act, one in which human beings know and reflect upon themselves and others primarily with and through connections with other people. In this paper, we review research on metacognition in schizophrenia using the integrative model of metacognition and a research paradigm in which metacognition is assessed within personal narratives. Stimulated by this work, we discuss how disturbances in intersubjective experience and metacognitive capacity mutually influence one another, with disruptions in metacognition perhaps more deeply understood as disruptions in relatedness with others. We then discuss how metacognition and intersubjectivity each affect mental health. We finally focus on the implications of this for treatments that target metacognition as well as future directions for research.

Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support.

BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15058.

Can acceptance and commitment therapy facilitate psychological adjustment after a severe traumatic brain injury? A pilot randomized controlled trial.

This study i⁠nvestigated if an Acceptance and Commitment Therapy (ACT) intervention (ACT-Adjust) can facilitate psychological adjustment and reduce psychological distress following severe traumatic brain injury (TBI). The study design comprised a single centre, two-armed, Phase II pilot randomized controlled trial. Nineteen individuals with severe TBI (PTA ≥7 days) who met a clinical threshold for psychological distress (Depression Anxiety Stress Scales-21; DASS > 9) were randomly allocated to either ACT-Adjust (n = 10) or an active control, Befriending Therapy (n = 9), in conjunction with a holistic rehabilitation programme. Primary (psychological flexibility, rehabilitation participation) and secondary (depression, anxiety & stress) outcomes were measured at three-time points (pre, post and follow up). Significant decreases were found for DASS-depression (group by time interaction, F 1,17 = 5.35, p = .03) and DASS-stress (group by time interaction, F 1,17 = 5.69, p = .03) in comparison to the Befriending group, but not for the primary outcome measures. The reduction in stress post-treatment was classed as clinically significant, however interaction differences for stress and depression were not maintained at one month follow up. Preliminary investigations indicate potential for ACT in decreasing psychological distress for individuals with a severe TBI with further sessions required to maintain treatment gains. The pilot results suggest further investigation is warranted in a larger scale clinical trial.

Perspectives of patients, carers and mental health staff on early warning signs of relapse in psychosis: a qualitative investigation.

BACKGROUND: Relapse prevention strategies based on monitoring of early warning signs (EWS) are advocated for the management of psychosis. However, there has been a lack of research exploring how staff, carers and patients make sense of the utility of EWS, or how these are implemented in context. AIMS: To develop a multiperspective theory of how EWS are understood and used, which is grounded in the experiences of mental health staff, carers and patients. METHOD: Twenty-five focus groups were held across Glasgow and Melbourne (EMPOWER Trial, ISRCTN: 99559262). Participants comprised 88 mental health staff, 21 patients and 40 carers from UK and Australia (total n = 149). Data were analysed using constructivist grounded theory. RESULTS: All participants appeared to recognise EWS and acknowledged the importance of responding to EWS to support relapse prevention. However, recognition of and acting on EWS were constructed in a context of uncertainty, which appeared linked to risk appraisals that were dependent on distinct stakeholder roles and experiences. Within current relapse management, a process of weighted decision-making (where one factor was seen as more important than others) described how stakeholders weighed up the risks and consequences of relapse alongside the risks and consequences of intervention and help-seeking. CONCLUSIONS: Mental health staff, carers and patients speak about using EWS within a weighted decision-making process, which is acted out in the context of relationships that exist in current relapse management, rather than an objective response to specific signs and symptoms.

Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation.

BACKGROUND: Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. OBJECTIVE: This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. METHODS: The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. RESULTS: The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. CONCLUSIONS: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15634.