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.

Social identification, identity integration and wellbeing in people who hear voices.

OBJECTIVES: Hearing voices is associated with public stigma and this can influence readiness to identify as a voice hearer (VH) and psychological wellbeing. In this study, we investigated the relationships between a VH social identity, the integration of that identity with other important social identities and wellbeing. DESIGN: Cross-sectional study, with a subset of longitudinal data across three time points. METHODS: People who self-identified as voice hearers completed questionnaires (VH social identity, identity integration, wellbeing and perceptions of in-group and out-group empathy) at three time points, spaced at 3-monthly intervals. The final sample comprised 182 participants at T1, 91 at T2 and 75 at T3. Hierarchical linear multiple regression analyses were used to test all hypotheses. RESULTS: The integration of a VH social identity was strongly associated with better psychological wellbeing at T1. Identity integration was also associated with static wellbeing scores at 6 months. Effects on wellbeing were not accounted for by either severity of voice-hearing or paranoia. Whilst perceptions of in-group empathy were associated with VH social identification, perceptions of outgroup empathy were important for identity integration. CONCLUSIONS: Integrating a VH social identity with other important identities into a coherent sense of self is important for wellbeing in voice hearers; perceived in-group and outgroup empathy are important in this process.

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.

A psychological intervention for engaging dialogically with auditory hallucinations (Talking With Voices): A single-site, randomised controlled feasibility trial.

There is growing clinical interest in addressing relationship dynamics between service-users and their voices. The Talking With Voices (TwV) trial aimed to establish feasibility and acceptability of a novel dialogical intervention to reduce distress associated with voices amongst adults diagnosed with schizophrenia spectrum disorders. The single-site, single-blind (rater) randomised controlled trial recruited 50 participants who were allocated 1:1 to treatment as usual (TAU), or TAU plus up to 26 sessions of TwV therapy. Participants were assessed at baseline and again at end of treatment (six-months). The primary outcomes were quantitative and qualitative assessments of feasibility and acceptability. Secondary outcomes involved clinical measures, including targeted instruments for voice-hearing, dissociation, and emotional distress. The trial achieved 100 % of the target sample, 24 of whom were allocated to therapy and 26 to TAU. The trial had high retention (40/50 [80 %] participants at six-months) and high intervention adherence (21/24 [87.5 %] receiving ≥8 sessions). Signals of efficacy were shown in targeted measures of voice-hearing, dissociation, and perceptions of recovery. Analysis on the Positive and Negative Syndrome Scale indicated that there were no differences in means of general psychosis symptom scores in TwV compared to the control group. There were four serious adverse events in the therapy group and eight in TAU, none of which were related to study proceedings. The trial demonstrates the acceptability of the intervention and the feasibility of delivering it under controlled, randomised conditions. An adequately powered definitive trial is necessary to provide robust evidence regarding efficacy evaluation and cost-effectiveness. Trial registration: ISRCTN 45308981.

Crisis-focused Cognitive Behavioural Therapy for psychosis (CBTp) in acute mental health inpatient settings (the CRISIS study): protocol for a pilot randomised controlled trial.

BACKGROUND: Cognitive Behavioural Therapy for psychosis (CBTp) has an established evidence base and is recommended by clinical guidelines to be offered during the acute phases of psychosis. However, few research studies have examined the efficacy of CBTp interventions specifically adapted for the acute mental health inpatient context with most research trials being conducted with white European community populations. AIMS: The aim of this study is to conduct a pilot randomised controlled trial (RCT), which incorporates the examination of feasibility markers, of a crisis-focused CBTp intervention adapted for an ethnically diverse acute mental health inpatient population, in preparation for a large-scale randomised controlled trial. The study will examine the feasibility of undertaking the trial, the acceptability and safety of the intervention and the suitability of chosen outcome measures. This will inform the planning of a future, fully powered RCT. METHODS: A single-site, parallel-group, pilot RCT will be conducted examining the intervention. Drawing on principles of coproduction, the intervention has been adapted in partnership with key stakeholders: service users with lived experience of psychosis and of inpatient care (including those from ethnic minority backgrounds), carers, multi-disciplinary inpatient clinicians and researchers. Sixty participants with experience of psychosis and in current receipt of acute mental health inpatient care will be recruited. Participants will be randomly allocated to either the crisis-focused CBTp intervention or treatment as usual (TAU). DISCUSSION: Findings of this pilot RCT will indicate whether a larger multi-site RCT is needed to investigate the efficacy of the intervention. If the initial results demonstrate that this trial is feasible and the intervention is acceptable, it will provide evidence that a full-scale effectiveness trial may be warranted. TRIAL REGISTRATION: This trial has been prospectively registered on the ISRCTN registry ( ISRCTN59055607 ) on the 18th of February 2021.

A treatment protocol to guide the delivery of dialogical engagement with auditory hallucinations: Experience from the Talking With Voices pilot trial.

PURPOSE: To present a treatment protocol for delivering Talking With Voices, a novel intervention for people with psychosis that involves dialogical engagement with auditory hallucinations. METHOD: This paper presents a manualized approach to therapy employed in the Talking With Voices trial, a feasibility and acceptability randomized control trial of 50 adult participants. A rationale for following a treatment manual is provided, followed by the theoretical underpinnings of the intervention and its principles and values, including the main tenet that voices can often be understood as dissociated parts of the self which serve a protective function by indicating social-emotional vulnerabilities. The four therapy phases for improving the relationship between the voice-hearer and their voices are outlined: (1) engagement and psychoeducation, (2) creating a formulation, (3) dialoguing with voices, and (4) consolidating outcomes, including key milestones at each phase. Implementation issues are discussed, as well as recommendations for best practice and future research. RESULTS: The Talking With Voices treatment protocol indicates that it is feasible to manualize a dissociation-based approach to support service users who are distressed by hearing voices. CONCLUSION: For some individuals, it is possible to engage in productive dialogue with even extremely hostile or distressing voices. Developing coping strategies, creating a formulation, and ultimately establishing a dialogue with voices has the potential to improve the relationship between voice(s) and voice-hearer. Further research is now required to evaluate feasibility, acceptability, and efficacy. PRACTITIONER POINTS: It is feasible to integrate a dissociation model of voice-hearing within a psychological intervention for people with psychosis. Combining psychosocial education, formulation and direct dialogue can be used to facilitate a more peaceful relationship between clients and their voices. Practitioners trained in other therapeutic modalities can draw on existing transferrable skills to dialogue with their clients' voices. The input of those with lived experience of mental health difficulties has an important role in guiding treatment design and delivery.

Psychological intervention, antipsychotic medication or a combined treatment for adolescents with a first episode of psychosis: the MAPS feasibility three-arm RCT.

BACKGROUND: When psychosis emerges in young people there is a risk of poorer outcomes, and access to evidence-based treatments is paramount. The current evidence base is limited. Antipsychotic medications show only a small benefit over placebo, but young people experience more side effects than adults. There is sparse evidence for psychological intervention. Research is needed to determine the clinical effectiveness and cost-effectiveness of psychological intervention versus antipsychotic medication versus a combined treatment for adolescents with psychosis. OBJECTIVES: The objective of Managing Adolescent first-episode Psychosis: a feasibility Study (MAPS) was to determine the feasibility of conducting a definitive trial to answer the question of clinical effectiveness and cost-effectiveness of these three treatment options. DESIGN: This was a prospective, randomised, open-blinded, evaluation feasibility trial with a single blind. Participants were allocated 1 : 1 : 1 to receive antipsychotic medication, psychological intervention or a combination of both. A thematic qualitative study explored the acceptability and feasibility of the trial. SETTING: Early intervention in psychosis services and child and adolescent mental health services in Manchester, Oxford, Lancashire, Sussex, Birmingham, Norfolk and Suffolk, and Northumberland, Tyne and Wear. PARTICIPANTS: People aged 14-18 years experiencing a first episode of psychosis either with an International Classification of Diseases, Tenth Revision, schizophrenia spectrum diagnosis or meeting the entry criteria for early intervention in psychosis who had not received antipsychotic medication or psychological intervention within the last 3 months. INTERVENTIONS: Psychological intervention involved up to 26 hours of cognitive-behavioural therapy and six family intervention sessions over 6 months, with up to four booster sessions. Antipsychotic medication was prescribed by the participant's psychiatrist in line with usual practice. Combined treatment was a combination of psychological intervention and antipsychotic medication. MAIN OUTCOME MEASURES: The primary outcome was feasibility (recruitment, treatment adherence and retention). We used a three-stage progression criterion to determine feasibility. Secondary outcomes were psychosis symptoms, recovery, anxiety and depression, social and educational/occupational functioning, drug and alcohol use, health economics, adverse/metabolic side effects and adverse/serious adverse events. RESULTS: We recruited 61 out of 90 (67.8%; amber zone) potential participants (psychological intervention, n = 18; antipsychotic medication, n = 22; combined treatment, n = 21). Retention to follow-up was 51 out of 61 participants (83.6%; green zone). In the psychological intervention arm and the combined treatment arm, 32 out of 39 (82.1%) participants received six or more sessions of cognitive-behavioural therapy (green zone). In the combined treatment arm and the antipsychotic medication arm, 28 out of 43 (65.1%) participants received antipsychotic medication for 6 consecutive weeks (amber zone). There were no serious adverse events related to the trial and one related adverse event. Overall, the number of completed secondary outcome measures, including health economics, was small. LIMITATIONS: Medication adherence was determined by clinician report, which can be biased. The response to secondary outcomes was low, including health economics. The small sample size obtained means that the study lacked statistical power and there will be considerable uncertainty regarding estimates of treatment effects. CONCLUSIONS: It is feasible to conduct a trial comparing psychological intervention with antipsychotic medication and a combination treatment in young people with psychosis with some adaptations to the design, including adaptations to collection of health economic data to determine cost-effectiveness. FUTURE WORK: An adequately powered definitive trial is required to provide robust evidence. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80567433. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 4. See the NIHR Journals Library website for further project information.

Psychosis is a mental health problem that can involve hearing, seeing or believing things that others do not. Although many young people who experience psychosis recover well from their first episode of psychosis, others can have more serious, longer-lasting problems. There has not been a large amount of research into the treatment of psychosis in young people; therefore, it is important to test different treatments against each other in clinical trials. 'Feasibility' trials, such as the one we carried out [Managing Adolescent first-episode Psychosis: a feasibility Study (MAPS)], test whether or not it is possible to run larger trials. MAPS was a small trial that was run in seven locations in the UK. People who were aged 14­18 years and experiencing psychosis were able to take part. Each participant was randomly assigned to receive psychological treatment (cognitive­behavioural therapy and optional family therapy), antipsychotic medication or a combination of both. All of the participants met with a trial research assistant three times for assessments about well-being and symptoms. Some clinicians, participants and family members were interviewed about their opinions of the trial and treatments. The trial also had patient and public involvement; service user researchers were involved in design, interview data collection, analysis and report writing. Sixty-one young people took part in MAPS, which was around 68% of our target number. In total, 84% completed the assessments with research assistants. The results showed that, overall, all treatments were acceptable to young people and their family members. However, a higher percentage of young people actually received the 'minimum dose' of psychological treatment than the 'minimum dose' of antipsychotic medication (82% vs. 65%). Results showed that it was possible to run a larger trial such as this. However, some changes would be required to run a larger trial, such as location (focusing on urban areas with well established early intervention in psychosis teams), increasing involvement of psychiatrists and increasing the age limit for participation to 25 years.

Combined individual and family therapy in comparison to treatment as usual for people at-risk of psychosis: A feasibility study (IF CBT): Trial rationale, methodology and baseline characteristics.

AIMS: Current National Institute for Health and Care Excellence (NICE) guidelines for psychosis recommend psychological therapy with or without family intervention for individuals at-risk of developing psychosis. NICE guidelines have a specific research recommendation to investigate the clinical and cost effectiveness of combined individual and family intervention. We report the rationale, design and baseline characteristics of a feasibility study which aimed to investigate combined Individual and Family Cognitive Behavioural Therapy (IFCBT) for those at-risk of developing psychosis. METHODS: The IFCBT study was a single blind, pilot randomized controlled trial (RCT) to compare a combined individual and family Cognitive Behavioural Therapy (CBT) intervention to treatment as usual. Participants were assessed using the Comprehensive Assessment of the At-risk Mental State (CAARMS) and randomly allocated to either therapy or enhanced treatment as usual (ETAU). All participants were followed up at 6 and 12 months. Primary feasibility outcomes were recruitment and retention of participants. Secondary outcomes included transition to psychosis and assessment of mood, anxiety and the relationship of the individual and nominated family member. RESULTS: We report data showing entry into the study from initial enquiry to randomization. We report the characteristics of the recruited sample of individuals (n = 70) and family members (n = 70) at baseline. CONCLUSIONS: The study recruited to 92% of target demonstrating it is feasible to identify and recruit participants. Our study aimed to add to the current evidence base regarding the utility of family interventions for people at-risk of psychosis.

Targeting dissociation using cognitive behavioural therapy in voice hearers with psychosis and a history of interpersonal trauma: A case series.

OBJECTIVES: Previous studies have suggested that dissociation might represent an important mechanism in the maintenance of auditory verbal hallucinations (i.e., voices) in people who have a history of traumatic life experiences. This study investigated whether a cognitive behavioural therapy (CBT) intervention for psychosis augmented with techniques specifically targeting dissociative symptoms could improve both dissociation and auditory hallucination severity in a sample of voice hearers with psychosis and a history of interpersonal trauma (e.g., exposure to sexual, physical, and/or emotional abuse). DESIGN: Case series. METHODS: A total of 19 service users with psychosis were offered up to 24 therapy sessions over a 6-month intervention window. Participants were assessed four times over a 12-month period using measures of dissociation, psychotic symptoms severity, and additional secondary mental-health and recovery measures. RESULTS: Sixteen participants engaged in the intervention and were included in last-observation-carried-forward analyses. Dropout rates were in line with those of other CBT for psychosis trials (26.3%). Repeated measures ANOVAs revealed large and significant improvements in dissociation (drm  = 1.23) and hallucination severity (drm  = 1.09) by the end of treatment; treatment gains were maintained 6 months following the end of therapy. Large and statistically significant gains were also observed on measures of post-traumatic symptoms, delusion severity, emotional distress, and perceived recovery from psychosis. CONCLUSIONS: The findings of this case series suggest that the reduction of dissociation represents a valuable and acceptable treatment target for clients with auditory verbal hallucinations and a trauma history. Future clinical trials might benefit from considering targeting dissociative experiences as part of psychological interventions for distressing voices. PRACTITIONER POINTS: Practitioners should consider the role of dissociation when assessing and formulating the difficulties of voice hearers with a history of trauma. Techniques to reduce dissociation can be feasibly integrated within psychological interventions for voices. Voice hearers with histories of trauma can benefit from psychological interventions aimed at reducing dissociation.

Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.

BACKGROUND: Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis. METHODS: We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433. FINDINGS: Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial. INTERPRETATION: This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence. FUNDING: National Institute for Health Research.

Relationships between psychiatric symptoms, functioning and personal recovery in psychosis.

BACKGROUND: Recovery from psychosis is increasingly being viewed as a combination of symptomatic, functional, and personal recovery. Negative and depressive symptoms have been linked to community functioning, and negative affect has been linked to personal recovery. The current study examines differential associations of symptoms with functional and personal recovery, and the interaction of cognitive and emotional components of psychotic experiences in predicting recovery. METHODS: Baseline data from four studies of individuals with schizophrenia-spectrum disorders were amalgamated for the current analyses. All studies utilized the Positive and Negative Syndrome Scale, Psychotic Symptom Rating Scale, Personal and Social Performance Scale, and the Questionnaire about the Process of Recovery. RESULTS: 971 individuals participated across the four studies. Affective symptoms were most strongly associated with personal recovery, accounting for 30% of the variance in personal recovery and only 2% of the variance in objective functioning. Negative and disorganized symptoms were related to both functional and personal recovery, excitement symptoms were only related to personal recovery, and broad measures of positive symptoms were not associated with either functional or personal recovery. Cognitive interpretations of psychotic experiences were more strongly related to objective functioning, and emotional components of psychotic experiences were more strongly related to personal recovery; cognitive interpretations moderated the relationship between emotional characteristics and recovery measures. CONCLUSIONS: Functional and personal recovery are distinct domains of recovery with differential relationships to symptomatology. Interventions that target cognitive interpretations of psychotic experiences and negative affect may be more likely to affect multiple domains of recovery.

Is cognitive behavioural therapy effective for individuals experiencing thought disorder?

Various clinical guidelines recommend cognitive behavioural therapy (CBT) to treat psychosis without reference to patients' thought disorder. However, there is a risk that disorganized thinking hampers CBT. We tested the prediction that thought disorder would interfere with the effectiveness of CBT for hallucinations and delusions, compared to treatment as usual and supportive counselling, in secondary data from two large, single blind randomised controlled trials. We fitted latent growth curve models separately for the development of frequency and distress of symptoms. CBT was significantly more successful than counselling in reducing delusional frequency in the short term and hallucinatory distress at any point, even in those with relatively high thought disorder. We found little evidence that clinicians should restrict CBT in this subgroup of patients. Nevertheless, the findings highlight the importance of effective initial treatment of thought disorder in maximising the benefit of CBT for psychosis, particularly for reducing distress from hallucinations.

Distress related to psychotic symptoms in individuals at high risk of psychosis.

This study assessed the relationship between distress, severity and frequency of attenuated psychotic symptoms in individuals meeting Ultra High Risk (UHR) criteria, both at baseline and over time. It also assessed distress in relation to attenuated symptoms and whether cognitive behavioural therapy (CBT) reduced distress over time by symptom type. At baseline a combined total of 592 UHR participants (mean age 19.9; males, 53.9%) from two studies were assessed using a confirmatory factor analysis (CFA). Change over time from this baseline point was assessed using latent growth curve (LGC) models, based on participants from one of the studies. Distress associated with psychotic symptom was shown to be a separate psychological construct from severity and frequency. Distress was also significantly associated with severity but not frequency. Longitudinal LGC models with 244 participants showed that distress, severity and frequency all reduced over six months, although the rate of distress reduction varied across symptom type. Non-bizarre ideas (NBI) were more distressing and had the fastest rate of distress reduction over time. The baseline distress for some symptoms also strongly predicted the symptom severity change over time, suggesting that distress may cause change in the UHR criteria for unusual thought content (UTC) and NBI symptoms. CBT was not shown to be significantly different from treatment as usual (TAU) in its effect on distress. However, distress reduces over time, particularly in the first 3 months after presentation. We recommend that distress should be used as an outcome in future research and as a clinical indicator. (250 words).

Comorbidity rates of depression and anxiety in first episode psychosis: A systematic review and meta-analysis.

Anxiety and depression symptoms are frequently experienced by individuals with psychosis, although prevalence rates have not been reviewed in first-episode psychosis (FEP). The aim of this systematic review was to focus on the prevalence rates for both anxiety and depression, comparing the rates within the same study population. A systematic review and meta-analysis was completed for all studies measuring both anxiety and depression in FEP at baseline. The search identified 6040 citations, of which n = 10 met inclusion criteria. These reported 1265 patients (age 28.3 ± 9.1, females: 39.9%) with diagnosed FEP. Studies which used diagnosis to define comorbidity count were included in separate meta-analyses for anxiety and depression, although the heterogeneity was high limiting interpretation of separate prevalence rates. A random-effects meta-analysis also compared the mean difference between anxiety and depression within the same studies. We show that anxiety and depression co-occur at a similar rate within FEP, although the exact rates are not reliable due to the heterogeneity between the small number of studies. Future research in FEP should consider routinely measuring anxiety and depression using continuous self-report measures of symptoms. Clinically we recommend that both anxiety and depression are equally targeted during psychological intervention in FEP, together with the psychotic symptoms.

Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14-18-year-olds: Managing Adolescent first episode Psychosis: a feasibility study (MAPS).

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.

Cognitive-behavioural therapy for clozapine-resistant schizophrenia: the FOCUS RCT.

BACKGROUND: Clozapine (clozaril, Mylan Products Ltd) is a first-choice treatment for people with schizophrenia who have a poor response to standard antipsychotic medication. However, a significant number of patients who trial clozapine have an inadequate response and experience persistent symptoms, called clozapine-resistant schizophrenia (CRS). There is little evidence regarding the clinical effectiveness of pharmacological or psychological interventions for this population. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of cognitive-behavioural therapy (CBT) for people with CRS and to identify factors predicting outcome. DESIGN: The Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial was a parallel-group, randomised, outcome-blinded evaluation trial. Randomisation was undertaken using permuted blocks of random size via a web-based platform. Data were analysed on an intention-to-treat (ITT) basis, using random-effects regression adjusted for site, age, sex and baseline symptoms. Cost-effectiveness analyses were carried out to determine whether or not CBT was associated with a greater number of quality-adjusted life-years (QALYs) and higher costs than treatment as usual (TAU). SETTING: Secondary care mental health services in five cities in the UK. PARTICIPANTS: People with CRS aged ≥ 16 years, with an International Classification of Diseases, Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms. INTERVENTIONS: Individual CBT included up to 30 hours of therapy delivered over 9 months. The comparator was TAU, which included care co-ordination from secondary care mental health services. MAIN OUTCOME MEASURES: The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months and the primary secondary outcome was PANSS total score at the end of treatment (9 months post randomisation). The health benefit measure for the economic evaluation was the QALY, estimated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), health status measure. Service use was measured to estimate costs. RESULTS: Participants were allocated to CBT (n = 242) or TAU (n = 245). There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) -3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (-2.40 points, 95% CI -4.79 to -0.02 points; p = 0.049). CBT was associated with a net cost of £5378 (95% CI -£13,010 to £23,766) and a net QALY gain of 0.052 (95% CI 0.003 to 0.103 QALYs) compared with TAU. The cost-effectiveness acceptability analysis indicated a low likelihood that CBT was cost-effective, in the primary and sensitivity analyses (probability < 50%). In the CBT arm, 107 participants reported at least one adverse event (AE), whereas 104 participants in the TAU arm reported at least one AE (odds ratio 1.09, 95% CI 0.81 to 1.46; p = 0.58). CONCLUSIONS: Cognitive-behavioural therapy for CRS was not superior to TAU on the primary outcome of total PANSS symptoms at 21 months, but was superior on total PANSS symptoms at 9 months (end of treatment). CBT was not found to be cost-effective in comparison with TAU. There was no suggestion that the addition of CBT to TAU caused adverse effects. Future work could investigate whether or not specific therapeutic techniques of CBT have value for some CRS individuals, how to identify those who may benefit and how to ensure that effects on symptoms can be sustained. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99672552. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 7. See the NIHR Journals Library website for further project information.

Should people with psychosis be supported in choosing cognitive therapy as an alternative to antipsychotic medication: A commentary on current evidence.

Evidence from randomised controlled trials suggest that both antipsychotic medication and cognitive behaviour therapy (CBT) can be helpful to people with a diagnosis of a schizophrenia spectrum disorder. On this basis, many clinical guidelines recommend that people with psychosis should be offered both antipsychotic medication and CBT and that they should be collaboratively involved in the decisions about which treatment options they choose. The reality of service provision is often very different, with data regarding the availability of such treatment options and the extent of user involvement in decision making suggesting that medication is much more widely available and that service users are often not involved in these decisions, despite retaining decision making capacity. Many patients choose not to take antipsychotic medication, often due to inefficacy or side effects, but there is little evidence regarding whether CBT can be effective as an alternative to antipsychotic medication. However, several recent trials suggest that CBT without medication may be a safe and acceptable option for people with psychosis. The implications for clinical practice and future research are considered and it is recommended that informed choices that include the option to try CBT without antipsychotic medication are supported.

Providing mental health peer support 2: Relationships with empowerment, hope, recovery, quality of life and internalised stigma.

OBJECTIVE: Qualitative research has identified personal costs and benefits for peer supporters associated with their role; however, quantitative evidence is sparse. This study used quantitative methods to explore relationships in experiences of providing peer support with constructs of empowerment, hope, recovery, quality of life and internalised stigma. Differences were examined for those in statutory versus non-statutory services; who had themselves received peer support versus those who had not and who identified having had negative experiences in clinical teams versus those without such experiences. METHODS: A cross-sectional online and postal survey was undertaken in tandem with a linked consensus study. In all, 147 peer supporters were recruited from a variety of organisations across the United Kingdom. Validated questionnaires were used to examine constructs. Instruments created for the study measured peer support experiences, and personal costs and benefits involved. Correlations were calculated and results informed further regression analysis. Chi-square tests and independent samples t-tests tested group differences. RESULTS: Peer supporters indicated they experienced almost twice as many role-related personal benefits than personal costs. Benefits included improvements to mental health and well-being, reduced use of services, increased social functioning and development of skills. Total number of personal costs experienced was significantly negatively related to peer supporters' empowerment and quality of life. There were no significant differences between the groups examined. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: An accumulation of personal costs may result in reduced quality of life; however, costs can be minimised by organisations. Limitations of the research are discussed and recommendations for future research are made including the need for longitudinal research.

Cognitive Behavioral Therapy for antipsychotic-free schizophrenia spectrum disorders: Does therapy dose influence outcome?

This study investigated the effect of "dose" and the components of Cognitive Behavioral Therapy (CBT) on treatment effects. It is a secondary analysis of the ACTION (Assessment of Cognitive Therapy Instead of Neuroleptics) trial which investigated CBT for people with schizophrenia spectrum disorders that chose not to take antipsychotic medication. Using instrumental variable methods, we found a "dose-response" such that each CBT session attended, reduced the primary outcome measure (the PANSS total score) by approximately 0.6 points (95% CI -1.20 to -0.06, p = 0.031). This suggests that length of therapy is important for those that receive CBT in the absence of antipsychotic medication. Secondly, using principal stratification we examined the process variables that modified treatment effects. Findings revealed that those who received a longitudinal formulation in the first 4 sessions of CBT had poorer treatment effects than those who did not, however this finding was not statistically significant (95% CI -37.244, 6.677, p = 0.173). However, it is important to note that these findings were evident in an exploratory analysis with a small sample. Future larger scale studies are needed to help understand components of effective treatment.