Motiv8: a study protocol for a cluster-randomised feasibility trial of a weight management intervention for adults with severe mental illness in secure forensic services.

INTRODUCTION: People with severe mental illness have physical comorbidities which result in significant reductions in quality of life and premature mortality. Effective interventions are required that are suitable for people in secure forensic mental health services. We conducted pilot work of a multidisciplinary weight management intervention (Motiv8) which showed improvements in physical and mental health and high levels of satisfaction. We aim to test the feasibility of Motiv8 under cluster randomised conditions, with an aim to investigate the acceptability, feasibility and potential effectiveness of this intervention to supplement standard secure care. METHODS AND ANALYSIS: A randomised waitlist-controlled feasibility trial of a lifestyle intervention (Motiv8) + TAU compared with TAU (+ Motiv8 waitlist) for adults on secure mental health units will be conducted. Thirty-two people (4 cohorts) will be recruited from secure services in Greater Manchester Mental Health NHS Foundation Trust. Participants will be randomly allocated to Motiv8 or TAU + Motiv8 waitlist. All participants will receive Motiv8 during the trial. Assessor-blinded physical/mental health and lifestyle assessments will be conducted at baseline, 10 weeks (post-intervention/waitlist), and after 12 weeks (post-waitlist intervention/follow-up). Motiv8 is a multidisciplinary intervention including exercise sessions, cooking/nutrition classes, physical health education, psychology sessions, sleep hygiene, peer support and medication review by pharmacy. A nested qualitative study will be conducted with a subsample of participants (n = 10) to explore their experiences of taking part. The analysis will focus on feasibility outcomes and tabulated success indicators of the study (e.g. Recruitment rates, retention rates, follow-up retention and response rates, attendance at sessions, the experience of involvement in the trial and delivery of the intervention, assessment of safety, development of a manualised intervention). Thematic analysis will be conducted through qualitative interviews. The analysis will aim to inform the development of a definitive trial. ETHICS AND DISSEMINATION: The trial has been granted ethical approval from the NHS Health Research Authority and adopted onto the UK Clinical Research Network Portfolio. Findings will be disseminated via peer-reviewed publications, professional and public networks, conferences and clinical services. TRIAL REGISTRATION: ISRCTN13539285.

'If he feels better I'll feel better' relationships with individuals at high-risk of developing psychosis.

AIM: A large proportion of individuals with an at-risk mental state (ARMS) live at home and are supported by their families. Recommended treatment includes family intervention (FI), and therefore, understanding relationships between individuals with an ARMS and their family members is key. This study aimed to provide a more holistic exploration of relationships within families of individuals with an ARMS by reporting the perceived impact of the condition on other family members including sibling and romantic relationships. METHOD: Fourteen semi-structured interviews with family members were analysed using thematic analysis. RESULTS: Parents wanted to maintain a safe family environment for all family members. This can result in spending less time with siblings who impacted on siblings' relationships with the service user and other family members. Romantic relationships were negatively impacted when there was unclear communication between the couple, as well as the partner's response and understanding of the ARMS condition. Clear communication across sibling and romantic relationships facilitated helpful family/carer's behaviour and understanding of the individuals' mental distress. CONCLUSION: FI should explore and support families with changes in sibling and romantic relationships. More research is needed to understand siblings' perspectives in families with individuals experiencing an ARMS and to develop resources to support partners and families in changes within their sexual and romantic relationships.

The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement.

BACKGROUND: Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. METHOD: The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. DISCUSSION: The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. TRIAL REGISTRATION: ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.

Therapeutic relationships in child and adolescent mental health services: A Delphi study with young people, carers and clinicians.

Therapeutic relationships have been widely recognized as crucial to good outcomes in psychotherapy. However, there is comparatively little research on what constitutes and impacts therapeutic relationships in the context of child and adolescent mental health services (CAMHS). Relationships within CAMHS are inherently complex, with multiple relationships taking place between young people, parents or carers and staff members of various disciplines. The Delphi method was used to gain consensus regarding the definition of therapeutic relationships, what helps to build and what hinders the formation of a good relationship in the context of CAMHS. Three expert groups (young people, carers and staff) totalling 88 participants were invited to complete an online Delphi survey across three rounds. Consensus was reached to define the therapeutic relationship as trust, reliability and absence of judgemental attitudes (n = 19 statements). Factors that help build good relationships predominantly referred to staff behaviours of setting up open communication channels, showing acceptance of the young person's difficulties and being consistent (n = 88 consensus agreement statements). Factors that hindered a good relationship were inconsistencies and lack of clear communication between all groups (n = 18 consensus agreement statements). Effective therapeutic relationships require key behaviours and approaches from clinicians. It is essential that staff members are open and honest in facilitating discussions about parental involvement within the relationship and that staff provide consistent and trusting support to young people and family members. Our findings demonstrate that key stakeholders agree on important aspects and that these could be a catalyst for renewed training and support structures.

The clinical and behavioral cardiometabolic risk of children and young people on mental health inpatient units: A systematic review and meta-analysis.

OBJECTIVE: Serious mental illness is associated with physical health comorbidities, however most research has focused on adults. We aimed to synthesise existing literature on clinical and behavioral cardiometabolic risk factors of young people on mental health inpatient units. METHODS: A systematic review and meta-analysis was conducted, using electronic searches of PsycINFO, EMBASE, AMED, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE. Eligible studies included child/adolescent mental health inpatient units for <25 years, reporting clinical/behavioral cardiometabolic risk factors. Studies containing adult samples, case-studies, or eating disorder populations were excluded. The main clinical outcome was weight, and main behavioral outcome was tobacco use. RESULTS: Thirty-nine studies were identified (n = 809,185). Pooled prevalence rates of young people who were overweight (BMI > 25) was 32.4% (95% CI 26.1%-39.5%; n = 2789), and who were obese (BMI > 30) was 15.5% (95% CI 4.5%-41.6%; n = 2612). Pooled prevalence rates for tobacco use was 51.5% (95% CI 32.2-70.2; N = 804,018). Early signs of metabolic risk were observed; elevated blood cholesterol, presence of physical health conditions, and behavioral risk factors (e.g. physical inactivity). CONCLUSIONS: This review highlights the vulnerability of young people admitted to inpatient units and emphasises the opportunity to efficiently monitor, treat and intervene to target physical and mental health.

Investigating expressed emotion in individuals at-risk of developing psychosis and their families over 12 months.

High levels of expressed emotion (EE) are present in families of individuals with an at-risk mental state (ARMS) of psychosis and can negatively impact on service users' functioning and symptoms, as well as relatives' psychological wellbeing. OBJECTIVES: This is the first longitudinal study to assess EE from the family/carers' perspective, as well as the service users' perceptions of the family/carers' EE. We explored the effects of EE on transition risk and outcomes of depression, worry, and anxiety. METHODS: Questionnaires were completed by 70 ARMS individuals and 70 family/carers at three time points: baseline, 6 and 12 months. All participants completed measures of anxiety, depression, and worry, plus a version of the Family Questionnaire to assess EE. RESULTS: EE scores reduced over time for both service users and family/carers. High EE perceived by service users at 6 months was associated with higher transition to psychosis at 12 months. High-EE levels at baseline were associated with higher levels of service user depression and family/carer anxiety at 12 months. Higher family/carer total EE scores were associated with less contact with the service user and higher levels of worry. CONCLUSIONS: Novel implications suggest that interventions to reduce high EE in families of people with ARMS would benefit service users by protecting them from higher levels of depression and transition to psychosis. Reducing high-EE attitudes would also benefit the family/carers by reducing levels of anxiety and worry. Family interventions focussing on multiple perceptions of the home environment could help to direct services and prevent negative psychological outcomes for all family members.

Physical health interventions on adolescent mental health inpatient units: A systematic review and call to action.

AIM: Physical health inequalities experienced by people with mental health conditions are labelled an international scandal; due to the 15 to 30-year gap in life expectancy, driven mostly by physical health conditions. Lifestyle interventions are recommended to prevent the onset of poor physical health in people with mental illness. Yet, there is less high-quality evidence for adolescents, particularly those in inpatient settings. We aimed to assess existing literature reporting physical health or lifestyle interventions conducted on adolescent mental health inpatient units. METHOD: An electronic search of MEDLINE, PsycINFO, Embase, the Cochrane Central Register of Controlled Trials and AMED was conducted on 13th June 2019. Eligible studies included peer-reviewed English language research articles of physical health interventions delivered within child and adolescent mental health inpatient services. A narrative synthesis was conducted on the data. RESULTS: Only three studies were identified implementing health interventions for adolescent inpatients. The interventions consisted of two physical health interventions aiming to increase activity levels within routine care (one gym-based, one sports led) and a yoga intervention. Outcome measurements varied and benefits were observed in relation to overall health (HONOSCA), physical health (waist, hip and chest circumference) and behaviour. CONCLUSIONS: Although preliminary results suggest lifestyle interventions may be feasible and beneficial for this group, more work is needed to fully understand the best way to implement these interventions within adolescent clinical settings. Adolescent inpatients are an important target for such interventions, affording the opportunity to prevent the onset of physical comorbidities.

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.

"It felt very special, it felt customised to me"-A qualitative investigation of the experiences of participating in a clinical trial of CBT for young people at risk of bipolar disorder.

OBJECTIVES: The Bipolar at Risk Trial (BART) was a feasibility randomized controlled trial investigating cognitive behavioral therapy (CBT) compared with treatment as usual (TAU) in young people at high risk of developing bipolar disorder (BD). This qualitative study aimed to investigate participants' experiences of trial involvement, and the acceptability of CBT for this population. DESIGN: Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history. A purposive sample of twenty-one participants from both the intervention and TAU arms of the trial was recruited. METHODS: Twenty-one semi-structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU). Interviews were audio recorded with consent from participants and transcribed verbatim. NVivo 11 Pro software was used to conduct an inductive thematic analysis. RESULTS: Super-ordinate themes were "adaptability and flexibility," "feeling understood and valued," and "relevance of study and intervention" which had two sub-themes-"value of the trial therapy" and "acceptability of trial processes." Participating in the trial and having therapy enabled participants to feel understood and valued by research assistants (RAs) and therapists. Participants viewed therapy as relevant to their current concerns and valued adaptability and flexibility of RAs and therapists. CONCLUSIONS: Findings highlight the importance and value of flexibility, adaptability, and understanding in relationships between participants and trial staff. Findings also indicate that the trial processes and CBT focusing on mood swings are acceptable and relevant to participants from this at risk population. PRACTITIONER POINTS: Young people at risk of bipolar disorder value a flexible approach to assessments and therapy, developing a rapport with research assistants and therapists and opening up to them when they feel comfortable to do so. CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant.

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine.

OBJECTIVES: Increasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders. In order to conduct successful and efficient trials of MBSR, evidence regarding the relative performance of strategies to improve recruitment, retention, and adherence is required, but few studies have examined these issues specifically. DESIGN: In preparation for a fully powered trial, we conducted a 2-arm, parallel comparison randomized controlled feasibility trial of MBSR vs. usual-care for 60 patients with migraine headache. SETTING: Two large U.S. health systems in Northern California. INTERVENTION: MBSR is an 8-week classroom-based intervention that combines mindfulness meditation and yoga, with didactic presentations about stress psychology and group process/experiential education. Participants received the intervention at their choice of one of several existing, vetted community-based classes. MAIN OUTCOME MEASURES: Successful recruitment was defined a priori as 18 participants within any 9-week period or 60 participants enrolled within a 36-week period. We considered participants adherent to the intervention if they attended at least 5 of the 8 weekly classes and the day-long retreat. RESULTS: We successfully enrolled 18 participants within a 7-week period, however, we did not attain our second goal of recruiting 60 participants within a 36-week period. Sixty-eight percent of our participants were adherent to the intervention. CONCLUSIONS: We found that close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the delivery system were crucial factors for successful participant recruitment, retention, and adherence in mindfulness 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.

"I don't think I took her fears seriously": Exploring the experiences of family members of individuals at-risk of developing psychosis over 12 months.

Individuals with an at-risk mental state (ARMS) of psychosis experience high levels of distress, anxiety, low mood, and suicidal ideation. Families of ARMS individuals provide significant support but are often neglected by services. This study is the first of its kind to use a novel longitudinal qualitative methodology to directly compare family/carers' earlier experiences supporting ARMS individuals to 12 months later. This provides a more ecologically valid insight into how perceptions change over time and how family/carers adapt. Semistructured interviews were conducted with 10 family/carers at two points within a 12-month period. This study was embedded within a randomized control trial, the Individual and Family Cognitive Behavioural Therapy trial. Interview transcripts were analysed using thematic analysis, with a focus on how experiences and reactions for family/carers changed over time. Over 12 months, four factors were important for family/carers to facilitate their caring role. These were summarized in the thematic map (LACE model): Looking after your own well-being; Accessing additional support from family intervention; Communicating openly with the individual; and Engaging with services for the individual. All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs, and helping them to feel more confident and less isolated in their carer role. Novel implications suggest that when feasible, services should involve family/carers of ARMS individuals in sessions and explore family/carer support strategies in managing their own distress. The most significant insight was the need to develop family/carer resources to educate, normalize, and validate their own experiences.

What does recovery mean to young people with mental health difficulties? - "It's not this magical unspoken thing, it's just recovery".

Background: There is extensive literature documenting the nature of recovery in mental health in adult populations, but there is very little exploring its nature and meaning for young people.Aims: To gain a detailed understanding from the perspective of young people about the concept of recovery in young people's mental health.Method: Semi structured interviews were conducted with 23 young people. Interviews were transcribed verbatim and analysed using thematic analysis.Results: Themes emerging from the interviews included young people's dynamic conceptualisations of recovery, awareness of others views of recovery, polarised goals of recovery, and facilitators and barriers of recovery.Conclusions: To be relevant for young people, the mental health recovery model must incorporate individual needs, developmental considerations and fluctuations in goals. It must also be embedded within the young person's ecological system such as family, friends and school, and be focussed around an explicit and collaborative recovery discussion with the young person.

Evaluation of the physical health of adolescent in-patients in generic and secure services: retrospective case-note review.

AIMS AND METHOD: To assess physical health needs of adolescent in-patients by routine monitoring. A retrospective analysis of case notes was conducted on a 6-month intake to generic and secure adolescent mental health units in Greater Manchester, UK. RESULTS: Fifty individuals were admitted (52% female, average age 15.84 years). Diagnoses varied and 66% were prescribed medications before admission. All had a physical health assessment, which identified various physical health risk factors. Average body mass index was 25.99 (range 15.8-44), and increased during in-patient treatment for 84% of individuals who had their body mass recorded more than once. A total of 28% of individuals smoked. Lipids and prolactin levels were elevated across the sample. CLINICAL IMPLICATIONS: This evaluation strengthens the argument to optimise physical healthcare for adolescent in-patients and develop physical health interventions, particularly given that we observed elevated lipids and prolactin. Physical health and well-being may not be prioritised when assessing and managing young peoples' mental health, despite their increased vulnerability for comorbid conditions.

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M).

BACKGROUND: Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial. METHODS/DESIGN: This study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018. DISCUSSION: To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02824250 . Registered on 6 July 2016.

Expressed emotion (EE) in families of individuals at-risk of developing psychosis: A systematic review.

The At-Risk Mental State (ARMS) for psychosis describes a state of high but not inevitable risk for developing a psychotic disorder. The distressing experiences for individuals with an ARMS may impact on themselves; their sense of wellbeing, psychosocial functioning and their family. Expressed emotion (EE) considers the environment and communication style of relatives towards the individual and is a key factor for determining outcomes in established psychosis. Following PRISMA guidelines, a systematic review of EE in relatives of ARMS was conducted. Fifteen studies were identified that investigated the presence of EE in the ARMS population. Approximately one third of ARMS relatives had high-EE. The results suggest that greater levels of criticism are associated with higher levels of symptoms and poorer functioning. In contradiction to psychosis literature, the construct emotional-over-involvement was found to be an adaptive response, where an optimal level of involvement combined with a warm-environment was associated with improved functioning and reduced symptoms. Limitations of the studies include small sample sizes and over-representation of Caucasian males and relatives as middle-aged mothers. Although approximately half of the studies included were longitudinal, only two measured EE over time, therefore, future research should include larger studies measuring EE at different time-points.

Antipsychotic drugs versus cognitive behavioural therapy versus a combination of both in people with psychosis: a randomised controlled pilot and feasibility study.

BACKGROUND: Little evidence is available for head-to-head comparisons of psychosocial interventions and pharmacological interventions in psychosis. We aimed to establish whether a randomised controlled trial of cognitive behavioural therapy (CBT) versus antipsychotic drugs versus a combination of both would be feasible in people with psychosis. METHODS: We did a single-site, single-blind pilot randomised controlled trial in people with psychosis who used services in National Health Service trusts across Greater Manchester, UK. Eligible participants were aged 16 years or older; met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service; were in contact with mental health services, under the care of a consultant psychiatrist; scored at least 4 on delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items on the Positive and Negative Syndrome Scale (PANSS); had capacity to consent; and were help-seeking. Participants were assigned (1:1:1) to antipsychotics, CBT, or antipsychotics plus CBT. Randomisation was done via a secure web-based randomisation system (Sealed Envelope), with randomised permuted blocks of 4 and 6, stratified by gender and first episode status. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions. Choice and dose of antipsychotic were at the discretion of the treating consultant. Participants were followed up for 1 year. The primary outcome was feasibility (ie, data about recruitment, retention, and acceptability), and the primary efficacy outcome was the PANSS total score (assessed at baseline, 6, 12, 24, and 52 weeks). Non-neurological side-effects were assessed systemically with the Antipsychotic Non-neurological Side Effects Rating Scale. Primary analyses were done by intention to treat; safety analyses were done on an as-treated basis. The study was prospectively registered with ISRCTN, number ISRCTN06022197. FINDINGS: Of 138 patients referred to the study, 75 were recruited and randomly assigned-26 to CBT, 24 to antipsychotics, and 25 to antipsychotics plus CBT. Attrition was low, and retention high, with only four withdrawals across all groups. 40 (78%) of 51 participants allocated to CBT attended six or more sessions. Of the 49 participants randomised to antipsychotics, 11 (22%) were not prescribed a regular antipsychotic. Median duration of total antipsychotic treatment was 44·5 weeks (IQR 26-51). PANSS total score was significantly reduced in the combined intervention group compared with the CBT group (-5·65 [95% CI -10·37 to -0·93]; p=0·019). PANSS total scores did not differ significantly between the combined group and the antipsychotics group (-4·52 [95% CI -9·30 to 0·26]; p=0·064) or between the antipsychotics and CBT groups (-1·13 [95% CI -5·81 to 3·55]; p=0·637). Significantly fewer side-effects, as measured with the Antipsychotic Non-neurological Side Effects Rating Scale, were noted in the CBT group than in the antipsychotics (3·22 [95% CI 0·58 to 5·87]; p=0·017) or antipsychotics plus CBT (3·99 [95% CI 1·36 to 6·64]; p=0·003) groups. Only one serious adverse event was thought to be related to the trial (an overdose of three paracetamol tablets in the CBT group). INTERPRETATION: A head-to-head clinical trial of CBT versus antipsychotics versus the combination of the two is feasible and safe in people with first-episode psychosis. FUNDING: National Institute for Health Research.

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.