Stakeholder perspectives of family interventions for schizophrenia in Indonesia: a qualitative study.

Mental illnesses comprise the single largest source of health-related economic burden globally and low-and middle-income countries (LMICs) are disproportionately affected. Many individuals with schizophrenia do not receive evidence-based, psychosocial interventions as these are largely unavailable, undeveloped, and under-researched in LMICs. Involving service-users and carers in the design of interventions is crucial to ensure stakeholder needs are adequately addressed by the intervention and to aid successful implementation. We aimed to explore the views and perspectives of different stakeholder groups about the delivery, format, and content of family interventions for people living with schizophrenia in Indonesia as a first step towards developing evidence-based, acceptable family interventions. This study used a qualitative design comprising single stakeholder focus groups. Data were analysed separately using the framework approach incorporating deductive and inductive coding within an existing heuristic framework. 51 participants consented to take part in this study comprising six stakeholder consultation groups including service-users (n = 15), caregivers (n = 15) and healthcare professionals (n = 21). Service users were diagnosed with schizophrenia. Caregivers comprised parents (n = 10, 67%), brothers (n = 2, 13%), sister (n = 1, 7%) and husbands (n = 2, 13%). Healthcare professionals were working as nurses (n = 6, 29%), doctors (n = 5, 23%) or cadre's (n = 10, 48%). Caregiver and service-user respondents had limited knowledge or experience of structured family interventions. There was strong support for such interventions, however, for effective delivery a number of challenges exist in terms of widespread stigmatised views, low expectations for involvement in sharing decisions about care and treatment, views that healthcare professionals are expert and have the authority to delegate tasks to families such as responsibility for ensuring medication adherence and understanding the need to balance the needs of both service-users and families when there are conflicting agendas for treatment. These findings can support the development of evidence-based family interventions for families of those with schizophrenia in Indonesia, as user-informed interventions enhance engagement, satisfaction, and adherence to family interventions.

Culturally adapted family intervention for people with schizophrenia in Indonesia (FUSION): a development and feasibility study protocol.

BACKGROUND: Mental illnesses comprise the single largest source of health-related economic burden globally, and low- and middle-income countries are disproportionately affected. The majority of people with schizophrenia who need treatment do not receive it and are often wholly reliant on family caregivers for daily care and support. Family interventions have an exceptionally robust evidence base for their efficacy in high-resource settings, but it is unknown whether they can produce equivalent effects in some low-resource settings where cultural beliefs, explanatory models of illness and contextual socio-economic issues differ. METHODS: This protocol describes the methods for a randomised controlled trial to determine the feasibility of testing culturally adapt and refine an evidence-based, family intervention for relatives and caregivers of people with schizophrenia in Indonesia. The feasibility and acceptability of implementing our adapted, co-produced intervention via task shifting in primary care settings will be evaluated using the Medical Research Council framework for complex interventions. We will recruit 60 carer-service-user dyads and randomise them in a 1:1 ratio either to receive our manualised intervention or continue to receive treatment as usual. Healthcare workers in primary care settings will be trained to deliver family interventions using our manualised intervention by a family intervention specialist. Participants will complete the ECI, IEQ, KAST and GHQ. Service-user symptom level and relapse status will be measured using the PANSS at baseline, post-intervention and 3 months later by trained researchers. Fidelity to the intervention model will be measured using the FIPAS. Qualitative evaluation will further assist with refining the intervention, evaluating trial processes and evaluating acceptability. DISCUSSION: National healthcare policy in Indonesia supports the delivery of mental health services in a complex network of primary care centres. This study will provide important information on the feasibility of delivering family interventions for people with schizophrenia via task shifting in primary care settings in Indonesia and allow further refinement of the intervention and trial processes.

Do different adverse childhood experiences lead to specific symptoms of psychosis in adulthood? A systematic review of the current literature.

Previous research has demonstrated significant associations between adverse childhood experiences (ACEs) and risks of psychosis. Further research has examined underlying mechanisms to understand the relationship between these variables. This review aimed to explore the associations between various ACEs and the development of different psychotic symptoms in adulthood. The Cochrane Library, Cinahl, PsychINFO, Medline, Embase, and Web of Science were searched from January 1980 to November 2021 to ensure a systematic review of relevant literature. Poverty, fostering, adoption, childhood emotional and physical neglect, and childhood physical (CPA), sexual (CSA), and emotional abuse (CEA) significantly correlated with delusions. Significant relationships were found between hallucinations and CSA and CPA. Paranoia correlated with violent adversities including CPA, assault, and witnessing killing. Limited associations were identified for thought disorder and negative symptoms. The findings of this review indicate that there may be a degree of specificity between various ACEs and psychotic symptoms, but these findings are subject to some limitations. The findings also demonstrate the importance of inquiring about and addressing ACE in clinical practice to develop formulations and treatment plans for individuals with psychosis.

E-cigarette use and associated factors among smokers with severe mental illness.

INTRODUCTION: Smoking is more prevalent among people with severe mental illness (SMI) than the general population. E-cigarettes could provide an effective means of helping people to quit smoking. The aim of this paper is to explore the use of e-cigarettes and factors related to their use in people smokers with SMI. METHODS: This is a cross sectional study including adult smokers with a documented diagnosis of SMI (ICD-10) recruited to the SCIMITAR + trial (2015-2016) from primary and secondary care. At baseline, participants were asked for demographic information and about their use of e-cigarettes. Data was were analysed to explore factors associated with e-cigarette use. After testing bivariate associations, logistic regressions were conducted. RESULTS: Among 526 participants, 58.7% were male, mean age 46 years (SD 12.1), the majority (70.3%) had tried an e-cigarette. Among those who had ever tried an e-cigarette, over half (54.6%) reported the reason was to quit smoking, while 13.9% reported that the reason was to reduce smoking. Having an educational qualification of GCSE or higher (odds ratio 2.17, 95% CI 1.22 to 3.86, p = 0.008) and having made a quit attempt in the past six months (OR 1.66, 95% CI 1.04 to 2.63, p = 0.032) was associated with ever having tried an e-cigarette. CONCLUSIONS: Ever use of an e-cigarette was associated with education levels and recent quit attempts. Future trials could explore the effectiveness of e-cigarettes as a cessation aid in this participant group.

A bespoke smoking cessation service compared with treatment as usual for people with severe mental ill health: the SCIMITAR+ RCT.

BACKGROUND: There is a high prevalence of smoking among people with severe mental ill health (SMI). Helping people with SMI to quit smoking could improve their health and longevity, and reduce health inequalities. However, those with SMI are less likely to access and engage with routine smoking cessation services than the general population. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual stop smoking services for people with SMI. DESIGN: A pragmatic, two-arm, individually randomised controlled trial. SETTING: Primary care and secondary care mental health services in England. PARTICIPANTS: Smokers aged ≥ 18 years with SMI who would like to cut down on or quit smoking. INTERVENTIONS: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual care. MAIN OUTCOME MEASURES: The primary outcome was self-reported, CO-verified smoking cessation at 12 months. Smoking-related secondary outcomes were self-reported smoking cessation, the number of cigarettes smoked per day, the Fagerström Test for Nicotine Dependence and the Motivation to Quit questionnaire. Other secondary outcomes were Patient Health Questionnaire-9 items, Generalised Anxiety Disorder Assessment-7 items and 12-Item Short-Form Health Survey, to assess mental health and body mass index measured at 6 and 12 months post randomisation. RESULTS: The trial randomised 526 people (265 to the intervention group, 261 to the usual-care group) aged 19 to 72 years (mean 46 years). About 60% of participants were male. Participants smoked between 3 and 100 cigarettes per day (mean 25 cigarettes per day) at baseline. The intervention group had a higher rate of exhaled CO-verified smoking cessation at 6 and 12 months than the usual-care group [adjusted odds ratio (OR) 12 months: 1.6, 95% confidence interval (CI) 0.9 to 2.8; adjusted OR 6 months: 2.4, 95% CI 1.2 to 4.7]. This was not statistically significant at 12 months (p = 0.12) but was statistically significant at 6 months (p = 0.01). In total, 111 serious adverse events were reported (69 in the BSC group and 42 in the usual-care group); the majority were unplanned hospitalisations due to a deterioration in mental health (n = 98). The intervention is likely (57%) to be less costly but more effective than usual care; however, this result was not necessarily associated with participants' smoking status. LIMITATIONS: Follow-up was not blind to treatment allocation. However, the primary outcome included a biochemically verified end point, less susceptible to observer biases. Some participants experienced difficulties in accessing nicotine replacement therapy because of changes in service provision. Efforts were made to help participants access nicotine replacement therapy, but this may have affected participants' quit attempt. CONCLUSIONS: People with SMI who received the intervention were more likely to have stopped smoking at 6 months. Although more people who received the intervention had stopped smoking at 12 months, this was not statistically significant. FUTURE WORK: Further research is needed to establish how quitting can be sustained among people with SMI. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72955454. 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. 50. See the NIHR Journals Library website for further project information.

Smoking is an important health issue, especially among people who have experienced mental ill health such as schizophrenia or bipolar disorder. This is because people with severe mental ill health (SMI) are more likely to smoke than the general population. Despite this, they are less likely to get help to stop smoking, and it may be that people with mental ill health problems need greater support to help them stop smoking. To address this problem, we developed and tested a 'bespoke smoking cessation' (BSC) service tailored to people with SMI. People aged ≥ 18 years who said that they would like to stop smoking were randomly allocated to either a BSC service or the usual stop smoking services. Those in the BSC service were allocated a mental health professional who had been trained to deliver smoking cessation interventions. The mental health professional worked with the participant and their care team to advise on stop smoking medication and provide information, support and motivation. Usual-care participants were signposted to local smoking services, but their subsequent care was not directly provided or supervised by trial smoking cessation advisors. Between October 2015 and December 2016, 526 people with SMI were recruited into the study: 265 of these people were randomly assigned to the BSC service and 261 were randomly assigned to usual care. At 6 and 12 months after randomisation, participants completed questionnaires that asked about their smoking status and health. Participants had their smoking status tested by measuring the amount of carbon monoxide in their breath. After 6 months, more people who received the BSC intervention had stopped smoking than those who had received usual care. At 12 months, the results were less clear in terms of the difference in the number of people who had stopped smoking. The BSC service cost less than or similar to usual care, when considering the overall health-care services. The improvement in health of people who received the BSC service remains uncertain. In addition, we do not know whether or not this was related to people stopping smoking.

Smoking cessation for people with severe mental illness (SCIMITAR+): a pragmatic randomised controlled trial.

BACKGROUND: People with severe mental illnesses such as schizophrenia are three times more likely to smoke than the wider population, contributing to widening health inequalities. Smoking remains the largest modifiable risk factor for this health inequality, but people with severe mental illness have not historically engaged with smoking cessation services. We aimed to test the effectiveness of a combined behavioural and pharmacological smoking cessation intervention targeted specifically at people with severe mental illness. METHODS: In the smoking cessation intervention for severe mental illness (SCIMITAR+) trial, a pragmatic, randomised controlled study, we recruited heavy smokers with bipolar disorder or schizophrenia from 16 primary care and 21 community-based mental health sites in the UK. Participants were eligible if they were aged 18 years or older, and smoked at least five cigarettes per day. Exclusion criteria included substantial comorbid drug or alcohol problems and people who lacked capacity to consent at the time of recruitment. Using computer-generated random numbers, participants were randomly assigned (1:1) to a bespoke smoking cessation intervention or to usual care. Participants, mental health specialists, and primary care physicians were unmasked to assignment. The bespoke smoking cessation intervention consisted of behavioural support from a mental health smoking cessation practitioner and pharmacological aids for smoking cessation, with adaptations for people with severe mental illness-such as, extended pre-quit sessions, cut down to quit, and home visits. Access to pharmacotherapy was via primary care after discussion with the smoking cessation specialist. Under usual care participants were offered access to local smoking cessation services not specifically designed for people with severe mental illnesses. The primary endpoint was smoking cessation at 12 months ascertained via carbon monoxide measurements below 10 parts per million and self-reported cessation for the past 7 days. Secondary endpoints were biologically verified smoking cessation at 6 months; number of cigarettes smoked per day, Fagerström Test for Nicotine Dependence (FTND) and Motivation to Quit (MTQ) questionnaire; general and mental health functioning determined via the Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder-7 (GAD-7) questionnaire, and 12-Item Short Form Health Survey (SF-12); and body-mass index (BMI). This trial was registerd with the ISRCTN registry, number ISRCTN72955454, and is complete. FINDINGS: Between Oct 7, 2015, and Dec 16, 2016, 526 eligible patients were randomly assigned to the bespoke smoking cessation intervention (n=265) or usual care (n=261). 309 (59%) participants were male, median age was 47·2 years (IQR 36·3-54·5), with high nicotine dependence (mean 24 cigarettes per day [SD 13·2]), and the most common severe mental disorders were schizophrenia or other psychotic illness (n=343 [65%]), bipolar disorder (n=115 [22%]), and schizoaffective disorder (n=66 [13%]). 234 (88%) of intervention participants engaged with the treatment programme and attended 6·4 (SD 3·5) quit smoking sessions, with an average duration of 39 min (SD 17; median 35 min, range 5-120). Verified quit data at 12 months were available for 219 (84%) of 261 usual care and 223 (84%) of 265 intervention participants. The proportion of participants who had quit at 12 months was higher in the intervention group than in the usual care group, but non-significantly (34 [15%] of 223 [13% of those assigned to group] vs 22 [10%] of 219 [8% of those assigned to group], risk difference 5·2%, 95% CI -1·0 to 11·4; odds ratio [OR] 1·6, 95% CI 0·9 to 2·9; p=0·10). The proportion of participants who quit at 6 months was significantly higher in the intervention group than in the usual care group (32 [14%] of 226 vs 14 [6%] of 217; risk difference 7·7%, 95% CI 2·1 to 13·3; OR 2·4, 95% CI 1·2 to 4·6; p=0·010). The incidence rate ratio for number of cigarettes smoked per day at 6 months was 0·90 (95% CI 0·80 to 1·01; p=0·079), and at 12 months was 1·00 (0·89 to 1·13; p=0·95). At both 6 months and 12 months, the intervention group was non-significantly favoured in the FTND (adjusted mean difference 6 months -0·18, 95% CI -0·53 to 0·17, p=0·32; and 12 months -0·01, -0·39 to 0·38, p=0·97) and MTQ questionnaire (adjusted mean difference 0·58, -0·01 to 1·17, p=0·056; and 12 months 0·64, 0·04 to 1·24, p=0·038). The PHQ-9 showed no difference between the groups (adjusted mean difference at 6 months 0·20, 95% CI -0·85 to 1·24 vs 12 months -0·12, -1·18 to 0·94). For the SF-12 survey, we saw evidence of improvement in physical health in the intervention group at 6 months (adjusted mean difference 1·75, 95% CI 0·21 to 3·28), but this difference was not evident at 12 months (0·59, -1·07 to 2·26); and we saw no difference in mental health between the groups at 6 or 12 months (adjusted mean difference at 6 months -0·73, 95% CI -2·82 to 1·36, and 12 months -0·41, -2·35 to 1·53). The GAD-7 questionnaire showed no difference between the groups (adjusted mean difference at 6 months -0·32 95% CI -1·26 to 0·62 vs 12 months -0·10, -1·05 to 0·86). No difference in BMI was seen between the groups (adjusted mean difference 6 months 0·16, 95% CI -0·54 to 0·85; 12 months 0·25, -0·62 to 1·13). INTERPRETATION: This bespoke intervention is a candidate model of smoking cessation for clinicians and policy makers to address high prevalence of smoking. The incidence of quitting at 6 months shows that smoking cessation can be achieved, but the waning of this effect by 12 months means more effort is needed for sustained quitting. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Collaborative, individualised lifestyle interventions are acceptable to people with first episode psychosis; a qualitative study.

BACKGROUND: The adverse impact of unhealthy lifestyle choices and the prescription of antipsychotic medications contribute to weight gain, poor cardiovascular health and reduced life expectancy for people with psychosis. The present study aimed to explore the acceptability and perceived outcomes of a lifestyle intervention designed to prevent or reduce weight gain in people with first-episode psychosis. METHODS: This was a qualitative study using a data-driven approach. People recovering from first-episode psychosis recruited from UK early intervention services and taking part in the active arm of a randomised controlled trial of a lifestyle intervention (the InterACT trial), were interviewed using a semi-structured interview schedule. Interviews were transcribed verbatim and analysed using Framework Analysis. RESULTS: Participants valued the collaborative and individualised approach taken by the intervention deliverers, and formed high quality relationships with them. Aspects of the intervention that were positively appraised included goal setting, social opportunities, and progress monitoring. Benefits of the intervention, including increased levels of exercise; improved diet and physical health; increased psychological wellbeing (e.g. confidence, self-esteem); and improved social relationships, were identified by participants, independent of actual weight loss. CONCLUSIONS: Future interventions should ensure that workers have the skills to form high quality relationships with users, and to individualise the intervention according to users' needs and preferences. Future trials that test healthy living interventions should consider supplementing physical outcome measures with wider psychosocial outcome assessments, in particular social relationship quality, psychological wellbeing, self-esteem and self-efficacy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN22581937 . Date of registration: 27 October 2010 (retrospectively registered).

Monitoring of physical health in services for young people at ultra-high risk of psychosis.

AIM: People with schizophrenia have poor physical health and high rates of premature mortality. Risk factors for later cardiovascular disease are present from an early stage, and recording of these factors is recommended in first-episode services. However, it is unclear whether cardiometabolic risk factors are monitored prior to first-episode psychosis. METHODS: A retrospective analysis was conducted on case notes of individuals accepted into a specialized early detection service for young people at ultra-high risk for psychosis. Notes were assessed to determine whether the following physical health measures were recorded: height, weight, body mass index, blood pressure, blood glucose and lipids, physical activity levels, smoking status, substance use and alcohol intake. RESULTS: Forty individuals were deemed at ultra-high risk for psychosis and accepted into the service. The two measures reported most frequently were whether a person used substances (82.5%) or alcohol (72.5%), but more specific details were not commonly reported. A minority of case files contained information on height (2.5%), weight (7.5%), body mass index (5%), blood glucose (2.5%), smoking status (15%) and physical activity (7.5%). Six case files had no measure of physical health. CONCLUSIONS: Physical health and unhealthy lifestyle factors were not assessed routinely in the specialized service. Clear monitoring guidelines should be developed to establish routine assessment of common metabolic risk factors present in this population.

Examining the physical health and lifestyle of young people at ultra-high risk for psychosis: A qualitative study involving service users, parents and clinicians.

Emerging evidence suggests young people at ultra-high risk for psychosis (UHR) are also at-risk for poor physical health, and display high rates of modifiable cardiometabolic risk factors. However, before we can develop effective interventions there is a need to understand factors affecting lifestyle choices in the UHR group. We conducted semi-structured qualitative interviews with 20 UHR individuals (50% male; mean age 21.7), 5 parents (4 mothers, 1 father), and 6 clinicians from early intervention services in the Northwest of England to identify barriers and facilitators to living a healthy lifestyle, including achieving regular exercise, eating well and refraining from excessive substance use. Thematic analysis revealed the main barriers to living a healthy lifestyle related to psychiatric symptoms, beliefs about self, social withdrawal and practical considerations such as accessibility and cost. Provision of social support and promoting autonomy emerged as the two main themes which would facilitate a healthy lifestyle. Promoting physical health in people with emerging symptoms of psychosis is an important, yet neglected area of mental health practice and warrants further investigation. UHR individuals experience numerous barriers to living a healthy lifestyle, and interventions should focus primarily on targeting autonomous motivation and providing social support to facilitate this change.

Physical health promotion for young people at ultra-high risk for psychosis: An application of the COM-B model and behaviour-change wheel.

People with psychotic illnesses, such as schizophrenia, have high rates of unhealthy lifestyle factors, such as smoking and physical inactivity. Young people who seek help for mental health care, particularly those at high risk for psychosis, often also display high rates of these unhealthy behaviours. Although healthy living interventions have been applied to people with established psychosis, no attempt has been made to offer them to young people at risk for developing psychosis, despite potential benefits to mental and physical health. We propose that the COM-B model (consisting of capability, opportunity and motivation) and behaviour-change wheel might be an appropriate framework that mental health nurses and other health professionals could apply. Using a systematic and theoretically-based approach to intervention development could result in effective methods of health promotion in this group. Further training and development for mental health nurses could encourage a greater integration of mental and physical health care.

Making the journey with me: a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness.

BACKGROUND: Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial. METHODS: Qualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method. RESULTS: Generic services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users' illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems. CONCLUSION: The bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79497236 . Registered 3(rd) July 2009.

Cardiometabolic risk factors in young people at ultra-high risk for psychosis: A systematic review and meta-analysis.

BACKGROUND: The physical health of people with schizophrenia is poor, and associated with increased morbidity and mortality. Unhealthy lifestyles and side-effects of antipsychotic medication contribute to cardiometabolic dysfunction. Yet it is unclear when this unhealthy profile starts. We aimed to see if people at ultra-high risk for psychosis (UHR) have increased rates of cardiometabolic risk factors. METHOD: An electronic search of MEDLINE, PsycINFO, Embase and the Cochrane Central Register of Controlled Trials was conducted on 1st May 2015 using terms associated with the ultra-high risk state and health. Eligible studies were peer-reviewed English language research articles with populations that met at-risk diagnostic criteria and reported cardiometabolic risk factors. A meta-analysis was conducted on smoking data, the cardiometabolic risk factor that yielded the most studies. RESULTS: Forty-seven eligible studies were identified. UHR samples had low levels of physical activity, and high rates of smoking and alcohol abuse compared with controls. No differences were found for body mass index. An overall pooled rate of smoking for UHR participants was 33% (95% CI=0.24-0.42) and significantly more UHR individuals smoked compared with controls with a pooled odds ratio of 2.3 (P<0.05; 95% CI=-1.48-3.48). CONCLUSIONS: UHR samples display cardiometabolic risk factors which are largely modifiable. The UHR phase is an important opportunity for early intervention services to improve physical health.

Health inequalities and psychosis: time for action.

People with psychosis face a life-restricting and life-shortening epidemic of obesity, diabetes and cardiovascular disease. This can be predicted by the associated antecedent risk factors evident from early in psychosis, yet remain largely ignored. Greater coordination between primary care, secondary care and public health to systematically prevent and intervene earlier for these physical illnesses offers a realistic solution to reduce this health inequality.

Bespoke smoking cessation for people with severe mental ill health (SCIMITAR): a pilot randomised controlled trial.

BACKGROUND: People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial. METHODS: The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236. FINDINGS: Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8-10·5). INTERPRETATION: We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial. FUNDING: National Institute of Health Research Health Technology Assessment Programme.

Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised control trial of the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation service.

BACKGROUND: There is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI. OBJECTIVE: The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI. DESIGN: A pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation. SETTING: Primary care and secondary care mental health services in England. PARTICIPANTS: Smokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking. INTERVENTIONS: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care. MAIN OUTCOME MEASURES: The primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation. RESULTS: The trial recruited 97 people aged 19-73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis. CONCLUSIONS: It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79497236. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.

An exploratory randomized controlled study of a healthy living intervention in early intervention services for psychosis: the INTERvention to encourage ACTivity, improve diet, and reduce weight gain (INTERACT) study.

BACKGROUND: People with psychosis often experience weight gain, which places them at risk of cardiovascular disease, diabetes, and early death. OBJECTIVE: To determine the uptake, adherence, and clinical effectiveness of a healthy living intervention designed to reduce weight gain. METHOD: An exploratory randomized controlled trial, comparing the intervention with treatment as usual (TAU) in 2 early intervention services for psychosis in England. DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses. The primary outcome was change in body mass index (BMI) from baseline to 12-month follow-up. The study was conducted between February 2009 and October 2012. RESULTS: 105 service users, with a BMI of ≥ 25 (≥ 24 in South Asians), were randomized to intervention (n = 54) or TAU (n = 51) after stratification by recent commencement of antipsychotic medication. Ninety-three service users (89%) were followed up at 12 months. Between-group difference in change in BMI was not significant (effect size = 0.11). The effect of the intervention was larger (effect size = 0.54, not significant) in 15 intervention (28%) and 10 TAU (20%) participants who were taking olanzapine or clozapine at randomization. CONCLUSIONS: The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group. TRIAL REGISTRATION: www.isrctn.org identifier: ISRCTN22581937.

Obesity and Serious Mental Ill Health: A Critical Review of the Literature.

Individuals who experience serious mental ill health such as schizophrenia are more likely to be overweight or obese than others in the general population. This high prevalence of obesity and other associated metabolic disturbances, such as type 2 diabetes and cardiovascular disease, contribute to a reduced life expectancy of up to 25 years. Several reasons have been proposed for high levels of obesity including a shared biological vulnerability between serious mental ill health and abnormal metabolic processes, potentially compounded by unhealthy lifestyles. However, emerging evidence suggests that the most significant cause of weight gain is the metabolic side effects of antipsychotic medication, usual treatment for people with serious mental ill health. In this paper we review the prevalence of obesity in people with serious mental ill health, explore the contribution that antipsychotic medication may make to weight gain and discuss the implications of this data for future research and the practice of mental health and other professionals.