Inequalities in physical comorbidity: a longitudinal comparative cohort study of people with severe mental illness in the UK 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. Next steps for meeting the needs of people with severe mental illness in low- and middle-income countries. Impact of socioeconomic deprivation on maternal perinatal mental illnesses presenting to UK general practice. Posttraumatic stress disorder, supported employment, and outcomes in people with severe mental illness. Randomized trial of social rehabilitation and integrated health care for older people with severe mental illness. Cognitive Behavioral HIV Risk Reduction in Those Receiving Psychiatric Treatment: A Clinical Trial Telephone-Delivered Physical Activity Intervention for Individuals With Serious Mental Illness Recognition of Co-Occurring Medical Conditions Among Patients With Serious Mental Illness Psychoeducation for Siblings of People with Severe Mental Illness Impact of a nurse-led intervention to improve screening for cardiovascular risk factors in people with severe mental illnesses. Phase-two cluster randomised feasibility trial of community mental health teams Assessing an Internet-based parenting intervention for mothers with a serious mental illness: a randomized controlled trial. Clinical Trial of Wellness Training: Health Promotion for Severely Mentally Ill Adults Involuntary out-patient commitment and reduction of violent behaviour in persons with severe mental illness. Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. Community-Level HIV Prevention for Persons with Severe Mental Illness Living in Supportive Housing Programs Cluster randomized adaptive implementation trial comparing a standard versus enhanced implementation intervention to improve uptake of an effective re-engagement program for patients with serious mental illness Computer-assisted self-assessment in persons with severe mental illness. Appeal of electronic cigarettes in smokers with serious mental illness. Composing a new song for trials: the Standardized Outcomes in Nephrology (SONG) initiative. Perceived Stigma of Patients with Severe Mental Illness in Hong Kong: Relationships with Patients’ Psychosocial Conditions and Attitudes of Family Caregivers and Health Professionals Integrating depression and chronic disease care among patients with diabetes and/or coronary heart disease: the design of the TEAMcare study. Case Managers Discovering What Recovery Means Through an HIV Prevention Intervention
Objectives Little is known about the prevalence of comorbidity rates in people with severe mental illness ( SMI ) in UK primary care . We calculated the prevalence of SMI by UK country , English region and deprivation quintile , antipsychotic and antidepressant medication prescription rates for people with SMI , and prevalence rates of common comorbidities in people with SMI compared with people without SMI . Design Retrospective cohort study from 2000 to 2012 . Setting 627 general practice s contributing to the Clinical Practice Research Data link , a UK primary care data base . Participants Each identified case ( 346 551 ) was matched for age , sex and general practice with 5 r and omly selected control cases ( 1 732 755 ) with no diagnosis of SMI in each yearly time point . Outcome measures Prevalence rates were calculated for 16 conditions . Results SMI rates were highest in Scotl and and in more deprived areas . Rates increased in Engl and , Wales and Northern Irel and over time , with the largest increase in Northern Irel and ( 0.48 % in 2000/2001 to 0.69 % in 2011/2012 ) . Annual prevalence rates of all conditions were higher in people with SMI compared with those without SMI . The discrepancy between the prevalence of those with and without SMI increased over time for most conditions . A greater increase in the mean number of additional conditions was observed in the SMI population over the study period ( 0.6 in 2000/2001 to 1.0 in 2011/2012 ) compared with those without SMI ( 0.5 in 2000/2001 to 0.6 in 2011/2012 ) . For both groups , most conditions were more prevalent in more deprived areas , whereas for the SMI group conditions such as hypothyroidism , chronic kidney disease and cancer were more prevalent in more affluent areas . Conclusions Our findings highlight the health inequalities faced by people with SMI . The provision of appropriate timely health prevention , promotion and monitoring activities to reduce these health inequalities are needed , especially in deprived areas 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 , r and omisation 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 r and omised controlled trial ( RCT ) . Simple r and omisation was used following a computer-generated r and om number sequence . Participants and practitioners were not blinded to allocation . SETTING Primary care and secondary care mental health services in Engl and . 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 Question naire-9 items and Short Form Question naire-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 r and omisation . 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 r and omised to the BSC intervention and 51 people were r and omised 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 IS RCT N79497236 . 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 The explicit inclusion of mental health within the Sustainable Development Goals is a welcome development , borne out of powerful advocacy using public health , economic and human rights arguments . As funding comes on line for scale-up of evidence -based mental health care by task-sharing with primary care , it is time to take stock about care for people affected by severe mental illness ( SMI ) . The existing evidence base for task shared care for SMI provides an imperative to get started , but is skewed towards relatively more affluent and urban population s in middle-income countries where specialist mental health professionals provide most of the care . R and omised , controlled trials and rigorous implementation research on task shared service models are underway which will go some way to improving underst and ing of the quality , safety , effectiveness and acceptability of more widely generalisable care for people with SMI . A sub-group of people with SMI have more complex and long-term needs for care , with a high risk of homelessness , imprisonment and human rights violations as family and social supports become overwhelmed . Case studies from non-governmental organisations provide examples of holistic approaches to rehabilitation , recovery and empowerment of people with SMI , but rigorous comparative studies are needed to identify the most efficient , effective and scalable approaches to care . Health system constraints are emerging as the over-riding barriers to successful task-sharing , highlighting a need to develop and evaluate chronic care models for people with SMI that succeed in reducing premature mortality , improving wellbeing and achieving better social outcomes . Addressing these evidence gaps is essential if task-sharing mental health care is going to deliver on its promise of promoting recovery for the full range of people affected by SMI BACKGROUND Although maternal perinatal mental illnesses commonly present to and are primarily treated in general practice , few population -based estimates of this burden exist , and the most affected socioeconomic groups of pregnant women remain unclear . AIM To provide estimates of maternal depression , anxiety and serious mental illness ( SMI ) in UK general practice and quantify impacts of socioeconomic deprivation . DESIGN AND SETTING Cross-sectional analysis of prospect ively recorded general practice records from a UK-wide data base . METHOD A pregnancy ending in live birth was r and omly selected for every woman of childbearing age , 1994 - 2009 . Prevalence and diagnostic overlap of mental illnesses were calculated using a combination of medical diagnoses and psychotropic drug prescriptions . Socioeconomic deprivation was assessed using multivariate logistic regression , adjusting for calendar period and pregnancy history . RESULTS Among 116 457 women , 5.1 % presented with antenatal depression and 13.3 % with postnatal depression . Equivalent figures for anxiety were 2.6 % and 3.7 % and for SMI 1/1000 and 2/1000 women . Socioeconomic deprivation increased the risk of all mental illnesses , although this was more marked in older women . Those age 35 - 45 years in the most deprived group had 2.63 times the odds of antenatal depression ( 95 % confidence interval [ CI ] = 2.22 to 3.13 ) compared with the least deprived ; in women aged 15 - 25 years the increased odds associated with deprivation was more modest ( odds ratio = 1.35 , 95 % CI = 1.07 to 1.70 ) . Similar patterns were found for anxiety and SMI . CONCLUSION Strong socioeconomic inequalities in perinatal mental illness persist with increasing maternal age . Targeting detection and effective interventions to high-risk women may reduce inequity and avoid substantial psychiatric morbidity OBJECTIVE To evaluate whether posttraumatic stress disorder ( PTSD ) is related to outcomes in persons with severe mental illness ( SMI ) participating in a study of vocational rehabilitation programs . BACKGROUND PTSD is a common comorbid disorder in people with SMI , but it is unknown whether PTSD interferes with the ability to benefit from rehabilitation programs such as supported employment . METHODS The relationships between PTSD and symptoms , health , quality of life , and work outcomes was examined in 176 clients with SMI participating in a 2-year r and omized controlled trial of three vocational rehabilitation programs : supported employment based on the Individual Placement and Support model , a psychosocial rehabilitation program based on transitional employment , and st and ard services .  RESULTS The overall rate of current PTSD in the sample was 16 percent . Compared with clients without PTSD , clients with PTSD had more severe psychiatric symptoms , worse reported health , lower self-esteem , and lower subjective quality of life . Clients with PTSD who participated in the Individual Placement and Support model ( the most effective vocational model of the three studied ) also had worse employment outcomes over the 2-year study period than clients without PTSD , with lower rates of competitive work , fewer hours worked , and fewer wages earned . Employment outcomes did not differ between clients with PTSD versus without PTSD in the other two vocational rehabilitation approaches . CONCLUSION The findings suggest that PTSD may contribute to worse work outcomes in clients participating in supported employment programs . Effective treatment of these clients with PTSD may improve their ability to benefit from supported employment OBJECTIVE The Helping Older People Experience Success ( HOPES ) program was developed to improve psychosocial functioning and reduce long-term medical burden in older people with severe mental illness ( SMI ) living in the community . HOPES includes 1 year of intensive skills training and health management , followed by a 1-year maintenance phase . METHOD To evaluate effects of HOPES on social skills and psychosocial functioning , we conducted a r and omized controlled trial with 183 older adults with SMI ( 58 % schizophrenia spectrum ) age 50 and older at 3 sites who were assigned to HOPES or treatment as usual with blinded follow-up assessment s at baseline and 1- and 2-year follow-up . RESULTS Retention in the HOPES program was high ( 80 % ) . Intent-to-treat analyses showed significant improvements for older adults assigned to HOPES compared to treatment as usual in performance measures of social skill , psychosocial and community functioning , negative symptoms , and self-efficacy , with effect sizes in the moderate ( .37-.63 ) range . Exploratory analyses indicated that men improved more than women in the HOPES program , whereas benefit from the program was not related to psychiatric diagnosis , age , or baseline levels of cognitive functioning , psychosocial functioning , or social skill . CONCLUSIONS The results support the feasibility of engaging older adults with SMI in the HOPES program , an intensive psychiatric rehabilitation intervention that incorporates skills training and medical case management , and improves psychosocial functioning in this population . Further research is needed to better underst and gender differences in benefit from the HOPES program Among severely mentally ill ( SMI ) substance abusers , HIV rates are elevated and HIV risk reduction interventions have been shown to be less effective . An enhanced cognitive behavioral HIV risk reduction intervention ( E-CB ) for SMI was compared to a health promotion condition ( HPC ) in 222 psychiatric out patients at 6 months postintervention . Compared to females , males in the E-CB improved on intention to practice safer sex and in condom use skills and in unprotected vaginal sex , but did not differ in HIV knowledge , perceived susceptibility , anxiety , condom attitudes , safer sex self-efficacy , unprotected vaginal sex acts , or sex partners . Across intervention groups , there were improvements in all areas except self-efficacy and number of partners . Risk reduction among SMI may be facilitated by increasing awareness of health related behaviors and HIV-targeted content . However , meaningful changes in critical risk reduction skills and intentions may require a more focused intervention and may vary by gender BACKGROUND : Obesity is prevalent in individuals with serious mental illness ( SMI ) . OBJECTIVE : The purpose of this study is to examine the feasibility of a telephone-delivered physical activity ( PA ) intervention for out patients with serious mental illness to maintain PA and to explore the preliminary efficacy of the intervention on health status . DESIGN : This study used a r and omized experimental design . The treatment group received pedometers and eight weekly phone calls ; the control group received written information regarding PA . Descriptive statistics were used to analyze data collected at baseline and 8 weeks . RESULTS : Twenty-two subjects with SMI ( mean age = 44.09 ± 7.6 years ; 54.5 % were male ) were recruited and 16 subjects completed the study in 8 weeks .  PA ( z = −2.37 , p = .02 ) increased in the treatment group ( n = 8) whereas the control group ( n = 8) maintained baseline PA level ( z = −1.61 , p = .11 ) . Health outcomes were not changed ( ps > .05 ) . CONCLUSION : Telephone-delivered intervention is feasible and has the potential to improve PA  in individuals with SMI We determined whether patients with serious mental illness ( SMI ) were less likely than non-SMI to self-report having a medical condition that was recorded in their medical record . We included all patients from the VA National Psychosis Registry diagnosed with SMI and a r and om sample of non-SMI patients in fiscal year 1999 who completed the Large Health Survey of Veteran Enrollees ( N = 35,837 ) . Among patients with diagnoses for any of 11 conditions recorded in administrative data , we evaluated whether patients reported having that same condition in the survey , using multivariable logistic regression and generalized estimating equations . Among patients diagnosed with a given condition , those with SMI were less likely to report being told by providers that they had seven of the 11 conditions examined : heart disease ( OR = 0.68 , p < 0.001 ) , arthritis ( OR = 0.79 , p < 0.001 ) , cancer ( OR = 0.69 , p < 0.001 ) , diabetes ( OR = 0.79 , p < 0.001 ) , back pain ( OR = 0.81 , p < 0.001 ) , congestive heart failure ( OR = 0.71 , p < 0.001 ) , and hypertension ( OR = 0.77 , p < 0.001 ) . Patients with SMI were less aware of co-occurring medical conditions Background Many people with severe mental illness ( SMI ) have siblings . Siblings are often both natural agents to promote service users ’ recovery and vulnerable to mental ill health due to the negative impact of psychosis within the family . Despite a wealth of research evidence supporting the effectiveness of psychoeducation for service users with SMI and their family members , in reducing relapse and promoting compliance with treatment , siblings remain relatively invisible in clinical service setting s as well as in research studies . If psychoeducational interventions target siblings and improve siblings ' knowledge , coping with caring and overall wellbeing , they could potentially provide a cost-effective option for supporting siblings with result ing benefits for service users ' outcomes . Objectives To assess the effectiveness of psychoeducation compared with usual care or any other intervention in promoting wellbeing and reducing distress of siblings of people affected by SMI . The secondary objective was , if possible , to determine which type of psychoeducation is most effective . Search methods We search ed the Cochrane Schizophrenia Group Trials Register and screened the reference lists of relevant reports and review s ( 12th November 2013 ) . We contacted trial authors for unpublished and specific data on siblings ' outcomes . Selection criteria All relevant r and omised controlled trials focusing on psychoeducational interventions targeting siblings of all ages ( on their own or amongst other family members including service users ) of individuals with SMI , using any means and formats of delivery , i.e. individual ( family ) , groups , computer-based . Data collection and analysis Two review authors independently screened the abstract s and extracted data and two other authors independently checked the screening and extraction process . We contacted authors of trials to ascertain siblings ' participation in the trials and seek sibling-specific data in those studies where siblings ' data were grouped together with other participants ' ( most commonly other family members'/carers ' ) outcomes . We calculated the risk difference ( RD ) , its 95 % confidence interval ( CI ) on an intention-to-treat basis . We presented continuous data using the mean difference statistic ( MD ) and 95 % CIs . We assessed risk of bias for the included study and rated quality of evidence using Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) . Main results We found 14 studies that included siblings amongst other family members in receipt of psychoeducational interventions . However , we were only able to include one small trial with relevant and available data ( n = 9 siblings out of n = 84 family member/carer- participants ) comparing psychoeducational intervention with st and ard care in a community care setting , over a duration of 21 months . There was insufficient evidence to determine the effects of psychoeducational interventions compared with st and ard care on ' siblings ' quality of life ' ( n = 9 , MD score 3.80 95 % CI -0.26 to 7.86 , low quality of evidence ) , coping with ( family ) burden ( n = 9 , MD -8.80 95 % CI -15.22 to -2.34 , low quality of evidence ) . No sibling left the study early by one year ( n = 9 , RD 0.00 CI -0.34 to 0.34 , low quality of evidence ) . Low quality and insufficient evidence meant we were unable to determine the effects of psychoeducational interventions compared with st and ard care on service users ' global mental state ( n = 9 , MD -0.60 CI -3.54 to 2.38 , low quality of evidence ) , their frequency of re-hospitalisation ( n = 9 , MD -0.70 CI -2.46 to 1.06 , low quality of evidence ) or duration of inpatient stay ( n = 9 , MD -2.60 CI -6.34 to 1.14 , low quality of evidence ) , whether their siblings received psychoeducation or not . No study data were available to address the other primary outcomes : ' siblings ' psychosocial wellbeing ' , ' siblings ' distress ' and adverse effects . Authors ' conclusions Most studies evaluating psychoeducational interventions recruited siblings along with other family members . However , the proportion of siblings in these studies was low and outcomes for siblings were not reported independently from those of other types of family members . Indeed , only data from one study with nine siblings were available for the review . The limited study data we obtained provides no clear good quality evidence to indicate psychoeducation is beneficial for siblings ' wellbeing or for clinical outcomes of people affected by SMI . More r and omised studies are justified and needed to underst and the role of psychoeducation in addressing siblings ' needs for information and support Background People with severe mental illnesses ( SMI ) are at increased risk of cardiovascular disease ( CVD ) . Clinical guidelines recommend regular screening for CVD risk factors . We evaluated a nurse led intervention to improve screening rates across the primary - secondary care interface . Methods Six community mental health teams ( CMHTs ) were r and omised to receive either the nurse led intervention plus education pack ( n = 3 ) or education pack only ( n = 3 ) . Intervention ( 6 months ) : The nurse promoted CVD screening in primary care and then in CMHTs . Patients who remained unscreened were offered screening by the nurse . After the intervention participants with SMI were recruited from each CMHT to collect outcome data . Main outcome : Numbers screened during the six months , confirmed in General Practice notes . Results All six CMHTs approached agreed to r and omisation . 121 people with SMI participated in outcome interviews during two waves of recruitment ( intervention arm n = 59 , control arm n = 62 ) . Participants from both arms of the trial had similar demographic profiles and rates of previous CVD screening in the previous year , with less than 20 % having been screened for each risk factor . After the trial , CVD screening had increased in both arms but participants from the intervention arm were significantly more likely to have received screening for blood pressure ( 96 % vs 68 % ; adjusted Odds Ratio ( OR ) 13.6 ; 95 % CI : 3.5 - 38.4 ) , cholesterol ( 66.7 % vs 26.9 % , OR 6.1 ; 3.2 - 11.5 ) , glucose ( 66.7 % vs 36.5 % OR 4.4 ; 2.7 - 7.1 ) , BMI ( 92.5 % vs 65.2 % OR 6.5 ; 2.1 - 19.6 ) , and smoking status ( 88.2 % vs 57.8 % OR 5.5 ; 3.2 - 9.5 ) and have a 10 year CVD risk score calculated ( 38.2 % vs 10.9 % ) OR 5.2 1.8 - 15.3 ) . Within the intervention arm approximately half the screening was performed in general practice and half by the trial nurse . Conclusions The nurse-led intervention was superior , result ing in an absolute increase of approximately 30 % more people with SMI receiving screening for each CVD risk factor . The feasibility of the trial was confirmed in terms of CMHT recruitment and the intervention , but the response rate for outcome collection was disappointing ; possibly a result of the cluster design . The trial was not large or long enough to detect changes in risk factors . Trial Registration International St and ard R and omised Controlled Trial Registration Number ( IS RCT RN ) 58625025 OBJECTIVE This study examined the effectiveness of an  Internet parenting education and support intervention among mothers with a serious mental illness ( SMI ) . METHODS Sixty mothers diagnosed with a schizophrenia spectrum or mood disorder who had primary /shared custody for a child 18 or younger were enrolled in a r and omized controlled trial ( RCT ) with two conditions . The experimental condition involved participation in the online parental education course and a listserv co-moderated by a parent with a mental illness and a mental health professional . The control condition involved participation in online education healthy lifestyle course . St and ardized measures were used at baseline and 3 months to assess outcomes . Using an intent-to-treat approach , group differences over time were assessed using a two-tailed independent sample t test on all dependent variables , including parental efficacy , skills , coping , support , and stress . RESULTS Participation in an online parenting intervention for mothers with a SMI  enhanced parenting and coping skills , and decreased parental stress . No support was found for improved efficacy or support . CONCLUSION This RCT establishes that mothers with a SMI are interested in and capable of receiving online parenting education and support . Findings demonstrate that an online parenting intervention can improve parenting and coping skills and decrease parental stress This r and omized controlled trial examined benefits of adding active health promotion to basic primary care ( BPC ) services for SMI adults . It compared BPC with BPC plus wellness training ( WT ) , a 12 months intervention promoting individual skills in self-management .  Three hundred nine participants enrolled during short-term residential treatment completed baseline assessment s and were assigned to treatment groups , before discharge . Outcomes of perceived health status ( SF-36 ) , global assessment of function , and ratings of self-efficacy were assessed at follow-up interviews at 6 , 12 , and 18 months . The intent-to-treat analysis employed multilevel regression to examine differences by group on outcomes across time , controlling for health related covariates . The WT group showed significantly better outcomes on the SF-36 physical functioning and general health scales . Findings affirm ability of SMI adults to benefit from active health promotion BACKGROUND Violent behaviour among persons with severe mental illness ( SMI ) causes public concern and is associated with illness relapse , hospital recidivism and poor outcomes in community-based treatment . AIMS To test whether involuntary out-patient commitment ( OPC ) may help to reduce the incidence of violence among persons with SMI . METHOD One-year r and omised trial of the effectiveness of OPC in 262 subjects with psychotic or major mood disorders and a history of hospital recidivism . Involuntarily hospitalised subjects awaiting OPC  were r and omly assigned to release or court-ordered treatment after discharge . Those with a recent history of serious assault remained under OPC until expiry of the court order ( up to 90 days ) ; then OPC orders were renewed at clinical /court discretion . Control subjects had no OPC . Four-monthly follow-up interviews with subject , case manager and collateral informant took place and service records were collected . RESULTS A significantly lower incidence of violent behaviour occurred in subjects with > or = 6 months ' OPC .  Lowest risk of violence was associated with extended OPC combined with regular out-patient services , adherence to prescribed medications and no substance misuse . CONCLUSIONS OPC may significantly reduce risk of violent behaviour in persons with SMI , in part by improving adherence to medications while diminishing substance misuse OBJECTIVE To demonstrate the effectiveness of a Diabetes Prevention Program-inspired 12-month behavioral intervention for patients with severe mental illness ( SMI ) and medication-associated obesity . METHOD This r and omized , controlled , parallel , superiority study screened 225 volunteers from November 2005 to August 2008 at the VA Greater Los Angeles Healthcare System . 122 out patients with DSM-IV-diagnosed SMI taking antipsychotic medications who had ≥ 7 % weight gain or body mass index ( BMI ) > 25 were r and omized by computer-generated number to Lifestyle Balance treatment intervention  ( n = 60 ) or usual care control  ( n = 62 ) groups . Clinical raters were masked to r and omization . Treatment intervention included weekly classes and individual counseling for 8 weeks , food and exercise diaries , rewards , caregiver consultations , and monthly booster classes and counseling for 1 year . Controls received self-help material s and visited at equivalent intervals without formal classes or counseling . Outcomes were changes in anthropometric measurements , psychiatric symptoms , health knowledge , and glucose , hemoglobin A1c , and lipid levels . RESULTS Our intention-to-treat analysis found significant differences in predicted trajectory of mean weight change between the groups over 12 months ( P < .01 ) , with treatment participants expected to lose an average 4.6 kg , while control participants would gain an average 0.6 kg . BMI and body fat percentage followed the same pattern . Both groups demonstrated statistically significant improvements in health knowledge quiz scores over time ( P = .006 ) , without significant difference between groups . CONCLUSIONS Treatment was more effective than usual care control in treating medication-associated obesity , independent of SMI diagnosis , antipsychotic medication , and knowledge gained , suggesting that behavioral interventions are effective in SMI patients . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00344500 SUMMARY Individuals with severe mental illness ( SMI ) are at risk for HIV/AIDS . Despite the availability of supportive community programs for those with SMI , there have been no published evaluations of community-level HIV prevention trials among this population . A pilot intervention trial was conducted to determine the feasibility of such an intervention in supportive housing programs ( SHPs ) . A multi-component community-level trial was implemented in two SHPs with a total of 28 residents . Participants completed assessment s at three time points : prior to the intervention ( baseline ) , following skills training ( post- assessment ) , and following the 4-month community intervention ( follow-up ) . Results demonstrated significant improvements in psychosocial risk factors at both post— and follow-up assessment s , with indications of sexual behavior change at follow-up . The community-level intervention appeared to reduce the risk of HIV among persons with SMI living in SHPs , and supports the importance of conducting larger scale intervention trials Background Persons with serious mental illness ( SMI ) are disproportionately burdened by premature mortality . This disparity is exacerbated by poor continuity of care with the health system . The Veterans Health Administration ( VA ) developed Re-Engage , an effective population -based outreach program to identify veterans with SMI lost to care and to reconnect them with VA services . However , such programs often encounter barriers getting implemented into routine care . Adaptive design s are needed when the implementation intervention requires augmentation within sites that do not initially respond to an initial implementation intervention . This protocol describes the methods used in an adaptive implementation design study that aims to compare the effectiveness of a st and ard implementation strategy ( Replicating Effective Programs , or REP ) with REP enhanced with External Facilitation ( enhanced REP ) to promote the uptake of Re-Engage . Methods / Design This study employs a four-phase , two-arm , longitudinal , clustered r and omized trial design . VA sites ( n = 158 ) across the United States with a design ated Re-Engage provider , at least one Veteran with SMI lost to care , and who received st and ard REP during a six-month run-in phase . Subsequently , 88 sites with inadequate uptake were stratified at the cluster level by geographic region ( n = 4 ) and VA regional service network ( n = 20 ) and r and omized to REP  ( n = 49 ) vs.  enhanced REP  ( n = 39 ) in phase two . The primary outcome was the percentage of veterans on each facility outreach list documented on an electronic web registry . The intervention was at the site and network level and consisted of st and ard REP versus REP enhanced by external phone facilitation consults . At 12 months ,  enhanced REP sites returned to st and ard REP and 36 sites with inadequate participation received enhanced REP for six months in phase three . Secondary implementation outcomes included the percentage of veterans contacted directly by site providers and the percentage re-engaged in VA health services . Discussion Adaptive implementation design s consisting of a sequence of decision rules that are tailored based on a site ’s uptake of an effective program may produce more relevant , rapid , and generalizable results by more quickly validating or rejecting new implementation strategies , thus enhancing the efficiency and sustainability of implementation research and potentially leading to the rollout of more cost-efficient implementation strategies . Trial registration Current Controlled TrialsIS RCT N21059161 BACKGROUND It has been difficult to improve care for severe mental illness ( SMI ) in usual care setting s because clinical information is not reliably and efficiently managed . Methods are needed for efficiently collecting this information to evaluate and improve health care quality . Audio computer-assisted self-interviewing ( ACASI ) can facilitate this data collection and has improved outcomes for a number of disorders , suggesting the need to test its accuracy and reliability in people with SMI . METHOD Ninety patients with DSM-IV schizophrenia or schizoaffective disorder ( N = 45 ) or bipolar disorder ( N = 45 ) recruited between Oct. 15 , 2002 , and July 1 , 2003 , were r and omly assigned to 1 of 2 study groups and completed 2 st and ardized symptom surveys ( Revised Behavior and Symptom Identification Scale and the symptom severity scale of the Schizophrenia Outcomes Module 2 ) 20 minutes apart in a crossover study design . Half of the patients first completed the scales via an in-person interview , and the other half first completed the scales via an  ACASI survey self-administered through an Internet browser using a touchscreen developed to meet the cognitive needs of people with SMI . We evaluated attitudes toward ACASI  , underst and ing of the ACASI survey , internal consistency , correlations between the ACASI and interview modes , concurrent validity , and a possible administration mode bias . RESULTS All ACASI and in-person interview scales had similar internal reliability , high correlations ( r = 0.78 - 1.00 ) , and mean scores similar enough as not to be different at p < .05 . A large majority rated the ACASI survey as easier , more enjoyable , more preferable if monthly completion of a survey were required , and more private , and 97 % to 99 % perfectly answered questions about how to use it . CONCLUSION ACASI data collection is reliable among people with bipolar disorder and schizophrenia and could be a valuable tool to improve their care INTRODUCTION Up to 75 % of people with serious mental illness ( SMI ) smoke , and most are highly dependent on nicotine , consuming more cigarettes per day than smokers without mental illness . Even with evidence -based treatment , relapses are common , result ing in high morbidity and early mortality from tobacco-related diseases . Electronic cigarettes ( e-cigarettes ) are theoretically safer because they deliver no tar or carbon monoxide ; however , their appeal is largely untested in people with SMI . METHODS We enrolled 21 chronic smokers with SMI who had failed a quit attempt and were not engaged in cessation treatment . Research staff provided e-cigarettes and instructions on how to use them , and assessed participants weekly for 4weeks . RESULTS Of the enrolled participants , 19 completed weekly assessment s. From baseline to the final study visit , mean self-reported use of combustible tobacco declined from 192 to 67cigarettes/week ( t=3.62 , df=17 , p=0.005 ) , confirmed by reduction in breath carbon monoxide from 27ppm to 15ppm ( t=3.246 , df=18 , p=0.004 ) . Use of e-cigarettes  did not escalate over the 4weeks . Temporary and mild side effects , including dry/sore throat , nausea , dizziness , and cough , were reported by 58 % of participants . End of trial ratings of enjoyment , satisfaction compared to regular cigarettes , and willingness to buy e-cigarettes were high ( ranging from 3.82 - 4.51 on a 5-point scale ) . CONCLUSIONS Results of this study suggest that people with SMI may find e-cigarettes an appealing substitute for combustible cigarettes . We found no evidence of increasing nicotine dependence . Further r and omized studies are needed to better assess e-cigarette appeal and toxicity R and omized trials provide the most reliable evidence about the safety and effectiveness of interventions to improve health care and patient outcomes . Unfortunately , the potential for trials to inform treatment decisions remains limited because the outcomes reported often do not resonate with what is directly meaningful and relevant to patients and their clinicians [ 1–3 ] . Further , inconsistent reporting of outcomes across trials prevents assessment of the comparative effect of interventions [ 4 ] . Outcome reporting bias , whereby authors cherry-pick the outcomes they report on the basis of favourable results , may also occur when there is not a st and ardized list of outcomes measured and reported [ 5 , 6 ] . Collectively these problems may undermine the reliability of published trials , leading to inefficient use of scarce research and health care re sources and unintended harm to patients [ 6 ] . Such dissonance in outcomes reported in trials is widespread and evident across all medical specialties . The growing recognition of the problem has prompted large-scale efforts to establish core outcome sets . Core outcome sets are an agreed st and ardized set of outcomes for a specific clinical area that are to be reported as a minimum in all trials in that area [ 7 ] . Outcomes are selected because they are critically important to all stakeholders — namely patients , their clinicians and policymakers— for decision making . Core outcome sets are not design ed to be comprehensive or exclusive . Typically they include only three to five outcomes . Other outcomes that are identified to be important ( i.e. to some stakeholder groups ) may also be recommended for some trials ( Figure 1 ) . The design ated primary outcome of any given trial may be outside the core outcome set and research ers may also opt to add other , trial-specific outcomes , chosen for reasons including responsiveness to the intervention and feasibility . Attempts to st and ardize outcomes began 50 years ago when the World Health Organization published recommendations for the minimum requirements for data collection in cancer trials [ 8 ] . In the 1990s , the Outcome Measures in Rheumatology ( OMERACT ) initiative was formed , and is perhaps the most widely recognized and largest initiative in the field of core outcome development . OMERACT engages patients and health professionals to st and ardize outcome measures for trials in rheumatology [ 9 ] and has pioneered method ologies for developing core outcome sets . The uptake of the OMERACT core outcome sets has improved the consistency of outcomes reported in trials [ 10 ] . In the past decade , core outcome sets in diverse medical specialties , including cardiology , dermatology , surgery , oncology , women ’s health and respiratory disease , have progressively been developed [ 7 , 9–11 ] . The use of core outcome sets is also increasingly being advocated by funders to ensure the relevance and potential impact of research . In the UK , funding organizations , including the National Institute for Health Research and the Health Research Board ( Irel and ) , advise research ers to include core outcome sets if they are available and highlight the  Core Outcome Measures in Effectiveness ( COMET ) data base of core outcomes as a key re source [ 7 ] . The COMET initiative was recently launched to facilitate the development , implementation and evaluation of core outcome sets [ 7 ] . There has been a long-st and ing need in nephrology to develop core outcomes [ 12–14 ] . More than 14 000 r and omized trials are available in the Cochrane Kidney and Transplant Specialised Register [ 15 ] and a search of Clinical Trials.gov trials for ‘ kidney disease ’ yields > 3000 ongoing trials . Despite this considerable investment in trials in nephrology , improvements in outcomes for patients with kidney disease have been modest at best . Across all stages of chronic kidney disease ( CKD ) , patients still have a markedly higher risk of mortality and serious comorbidities , including cardiovascular disease , diabetes , cancer and infection , compared with the general population [ 16–18 ] . Patients with CKD have poor quality of life , particularly if they are on dialysis , to the extent that many patients || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || This descriptive survey investigated the level of perceived stigma among Chinese patients with severe mental illness ( SMI ) and its relationships with patients ’ psychosocial conditions and family caregivers ’ and mental health professionals ’ attitudes toward SMI in Hong Kong . A clustered , r and om sample of 311 patients and their family caregivers and 73 Chinese professionals participated . The patients reported a high level of withdrawal/secrecy and the professionals perceived a low to moderate level of stereotype/restriction to their patients . Families ’ expressed emotion and caregiving burden could increase patients ’ perceived stigma . Strategies in de-stigmatization of mental illness have been discussed , particularly from family-based approach Diabetes and coronary heart disease ( CHD ) are two of the most prevalent medical illnesses in the US population and comorbid depression occurs in up to 20 % of these patients . Guidelines for management of diabetes and CHD overlap for healthy lifestyle and disease-control recommendations . However , the majority of patients with these medical illnesses have been shown to have inadequate control of key risk factors such as blood pressure , LDL cholesterol , or blood sugar . Comorbid depression has been shown to adversely affect self-care of diabetes and CHD , and is associated with an increased risk of complications and mortality . Interventions that have improved quality and outcomes of depression care alone in patients with diabetes and CHD have not demonstrated benefits in self-care , improved disease control or morbidity and mortality . This paper describes the design and development of a new biopsychosocial intervention ( TEAMcare ) aim ed at improving both medical disease control and depression in patients with poor control of diabetes and /or CHD who met the criteria for comorbid depression . A team approach is used with a nurse interventionist who receives weekly psychiatric and primary care physician caseload supervision in order to enhance treatment by the primary care physician . This intervention is being tested in an NIMH-funded r and omized controlled trial in a large integrated health plan Following a r and omized trial of case manager delivered HIV prevention intervention to persons with severe mental illness ( SMI ) , this study sought to document changes within the service environment and with case managers themselves as a result of their experience and skills training . Utilizing qualitative methods , research ers conducted focus groups and in-depth interviews with 22 case managers and 3 administrators at an urban community mental health center . Beyond confirming previously established barriers to case manager delivery of HIV prevention interventions for persons with SMI , most noteworthy was the finding that case managers were generally unskilled in conducting assessment s and tended to focus on “ spoiled identity ” and illness parts of their consumers . Experimental case managers revealed that they had been transformed by the training experience in a manner permitting them to both underst and and work from a recovery model . Implication s and directions for further study are discussed
Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .