A Model for Advancing Scale-Up of Complex Interventions for Vulnerable Populations: the ALACRITY Center for Health and Longevity in Mental Illness.

Many of the most pressing health issues in the USA and worldwide require complex, multi-faceted solutions. Delivery of such solutions is often complicated by the need to reach and engage vulnerable populations facing multiple barriers to care. While the fields of quality improvement and implementation science have made valuable gains in the development and spread of individual strategies to improve evidence-based practice delivery, models for coordinated deployment of numerous strategies to simultaneously implement multiple evidence-based interventions in vulnerable populations are lacking. In this Perspective, we describe a model for this type of comprehensive research-practice translation effort: the Johns Hopkins ALACRITY Center for Health and Longevity in Mental Illness, which is focused on reducing premature mortality in the population with serious mental illness. We describe the Center's conceptual framework, which is built upon an integrated set of quality improvement and implementation science frameworks, provide an overview of the Center's organizational structure and core research-practice translation activities, and discuss our vision for how the Center may evolve over time. Lessons learned from this Center's efforts could inform models to address other critical health issues in vulnerable populations that require multi-component solutions at the policy, system, provider, and patient levels.

A behavioral weight-loss intervention in persons with serious mental illness.

BACKGROUND: Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness. METHODS: We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months. RESULTS: Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events. CONCLUSIONS: A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings support implementation of targeted behavioral weight-loss interventions in this high-risk population. (Funded by the National Institute of Mental Health; ACHIEVE ClinicalTrials.gov number, NCT00902694.).

Recruitment and enrollment of African Americans and Caucasians in a health promotion trial for persons with serious mental illness.

African Americans with serious mental illness (SMI) continue to experience inadequate representation in clinical trials. Persons with SMI, regardless of race, have an increased burden of all cardiovascular disease (CVD) risk factors including obesity, hypertension, diabetes mellitus, dyslipidemia, metabolic syndrome and tobacco smoking. Having SMI and being African American, however, is each associated with an increased risk of CVD mortality compared to the general population. There is a critical need, therefore, to adapt health promotion interventions for African Americans with SMI. We sought to examine overall recruitment into a randomized clinical trial of CVD prevention among persons with SMI, and to examine racial differences in interest, enrollment, and potential barriers to participation. Although similar levels of interest in participation were seen between African Americans and Caucasians in signing screening consent, 9.6% fewer African Americans enrolled due to inability to complete initial data collection. Further work is needed to better understand the nature of the barriers encountered by African Americans with SMI who otherwise may be interested in participating within clinical trials.

Implementing an evidence-based behavioral weight-loss program in community mental health centers: A randomized pilot study.

Background: Obesity is a leading cause of preventable death among individuals with serious mental illness (SMI). A prior randomized controlled trial demonstrated the efficacy of a lifestyle style intervention tailored to this population; however, such interventions need to be adapted and tested for real-world settings. Aims: This study evaluated implementation interventions to support community mental health program staff to deliver an evidence-based lifestyle intervention to clients with obesity and SMI. Materials & Methods: In this cluster-randomized pilot trial, the standard arm combined multimodal training with organizational strategy meetings and the enhanced arm included all standard strategies plus performance coaching. Staff-coaches delivered a 6-month group-based lifestyle intervention to clients with SMI. Primary outcomes were changes in staff knowledge, self-efficacy, and fidelity scores for lifestyle intervention delivery. Linear mixed-effects modeling was used to analyze outcomes, addressing within-site clustering and within-participant longitudinal correlation of outcomes. Results: Three sites were in the standard arm (7 staff-coaches); 5 sites in the enhanced arm (11 staff-coaches). All sites delivered all 26 modules of the lifestyle intervention. Staff-coaches highly rated the training strategy's acceptability, feasibility and appropriateness. Overall, mean knowledge score significantly increased pre-post by 5.5 (95% CI: 3.9, 7.1) and self-efficacy was unchanged; neither significantly differed between arms. Fidelity ratings remained stable over time and did not differ between arms. Clients with SMI achieved a mean 6-month weight loss of 3.8 kg (95% CI: 1.6, 6.1). Conclusions: Mental health staff delivering a lifestyle intervention was feasible using multicomponent implementation interventions, and preliminary results show weight reduction among clients with SMI. The addition of performance coaching did not significantly change outcomes. Future studies are needed to definitively determine the effect on client health outcomes.

Cigarette Smoking and Health Characteristics in Individuals With Serious Mental Illness Enrolled in a Behavioral Weight Loss Trial.

Objective: Cigarette smoking is the most preventable cause of disease and death in the US. We examined the prevalence of smoking and the association between smoking status and health characteristics in persons with serious mental illness. Methods: A total of 291 overweight or obese adults with serious mental illness were enrolled in a behavioral weight loss trial. Cigarette smoking, co-occurring medical diagnoses, dietary intake, blood pressure, cardiovascular fitness, body mass index, quality of life, and psychiatric symptoms were assessed at baseline in 2008-2011. Fasting glucose and lipid markers were measured from blood samples. Cardiovascular risk profile was calculated based on the global Framingham Health Study Risk Equation. Results: A total of 128 (44%) of participants were current smokers or had smoked in the previous one year. The smokers had significantly higher diastolic blood pressure and blood triglyceride levels, and lower HDL cholesterol than the nonsmokers, adjusted for age, sex, education, and diagnosis. They were more likely to have a history of emphysema, and had a 10-year cardiovascular disease risk of 13.2%, significantly higher than the 7.4% in the nonsmokers. The smokers also had elevated ratings of psychopathology on the BASIS-24 scale. Smokers did not differ from nonsmokers in cardiovascular fitness, body mass index, depression, quality of life, or other comorbid medical diagnoses. There was no characteristic in which smokers appeared healthier than nonsmokers. Conclusions: The prevalence of smoking in this contemporary cohort of individuals with serious mental illness who were motivated to lose weight was more than twice that in the overall population. Smokers had more indicators of cardiovascular disease and poorer mental health than did nonsmokers. The high burden of comorbidity in smokers with serious mental illness indicates a need for broad health interventions.

Designing Practical Motivational Interviewing Training for Mental Health Practitioners Implementing Behavioral Lifestyle Interventions: Protocol for 3 Pilot Intervention Studies.

BACKGROUND: Motivational interviewing (MI) is an evidence-based, patient-centered communication method shown to be effective in helping persons with serious mental illness (SMI) to improve health behaviors. In clinical trials where study staff conducted lifestyle interventions incorporating an MI approach, cardiovascular disease (CVD) risk profiles of participants with SMI showed improvement. Given the disproportionate burden of CVD in this population, practitioners who provide somatic and mental health care to persons with SMI are ideally positioned to deliver patient-centered CVD risk reduction interventions. However, the time for MI training (traditionally 16-24 hours), follow-up feedback, and the coaching required to develop and maintain patient-centered skills are significant barriers to incorporating MI when scaling up these evidence-based practices. OBJECTIVE: We describe the design and development of the following 2 scalable MI training approaches for community mental health practitioners: real-time brief workshops and follow-up asynchronous avatar training. These approaches are being used in 3 different pilot implementation research projects that address weight loss, smoking cessation, and CVD risk reduction in people with SMI who are a part of ALACRITY Center, a research-to-practice translation center funded by the National Institute of Mental Health. METHODS: Clinicians and staff in community mental health clinics across Maryland were trained to deliver 3 distinct evidence-based physical health lifestyle interventions using an MI approach to persons with SMI. The real-time brief MI workshop training for ACHIEVE-D weight loss coaches was 4 hours; IMPACT smoking cessation counselors received 2-hour workshops and prescribers received 1-hour workshops; and RHYTHM CVD risk reduction program staff received 4 hours of MI. All workshop trainings occurred over videoconference. The asynchronous avatar training includes 1 common didactic instructional module for the 3 projects and 1 conversation simulation unique to each study's target behavior. Avatar training is accessible on a commercial website. We plan to assess practitioners' attitudes and beliefs about MI and evaluate the impact of the 2 MI training approaches on their MI skills 3, 6, and 12 months after training using the MI Treatment Integrity 4.2.1 coding tool and the data generated by the avatar-automated scoring system. RESULTS: The ALACRITY Center was funded in August 2018. We have implemented the MI training for 126 practitioners who are currently delivering the 3 implementation projects. We expect the studies to be complete in May 2023. CONCLUSIONS: This study will contribute to knowledge about the effect of brief real-time training augmented with avatar skills practice on clinician MI skills. If MI Treatment Integrity scoring shows it to be effective, brief videoconference trainings supplemented with avatar skills practice could be used to train busy community mental health practitioners to use an MI approach when implementing physical health interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44830.

Scaling a behavioral weight-loss intervention for individuals with serious mental illness using the enhanced replicating effective programs framework: A preconditions phase proof-of-concept study.

Background: Given the obesity's high prevalence among individuals with serious mental illness (SMI), translating weight-loss interventions with demonstrated effectiveness is needed. This study describes the initial translation phase of such an intervention using the Enhanced Replicating Effective Programs (REP) Framework for delivery by mental health program staff. Methods: The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (Achieving Healthy Lifestyles in Psychiatric Rehabilitation) trial intervention was preliminarily adapted to create the ACHIEVE-Dissemination (ACHIEVE-D) curriculum. A treatment-only study was conducted to rapidly evaluate the curriculum using a mixed-methods approach including surveys and focus groups. A study coach delivered an abbreviated curriculum to individuals with SMI from a single psychiatric program. Among all participants with SMI (n = 17), outcomes were attendance and satisfaction; 14 participated in a focus group. The program staff observed curriculum delivery and participated in a focus group (n = 3). Results: Overall, 23 group sessions were delivered. Median attendance was 78.6% across participants with SMI; 92.9% would recommend ACHIEVE-D to others. The staff found the curriculum acceptable, particularly its structured nature, inclusion of weight management and exercise, and integrated goal setting and tracking. These improvements recommended by participants and/or staff were to assess participant readiness-to-change prior to enrollment, change the frequency of weigh-ins, and train staff coaches on anticipated challenges (e.g., exercise engagement, weight fluctuations). Conclusions: During this first REP phase, individuals with SMI and program staff were satisfied with ACHIEVE-D. Additional refinements will aid future implementation and improve participant experience.

Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness: A Randomized Clinical Trial.

Importance: Tobacco smoking drives markedly elevated cardiovascular disease risk and preventable death in persons with serious mental illness, and these risks are compounded by the high prevalence of overweight/obesity that smoking cessation can exacerbate. Guideline-concordant combined pharmacotherapy and behavioral smoking cessation treatment improves abstinence but is not routinely offered in community settings, particularly to those not seeking to quit smoking immediately. Objective: To determine the effectiveness of an 18-month pharmacotherapy and behavioral smoking cessation intervention incorporating weight management and support for physical activity in adults with serious mental illness interested in quitting smoking within 1 or 6 months. Design, Setting, and Participants: This was a randomized clinical trial conducted from July 25, 2016, to March 20, 2020, at 4 community health programs. Adults with serious mental illness who smoked tobacco daily were included in the study. Participants were randomly assigned to intervention or control, stratified by willingness to try to quit immediately (within 1 month) or within 6 months. Assessors were masked to group assignment. Interventions: Pharmacotherapy, primarily varenicline, dual-form nicotine replacement, or their combination; tailored individual and group counseling for motivational enhancement; smoking cessation and relapse prevention; weight management counseling; and support for physical activity. Controls received quitline referrals. Main Outcome and Measures: The primary outcome was biochemically validated, 7-day point-prevalence tobacco abstinence at 18 months. Results: Of the 298 individuals screened for study inclusion, 192 enrolled (mean [SD] age, 49.6 [11.7] years; 97 women [50.5%]) and were randomly assigned to intervention (97 [50.5%]) or control (95 [49.5%]) groups. Participants self-identified with the following race and ethnicity categories: 93 Black or African American (48.4%), 6 Hispanic or Latino (3.1%), 90 White (46.9%), and 9 other (4.7%). A total of 82 participants (42.7%) had a schizophrenia spectrum disorder, 62 (32.3%) had bipolar disorder, and 48 (25.0%) had major depressive disorder; 119 participants (62%) reported interest in quitting immediately (within 1 month). Primary outcome data were collected in 183 participants (95.3%). At 18 months, 26.4% of participants (observed count, 27 of 97 [27.8%]) in the intervention group and 5.7% of participants (observed count, 6 of 95 [6.3%]) in the control group achieved abstinence (adjusted odds ratio [OR], 5.9; 95% CI, 2.3-15.4; P < .001). Readiness to quit within 1 month did not statistically significantly modify the intervention's effect on abstinence. The intervention group did not have significantly greater weight gain than the control group (mean weight change difference, 1.6 kg; 95% CI, -1.5 to 4.7 kg). Conclusions and Relevance: Findings of this randomized clinical trial showed that in persons with serious mental illness who are interested in quitting smoking within 6 months, an 18-month intervention with first-line pharmacotherapy and tailored behavioral support for smoking cessation and weight management increased tobacco abstinence without significant weight gain. Trial Registration: ClinicalTrials.gov Identifier: NCT02424188.

A Community-Engaged Process for Adapting a Cardiovascular Health Intervention for Persons with Serious Mental Illness.

Introduction: People with serious mental illness experience grave disparities in cardiovascular disease risk factors. To promote scale-up of effective cardiovascular disease risk reduction interventions from clinical trials, it is important to involve end-users in adapting interventions to fit the needs of community-based settings. Objective: We describe a novel, theory-informed process of garnering community input to adapt IDEAL Goals, an evidence-based intervention for improving cardiovascular disease risk factors in persons with serious mental illness. Setting: Outpatient community mental health programs in Maryland and Michigan implementing behavioral health homes, which provide enhanced support to people living with both physical and mental illnesses. Participants: Clinicians, frontline staff, and administrators from community mental health organizations and persons with serious mental illness. Methods: Our approach to community engagement is based on the Replicating Effective Programs (REP) framework. During the REP preimplementation phase, we used 2 community engagement activities: (1) a "needs assessment" to identify anticipated implementation barriers and facilitators, and (2) "community working groups" to collaboratively engage with end-users in adapting the intervention and implementation strategies. Main Findings: We used the Stakeholder Engagement Reporting Questionnaire to describe our processes for conducting a needs assessment, involving site-level surveys (N=26) and individual interviews (N=94), and convening a series of community working groups with clinicians and staff (mean, 24 per meeting) and persons with serious mental illness (mean, 8 per meeting). Conclusions: By specifying the nature and extent of our community engagement activities, we aim to contribute to the evidence base of how to better integrate and measure community-engaged processes in the adaptation of evidence-based interventions.

Physical Activity Levels and Screen Time among Youth with Overweight/Obesity Using Mental Health Services.

Youth with mental illness have higher levels of obesity than children in the general population. Both regular physical activity and limited screen time have been recommended to reduce and prevent childhood obesity. This study examines accelerometer-based moderate-vigorous physical activity (MVPA) and screen time among youth with overweight/obesity issues who are receiving mental health care. This study looked at a 12-month weight management randomized clinical trial for overweight/obese youth aged 8-18 years who are receiving mental health services. At baseline, MVPA was assessed using accelerometers, and screen time was self-reported. Among 100 youth, 43% were female, 44% were Black, and 48% were <13 years old. In an adjusted general linear model, higher levels of MVPA were associated with the younger age group (p = 0.012), male participants (p = 0.013), and lower BMI z-scores (p = 0.014). In a separate model, higher screen time was associated with participants who were Black (p = 0.007). Achieving optimal cardiovascular health at the population level requires an understanding of the groups that are most in need of additional assistance. These data reinforce that targeted lifestyle approaches to promote increased physical activity and decreased screen time among overweight/obese youth using mental health services may need additional tailoring for sex, age, and race subgroups.

Dietary intake of adults with serious mental illness.

OBJECTIVE: Suboptimal diet may be related to the high prevalence of obesity and cardiovascular disease (CVD) in persons with serious mental illnesses, but few studies have characterized dietary intake in this population. METHODS: Participants were 102 overweight/obese adults with serious mental illnesses who were being screened for a weight loss trial in psychiatric rehabilitation centers. Direct observation of participant meals was completed using a standardized measurement form. RESULTS: CVD risk factors were common: mean body mass index was 35.7 kg/m2; 30% had diabetes. Participants consumed 100% of caloric beverages served (7.2 oz/meal) but consumption was significantly less than served for fruits (difference of 0.12 cups/meal, p=0.003) and vegetables (0.14 cups/meal, p=0.021). The majority (56%) of meat consumed was high fat. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Interventions designed to improve dietary intake of persons with serious mental illnesses are needed to improve health in this population at high risk for CVD.

Adapting the Comprehensive Unit Safety Program (CUSP) implementation strategy to increase delivery of evidence-based cardiovascular risk factor care in community mental health organizations: protocol for a pilot study.

BACKGROUND: People with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder experience excess mortality driven in large part by high rates of poorly controlled and under-treated cardiovascular risk factors. In the USA, integrated "behavioral health home" models in which specialty mental health organizations coordinate and manage physical health care for people with SMI are designed to improve guideline-concordant cardiovascular care for this group. Such models have been shown to improve cardiovascular care for clients with SMI in randomized clinical trials, but real-world implementation has fallen short. Key implementation barriers include lack of alignment of specialty mental health program culture and physical health care coordination and management for clients with SMI and lack of structured protocols for conducting effective physical health care coordination and management in the specialty mental health program context. This protocol describes a pilot study of an implementation intervention designed to overcome these barriers. METHODS: This pilot study uses a single-group, pre/post-study design to examine the effects of an adapted Comprehensive Unit Safety Program (CUSP) implementation strategy designed to support behavioral health home programs in conducting effective cardiovascular care coordination and management for clients with SMI. The CUSP strategy, which was originally designed to improve inpatient safety, includes provider training, expert facilitation, and implementation of a five-step quality improvement process. We will examine the acceptability, appropriateness, and feasibility of the implementation strategy and how this strategy influences mental health organization culture; specialty mental health providers' self-efficacy to conduct evidence-based cardiovascular care coordination and management; and receipt of guideline-concordant care for hypertension, dyslipidemia, and diabetes mellitus among people with SMI. DISCUSSION: While we apply CUSP to the implementation of evidence-based hypertension, dyslipidemia, and diabetes care, this implementation strategy could be used in the future to support the delivery of other types of evidence-based care, such as smoking cessation treatment, in behavioral health home programs. CUSP is designed to be fully integrated into organizations, sustained indefinitely, and used to continually improve evidence-based practice delivery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04696653 . Registered on January 6, 2021.

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial.

BACKGROUND: Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE). The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. METHODS/DESIGN: A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2) will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. DISCUSSION: Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness.

Protein intake is associated with cognitive functioning in individuals with psychiatric disorders.

Schizophrenia and bipolar disorder are associated with reduced cognitive functioning which contributes to problems in day-to-day functioning and social outcomes. A paucity of research exists relating dietary factors to cognitive functioning in serious mental illnesses, and results are inconsistent. The study aims to describe the nutritional intake of persons with schizophrenia and those with a recent episode of acute mania and to determine relationships between the intake of protein and other nutrients on cognitive functioning in the psychiatric sample. Persons with schizophrenia and those with acute mania were assessed using a 24-h dietary recall tool to determine their intakes of protein and other nutrients. They were also assessed with a test battery measuring different domains of cognitive functioning. Results indicate that lower amounts of dietary protein intake were associated with reduced cognitive functioning independent of demographic and clinical factors. The association was particularly evident in measures of immediate memory and language. There were not associations between cognitive functioning and other nutritional variables, including total energy, gluten, casein, saturated fat, or sugar intakes. The impact of dietary interventions, including protein intake, on improving cognitive functioning in individuals with psychiatric disorders warrants further investigation.

Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.

Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment. Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness. Design, Setting, and Participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019. Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes. Main Outcomes and Measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control. Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. Conclusions and Relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population. Trial Registration: ClinicalTrials.gov Identifier: NCT02127671.

Effect of a Behavioral Weight Loss Intervention in People With Serious Mental Illness and Diabetes.

OBJECTIVE: Given the high prevalence of obesity and diabetes in patients with serious mental illness (SMI) and the lack of evidence on the effects of weight loss programs in SMI patients with diabetes, we evaluated the effectiveness of a behavioral weight loss intervention among SMI participants with and without diabetes. RESEARCH DESIGN AND METHODS: Using data from ACHIEVE, a randomized controlled trial to evaluate the effects of a behavioral weight loss intervention among overweight/obese people with SMI, we assessed and compared weight change from baseline to 18 months in participants with and without diabetes using a longitudinal mixed-effects model. RESULTS: Of the 291 trial participants, 82 (28.2%) participants had diabetes (34 and 48 in intervention and control groups, respectively) at baseline. Participants with diabetes were more likely to be taking antipsychotics (31.7% vs. 18.7%, P = 0.02). At 18 months, participants in the control group with diabetes lost 1.2 lb (0.6%) of body weight compared with 0.8 lb (0.7%) among those without diabetes. In the intervention group, participants with diabetes lost 13.7 lb (6.6%) of their initial body weight compared with 5.4 lb (2.9%) for those without diabetes. Corresponding net effects (intervention minus control) were 4.6 lb (2.2%) and 12.5 lb (6.0%) net weight reduction over 18 months in the no diabetes and the diabetes subgroups, respectively. However, the between-group difference in intervention effects was statistically nonsignificant (absolute weight change: P-interaction = 0.08; % weight change: P-interaction = 0.10). CONCLUSIONS: A behavioral weight loss intervention is effective among overweight and obese individuals with SMI regardless of their diabetes status.

Effects of a behavioural weight loss intervention in people with serious mental illness: Subgroup analyses from the ACHIEVE trial.

BACKGROUND: Persons with serious mental illnesses (SMI) such as schizophrenia and bipolar disorder have an increased risk of obesity and related chronic diseases and die 10-20years earlier than the overall population, primarily due to cardiovascular disease. In the ACHIEVE trial, a behavioural weight loss intervention led to clinically significant weight loss in persons with SMI. As the field turns its attention to intervention scale-up, it is important to understand whether the effectiveness of behavioural weight loss interventions for people with SMI, like ACHIEVE, differ for specific subgroups. METHODS: This study examined whether the effectiveness of the ACHIEVE intervention differed by participant characteristics (e.g. age, sex, race, psychiatric diagnosis, body mass index) and/or their weight-related attitudes and behaviours (e.g. eating, food preparation, and shopping habits). We used likelihood-based mixed effects models to examine whether the baseline to 18 month effects of the ACHIEVE intervention differed across subgroups. RESULTS: No statistically significant differences were found in the effectiveness of the ACHIEVE intervention across any of the subgroups examined. CONCLUSIONS: These findings suggest that the ACHIEVE behavioural weight loss intervention is broadly applicable to the diverse population of individuals with SMI.

Bringing an Effective Behavioral Weight Loss Intervention for People With Serious Mental Illness to Scale.

People with serious mental illnesses (SMIs) die 10-20 years earlier than the general population, mainly due to cardiovascular disease. Obesity is a key driver of cardiovascular risk in this group. Because behavioral weight loss interventions tailored to the needs of people with SMI have been shown to lead to clinically significant weight loss, achieving widespread implementation of these interventions is a public health priority. In this Perspective, we consider strategies for scaling the ACHIEVE behavioral weight loss intervention for people with SMI, shown to be effective in a randomized clinical trial (RCT), to mental health programs in the U.S. and internationally. Given the barriers to high-fidelity implementation of the complex, multi-component ACHIEVE intervention in often under-resourced mental health programs, we posit that substantial additional work is needed to realize the full public health potential of this intervention for people with SMI. We discuss considerations for successful "scale-up," or efforts to expand ACHIEVE to similar settings and populations as those included in the RCT, and "scale-out," or efforts to expand the intervention to different mental health program settings/sub-populations with SMI. For both, we focus on considerations related (1) intervention adaptation and (2) implementation strategy development, highlighting four key domains of implementation strategies that we believe need to be developed and tested: staff capacity building, leadership engagement, organizational change, and policy strategies. We conclude with discussion of the types of future research needed to support ACHIEVE scale-up/out, including hybrid trial designs testing the effectiveness of intervention adaptations and/or implementations strategies.

Need for Cardiovascular Risk Reduction in Persons With Serious Mental Illness: Design of a Comprehensive Intervention.

Persons with serious mental illness (SMI) comprise a high-risk group for cardiovascular disease (CVD)-related mortality with rates at least twice those of the overall US. Potentially modifiable CVD risk behaviors (tobacco smoking, obesity, physical inactivity, unhealthy diet) and risk factors (hypertension, diabetes, dyslipidemia) are all markedly elevated in persons with SMI. Evaluations of programs implementing integrated medical care into specialty mental health settings have not shown meaningful effects on CVD risk factor reduction. Rigorously tested, innovative interventions are needed to address the large burden of CVD risk in populations with SMI. In this article, we describe the design of a comprehensive 18-month intervention to decrease CVD risk that we are studying in a randomized clinical trial in a community mental health organization with psychiatric rehabilitation programs. The individual-level intervention incorporated health behavior coaching and care coordination/care management to address all seven CVD risk behaviors and risk factors, and is delivered by a health coach and nurse. If successful, the intervention could be adopted within current integrated care models and significantly improve the physical health of persons with SMI.

Cardiorespiratory benefits of group exercise among adults with serious mental illness.

This study examined cardiorespiratory fitness (CRF) among adults with serious mental illness (SMI) participating in group exercise classes. Overweight and obese adults with SMI were randomized to either a control condition or a weight management condition with group exercise classes (n = 222). Submaximal bicycle ergometry was used to assess CRF at baseline, 6 and 18 months. Those with ≥ 66% participation in the exercise classes had a lower heart rate response at 6 and 18 month follow-up. Participation in group exercise classes was associated with improved short and long term cardiovascular fitness among adults with SMI.