Level and timing of product substitution in a trial of e-cigarettes for smokers not interested in quitting.

INTRODUCTION: The e-cigarette market is large and diverse. Traditional smoking cessation trials involving a control group and a 6-month observation period are an inefficient methodology for testing the multiple treatment options e-cigarettes provide for harm reduction in cigarette smokers. We determined when product substitution occurred in the e-cigarette provision arm of an e-cigarette substitution trial for cigarette smokers who were not interested in quitting. METHODS: We conducted a secondary analysis of 120 cigarette smokers with severe mental illness (recruitment 2017-2020) who were given disposable e-cigarettes for 8 weeks and assessed at weeks 0 (t0), 2, 4, 6, and 8. We explored product substitution through visit-to-visit correlations in change in product use, then developed a dual process growth model for cigarette and e-cigarette use to test the association between increases in e-cigarette use and concurrent decreases in cigarettes smoked. RESULTS: Mean age of the participants was 45.9 years, and 42.7% smoked ≥20 cigarettes per day. Almost all product substitution occurred between t0 and t2. For the average smoker (18 cigarettes per day), t2 cigarette frequency decreased by 0.39 (95% CI: -0.56 - -0.22) cigarettes for each additional e-cigarette session. There was effect modification (p=0.033), such that baseline light smokers (<10 cigarettes/day) had no significant decrease in t2 cigarette frequency, regardless of their initial increase in e-cigarette use, while heavy smokers (38 cigarettes/day) switched products nearly on a one-to-one basis. CONCLUSIONS: In this study, most product substitution occurred early, and heavier smokers had larger t2 decreases in cigarettes/day with increased e-cigarette use. If confirmed with replication studies, the findings could suggest establishment of a novel outcome for e-cigarette studies - early product substitution - and support the value of short-term comparative effectiveness trials that compare multiple potentially lower harm tobacco products. CLINICAL TRIAL REGISTRATION: The study was registered on the official website of ClinicalTrials.gov. IDENTIFIER: ID NCT03050853.

Healthy choices, healthy changes: A randomized trial of incentives to promote healthy eating and exercise in people with schizophrenia and other serious mental illnesses.

INTRODUCTION: People with schizophrenia and other serious mental illnesses (SMI) represent a concerning health disparity population, with 10-30 fewer years of life compared to the general population, mainly from high rates of cardiovascular disease (CVD). Preventing CVD is possible with exercise and diet interventions, but only 50 % of participants in clinical trials achieve reduction in CVD risk. This study assessed whether cash incentives improved weight loss, cardiovascular endurance, and/or mortality risk when added to one of four healthy lifestyle programs (gym membership, Weight Watchers membership, the InSHAPE program, InSHAPE + Weight Watchers). METHODS: From 2012 to 2015, 1348 overweight or obese adults with SMI enrolled in a study using equipoise stratified randomization. Participants were randomly assigned to intervention, then to cash incentives, or not, for participation (gym and/or Weight Watchers), with baseline and quarterly assessments for 12 months. We examined effects of the interventions, key covariates, and incentives, using generalized linear models. RESULTS: Main effects of randomization to receive cash incentives was not significant for any outcome; whereas total amount of incentives was significantly associated with all three primary outcomes (weight loss, cardiovascular endurance, mortality risk), mainly for participants in the InSHAPE+WW group who received additional cash incentives. CONCLUSIONS: Incentives may be effective at preventing CVD and improving health outcomes for people with SMI, especially in the context of intensive support for healthy lifestyle behaviors. Policy changes are required to increase access to healthy lifestyle programming and more research is needed to establish the optimal amount of incentives for people with SMI. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02515981.

Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation.

BACKGROUND: Schizophrenia and related disorders are highly disabling and create substantial burdens for families, communities, and health care systems. Although pharmacological treatments can often lessen the psychotic symptoms that are a hallmark of schizophrenia, they do not lessen the social and cognitive deficits that create the greatest impediments to community engagement and functional recovery. This study builds on prior research on psychosocial rehabilitation by comparing the effectiveness of two treatments demonstrated as efficacious in improving social and community functioning, Cognitive Enhancement Therapy (CET) and a version of Social Skills Training (HOPES/SST). METHODS: The study uses a randomized cluster design in which a pair of clinicians at community- and hospital-based mental service centers deliver either CET or HOPES to at least one group of 6-8 eligible clients for 12 months. Clinicians are trained and then supervised weekly, with ongoing process measurement of treatment fidelity, attendance, satisfaction, and retention, and use of other services. Measures administered at baseline and at 6 and 12 months while in treatment, and then at 18 and 24 months after treatment include social adjustment, quality of life, social skills, positive and negative symptoms, and neuro- and social cognition. We hypothesize that CET will be associated with greater improvements than SST in both the primary outcome of community functioning and the secondary outcomes of neuro- and social cognition and social skills. Secondarily, we hypothesize that more cognitive impairment at baseline and younger age will predict more benefit from CET compared to HOPES. DISCUSSION: Resource shortages endemic in mental health services and exacerbated by the pandemic highlight the importance of identifying the most effective approach to improving social and community functioning. We aim to improve understanding of the impact of two efficacious psychosocial treatments and to improve clinicians' ability to refer to both treatments the individuals who are most likely to benefit from them. We expect the result to be programmatic improvements that improve the magnitude and durability of gains in community functioning. TRIAL REGISTRATION: ClinicalTrial.gov NCT04321759 , registered March 25, 2020.

E-Cigarette Provision to Promote Switching in Cigarette Smokers With Serious Mental Illness-A Randomized Trial.

BACKGROUND: High cigarette smoking prevalence and low quit rates in people with serious mental illness (SMI) contribute to disparate rates of chronic disease and premature death. This prospective trial tested the impact of switching to a potentially lower-harm nicotine-containing product on smoking in this population. AIMS AND METHODS: A total of 240 cigarette smokers with SMI who tried but were currently unwilling to quit were randomly assigned to receive disposable e-cigarettes for 8 weeks or not, with assessments at baseline, 2, 4, 6, 8, 13, and 26 weeks. Generalized linear mixed models examined the effects of e-cigarette provision on e-cigarette appeal, cigarettes per day (CPD), breath carbon monoxide (CO), nicotine dependence, and side effects. Clinical Trial registration: NCT03050853. RESULTS: Self-reported smoking was similar between groups at baseline (mean = 18.7 CPD). By week 2, 79% of the e-cigarette group were using e-cigarettes daily. During weeks 2-8, CPD and CO decreased in the e-cigarette versus assessment-only group (eg, 7.5 CPD [95% CI = 5.9, 9.2] vs. 18.1 CPD [CI = 16.4, 19.8] and 16.4 ppm [CI = 13.4, 19.5] vs. 25.4 ppm [CI = 22.4, 28.9], respectively, at week 2). Additionally, 19%-22% in the e-cigarette group reported smoking no cigarettes in weeks 2-8 compared to 0% in the assessment-only group. By 13 and 26 weeks, group differences in CPD, but not CO, remained significant. Nicotine dependence did not increase and side effects were minor. CONCLUSIONS: Providing e-cigarettes for 8 weeks to smokers with SMI resulted in substantial reductions in CPD and CO. Enhancing and maintaining switching from cigarettes to e-cigarettes warrant further study. IMPLICATIONS: This was the first prospective study to compare e-cigarette provision with assessments only to evaluate the appeal and impact of e-cigarettes on smoking behavior, carbon monoxide exposure, and nicotine dependence among smokers with SMI who had tried but were unable to quit and were not currently interested in cessation treatment. The finding that e-cigarette provision led to significant reductions in smoking and carbon monoxide without increasing nicotine dependence has implications for reducing harm not only among the millions of smokers with SMI who struggle to quit, but also for other vulnerable smokers who cannot achieve cessation.

Loneliness and its Association with Health Behaviors in People with a Lived Experience of a Serious Mental Illness.

To explore the association between loneliness and efficacy to engage in health behaviors that are known to reduce the risk of early mortality in people with serious mental illness (SMI). This secondary data analysis was based on a cross-sectional study of 113 participants with SMI residing in New Hampshire. Ordinary Least Squares regressions were used to examine bivariate relationships between variables of interest. Participants had a primary mental health diagnosis of major depressive disorder (37.2%), schizophrenia spectrum disorder (28.3%), bipolar disorder (29.2%), or posttraumatic stress disorder (5.3%). High levels of loneliness were associated with low levels of self-efficacy to manage chronic diseases (p = 0.0001), as well as low levels of self-efficacy to manage psychological well-being (R2 = .31; F = 9.49, p = 0.0001; RMSE = 1.66). Loneliness may serve as a barrier to healthy behaviors, and thus, contribute to early mortality among people with SMI. The growing body of literature that demonstrates the importance of addressing loneliness in people with SMI should stimulate policymakers and researchers to target loneliness as a mechanism to address early mortality in people with SMI.

Randomized Trial of Interventions for Smoking Cessation Among Medicaid Beneficiaries With Mental Illness.

OBJECTIVE: Medicaid beneficiaries with severe mental illnesses are a financially disadvantaged group with high rates of smoking and poor cessation outcomes. This study examined whether abstinence-contingent monetary incentives improved outcomes when added to cessation treatments at community mental health centers: prescriber visit for pharmacotherapy only (PV only), prescriber visit and facilitated quitline (PV+Q), and prescriber visit and telephone cognitive-behavioral therapy (PV+CBT). METHODS: During 2012-2015, a total of 1,468 adult, daily smoking Medicaid beneficiaries with mental illnesses received Web-based motivational tobacco education. Eligible participants who wanted cessation treatment (N=661) were randomly assigned to treatment with or without abstinence-contingent incentives for four weeks after a quit attempt and assessed for biologically verified abstinence at three, six, nine, and 12 months. To examine intervention effect on abstinence over time, logistic generalized linear models estimated with generalized estimating equations were used, with missing observations imputed as smoking. RESULTS: Participants included smokers with schizophrenia disorders (N=148), bipolar disorder (N=150), major depressive disorder (N=158), and anxiety and other disorders (N=205). There was no significant effect of intervention (PV only, PV+Q, and PV+CBT). However, participants who received monetary incentives were more likely to be abstinent from smoking over time (adjusted odds ratio [AOR]=1.77, p=.009). Post hoc comparisons indicated greater abstinence at 12 months in PV+Q with incentives than in PV+Q without incentives (14% versus 4% abstinent, AOR=3.94, p=.014). Treatment participation and cessation outcomes did not differ significantly between diagnostic groups. CONCLUSIONS: Abstinence-contingent incentives improved cessation outcomes among financially disadvantaged smokers with mental illness receiving tobacco treatment at community mental health centers.

One size doesn't fit all: A trial of individually tailored skills training.

OBJECTIVES: This article describes a pilot test of an individually tailored program to improve community living and health self-management skills in older adults with serious mental illness. METHOD: This study provided the Helping Older People Experience Success-Individually Tailored (HOPES-I) intervention, an adaptation of an empirically supported, manualized, group-based skills training program shown to improve community functioning, psychiatric symptoms, self-efficacy, and receipt of preventive health. HOPES-I targets 5 skill areas: leisure time, communication, independent living, friendships, and health self-management. We enrolled 47 adults age 50 and older (mean age = 62) with serious mental illness (38% schizophrenia spectrum, 62% mood disorders). Trained HOPES-I coaches evaluated participants' skills and functioning and engaged them in shared decision-making to select which curricular areas to receive. Participants received 1 HOPES-I session per week for 9-12 months, with assessments of overall psychosocial functioning and the 5 skill areas targeted by the program at baseline, postintervention, and at 3 and 6 months. RESULTS: Participants with baseline impairments in overall functioning and in each of the skill areas targeted by the program demonstrated significant improvements on related outcome measures. Selection of specific HOPES-I curriculum was not associated with level of impairment in associated skill areas at baseline, but participants with more impairment overall chose and completed more curriculum modules. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: The results of this study support the feasibility and potential benefits of an individually tailored skills training program for the rapidly growing and vulnerable group of older people with serious mental illness. (PsycINFO Database Record

Appeal of electronic cigarettes in smokers with serious mental illness.

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, resulting 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 assessments. 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 randomized studies are needed to better assess e-cigarette appeal and toxicity.

Automated telehealth for managing psychiatric instability in people with serious mental illness.

BACKGROUND: Serious mental illness (SMI) with psychiatric instability accounts for disproportionately high use of emergency room visits and hospitalizations. AIM: To evaluate the effectiveness of an automated telehealth intervention supported by nurse health care management for improving psychiatric illness management and reducing acute service use among individuals with SMI and psychiatric instability. METHODS: Thirty-eight individuals with SMI received the automated telehealth intervention for 6 months. Psychiatric symptoms, illness self-management, and self-reported service use (emergency room visits and hospital admissions) were collected at baseline, 3- and 6-months. Measures of quality of life, health indicators, and subjective health status were also collected. RESULTS: Participants demonstrated improvements in self-reported psychiatric symptoms and illness self-management skills, an 82% decrease in hospital admissions (from 76 to 14 hospitalizations, p < 0.001) and a 75% decrease in emergency room visits (from 63 to 16 visits, p < 0.001). Improvements were also observed in quality of life, severity of depressive symptoms, and mental health status. CONCLUSION: These highly promising findings support the use of an automated telehealth device monitored by a nurse care manager for people with SMI, and highlight the potential for cost savings through reductions in acute health care utilization.

Integrated IMR for psychiatric and general medical illness for adults aged 50 or older with serious mental illness.

OBJECTIVES: Self-management is promoted as a strategy for improving outcomes for serious mental illness as well as for chronic general medical conditions. This study evaluated the feasibility and effectiveness of an eight-month program combining training in self-management for both psychiatric and general medical illness, including embedded nurse care management. METHODS: Participants were 71 middle-aged and older adults (mean age=60.3 ± 6.5) with serious mental illness and chronic general medical conditions who were randomly assigned to receive integrated Illness Management and Recovery (I-IMR) (N=36) or usual care (N=35). Feasibility was determined by attendance at I-IMR and nurse sessions. Effectiveness outcomes were measured two and six months after the intervention (ten- and 14-month follow-ups) and included self-management of psychiatric and general medical illness, participation in psychiatric and general medical encounters, and self-reported acute health care utilization. RESULTS: I-IMR participants attended 15.8 ± 9.5 I-IMR and 8.2 ± 5.9 nurse sessions, with 75% attending at least ten I-IMR and five nurse sessions. Compared with usual care, I-IMR was associated with greater improvements in participant and clinician ratings for psychiatric illness self-management, greater diabetes self-management, and an increased preference for detailed diagnosis and treatment information during primary care encounters. The proportion of I-IMR participants with at least one psychiatric or general medical hospitalization decreased significantly between baseline and ten- and 14-month follow-ups. CONCLUSIONS: I-IMR is a feasible intervention for this at-risk group and demonstrated potential effectiveness by improving self-management of psychiatric illness and diabetes and by reducing the proportion of participants requiring psychiatric or general medical hospitalizations.

Clinically significant improved fitness and weight loss among overweight persons with serious mental illness.

OBJECTIVE: The objective of this study was to evaluate the effectiveness of a fitness health mentor program (In SHAPE) in improving physical fitness and weight loss among overweight and obese adults with serious mental illness. METHODS: A randomized controlled trial was conducted with 133 persons with serious mental illness and a body mass index (BMI) >25 who were assigned either to the In SHAPE program (one year of weekly sessions with a fitness trainer plus a fitness club membership) or to one year of fitness club membership and education. Assessments were conducted at baseline and three, six, nine, and 12 months later. RESULTS: Participants had a mean baseline weight of 231.8±54.8 pounds and a mean BMI of 37.6±8.2. At 12-month follow-up, In SHAPE (N=67) compared with fitness club membership and education (N=66) was associated with three times greater fitness club attendance, twice as much participation in physical exercise, greater engagement in vigorous physical activity, and improvement in diet. Twice the proportion of participants (40% versus 20%) achieved clinically significant improvement in cardiorespiratory fitness (>50 m on the six-minute walk test). Weight loss and BMI did not differ between groups. Among In SHAPE participants, 49% achieved either clinically significant increased fitness or weight loss (5% or greater), and 24% achieved both clinically significant improved fitness and weight loss. CONCLUSIONS: The In SHAPE program achieved clinically significant reduction in cardiovascular risk for almost one-half of participants at 12 months. Although the intervention showed promise in improving fitness, optimizing weight loss may require additional intensive, multicomponent dietary interventions.

Development and reliability of a measure of clinician competence in providing illness management and recovery.

OBJECTIVE: Illness management and recovery (IMR) is an evidence-based, manualized illness self-management program for people with severe mental illness. This study sought to develop a measure of IMR clinician competence and test its reliability and validity. METHODS: Two groups of subject matter experts each independently created a clinician-level IMR competence scale based on the IMR Fidelity Scale and on two unpublished instruments used to evaluate provider competence. The two versions were merged, and investigators used the initial version to independently rate recordings of IMR sessions. Ratings were compared and discussed, discrepancies were resolved, and the scale was revised through 14 iterations. The resulting IMR Treatment Integrity Scale (IT-IS) includes 13 required items and three optional items rated only when the particular skill is attempted. Four independent raters then used the IT-IS to score tapes of 60 IMR sessions and 20 control group sessions. RESULTS: The IT-IS showed excellent interrater reliability (.92). A factor analysis supported a one-factor model that showed good internal consistency. The scale successfully differentiated between IMR and control groups. Reliability and validity of individual items varied widely. CONCLUSIONS: The IT-IS is a promising measure of clinician competence in providing IMR. The scale could be used for research and quality assurance and as a supervisory feedback tool. Future research is needed to examine item-level changes, predictive validity of the IT-IS, discriminant validity compared with other more structured interventions, and the reliability and validity of the scale for nongroup IMR.

Do smoking cessation websites meet the needs of smokers with severe mental illnesses?

Many people learn about smoking cessation through information on the Internet. Whether people with severe mental illnesses, who have very high rates of smoking, are able to use currently available websites about smoking cessation is unknown. The study reported here assessed whether four smoking cessation websites met usability guidelines and whether they were usable by smokers with severe mental illnesses. Four websites that appeared first on a Google search and represented an array of sponsors were selected. First, five experts rated the websites on adequacy of content in six areas and usability in 20 areas. Second, 16 smokers with severe mental illnesses performed two search tasks on the websites with researchers observing their searches and interviewing them regarding usability. One of the websites was rated by experts as acceptable for content and usability, but most of the participants were unable to navigate this website. The only website that was navigable received poor content ratings by experts. Four easily accessible websites did not meet the needs of smokers with severe mental illnesses. Although the Internet is a promising strategy to provide education about treatments, website developers must attend to the needs and capacities of multiple user groups.