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.

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.

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.

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.