Background Approximately 400,000 people who smoke cigarettes survive Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) each year in the US. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS. A single, integrated treatment targeting depressed mood and smoking could be effective in reducing post-ACS mortality. Method/design The overall aim of the current study is to conduct a fully powered efficacy trial enrolling 324 smokers with ACS and randomizing them to 12 weeks of an integrated smoking cessation and mood management treatment [Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)] or control (smoking cessation and general health education). Both groups will be offered 8 weeks of the nicotine patch if medically cleared. Counseling in both arms will be provided by tobacco treatment specialists. Follow-up assessments will be conducted at end-of-treatment (12-weeks) and 6, 9, and 12 months after hospital discharge. We will track major adverse cardiac events and all-cause mortality for 36 months post-discharge. Primary outcomes are depressed mood and biochemically validated 7-day point prevalence abstinence from smoking over 12 months. Discussion Results of this study will inform smoking cessation treatments post-ACS and provide unique data on the impact of depressed mood on success of post-ACS health behavior change attempts. Trial registration ClinicalTrials.gov, NCT03413423. Registered 29 January 2018. https://beta.clinicaltrials.gov/study/NCT03413423.
Background Rates of smoking among those with serious mental illness (SMI) are two to three times higher than for the general population. Smoking is rarely addressed in mental health settings. Innovative outreach and treatment strategies are needed to address these disparities. The current study is a pilot study of the feasibility and acceptability of a chronic care model of tobacco cessation treatment implemented in outpatient psychiatry clinics. Methods Participants were recruited from two outpatient psychiatric clinics and randomly assigned to intervention (counseling and nicotine replacement for 8 weeks, plus ongoing proactive outreach calls inviting reengagement in treatment) or control (brief education and referral to the state quit line). Assessments were conducted at 8 weeks (end of initial treatment block) and 6 months (end of window for retreatment). Feasibility was assessed by enrollment rate, treatment engagement, and completion of follow-up assessments. Acceptability was assessed both quantitatively and qualitatively. Preliminary efficacy was assessed by 7-day and 30-day abstinence rates, rate of quit attempts, and cigarettes per day. Psychological health was measured to assess for changes related to treatment group or attempts to quit smoking. Results Nineteen participants were randomized to intervention and 19 to control. Recruitment proved feasible, and high rates of treatment engagement (mean of 4.5 sessions completed in initial treatment block, 89.5% uptake of nicotine replacement) and retention (94.7% of follow-up assessments completed) were observed. Treatment acceptability was high. As anticipated, there were no significant differences in abstinence between groups, but results generally favored the intervention group, including bio-verified 7-day abstinence rates of 21.1% in intervention vs. 17.6% in control and self-reported 30-day abstinence rates of 16.1% in intervention vs. 5.1% in control at 8 weeks. Significantly more intervention participants made at least one quit attempt (94.7% vs 52.6%; OR = 16.20, 95% CI: 1.79–147.01). Cigarettes per day decreased significantly more in the intervention group at 8 weeks (b = − 13.19, SE = 4.88, p = .02). Conclusions It was feasible to recruit and retain SMI patients in a smoking cessation trial in the context of outpatient psychiatry. The novel chronic care model treatment was acceptable to patients and showed promise for efficacy. If efficacious, a chronic care model could be effective at reducing smoking among SMI patients. Trial registration ClinicalTrial.gov #: NCT03822416 (registered January 30th 2019).
Background Patients with acute coronary syndrome (ACS) with depressed mood demonstrate poor cardiovascular behavioral risk profiles and elevated risk for recurrent ACS and mortality. Behavioral Activation (BA) offers an intervention framework for an integrated treatment targeting both depression and critical health behaviors post-ACS. Behavioral Activation for Health and Depression (BA-HD) was developed and pilot tested in a multiphase iterative process. Methods First, an initial treatment manual was conceptualized based on the team’s prior work, as well as the extant literature. Second, qualitative interviews were conducted with target patients and target providers on the proposed BA-HD treatment rationale, content, and structure. Framework matrix analyses were used to summarize and aggregate responses. Third, an expert panel was convened to elicit additional manual refinements. Finally, patients with post-ACS depression and health behavior non-adherence were recruited to complete an open pilot trial to evaluate acceptability (Client Satisfaction Questionnaire [CSQ], exit interview) and treatment engagement (number of sessions attended; treatment completion was considered completion of 8 out of 10 possible sessions). Results The initial BA-HD treatment manual expanded an existing treatment manual for post-ACS BA-based mood management and smoking cessation to target four health behaviors relevant to post-ACS patients (e.g., smoking cessation, medication adherence, physical activity, and diet). After the initial conceptualization, ten post-ACS patients and eight cardiac rehabilitation professionals completed qualitative interviews. Patients endorsed bi-directional interactions between mood and health behaviors post-ACS. Both patients and providers expressed general support of the proposed treatment rationale and values-guided, collaborative goal-setting approach. Patients, providers, and experts provided feedback that shaped the iterative manual development. After the BA-HD manual was finalized, eight participants were enrolled in a single-arm pilot trial. The mean CSQ score was 30.57 ± 2.23, indicating high satisfaction. Seven out of eight (88%) completed treatment. Pre- to post treatment improvements in depressed mood and health behaviors were promising. Conclusions BA-HD treatment is an acceptable approach to target both mood and health behaviors in post-ACS patients with depression. A future larger, controlled trial is needed to evaluate the efficacy of the BA-HD treatment. Trial registration ClinicalTrials.gov Identifier: NCT04158219
BACKGROUND: Centers for Medicare & Medicaid Services (CMS) began encouraging governors to implement work requirements for Medicaid enrollees using section 1115 waivers in 2018. Significant controversy surrounds such attempts, but we know little about the perceptions and experiences of enrollees. OBJECTIVE: To characterize experiences of work and its relationship to participation in Medicaid and other public programs among potential targets of Medicaid work requirements. DESIGN: In-depth, semi-structured, one-time qualitative interviews. PARTICIPANTS: 35 very low-income, non-disabled Medicaid expansion enrollees participating in a countysponsored Medicaid managed care plan as a part of a larger study. APPROACH: We used a biographical narrative interpretive method during interviews including questions about the use of employment and income support and other public programs including from state and federal disability programs. Our team iteratively coded verbatim transcripts allowing for emergent themes. KEY RESULTS: Interview data revealed high motivation for, and broad participation in, formal and informal paid work. Eight themes emerged: (1) critical poverty (for example, "I'm not content, but what choices do I have?"); (2) behavioral and physical health barriers to work; (3) social barriers: unstable housing, low education, criminal justice involvement; (4) work, pride, and shame; (5) inflexible, unstable work (for example, "Can I have a job that will accommodate my doctor appointments?…Will my therapy have to suffer? You know? So it's a double edged sword."); (6) Medicaid supports the ability to work; (7) lack of transparency and misalignment of program eligibility (for example, "It's not like I don't want to work because I would like to work. It's just that I don't want to be homeless again, right?"); and (8) barriers, confusion, and contradictions about federal disability. CONCLUSIONS:We conclude that bipartisan solutions prioritizing the availability of well-paying jobs and planful transitions off of public programs would best serve very low-income, work-capable Medicaid enrollees.
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