Resistance training for Black men with depressive symptoms: a pilot randomized controlled trial to assess acceptability, feasibility, and preliminary efficacy.

BACKGROUND: Depression is under-recognized in Black men, who are less likely to seek or have access to psychiatric treatment. Resistance training (RT; i.e., weight lifting) can improve depressive symptoms and may be more acceptable to Black men, but its effects have not been examined for Black men with depressive symptoms. METHODS: Fifty Black men with depressive symptoms were randomized to either (a) 12 weeks of RT (coupled with Behavioral Activation techniques to promote adherence) or (b) an attention-control group (Health, Wellness, and Education; HWE). Both groups met twice/week for 12 weeks, and follow-up assessments were done at end-of-treatment (EOT) and 6 months after enrollment. Changes in physical activity and muscular strength were collected as a manipulation check. The primary outcome was interviewer assessed symptoms of depression using the Quick Inventory of Depression Symptomology (QIDS). Secondary outcomes included self-reported depressive symptoms, anxiety, and stress. The association between change in QIDS from baseline to EOT and concurrent changes in physical activity and muscular strength in the RT group were explored as an initial assessment of mechanism. Longitudinal mixed effects regression models with subject-specific intercepts were used to examine intervention effects. RESULTS: A sample with high rates of medical comorbidities (e.g., 44% HIV positive), substance use (e.g., 34% smoking), and negative social determinates of health (e.g., 50% unemployed) was enrolled. Recruitment, engagement, and retention data indicate that the intervention and design were feasible. The RT group showed greater gains in self-reported exercise (b = 270.94, SE = 105.69, p = .01) and muscular strength (b = 11.71, SE = 4.23, p = .01 for upper body and b = 4.24, SE = 2.02, p = .04 for lower body) than the HWE group. The RT group had greater reductions in QIDS scores at both EOT (b = -3.00, SE = 1.34, p = .01) and 6 months (b = -2.63, SE = 1.81, p = .04). The RT group showed a greater reduction in anxiety at EOT (b = -2.67, SE = 1.06, p = .02). Findings regarding self-reported depressive symptoms and stress were non-significant, but in the expected direction with effect sizes in the small to medium range. In the RT group, improvement on the QIDS between baseline and EOT was associated with concurrent improvements in physical activity (b = 21.03, SE = 11.16, p = .02) and muscular strength (b = 1.27, SE = .44, p = .03 for upper body and b = .75, SE = .14, p = .03 for lower body). CONCLUSIONS: Results suggest that RT is feasible and may be efficacious for reducing depressive symptoms among underserved urban Black men. TRIAL REGISTRATION: ClinicalTrial.gov #: NCT03107039 (Registered 11/04/2017).

Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial.

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).

Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial.

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 .

The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome.

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.

Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail: A Pilot Randomized Clinical Trial.

Importance: Tobacco use prevalence among individuals involved in the criminal-legal system is 125% higher than that of the general population and leads to high levels of smoking-related morbidity and mortality. Objective: To examine the acceptability, feasibility, and preliminary clinical outcomes of a smoking cessation intervention for individuals who are incarcerated. Design, Setting, and Participants: This pilot randomized clinical trial was conducted from January 2019 to May 2020. Participants were recruited in a pretrial county jail in a large Midwestern US city and were followed up after release. Participants were incarcerated, smoked daily before incarceration, desired to stay quit or reduce cigarette smoking upon release, and expected to be released to the community within 90 days of enrollment. Data analysis was performed from June to October 2020. Interventions: Participants randomized to the counseling plus nicotine replacement therapy (NRT) group received 1 hour of smoking cessation counseling in jail, a supply of nicotine lozenges upon release, and up to 4 telephone counseling sessions after release. Those randomized to brief health education (BHE) received 30 minutes of general health education in jail. Main Outcomes and Measures: The primary clinical outcome was biologically verified 7-day point prevalence abstinence (PPA) at 3 weeks after release. Secondary clinical outcomes included 7-day PPA at 12 weeks, changes in number of cigarettes per day, and time to smoking lapse and relapse. Results: A total of 46 participants (42 men [91%]; mean [SD] age, 38.2 [9.1] years) were enrolled and remained eligible at release; 23 were randomized to the counseling plus NRT group and 23 were randomized to the BHE group. Recruitment, enrollment, and retention of participants was feasible and acceptable. There were no significant differences in smoking abstinence between groups as determined by 7-day PPA at 3 weeks (adjusted 7-day PPA, 11.9% for counseling plus NRT vs 10.6% for BHE; odds ratio, 1.13; 95% CI, 0.14-9.07) and at 12 weeks (adjusted 7-day PPA, 11.1% for counseling plus NRT vs 14.3% for BHE; odds ratio, 0.75; 95% CI, 0.09-6.11). Cigarettes per day for the counseling plus NRT group decreased more compared with the BHE group at both 3 weeks (difference [SE], -4.58 [1.58] cigarettes per day; 95% CI, -7.67 to -1.48 cigarettes per day; P = .007) and 12 weeks (difference [SE], -3.26 [1.58] cigarettes per day; 95% CI, -5.20 to -0.20 cigarettes per day; P = .04) after release. Conclusions and Relevance: Initiation of counseling plus NRT during incarceration and continuing after release is feasible and acceptable to participants and may be associated with reduced cigarette use after release. However, additional supports are needed to increase engagement in telephone counseling after release. A larger clinical trial is warranted to determine the effectiveness of counseling plus NRT. Trial Registration: ClinicalTrials.gov Identifier: NCT03799315.