HIV-PASS (Pain and Sadness Support): Randomized Controlled Trial of a Behavioral Health Intervention for Interference Due to Pain in People Living With HIV, Chronic Pain, and Depression.

OBJECTIVE: This study aimed to determine whether HIV-Pain and Sadness Support (HIV-PASS), a collaborative behavioral health intervention based on behavioral activation, is associated with decreased pain-related interference with daily activities, depression, and other outcomes in people living with HIV. METHODS: We conducted a three-site clinical trial ( n = 187) in which we randomly assigned participants to receive either HIV-PASS or health education control condition. In both conditions, participants received seven intervention sessions, comprising an initial in-person joint meeting with the participant, their HIV primary care provider and a behavioral health specialist, and six, primarily telephone-based, meetings with the behavioral health specialist and participant. The intervention period lasted 3 months, and follow-up assessments were conducted for an additional 9 months. RESULTS: Compared with health education, HIV-PASS was associated with significantly lower pain-related interference with daily activities at the end of month 3 (our primary outcome; b = -1.31, 95% confidence interval = -2.28 to -0.34). We did not observe other differences between groups at 3 months in secondary outcomes that included worst or average pain in the past week, depression symptoms, anxiety, and perceived overall mental and physical health. There were no differences between groups on any outcomes at 12 months after enrollment. CONCLUSIONS: A targeted intervention can have positive effects on pain interference. At the end of intervention, effects we found were in a clinically significant range. However, effects diminished once the intervention period ended. TRIAL REGISTRATION: ClinicalTrials.gov NCT02766751.

Strategies Used to Manage Chronic Pain in HIV-Disease: Comparing Persons Prescribed Opioids Versus Persons not Receiving Opioids.

Chronic pain is common in people living with HIV (PLWH), causes substantial disability and is associated with limitations in daily activities. Opioids are commonly prescribed for pain treatment among PLWH, but evidence of sustained efficacy is mixed. There is little information available on how PLWH who have chronic pain use multimodal strategies in pain management. The current cross-sectional study examined background characteristics, self-reported pain, and the use of other pain treatments among 187 PLWH with chronic pain and depressive symptoms who were and were not prescribed opioids. Approximately 20.9% of participants reported using prescription opioids at the time of the study interview. These individuals were significantly more likely to report having engaged in physical therapy or stretching, strengthening or aerobic exercises in the previous 3 months, recent benzodiazepine use, and receiving disability payments. There were no significant differences in pain characteristics (pain-related interference, average pain severity, and worst pain severity) between the two groups. Those not prescribed opioids were more likely to report better concurrent physical functioning and general health, and fewer physical role limitations, but higher depression symptom severity. Our findings suggest that many PLWH with chronic pain and depressive symptoms express high levels of pain with deficits in physical function or quality of life despite their use of opioids. The high rate of co-use of opioids and benzodiazepines (30.8%) is a concern because it may increase risk of overdose. An integrated care approach that includes a variety of effective non-pharmacologic treatment strategies such as physical therapy may be beneficial in reducing the reliance on opioids for pain management.

Anger and substance use in HIV-positive patients with chronic pain.

Chronic pain increases the risk of substance use in people living with HIV (PLWH). Depression and anxiety have also been identified as risk factors for substance use among PLWH. Relatedly, other negative mood states, such as anger, may influence chronic pain among PLWH. The current cross-sectional study examined whether the distinct negative mood state of anger is associated with substance use among 187 PLWH who report chronic pain. Using negative binomial regression analyses, we found higher levels of anger were positively associated with alcohol use. Higher levels of anger were inversely associated with benzodiazepine use. No association was found between anger and marijuana use, and there were no significant interactions between anger and pain severity on substance use. Our findings suggest that anger is an independent risk factor for substance use among PLWH and chronic pain. Addressing anger may be useful when adapting behavioral therapies in the treatment of pain among PLWH.

The Effect of Yoga on Anxiety, Attention and Social-Emotional Symptoms in Preschool Children: A Pilot Quasi-Experimental Study.

This study evaluated the effectiveness of a short yoga session on behavioral and cognitive outcomes in preschool children. 72 children ages 4-6 from a local preschool were divided into an intervention group (n = 32), and a control group (n = 40) that completed a 15 min, age-appropriate yoga video consisting of interactive poses including: sun salutation, cat, cow, downward dog, upward dog, warrior, gorilla, etc. Three teacher-rated questionnaires and a cancellation task (Cx) were administered pre-intervention and post-intervention. Significant improvement was demonstrated in the yoga group on the teacher-rated questionnaire scores, but not the control group. Correct cancellations increased more in the yoga group compared to the control group, with remaining cancellation metrics demonstrating interaction effects. Findings indicated that a short yoga session improves measures of anxiety, social-emotional behavior, and attention in preschool children. This study suggests that a short 15-minute yoga session may improve behavior and attention in preschool children.

Acceptance of chronic pain in depressed patients with HIV: correlations with activity, functioning, and emotional distress.

Chronic pain is highly prevalent among persons with HIV (PWH), as is depression. Both comorbidities might contribute to, as well as be maintained by, avoidance-based coping. A promising alternative to avoidance-based coping is acceptance. Acceptance of pain is associated with improved functioning and quality of life in chronic pain patients, but this relationship has not been substantially explored among PWH. Cross-sectional data from 187 adult outpatients enrolled in a randomized trial for depressed PWH with chronic pain were analyzed. Controlling for pain severity and demographics, the relationships among pain acceptance and indicators of activity, functioning, and emotional distress (i.e., anxiety and anger) were assessed in seven regression models. No significant relationships were found between self-reported physical activity or objective measurement of mean steps/day with pain acceptance. Results revealed an inverse relationship between chronic pain acceptance and pain-related functional interference (by.x = -.52, p < .01) and a positive relationship with self-reported functioning (by.x = 7.80, p < .01). A significant inverse relationship with anxiety symptoms (by.x = -1.79, p < .01) and pain acceptance was also found. Acceptance of chronic pain can facilitate decreased emotional distress, improved well-being, and better functioning and quality of life. Further investigation of chronic pain acceptance among PWH could inform the development of acceptance-based interventions.

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).

Testing the Feasibility and Acceptability of a Religiously-Tailored Text Messaging Intervention to Reduce Smoking Among Somali Muslim Men During Ramadan.

INTRODUCTION: The prevalence of smoking among Somali Muslim male immigrants residing in Minnesota is estimated at 44%, however smoking reduction is common during the month of Ramadan. This study evaluated the feasibility and impact of a religiously tailored text message intervention delivered during Ramadan to encourage smoking reduction among Somali Muslim men who smoke. METHODS: Fifty Somali men were recruited. Participants received two text messages per day starting 1 week prior to and throughout the month of Ramadan. Approximately half were religiously tailored and half were about the risks of smoking and benefits of quitting. Smoking behavior was assessed at baseline, and at weeks 4 (end of Ramadan), 8, and 16. Outcomes included feasibility, acceptability, and preliminary impact of the text message intervention on smoking reduction and bioverified abstinence. RESULTS: The average age was 41 years. Average time to first cigarette was 1.8 hours at baseline, and 46% of participants smoked menthol cigarettes. Eighteen of 50 participants selected English and 32 selected Somali text messages. Subjects significantly reduced self-reported cigarettes per day (CPD) from 12.4 CPD at baseline to 5.8 CPD at week 16 (p < 0.001). Seven subjects reported quitting at week 16, five completed CO testing, confirming self-reported abstinence. The majority of participants found the cultural and religious references encouraging at the end of the week 16 survey. CONCLUSIONS: Religiously tailored text messages to decrease smoking are feasible and acceptable to Somali Muslim men who smoke during Ramadan. This intervention for addressing smoking disparities is worthy of further study. IMPLICATIONS: Recruitment of Somali Muslim men who smoke is feasible and supports the idea that further studies targeting smoking during Ramadan are practical. Ramadan presents a window of opportunity upon which to build smoking cessation interventions for smokers who identify as Muslim. These preliminary findings suggest that text messaging is a feasible and acceptable intervention strategy, and that religious tailoring was well received. Such an approach may offer potential for addressing smoking disparities among Somali Muslim male smokers. TRIAL REGISTRATION: ClinicalTrial.gov: NCT03379142.

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).

Electronic cigarette use patterns and chronic health conditions among people experiencing homelessness in MN: a statewide survey.

BACKGROUND: Adults experiencing homelessness have higher rates of disease and premature morbidity compared to the general population. Tobacco use is a primary contributing factor to these disparities; however, less is known regarding e-cigarette use patterns among adults experiencing homelessness and whether e-cigarettes are used in a manner that is narrowing or widening health disparities. This study aimed to describe the 1) prevalence and trends in e-cigarette use, 2) correlates of e-cigarettes use, and 3) rates of chronic health conditions by product use pattern in a community-based sample of adults experiencing homelessness. METHODS: Adults experiencing homelessness in Minnesota were surveyed by self-report in 2015 (n = 3672) and 2018 (n = 4181) regarding e-cigarette and combustible cigarette use, potential correlates of e-cigarette use, and self-reported chronic health conditions (i.e., asthma, hypertension, diabetes, and cancer). RESULTS: Frequency of use increased from 2015 to 2018 for combustible cigarettes (66.9% vs. 72.3%), e-cigarettes (11.4% vs. 14.5%), and dual combustible/e-cigarette use (10.2% vs. 12.9%). The strongest bivariate correlates of past 30-day e-cigarette use were younger age, non-binary gender identification, non-heterosexual orientation, identification as White/Caucasian, greater frequency of lifetime homelessness, substance use, lack of regular place for medical care, mental health diagnosis, criminal justice involvement, and combustible cigarette smoking. Dual users had significantly higher rates of asthma and cancer than both those using combustible cigarettes and those using neither combustible nor e-cigarettes. CONCLUSIONS: During a time when cigarette smoking, e-cigarette use, and dual use were decreasing in the general population in Minnesota, rates increased in the homeless population. We observed that the rates of dual use were more than five times greater among homeless adults compared to the general population in 2018. Correlates of e-cigarette use were identified and should be used to identify subpopulations for intervention targeting. Mechanisms of the relationship between dual use and increased risks of health conditions deserve further study.

Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial.

BACKGROUND: Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS) significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC). METHODS: Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. RESULTS: Fifty-nine participants (28 BAT-CS, 31 SC) were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41-3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42-3.82) for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03). At 24-weeks, effect sizes for mood and stress outcomes ranged from η2partial of.07-.11, with significant between treatment effects for positive affect, negative affect, and stress. CONCLUSIONS: The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. TRIAL REGISTRATION: NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

Valued Life Activities, Smoking Cessation, and Mood in Post-Acute Coronary Syndrome Patients.

BACKGROUND: Continued engagement in valued life activities is a protective factor for depression and has been linked to readiness to quit smoking in medical populations but has never been examined among acute coronary syndrome (ACS) patients. PURPOSE: The purpose of this study is to investigate relationships among valued life activities, mood, and smoking post-ACS. METHODS: Participants were 54 post-ACS patients who were smoking before ACS hospitalization. Data on mood, smoking status, engagement in valued activities, restriction of valued activities, and satisfactory replacement of restricted activities was collected 1-12 months post-ACS. RESULTS: Depressive symptoms were associated with both less valued activity engagement and greater valued activity restriction. Positive affect was associated with greater valued activity engagement and negative affect was associated with greater valued activity restriction. Satisfactory replacement of restricted activities was associated with greater positive affect, fewer depressive symptoms, and quitting smoking post-ACS. The majority of these relationships remained significant after controlling for relevant covariates, including physical functioning. CONCLUSIONS: Valued activity restriction and engagement may contribute to depressed mood and failure to quit smoking in ACS patients. Psychotherapies that target greater engagement in valued life activities deserve further investigation in ACS patients.

Tic-related activity restriction as a predictor of emotional functioning and quality of life.

OBJECTIVES: Tourette Syndrome (TS) is a chronic neuropsychiatric condition that frequently persists into adulthood. Existing research has identified demographic and symptom-level variables associated with psychopathology and poor quality of life in TS. However, behavior patterns associated with enhanced or adaptive psychological and global functioning among adults with TS have yet to be empirically identified. The current study examined whether tic-specific activity restriction is related to emotional functioning and quality of life in adults with TS. METHODS: Participants were 509 adults from the Tourette Syndrome Impact Survey who completed self-report measures of demographics, tic severity, emotional functioning, quality of life, and tic-related general and social activity restriction. RESULTS: Partial correlations controlling for tic severity indicated that tic-related general and social activity restriction were significantly correlated with lower quality of life and poorer emotional functioning. Hierarchical linear regression models indicated that activity restriction significantly predicted lower quality of life and poorer emotional functioning when controlling for tic severity and demographic variables. CONCLUSIONS: Adults who restrict fewer activities due to tics, regardless of tic severity, experience greater quality of life and better emotional functioning. Clinically, adults with chronic tics may benefit from interventions focused on enhancing engagement in valued life activities.

The home environment and childhood obesity in low-income households: indirect effects via sleep duration and screen time.

BACKGROUND: Childhood obesity disproportionally affects children from low-income households. With the aim of informing interventions, this study examined pathways through which the physical and social home environment may promote childhood overweight/obesity in low-income households. METHODS: Data on health behaviors and the home environment were collected at home visits in low-income, urban households with either only normal weight (n = 48) or predominantly overweight/obese (n = 55) children aged 6-13 years. Research staff conducted comprehensive, in-person audits of the foods, media, and sports equipment in each household. Anthropometric measurements were collected, and children's physical activity was assessed through accelerometry. Caregivers and children jointly reported on child sleep duration, screen time, and dietary intake of foods previously implicated in childhood obesity risk. Path analysis was used to test direct and indirect associations between the home environment and child weight status via the health behaviors assessed. RESULTS: Sleep duration was the only health behavior associated with child weight status (OR = 0.45, 95% CI: 0.27, 0.77), with normal weight children sleeping 33.3 minutes/day longer on average than overweight/obese children. The best-fitting path model explained 26% of variance in child weight status, and included paths linking chaos in the home environment, lower caregiver screen time monitoring, inconsistent implementation of bedtime routines, and the presence of a television in children's bedrooms to childhood overweight/obesity through effects on screen time and sleep duration. CONCLUSIONS: This study adds to the existing literature by identifying aspects of the home environment that influence childhood weight status via indirect effects on screen time and sleep duration in children from low-income households. Pediatric weight management interventions for low-income households may be improved by targeting aspects of the physical and social home environment associated with sleep.

Changes in risk perception following a smoking cessation intervention: the role of acculturation in a sample of Latino caregivers.

The present exploratory study examined the role of acculturation in the perception of the risks of smoking following a smoking cessation induction intervention among Latino caregivers of children with asthma. The sample consisted of 131 Latino smokers (72.9% female; 18.3% born in the U.S.) who were caregivers of a child with asthma. Caregivers were randomized to one of two smoking cessation interventions that were part of a home-based asthma program. Self-report measures of risk-perception were assessed at baseline, end of treatment (2 months after baseline), and 2- and 3-months post-treatment. At baseline, caregivers, regardless of level of acculturation, reported moderate to high levels of concern about the effects of secondhand smoke on their child's health as well as perceived risk regarding the effect of smoking on their own health. However, caregivers who were low in acculturation had a greater increase in concern about the effects of smoking on their child from pre-to post treatment compared to those who were high in acculturation (p = .001). Lastly, level of acculturation moderated the association between caregivers' concern about smoking on their child's health and their motivation to quit smoking (p < .05), but not cessation rates or reduced secondhand smoke exposure (p > .05). Specifically, motivation to quit at 3 months was greater for those with low acculturation. Though exploratory, these findings suggest that risk perception may be more easily influenced in low versus high acculturated populations and this should be considered in the design of clinical interventions and potentially mass media campaigns seeking to influence risk of caregiver behavior on child health with ethnic and racial minorities.

Lung cancer screening provider recommendation and completion in black and White patients with a smoking history in two healthcare systems: a survey study.

BACKGROUND: Annual lung cancer screening (LCS) with low dose CT reduces lung cancer mortality. LCS is underutilized. Black people who smoke tobacco have high risk of lung cancer but are less likely to be screened than are White people. This study reports provider recommendation and patient completion of LCS and colorectal cancer screening (CRCS) among patients by race to assess for utilization of LCS. METHODS: 3000 patients (oversampled for Black patients) across two healthcare systems (in Rhode Island and Minnesota) who had a chart documented age of 55 to 80 and a smoking history were invited to participate in a survey about cancer screening. Logistic regression analysis compared the rates of recommended and received cancer screenings. RESULTS: 1177 participants responded (42% response rate; 45% White, 39% Black). 24% of respondents were eligible for LCS based on USPSTF2013 criteria. One-third of patients eligible for LCS reported that a doctor had recommended screening, compared to 90% of patients reporting a doctor recommended CRCS. Of those recommended screening, 88% reported completing LCS vs. 83% who reported completion of a sigmoidoscopy/colonoscopy. Black patients were equally likely to receive LCS recommendations but less likely to complete LCS when referred compared to White patients. There was no difference in completion of CRCS between Black and White patients. CONCLUSIONS: Primary care providers rarely recommend lung cancer screening to patients with a smoking history. Systemic changes are needed to improve provider referral for LCS and to facilitate eligible Black people to complete LCS.

Pilot trial results of D-HOMES: a behavioral-activation based intervention for diabetes medication adherence and psychological wellness among people who have been homeless.

Introduction: People living with type 2 diabetes who experience homelessness face a myriad of barriers to engaging in diabetes self-care behaviors that lead to premature complications and death. This is exacerbated by high rates of comorbid mental illness, substance use disorder, and other physical health problems. Despite strong evidence to support lay health coach and behavioral activation, little research has effectively engaged people living with type 2 diabetes who had experienced homelessness (DH). Methods: We used community engaged research and incremental behavioral treatment development to design the Diabetes HOmeless MEdication Support (D-HOMES) program, a one-on-one, 3 month, coaching intervention to improve medication adherence and psychological wellness for DH. We present results of our pilot randomized trial (with baseline, 3 mo., 6 mo. assessments) comparing D-HOMES to enhanced usual care (EUC; brief diabetes education session and routine care; NCT05258630). Participants were English-speaking adults with type 2 diabetes, current/recent (<24 mo.) homelessness, and an HbA1c_7.5%. We focused on feasibility (recruitment, retention, engagement) and acceptability (Client Satisfaction Questionnaire, CSQ-8). Our primary clinical outcome was glycemic control (HbA1c) and primary behavioral outcome was medication adherence. Secondary outcomes included psychological wellness and diabetes self-care. Results: Thirty-six eligible participants enrolled, 18 in each arm. Most participants identified as Black males, had high rates of co-morbidities, and lived in subsidized housing. We retained 100% of participants at 3-months, and 94% at 6-months. Participants reported high satisfaction (mean CSQ-8 scores=28.64 [SD 3.94] of 32). HbA1c reduced to clinically significant levels in both groups, but we found no between group differences. Mean blood pressure improved more in D-HOMES than EUC between baseline and 6 mo. with between group mean differences of systolic -19.5 mmHg (p=0.030) and diastolic blood pressure -11.1 mmHg (p=0.049). We found no significant between group differences in other secondary outcomes. Conclusion: We effectively recruited and retained DH over 6 months. Data support that the D-HOMES intervention was acceptable and feasible. We observe preliminary blood pressure improvement favoring D-HOMES that were statistically and clinically significant. D-HOMES warrants testing in a fully powered trial which could inform future high quality behavioral trials to promote health equity. Clinical trial registration: https://clinicaltrials.gov/study/NCT05258630?term=D-HOMES&rank=1, identifier NCT05258630.

Greater engagement in valued activities is associated with less barriers to quitting smoking among smokers with mobility impairments.

BACKGROUND: Individuals with mobility impairments (MI; use equipment to ambulate) have a high prevalence of both smoking and depression. Behavioral activation (BA) purports that depressed mood is remediated through valued activity engagement and may facilitate smoking cessation in MI populations. OBJECTIVE: We examined cross-sectional associations between activity engagement and variables important for smoking cessation among a high-risk group of smokers (people with MIs) and also describe a smoking cessation intervention based on BA, given the lack of studies on smokers with MIs. METHODS: This study used data from a smoking cessation trial enrolling smokers with MIs (n = 263). We assessed valued activities, activity type, activity restriction due to MI, and replacement of restricted activities. Motivation and confidence to quit smoking, number of cigarettes per day, and mood were also assessed. Analysis was performed with generalized linear (or logistic) regression models adjusted for age and physical functioning using aggregated data at baseline. RESULTS: Greater number and frequency of valued activities was associated with less smoking, depression, negative affect, and stress and higher positive affect and self-efficacy to quit. Activity restriction was associated with greater odds of major depression, and activity replacement with lower odds of major depression, lower stress, and higher positive affect and self-efficacy. Strength of associations varied by activity type. CONCLUSIONS: Consistent with our theoretical model, BA activity constructs were associated with several mediators of smoking outcomes in the expected directions. Smokers engaging in valued activities have more favorable profiles for smoking cessation and mood management.

The development and initial feasibility testing of D-HOMES: a behavioral activation-based intervention for diabetes medication adherence and psychological wellness among people experiencing homelessness.

Introduction: Compared to stably housed peers, people experiencing homelessness (PEH) have lower rates of ideal glycemic control, and experience premature morbidity and mortality. High rates of behavioral health comorbidities and trauma add to access barriers driving poor outcomes. Limited evidence guides behavioral approaches to support the needs of PEH with diabetes. Lay coaching models can improve care for low-resource populations with diabetes, yet we found no evidence of programs specifically tailored to the needs of PEH. Methods: We used a multistep, iterative process following the ORBIT model to develop the Diabetes Homeless Medication Support (D-HOMES) program, a new lifestyle intervention for PEH with type 2 diabetes. We built a community-engaged research team who participated in all of the following steps of treatment development: (1) initial treatment conceptualization drawing from evidence-based programs, (2) qualitative interviews with affected people and multi-disciplinary housing and healthcare providers, and (3) an open trial of D-HOMES to evaluate acceptability (Client Satisfaction Questionnaire, exit interview) and treatment engagement (completion rate of up to 10 offered coaching sessions). Results: In step (1), the D-HOMES treatment manual drew from existing behavioral activation and lay health coach programs for diabetes as well as clinical resources from Health Care for the Homeless. Step (2) qualitative interviews (n = 26 patients, n = 21 providers) shaped counseling approaches, language and choices regarding interventionists, tools, and resources. PTSD symptoms were reported in 69% of patients. Step (3) trial participants (N = 10) overall found the program acceptable, however, we saw better program satisfaction and treatment engagement among more stably housed people. We developed adapted treatment materials for the target population and refined recruitment/retention strategies and trial procedures sensitive to prevalent discrimination and racism to better retain people of color and those with less stable housing. Discussion: The research team has used these findings to inform an NIH-funded randomized control pilot trial. We found synergy between community-engaged research and the ORBIT model of behavioral treatment development to develop a new intervention designed for PEH with type 2 diabetes and address health equity gaps in people who have experienced trauma. We conclude that more work and different approaches are needed to address the needs of participants with the least stable housing.

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 .