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Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers.

ABSTRACT: Smoking prevalence rates among the lesbian, gay, bisexual, and transgender (LGBT) population are significantly higher than the general population. However, there is limited research on smoking cessation treatments in this group, particularly on culturally targeted interventions. Moreover, there are few interventions that address culturally specific psychosocial variables (e.g., minority stress) that may influence outcomes. This paper describes the protocol for a comparative effectiveness trial testing an evidence-based smoking cessation program, Courage to Quit, against a culturally tailored version for LGBT smokers, and examines the role of culturally specific psychosocial variables on cessation outcomes.To examine the effectiveness of a culturally targeted versus standard smoking cessation intervention, the study utilizes a 2-arm block, randomized, control trial (RCT) design. Adult LGBT participants (n?=?400) are randomized to one of the two programs each consisting of a six-session group program delivered in a community center and an eight week supply of the transdermal nicotine patch. Four individualized telephone counseling sessions occur at weeks 2, 5, 7, and 9, at times of greatest risk for relapse. Study outcome measures are collected at baseline, and 1, 3, 6, and 12 months post quit date. Primary outcomes are expired air carbon monoxide verified 7-day point-prevalence quit rates at each measurement period. Secondary outcomes assess changes in cravings, withdrawal symptoms, smoking cessation self-efficacy, and treatment adherence. Additionally, study staff examines the role of culturally specific psychosocial variables on cessation outcomes using path analysis.Determining the efficacy of culturally specific versus standard evidence based approaches to smoking cessation is a critical issue facing the field today. This study provides a model for the development and implementation of a culturally tailored smoking cessation intervention for LGBT participants and addresses a gap in the field by examining the role of culturally psychosocial variables associated with cessation outcomes.U.S. National Institutes of Health Clinical Trials NCT01633567 Registered 30 May 2012.

SUBMITTER: Matthews AK

PROVIDER: S-EPMC4269994 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers.

Matthews Alicia K AK McConnell Elizabeth A EA Li Chien-Ching CC Vargas Maria C MC King Andrea A

BMC psychology 20140530 1

<h4>Background</h4>Smoking prevalence rates among the lesbian, gay, bisexual, and transgender (LGBT) population are significantly higher than the general population. However, there is limited research on smoking cessation treatments in this group, particularly on culturally targeted interventions. Moreover, there are few interventions that address culturally specific psychosocial variables (e.g., minority stress) that may influence outcomes. This paper describes the protocol for a comparative ef ...[more]

PMID: 25566383

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Project description:African American smokers experience disproportionately higher rates of tobacco-related illnesses compared to Caucasians. It has been suggested that interventions targeted to specific racial/ethnic groups (i.e., culturally specific) are needed; however, the literature examining the efficacy of culturally specific interventions is equivocal. Moreover, there are few descriptions of methods used to create these interventions. The main aim of this study is to test the efficacy of a culturally specific smoking cessation intervention among African Americans.A 2-arm randomized controlled trial (RCT) will be conducted to assess the efficacy of a culturally specific group cognitive behavioral therapy (CBT), compared to standard group CBT among treatment-seeking smokers from the community. Participants in both conditions receive the transdermal nicotine patch (TNP) for 8-weeks. We intend to randomize at least 247 adult smokers who self-identify as African American into the trial. Enrolled participants are block randomized into one of two groups: Standard group CBT (control) or a culturally specific group CBT (CS-CBT). Groups are matched for time and attention, and consist of eight sessions. The primary outcome variable is 7-day point prevalence abstinence (7-day ppa). Smoking status is assessed at the end-of-counseling (EOC), and 3, 6, and 12-month follow-ups, with self-reported abstinence verified by saliva cotinine. We hypothesize that the CS-CBT condition will produce significantly greater smoking cessation rates compared to the control condition. We also expect that this effect will be moderated by acculturation and ethnic identity, such that the CS-CBT will show the greatest effect on cessation among participants who are less acculturated and have greater ethnic identity.Answering the fundamental question of whether culturally specific interventions lead to incremental efficacy over established, evidence-based approaches is of utmost importance. This study will have implications for the development and implementation of smoking cessation interventions among African Americans and other racial/ethnic minority groups.NCT01811758.

Project description:IntroductionNegative affect has been identified as a factor influencing continued smoking during pregnancy. In this study, a multi-component emotion regulation intervention was developed to address negative emotional smoking triggers and pilot-tested among low-income pregnant smokers. Treatment feasibility and acceptability, cotinine-verified rates of smoking cessation, and self-report of mean cigarettes smoked were assessed.MethodsPregnant smokers who self-reported smoking in response to negative affect (N = 70) were randomly assigned to receive one of two 8-session interventions: (1) emotion regulation treatment combined with standard cognitive-behavioral smoking cessation (ERT + CBT) or (2) a health and lifestyle plus standard smoking cessation active control (HLS + CBT). Outcomes for the 4-month period following the quit date are reported.ResultsTreatment attendance and subjective ratings provide evidence for the feasibility and acceptability of the ERT + CBT intervention. Compared with the HLS + CBT control condition, the ERT + CBT condition demonstrated higher abstinence rates at 2 months (ERT + CBT = 23% vs. HLS + CBT = 0%, OR = 13.51; 95% CI = 0.70-261.59) and 4 months (ERT = 18% vs. HLS = 5%; OR = 2.98; 95% CI = 0.39-22.72) post-quit. Mean number of cigarettes per day was significantly lower in ERT + CBT at 2 months (ERT + CBT = 2.73 (3.35) vs. HLS + CBT = 5.84 (6.24); p = .05) but not at 4 months (ERT + CBT = 2.15 (3.17) vs. HLS + CBT = 5.18 (2.88); p = .06) post-quit.ConclusionsThe development and initial test of the ERT + CBT intervention supports its feasibility and acceptability in this difficult-to-treat population. Further development and testing in a Stage II randomized clinical trial are warranted.ImplicationsNegative affect has been identified as a motivator for continued smoking during pregnancy. To date, smoking cessation interventions for pregnant smokers have not specifically addressed the role of negative affect as a smoking trigger. This treatment development pilot study provides support for the feasibility and acceptability of a multi-component ERT + CBT for low-income pregnant smokers who self-report smoking in response to negative affect. Study findings support further testing in a fully-powered Stage II efficacy trial powered to assess mediators and moderators of treatment effects.

Project description:Many lifelong smokers establish smoking habits during young adulthood. A university can be an effective setting for early smoking cessation. We evaluated long-term predictors of smoking cessation among smokers in a university setting.We longitudinally followed a cohort of smokers enrolled in a university smoking cessation program in Seoul, South Korea. Sociodemographic factors, smoking-related variables, and changes in smoking habits were assessed during 6-week visit sessions and follow-up telephone interviews conducted 1 year or more later.A total of 205 participants were followed up (mean follow-up duration: 27.1 months). Cessation rates were 47.3% at the end of the visit sessions and 28.8% at follow-up. The long-term persistent smoking rate was significantly higher among individuals with peers who smoked (odds ratio [OR] = 8.64; 95% confidence interval [CI] = 1.75, 42.80), with family members who smoked (OR = 3.28; 95% CI = 1.20, 9.00), and who smoked 10 to 19 cigarettes/day (OR?=?4.83; 95% CI?=?1.49, 15.69). Conversely, persistent smoking was less likely among those who attended the program regularly (OR?=?0.84 per visit; 95% CI?=?0.72, 0.99) and attempted quitting more frequently (OR?=?0.93 per attempt; 95% CI?=?0.87, 0.99). Use of smoking cessation medications (varenicline or bupropion) was not significantly associated with long-term quitting (OR?=?0.71; 95% CI?=?0.26, 1.93).Peer influences were the strongest predictors of failure in long-term cessation among smokers who attempted to quit. Similarly, the existence of smokers in the family was negatively associated with successful quitting. Regular attendance at a smoking cessation program and a high number of attempts to quit were positively associated with successful quitting. Targeting peer and family smoking groups together rather than targeting individual smokers alone, implementing active cessation programs encouraging regular attendance, and providing comprehensive antismoking environments might be effective strategies in a university setting.

Project description:IntroductionProject CLIQ (Community Link to Quit) was a proactive population-outreach strategy using an electronic health records-based smoker registry and interactive voice recognition technology to connect low- to moderate-income smokers with cessation counseling, medications, and social services. A randomized trial demonstrated that the program increased cessation. We evaluated the cost-effectiveness of CLIQ from a provider organization's perspective if implemented outside the trial framework.MethodsWe calculated the cost, cost per smoker, incremental cost per additional quit, and, secondarily, incremental cost per additional life year saved of the CLIQ system compared to usual care using data from a 2011-2013 randomized trial assessing the effectiveness of the CLIQ system. Sensitivity analyses considered economies of scale and initial versus ongoing costs.ResultsOver a 20-month period (the duration of the trial) the program cost US $283 027 (95% confidence interval [CI] $209 824-$389 072) more than usual care in a population of 8544 registry-identified smokers, 707 of whom participated in the program. The cost per smoker was $33 (95% CI 28-40), incremental cost per additional quit was $4137 (95% CI $2671-$8460), and incremental cost per additional life year saved was $7301 (95% CI $4545-$15 400). One-time costs constituted 28% of costs over 20 months. Ongoing costs were dominated by personnel costs (71% of ongoing costs). Sensitivity analyses showed sharp gains in cost-effectiveness as the number of identified smokers increased because of the large initial costs.ConclusionsThe CLIQ system has favorable cost-effectiveness compared to other smoking cessation interventions. Cost-effectiveness will be greatest for health systems with high numbers of smokers and with the high smoker participation rates.ImplicationsHealth information systems capable of establishing registries of patients who are smokers are becoming more prevalent. This economic analysis illustrates the cost implications for health care systems adopting a proactive tobacco treatment outreach strategy for low- and middle-income smokers. We find that under many circumstances, the CLIQ system has a favorable cost-per-quit compared to other population-based tobacco treatment strategies. The strategy could be widely disseminable if health systems leverage economies of scale.

Project description:BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content "paths" based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ(2)(1)=1.4, P=.24; R(2)=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ(2)(1)=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ(2)(1)=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ(2)(1)=0.12, P=.73), or missing 5 or more program messages (χ(2)(1)=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.Trial registrationClinicaltrials.gov NCT00912795 http://clinicaltrials.gov/ct2/show/NCT00912795 (Archived by WebCite® at http://www.webcitation.org/6Ch1cIA8l).

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Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers.

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Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers.

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