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A Mediation Analysis of Motivational, Reduction, and Usual Care Interventions for Smokers Who Are Not Ready to Quit.

ABSTRACT: We recently conducted a large randomized controlled trial (RCT) (N = 560) that failed to replicate our initial RCT's findings that brief motivational and reduction interventions increased quit attempts (QA) and point-prevalence abstinence (PPA) in smokers not ready to quit. The present study aimed to test why our interventions were ineffective.A secondary analysis of a 3-arm RCT tested (1) whether telephone-based motivational or reduction interventions changed the following hypothesized mediators more than usual care: cigarettes per day (CPD), dependence, pros of smoking, cons of smoking, self-efficacy, or intention to quit; (2) whether changes in these hypothesized mediators predicted QAs and PPA at a 6-month follow-up, and (3) whether the interventions affected QAs and PPA via the hypothesized mediators.In comparison to usual care, the motivational intervention did not significantly influence the hypothesized mediators. The reduction intervention resulted in a significantly greater decrease in CPD and pros of smoking and increase in self-efficacy and intention to quit than usual care. Decreases in CPD and dependence and increases in self-efficacy and intention to quit were associated with increased QAs. The reduction intervention's influence on QAs was mediated by decreases in CPD and increases in self-efficacy and intention to quit. Findings regarding PPA were similar.Our failure to replicate may be due, in part, to the fact that, compared to usual care, (1) the motivational intervention had no effect on the hypothesized mediators, and (2) the reduction intervention had a statistically significant but clinically insignificant effect on the hypothesized mediators.This study demonstrates that mediation analysis may be useful to understand why an intervention is not more effective than usual care. We identified reductions in CPD and dependence and increases in self-efficacy and intention to quit as predictors of quitting. Further research should focus on developing more effective interventions to target these constructs, and cause clinically significant changes among smokers who are not ready to quit.

SUBMITTER: Klemperer EM

PROVIDER: S-EPMC5896464 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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A Mediation Analysis of Motivational, Reduction, and Usual Care Interventions for Smokers Who Are Not Ready to Quit.

Klemperer Elias M EM Hughes John R JR Callas Peter W PW Solomon Laura J LJ

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20170801 8

<h4>Introduction</h4>We recently conducted a large randomized controlled trial (RCT) (N = 560) that failed to replicate our initial RCT's findings that brief motivational and reduction interventions increased quit attempts (QA) and point-prevalence abstinence (PPA) in smokers not ready to quit. The present study aimed to test why our interventions were ineffective.<h4>Methods</h4>A secondary analysis of a 3-arm RCT tested (1) whether telephone-based motivational or reduction interventions change ...[more]

PMID: 28182218

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Project description:AimsTo test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit.DesignA parallel-group randomized controlled trial of brief motivational (n = 185), reduction (n = 186) or usual care (n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided.SettingUnited States.ParticipantsA total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days.MeasurementsThe primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began.FindingsA priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09).ConclusionsAmong adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months.

Project description:IntroductionThis study used data from a randomized controlled trial evaluating the efficacy of motivational interviewing (MI) relative to health education (HE) and brief advice (BA) to encourage quit attempts and cessation in order to determine their relative cost-effectiveness.Aims and methodsUrban community residents (n = 255) with low desire to quit smoking were randomized to MI, HE, or BA which differed in communication style and/or number of treatment sessions. Incremental cost-effectiveness ratios were used to compare the intensive interventions (MI and HE) to BA for facilitating quit attempts and smoking cessation. Costs were calculated from the perspective of an agency that might engage in program delivery. Sensitivity analysis examined different assumptions for MI training and pharmacotherapy costs.ResultsTotal intervention delivery time costs per participant for MI, HE, and BA were $46.63, $42.87, and $2.4, respectively. Cost-effectiveness ratios per quit attempt at 24 weeks were $380 for MI, $272 for HE, and $209 for BA. The cost per additional quit attempt for MI and HE relative to BA was $508 and $301, respectively. The cost per additional quit for MI and HE relative to BA was $2030 and $752, respectively. Four separate sensitivity analyses conducted in our study did not change the conclusion the HE had a lower Incremental Cost-Effectiveness Ratio for both quit attempts and cessation.ConclusionsHE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit. Providing valuable cost information in choosing different clinical methods for motivating smokers to quit.ImplicationsAll direct costs and activity-based time costs associated with delivering the intervention were analyzed from the perspective of an agency that may wish to replicate these strategies. A randomized controlled trial evaluating the efficacy of MI relative to HE and BA to encourage quit attempts and cessation determined their relative cost-effectiveness. HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable. Despite guideline recommendations, MI may not be the best approach to encourage quit attempts in diverse populations. Rather, a structured, intensive HE intervention might be the most cost-effective alternative.

Project description:BACKGROUND:Motivational Interviewing (MI), Brief Advice (BA) and Health Education (HE) are established smoking cessation induction methods for smokers with low desire to quit. Although randomized controlled trials (RCT's) have been frequently used to assess these interventions the temporal efficacy and effectiveness of these interventions have been poorly elaborated. The present work endeavors to fill the gap by considering the full range of possible motivational outcomes for all of the participants. METHODS:As a two-step process, Markov Chain (MC) and Ordinary Differential Equation (ODE) models were successively employed to examine the temporal efficacy and effectiveness of these interventions by computing the gradual movements of participants from an initial stage of unmotivated smoker to stages of increased motivation to quit and cessation. Specifically, in our re-analysis of data from the RCT we examined the proportion of participants in 4 stages of readiness to quit (unmotivated, undecided, motivated, former smokers) over 6 months, across treatment groups [MI (n = 87), BA (n = 43) and HE (n = 91)]. RESULTS:Although HE had greater efficacy compared to MI and BA (i.e., the highest smoking cessation rates), it had lower effectiveness at certain time points. This was due to the fact that HE had the greatest proportion of motivated smokers who quit smoking but simultaneously a large proportion of the motivated smokers became unmotivated to quit. The effectiveness of HE dropped substantially in weeks 3-12 and remained below the effectiveness of BA from week 12 onward. The 2-year ODE model projections show that the prevalence of motivated smokers in HE group may fall below 5%. The prevalence of HE former smokers can reach an equilibrium of 26%, where the prevalence of both BA and MI former smokers exceeds this equilibrium. CONCLUSIONS:The methodology proposed in this paper strongly benefits from the capabilities of both MC and ODE modeling approaches, in the event of low observations over the time. Particularly, the temporal population sizes are first estimated by the MC model. Then they are used to parametrize the ODE model and predict future values. The methodology enabes us to determine and compare the temporal efficacy and effectiveness of smoking cessation interventions, yielding predictive and analytic insights related to temporal characteristics and capabilities of these interventions during the study period and beyond. TRIAL REGISTRATION:Testing Counseling Styles to Motivate Smokers to Quit, NCT01188018 , (July 4, 2012). This study is registered at www.clinicaltrials.gov NCT01188018.

Project description:IntroductionDespite limitations in evidence, the current Clinical Practice Guideline advocates Motivational Interviewing for smokers not ready to quit. This study evaluated the efficacy of Motivational Interviewing for inducing cessation-related behaviors among smokers with low motivation to quit.DesignRandomized clinical trial.Setting/participantsTwo-hundred fifty-five daily smokers reporting low desire to quit smoking were recruited from an urban community during 2010-2011 and randomly assigned to Motivational Interviewing, health education, or brief advice using a 2:2:1 allocation. Data were analyzed from 2012 to 2014.InterventionFour sessions of Motivational Interviewing utilized a patient-centered communication style that explored patients' own reasons for change. Four sessions of health education provided education related to smoking cessation while excluding elements characteristic of Motivational Interviewing. A single session of brief advice consisted of brief, personalized advice to quit.Main outcomes measuresSelf-reported quit attempts; smoking abstinence (biochemically verified); use of cessation pharmacotherapies; motivation; and confidence to quit were assessed at baseline and 3- and 6-month follow-ups.ResultsUnexpectedly, no significant differences emerged between groups in the proportion who made a quit attempt by 6-month follow-up (Motivational Interviewing, 52.0%; health education, 60.8%; brief advice, 45.1%; p=0.157). Health education had significantly higher biochemically verified abstinence rates at 6 months (7.8%) than brief advice (0.0%) (8% risk difference, 95% CI=3%, 13%, p=0.003), with the Motivational Interviewing group falling in between (2.9% abstinent, 3% risk difference, 95% CI=0%, 6%, p=0.079). Both Motivational Interviewing and health education groups showed greater increases in cessation medication use, motivation, and confidence to quit relative to brief advice (all p<0.05), and health education showed greater increases in motivation relative to Motivational Interviewing (Cohen's d=0.36, 95% CI=0.12, 0.60).ConclusionsAlthough Motivational Interviewing was generally more efficacious than brief advice in inducing cessation behaviors, health education appeared the most efficacious. These results highlight the need to identify the contexts in which Motivational Interviewing may be most efficacious and question recommendations to use Motivational Interviewing rather than other less complex cessation induction interventions.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01188018.

Project description:BackgroundAlthough the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition.Methods/designA sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation.DiscussionThis trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline.Trial registrationClinicalTrials.gov NCT01188018.

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A Mediation Analysis of Motivational, Reduction, and Usual Care Interventions for Smokers Who Are Not Ready to Quit.

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A Mediation Analysis of Motivational, Reduction, and Usual Care Interventions for Smokers Who Are Not Ready to Quit.

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