Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial.
ABSTRACT: Although 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.A 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.This 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.ClinicalTrials.gov NCT01188018.
Project description:Despite 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.Randomized clinical trial.Two-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.Four 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.Self-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.Unexpectedly, 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).Although 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.This study is registered at www.clinicaltrials.gov NCT01188018.
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:INTRODUCTION:More than half of the smoking population in Hong Kong are unmotivated to quit. Only about 2% of tobacco users in the territory have ever used cessation aids such as nicotine replacement therapy (NRT). The present study aims to assess the effectiveness of delivering 1-week free NRT sample plus brief intervention to smokers at outdoor smoking hotspots on quit attempts and use of smoking cessation services. METHODS AND ANALYSIS:This is a two-arm, pragmatic, multisite, cluster randomised controlled trial (RCT) on the effectiveness of increasing quit attempts, use of cessation service and recruitment outcomes. Trained smoking cessation ambassadors will approach smokers at outdoor smoking hotspots, and deliver brief smoking cessation advice. Recruitment sessions are randomised to intervention or control group (allocation ratio 1:1). Participants in the intervention group (n=550) will receive 1-week free NRT sample (either patch or gum), brief medication advice from an onsite nurse and cessation service referral, whereas participants in control group (n=275) will only receive the brief advice and service referral. The primary outcomes are the proportion of participants who enrol in any cessation service in Hong Kong within 1?month of the recruitment, and the proportion of participants who report quit attempts at 1-month follow-up. Secondary outcomes include self-reported use of NRT, self-reported 7-day tobacco abstinence, 30-day abstinence at 3 months and 6?months, biochemically validated abstinence at 6?months, perceived importance, difficulty and confidence to quit (scale 0-10), and Incremental Behavior Change towards Smoking Cessation. Process outcomes include number of smokers who will be approached, will accept the brief smoking cessation advice or be recruited to participate in the RCT. ETHICS AND DISSEMINATION:The Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster approved the trial (UW 18-118). Findings will be disseminated through funding website, publication and conference presentations. TRIAL REGISTRATION NUMBER:NCT03717051.
Project description:To assess the effects of adding motivational interviewing (MI) counseling to nicotine patch for smoking cessation among homeless smokers.Two-group randomized controlled trial with 26-week follow-up.A total of 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/St Paul, Minnesota, USA.All participants received 8-week treatment of 21-mg nicotine patch. In addition, participants in the intervention group received six individual sessions of MI counseling which aimed to increase adherence to nicotine patches and to motivate cessation. Participants in the standard care control group received one session of brief advice to quit smoking. Primary outcome was 7-day abstinence from cigarette smoking at 26 weeks, as validated by exhaled carbon monoxide and salivary cotinine.Using intention-to-treat analysis, verified 7-day abstinence rate at week 26 for the intervention group was non-significantly higher than for the control group (9.3% versus 5.6%, P?=?0.15). Among participants who did not quit smoking, reduction in number of cigarettes from baseline to week 26 was equally high in both study groups (-13.7?±?11.9 for MI versus -13.5?±?16.2 for standard care).Adding motivational interviewing counseling to nicotine patch did not increase smoking rate significantly at 26-week follow-up for homeless smokers.
Project description:BACKGROUND:Executive function (EF) is considered an important mediator of health outcomes. It is hypothesized that those with better EF are more likely to succeed in turning their intentions into actual health behaviors. Prior studies indicate EF is associated with smoking cessation. Experimental and longitudinal studies, however, have yielded mixed results. Few studies have examined whether EF predicts post-treatment smoking behavior. Fewer still have done so prospectively in a large trial. We sought to determine if EF predicts quit attempts and cessation among community smokers in a large randomized trial evaluating the efficacy of motivational interventions for encouraging cessation. METHODS:Participants (N=255) completed a baseline assessment that included a cognitive battery to assess EF (Oral Trail Making Test B, Stroop, Controlled Oral Word Association Test). Participants were then randomized to 4 sessions of Motivational Interviewing or Health Education or one session of Brief Advice to quit. Quit attempts and cessation were assessed at weeks 12 and 26. RESULTS:In regression analyses, none of the EF measures were statistically significant predictors of quit attempts or cessation (all ps>0.20). CONCLUSIONS:Our data did not support models of health behavior that emphasize EF as a mediator of health outcomes. Methodological shortcomings weaken the existing support for an association between EF and smoking behavior. We suggest methodological improvements that could help move this potentially important area of research forward.
Project description:BACKGROUND:The recent development of smoking cessation interventions for smokers with chronic diseases has focused heavily on brief interventions. However, these interventions are too brief to make an impact on these smokers, especially when most of them are without any intention to quit. Previous studies showed that smokers who did not want to quit might be interested in changing other health behaviours. Also, once people engage in a health behaviour, they are found more likely to change other unhealthy habits. Hence, a general health promotion approach could be a feasible approach to motivate smokers who do not want to quit to first engage in any desirable health behaviour, and later quit smoking when they intend to do so. This study aims to determine the potential efficacy and effect size of such intervention approach in promoting smoking cessation for smokers with chronic diseases. METHODS:This is a randomized controlled trial. A convenience sample of 60 smokers with chronic diseases will be randomly assigned into either experimental (n?=?30) or control group (n?=?30). Smokers in the experimental group will receive an individual face-to-face brief motivational interviewing (MI) with generic advice on selected health behaviour. More brief MI messages will be delivered to them via WhatsApp/WeChat for 6?months. For subject in the control group, they will be asked to indicate their desirable health-related practice. However, no MI and booster interventions will be given. All subjects will complete a questionnaire at 1, 3, 6 and 12?months. Subjects abstinent from cigarettes at 12?months will perform a biochemical validation. The primary outcome is biochemically validated smoking abstinence at 12?months. Effect size of the intervention will be estimated by the odd ratios using intention-to-treat. DISCUSSION:This is the first study to determine the potential efficacy for the use of a personalized general health promotion approach in promoting smoking cessation for smokers with chronic diseases. If our proposed intervention is effective, we will able to assist smokers with chronic disease to quit smoking and change their health behaviour simultaneously. TRIAL REGISTRATION:CinicalTrials.gov NCT03983330 (Prospectively registered), registered on June 12, 2019.
Project description:BACKGROUND:Within a web-assisted tobacco intervention, we provided a function for smokers to asynchronously communicate with a trained tobacco treatment specialist (TTS). Previous studies have not attempted to isolate the effect of asynchronous counseling on smoking cessation. OBJECTIVE:This study aimed to conduct a semiquantitative analysis of TTS-smoker communication and evaluate its association with smoking cessation. METHODS:We conducted a secondary analysis of data on secure asynchronous communication between trained TTSs and a cohort of smokers during a 6-month period. Smokers were able to select their preferred TTS and message them using a secure web-based form. To evaluate whether the TTS used evidence-based practices, we coded messages using the Motivational Interviewing Self-Evaluation Checklist and Smoking Cessation Counseling (SCC) Scale. We assessed the content of messages initiated by the smokers by creating topical content codes. At 6 months, we assessed the association between smoking cessation and the amount of TTS use and created a multivariable model adjusting for demographic characteristics and smoking characteristics at baseline. RESULTS:Of the 725 smokers offered asynchronous counseling support, 33.8% (245/725) messaged the TTS at least once. A total of 1082 messages (TTSs: 565; smokers 517) were exchanged between the smokers and TTSs. The majority of motivational interviewing codes were those that supported client strengths (280/517, 54.1%) and promoted engagement (280/517, 54.1%). SCC code analysis showed that the TTS provided assistance to smokers if they were willing to quit (247/517, 47.8%) and helped smokers prepare to quit (206/517, 39.8%) and anticipate barriers (197/517, 38.1%). The majority of smokers' messages discussed motivations to quit (234/565, 41.4%) and current and past treatments (talking about their previous use of nicotine replacement therapy and medications; 201/565, 35.6%). The majority of TTS messages used behavioral strategies (233/517, 45.1%), offered advice on treatments (189/517, 36.5%), and highlighted motivations to quit (171/517, 33.1%). There was no association between the amount of TTS use and cessation. In the multivariable model, after adjusting for gender, age, race, education, readiness at baseline, number of cigarettes smoked per day at baseline, and the selected TTS, smokers messaging the TTS one or two times had a smoking cessation odds ratio (OR) of 0.8 (95% CI 0.4-1.4), and those that messaged the TTS more than two times had a smoking cessation OR of 1.0 (95% CI 0.4-2.3). CONCLUSIONS:Our study demonstrated the feasibility of using asynchronous counseling to deliver evidence-based counseling. Low participant engagement or a lack of power could be potential explanations for the nonassociation with smoking cessation. Future trials should explore approaches to increase participant engagement and test asynchronous counseling in combination with other approaches for improving the rates of smoking cessation.
Project description:Background:Nearly 275 million individuals in India consume tobacco every day, with more than 1 million dying annually as a result. Few people in India have access to smoking cessation services, an essential component of combating tobacco use globally. We hypothesize that a strategy of systematic community health worker (CHW) based counseling that covers eligible people who smoke in a geographical area, combined with text messaging support, will result in improved quit rates. Methods:The study is a cluster randomized controlled trial that will be conducted at 2 sites in India. Sixteen clusters will be randomized into either an intervention or control arm. A total of 560 smokers between the age of 18 and 70 will be recruited from their home through CHWs. Smokers at all stages of change will be offered the intervention, which is based on the transtheoretical model of change. Results:Pre-contemplative participants will be offered health education and motivational interviewing through CHWs. They will also be offered a low frequency form of text messaging, focused on health education and the benefits of quitting. Participants who are actively contemplating quitting smoking will be offered a more intensive intervention, with more frequent visits by CHWs and more intensive text messaging support. Contemplative participants will be encouraged to set a quit date, and all participants will be assessed periodically for stage of change to provide the appropriate intervention. Participants who set a quit date will be encouraged to use NRT to help with quitting. Control group participants are provided with brief smoking cessation advice only, at the start of the trial. The primary outcome will be self-reported abstinence for the past 14 days, biochemically verified by exhaled CO levels (cut-off 10 ppm) assessed at the end of 1 year of the intervention. Conclusions:We will test whether a CHW-based intervention that incorporates motivational interviewing, text messaging and supportive counseling can prove effective in systematically helping smokers quit.
Project description:Smoking remains the leading cause of preventable illness and mortality in the United States. Individuals with Posttraumatic Stress Disorder (PTSD) have smoking rates higher than that of others and fewer individuals with PTSD have quit smoking. This randomized controlled trial was designed to test the effectiveness of integrating telehealth care management and smoking cessation with motivational interviewing for Veterans with PTSD.All smokers with PTSD, regardless of their desire to quit, were invited to participate. Enrollment occurred between November 2009 and April 2013. Target enrollment was 120 participants. Enrolled participants were randomized to either the control group, receiving usual care including a telehealth PTSD program, with a device that delivered PTSD information and in-home care management, or the intervention group, which included (1) a telehealth PTSD program, (2) motivational interviewing-based smoking cessation curricula via the telehealth device, and (3) weekly motivational interviewing counseling phone calls. Outcomes are self-reported 24-hour quit attempts, progression along the stages of change and 7-day point prevalence quit smoking rates for the intervention group compared to usual care alone. Secondary outcomes include participants' perception of care coordination, patient satisfaction with motivational interviewing, PTSD symptoms, pain, depression and quality of life.Motivational interviewing has been shown to increase readiness for change and smoking cessation care has been shown to be more successful when incorporated into in-person mental health care. Our study builds on previous studies. It integrates a written smoking cessation curriculum and phone-based motivational interviewing counseling into an established PTSD home telehealth care coordination program. This paper describes the design and methods of our randomized control trial.ClinicalTrials.gov, NCT00908882, May 22, 2009.
Project description:INTRODUCTION:Adherence to smoking cessation treatment is generally low, especially among socio-economically disadvantaged groups including individuals experiencing homelessness and those with mental illnesses. Despite the high smoking rates in homeless populations (~70%) no study to date has systematically examined predictors of adherence to nicotine replacement therapy (NRT) in this population. OBJECTIVE:The aim of this secondary analysis was to identify predictors of adherence to NRT in a smoking cessation trial conducted among homeless smokers. METHODS:Secondary analysis of data from a randomized controlled trial enrolling 430 persons who were homeless and current cigarette smokers. Participants were assigned to one of the two study conditions to enhance smoking cessation: Motivational Interviewing (MI; 6 sessions of MI + 8 weeks of NRT) or Standard Care (Brief advice to quit+ 8 weeks of NRT). The primary outcome for the current analysis was adherence to NRT at end of treatment (8 weeks following randomization). Adherence was defined as a total score of zero on a modified Morisky adherence scale). Demographic and baseline psychosocial, tobacco-related, and substance abuse measures were compared between those who did and did not adhere to NRT. RESULTS:After adjusting for confounders, smokers who were depressed at baseline (OR=0.58, 95% CI, 0.38-0.87, p=0.01), had lower confidence to quit (OR=1.10, 95% CI, 1.01-1.19, p=0.04), were less motivated to adhere (OR=1.04, 95% CI, 1.00-1.07, p=0.04), and were less likely to be adherent to NRT. Further, age of initial smoking was positively associated with adherence status (OR= 0.83, 95% CI, 0.69-0.99, p=0.04). CONCLUSION:These results suggest that smoking cessation programs conducted in this population may target increased adherence to NRT by addressing both depression and motivation to quit. TRIAL REGISTRATION:clinicaltrials.gov: NCT00786149.