Dataset Information

Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial.

ABSTRACT:

Background

Partial adherence in Internet smoking cessation interventions presents treatment and evaluation challenges. Increasing adherence may improve outcomes.

Purpose

To present smoking outcomes from an Internet randomized trial of two strategies to encourage adherence to tobacco dependence treatment components: (i) a social network (SN) strategy to integrate smokers into an online community and (ii) free nicotine replacement therapy (NRT). In addition to intent-to-treat analyses, we used novel statistical methods to distinguish the impact of treatment assignment from treatment utilization.

Methods

A total of 5,290 current smokers on a cessation website (WEB) were randomized to WEB, WEB + SN, WEB + NRT, or WEB + SN + NRT. The main outcome was 30-day point prevalence abstinence at 3 and 9 months post-randomization. Adherence measures included self-reported medication use (meds), and website metrics of skills training (sk) and community use (comm). Inverse Probability of Retention Weighting and Inverse Probability of Treatment Weighting jointly addressed dropout and treatment selection. Propensity weights were used to calculate Average Treatment effects on the Treated.

Results

Treatment assignment analyses showed no effects on abstinence for either adherence strategy. Abstinence rates were 25.7%-32.2% among participants that used all three treatment components (sk+comm +meds).Treatment utilization analyses revealed that among such participants, sk+comm+meds yielded large percentage point increases in 3-month abstinence rates over sk alone across arms: WEB = 20.6 (95% CI = 10.8, 30.4), WEB + SN = 19.2 (95% CI = 11.1, 27.3), WEB + NRT = 13.1 (95% CI = 4.1, 22.0), and WEB + SN + NRT = 20.0 (95% CI = 12.2, 27.7).

Conclusions

Novel propensity weighting approaches can serve as a model for establishing efficacy of Internet interventions and yield important insights about mechanisms.

Clinical trials.gov

NCT01544153.

SUBMITTER: Graham AL

PROVIDER: S-EPMC6037305 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Web-based smoking cessation interventions can deliver evidence-based treatments to a wide swath of the population, but effectiveness is often limited by insufficient adherence to proven treatment components. This study evaluated the impact of a social network (SN) intervention and free nicotine replacement therapy (NRT) on adherence to evidence-based components of smoking cessation treatment in the context of a Web-based intervention.A sample of adult U.S. smokers (N = 5290) was recruited via BecomeAnEX.org, a free smoking cessation Web site. Smokers were randomized to one of four arms: (1) an interactive, evidence-based smoking cessation Web site (WEB) alone; (2) WEB in conjunction with an SN intervention designed to integrate participants into the online community (WEB+SN); (3) WEB plus free NRT (WEB+NRT); and (4) the combination of all treatments (WEB+SN+NRT). Adherence outcomes assessed at 3-month follow-up were as follows: Web site utilization metrics, use of skills training components, intratreatment social support, and pharmacotherapy use.WEB+SN+NRT outperformed all others on Web site utilization metrics, use of practical counseling tools, intratreatment social support, and NRT use. It was the only intervention to promote the sending of private messages and the viewing of community pages over WEB alone. Both social network arms outperformed WEB on most metrics of online community engagement. Both NRT arms showed higher medication use compared to WEB alone.This study demonstrated the effectiveness of two approaches for improving adherence to evidence-based components of smoking cessation treatment. Integrated approaches to medication provision and social network engagement can enhance adherence to components known to improve cessation.This study demonstrated that an integrated approach to medication provision and social network integration, when delivered through an online program, can enhance adherence across all three recommended components of an evidence-based smoking cessation program (skills training, social support, and pharmacotherapy use). Nicotine replacement therapy-when provided as part of an integrated program-increases adherence to other program elements, which in turn augment its own therapeutic effects. An explicit focus on approaches to improve treatment adherence is an important first step to identifying leverage points for optimizing intervention effectiveness.

Project description:Seasonal variations in smoking and quitting behaviors have been documented, with many smokers seeking cessation assistance around the start of the New Year. What remains unknown is whether smokers who are recruited to cessation treatment trials during the New Year are as motivated to quit, or as likely to enroll in a research trial, adhere to a research protocol, and benefit from a cessation intervention compared to those who are recruited during other times of the year.The objective of this study was to determine whether smokers recruited during the New Year period differ on measures of motivation and desire to quit, recruitment and retention rates, website utilization rates, and short-term cessation outcomes compared to smokers recruited at other times.Participants were current smokers who had registered on a free Web-based cessation program (BecomeAnEX.org) and were invited to participate in a clinical trial. The New Year period was defined according to a clear peak and drop in the proportion of visitors who registered on the site, spanning a 15-day period from December 26, 2012 to January 9, 2013. Two other 15-day recruitment periods during summer (July 18, 2012 to August 1, 2012) and fall (November 7, 2012 to November 21, 2012) were selected for comparison. Data were examined from 3 sources: (1) a Web-based clinical trials management system that automated the recruitment and enrollment process, (2) self-report assessments at baseline and 3 months postrandomization, and (3) online tracking software that recorded website utilization during the first 3 months of the trial.Visitors to BecomeAnEX during the New Year period were more likely to register on the site than smokers who visited during summer or fall (conversion rates: 7.4%, 4.6%, 4.9%, respectively; P<.001), but there were no differences in rates of study acceptance, consent, randomization, 3-month follow-up survey completion, or cessation between the 3 periods. New Year participants were older, more educated, more likely to be employed full time, and more likely to have a relationship partner compared with participants recruited at other times during the year, but did not differ on measures of motivation and desire to quit.Smokers visiting a Web-based cessation program during the New Year period were more likely to register for treatment and differ on several demographic variables, but showed similar patterns of treatment engagement, retention, follow-up, and short-term cessation outcomes compared with participants who visited the site during other periods of the year. These results allay scientific concerns about recruiting participants during this time frame and are reassuring for researchers conducting Web-based cessation trials.

Project description:Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components.We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome.This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses.NCT02585206.

Project description:BACKGROUND:Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator of treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to blended and face-to-face alone smoking cessation treatments with similar content and intensity. OBJECTIVE:The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment with adherence to a face-to-face treatment; (2) to compare adherence within the blended treatment to its face-to-face mode and web mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment. METHODS:We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic who were randomly assigned either to the blended smoking cessation treatment (n=130) or to a face-to-face treatment with identical components (n=162). For both treatments (blended and face-to-face) and for the two modes of delivery within the blended treatment (face-to-face vs web mode), adherence levels (ie, treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics. RESULTS:We found no significant difference in adherence between the blended and the face-to-face treatments. Participants in the blended treatment group spent an average of 246 minutes in treatment (median 106.7% of intended treatment time, IQR 150%-355%) and participants in the face-to-face group spent 238 minutes (median 103.3% of intended treatment time, IQR 150%-330%). Within the blended group, adherence to the face-to-face mode was twice as high as that to the web mode. Participants in the blended group spent an average of 198 minutes (SD 120) in face-to-face mode (152% of the intended treatment time) and 75 minutes (SD 53) in web mode (75% of the intended treatment time). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both the blended and face-to-face groups. For the face-to-face group, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (blended R2=0.049; face-to-face R2=0.076). Within the blended group, living without children predicted higher adherence to the face-to-face mode (R2=0.034), independent of age. Higher adherence to the web mode of the blended treatment was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting, and less health complaints (R2=0.164). CONCLUSIONS:This study represents one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher for the face-to-face mode than for the web mode. This supports the idea that in blended treatment, one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study suggests that other variables such as provider-related health system factors and time-varying patient characteristics should be explored in future research. TRIAL REGISTRATION:Netherlands Trial Register NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113.

Project description:BACKGROUND AND AIMS:Millions of people world-wide use websites to help them quit smoking, but effectiveness trials have an average 34% follow-up data retention rate and an average 9% quit rate. We compared the quit rates of a website using a new behavioral approach called Acceptance and Commitment Therapy (ACT; WebQuit.org) with the current standard of the National Cancer Institute's (NCI) Smokefree.gov website. DESIGN:A two-arm stratified double-blind individually randomized trial (n = 1319 for WebQuit; n = 1318 for Smokefree.gov) with 12-month follow-up. SETTING:United States. PARTICIPANTS:Adults (n = 2637) who currently smoked at least five cigarettes per day were recruited from March 2014 to August 2015. At baseline, participants were mean [standard deviation (SD)] age 46.2 years (13.4), 79% women and 73% white. INTERVENTIONS:WebQuit.org website (experimental) provided ACT for smoking cessation; Smokefree.gov website (comparison) followed US Clinical Practice Guidelines for smoking cessation. MEASUREMENTS:The primary outcome was self-reported 30-day point prevalence abstinence at 12 months. FINDINGS:The 12-month follow-up data retention rate was 88% (2309 of 2637). The 30-day point prevalence abstinence rates at the 12-month follow-up were 24% (278 of 1141) for WebQuit.org and 26% (305 of 1168) for Smokefree.gov [odds ratio (OR) = 0.91; 95% confidence interval (CI) = 0.76, 1.10; P = 0.334] in the a priori complete case analysis. Abstinence rates were 21% (278 of 1319) for WebQuit.org and 23% (305 of 1318) for Smokefree.gov (OR = 0.89 (0.74, 1.07; P = 0.200) when missing cases were imputed as smokers. The Bayes factor comparing the primary abstinence outcome was 0.17, indicating 'substantial' evidence of no difference between groups. CONCLUSIONS:WebQuit.org and Smokefree.gov had similar 30-day point prevalence abstinence rates at 12 months that were descriptively higher than those of prior published website-delivered interventions and telephone counselor-delivered interventions.

Project description:BACKGROUND:The content of online computer-tailored interventions is often determined to match an individual's characteristics, beliefs, and behavioral factors. These content-tailored interventions lead to better message processing and a higher likelihood of behavior change such as smoking cessation. However, a meta-analysis of online computer-tailored interventions showed that effect sizes, albeit positive, remain small, suggesting room for improvement. A promising strategy to enhance the effectiveness of online computer-tailored interventions is to tailor the message frame (ie, how a message is communicated) based on the preferred communication style of the user in addition to content-tailoring. One factor that determines an individual's communication style preference is the need for autonomy; some individuals prefer an autonomy-supportive communication style (offering choice and use of suggestive language), whereas others might prefer a directive communication style, which is replete with imperatives and does not provide choice. Tailoring how messages are presented (eg, based on the need for autonomy) is called message frame-tailoring. OBJECTIVE:The aim of the present study was to test the effectiveness of message frame-tailoring based on the need for autonomy, in isolation and in combination with content-tailoring, within the context of an online computer-tailored smoking cessation intervention. The primary outcome measure was the 7-day point-prevalence of smoking abstinence. Secondary outcomes were perceived message relevance, self-determined motivation to quit smoking, and sociocognitive beliefs. METHODS:A randomized controlled trial with a 2 (message frame-tailoring vs no message frame-tailoring) by 2 (content-tailoring vs no content-tailoring) design was conducted among adult smokers intending to quit smoking (N=273). RESULTS:Structural equation modeling revealed that the content-tailored condition increased smoking abstinence rates 1 month after the start of the intervention (beta=.57, P=.02). However, neither message frame-tailoring nor its interaction with content-tailoring significantly predicted smoking abstinence. In our model, message frame-tailoring, content-tailoring, as well as their interaction significantly predicted perceived relevance of the smoking cessation messages, which consequently predicted self-determined motivation. In turn, self-determined motivation positively affected attitudes and self-efficacy for smoking cessation, but only self-efficacy consequently predicted smoking abstinence. Participants in the control condition perceived the highest level of message relevance (mean 4.78, SD 1.27). However, messages that were frame-tailored for individuals with a high need for autonomy in combination with content-tailored messages led to significantly higher levels of perceived message relevance (mean 4.83, SD 1.03) compared to those receiving content-tailored messages only (mean 4.24, SD 1.05, P=.003). CONCLUSIONS:Message frame-tailoring based on the need for autonomy seems to be an effective addition to conventional content-tailoring techniques in online smoking cessation interventions for people with a high need for autonomy; however, this is not effective in its current form for people with a low need for autonomy. TRIAL REGISTRATION:Dutch Trial Register (NL6512/NRT-6700); https://www.trialregister.nl/trial/6512.

Project description:IntroductionDespite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments.MethodsTrial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization.ResultsCessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home.ConclusionsSubstantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers' willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions.ImplicationsThe findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers' willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.