Addressing heavy drinking in smoking cessation treatment: a randomized clinical trial

Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117). Across follow-ups over 26 weeks, participants in ST-BI reported approximately 20% fewer drinks per week (p < .027) and greater smoking abstinence (adjusted odds ratio = 1.56; 95% confidence interval = 1.01, 2.43) than did those in ST; however, effects on smoking were primarily evident at 2 weeks after quit date and were essentially absent by 16 weeks. The effect of ST-BI on smoking outcome was most robust among moderately heavy drinkers compared with that on very heavy drinkers. Integrating brief alcohol intervention into smoking cessation treatment appears feasible, but further development is needed to yield lasting effects on smoking.     

A theory-based video messaging mobile phone intervention for smoking cessation: randomized controlled trial

Background

Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called “STUB IT”) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques.

Objective

The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation.

Methods

A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks.

Results

The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated.

Conclusions

This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation.

Trial registration

Australian New Zealand Clinical Trials Registry Number: ACTRN12606000476538; http://www.anzctr.org.au/trial_view.aspx?ID=81688 (Archived by WebCite at http://www.webcitation.org/5umMU4sZi)     

Effect of tailoring in an internet-based intervention for smoking cessation: randomized controlled trial

Background

Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components.

Objective

The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content.

Methods

We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email.

Results

Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P < .001). The corresponding figures at 3 months were 13.5% (122/902) and 9.4% (84/896, P =.006) and at 12 months were 11.2% (47/419) and 11.7% (50/428, P = .91). Likewise, the intervention group had higher self-efficacy and perceived tailoring at 1 and 3 months. Self-efficacy was found to partially mediate the effect of the intervention.

Conclusion

Tailoring an Internet-based intervention for smoking cessation seems to increase the success rates in the short term, but not in the long term.     

The role of engagement in a tailored web-based smoking cessation program: randomized controlled trial

Background

Web-based programs for health promotion, disease prevention, and disease management often experience high rates of attrition. There are 3 questions which are particularly relevant to this issue. First, does engagement with program content predict long-term outcomes? Second, which users are most likely to drop out or disengage from the program? Third, do particular intervention strategies enhance engagement?

Objective

To determine: (1) whether engagement (defined by the number of Web sections opened) in a Web-based smoking cessation intervention predicts 6-month abstinence, (2) whether particular sociodemographic and psychographic groups are more likely to have lower engagement, and (3) whether particular components of a Web-based smoking cessation program influence engagement.

Methods

A randomized trial of 1866 smokers was used to examine the efficacy of 5 different treatment components of a Web-based smoking cessation intervention. The components were: high- versus low-personalized message source, high- versus low-tailored outcome expectation, efficacy expectation, and success story messages. Moreover, the timing of exposure to these sections was manipulated, with participants randomized to either a single unified Web program with all sections available at once, or sequential exposure to each section over a 5-week period of time. Participants from 2 large health plans enrolled to receive the online behavioral smoking cessation program and a free course of nicotine replacement therapy (patch). The program included: an introduction section, a section focusing on outcome expectations, 2 sections focusing on efficacy expectations, and a section with a narrative success story (5 sections altogether, each with multiple screens). Most of the analyses were conducted with a stratification of the 2 exposure types. Measures included: sociodemographic and psychosocial characteristics, Web sections opened, perceived message relevance, and smoking cessation 6-months following quit date.

Results

The total number of Web sections opened was related to subsequent smoking cessation. Participants who were younger, were male, or had less formal education were more likely to disengage from the Web-based cessation program, particularly when the program sections were delivered sequentially over time. More personalized source and high-depth tailored self-efficacy components were related to a greater number of Web sections opened. A path analysis model suggested that the impact of high-depth message tailoring on engagement in the sequentially delivered Web program was mediated by perceived message relevance.

Conclusions

Results of this study suggest that one of the mechanisms underlying the impact of Web-based smoking cessation interventions is engagement with the program. The source of the message, the degree of message tailoring, and the timing of exposure appear to influence Web-based program engagement.     

A controlled smoking cessation trial for substance-dependent inpatients

Smoking treatment for newly recovering drug and alcohol-dependent smokers in a residential rehabilitation program was examined. The randomly assigned conditions (n = 50 each) were multicomponent smoking treatment (MST), MST plus generalization training of smoking cessation to drug and alcohol cessation (MST+G), or usual care (UC). Fifty participants who declined smoking treatment (treatment refusers) also were studied. Both treatment conditions achieved continuous smoking abstinence rates (MST: 12%, MST+G: 10%, at 12-month follow-up) that were significantly higher than in the UC condition (0%). The MST condition had a continuous drug and alcohol abstinence rate that was significantly higher than that of the MST+G condition (40% vs. 20% at 12-month follow-up) although neither differed significantly from that of the UC condition (33%). These results support the feasibility of smoking treatment for this population and provide information regarding appropriate treatment components.     

Effectiveness of a Web-based multiple tailored smoking cessation program: a randomized controlled trial among Dutch adult smokers

Background

Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver. Most important, a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained. However, such a smoking cessation program has yet to be developed and implemented in the Netherlands.

Objective

To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers.

Methods

Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet. Those interested and motivated to quit smoking within 6 months (N = 1123) were randomly assigned to either the experimental (n = 552) or control group (n = 571). Respondents in the experimental group received the fully automated Web-based smoking cessation program, while respondents in the control group received no intervention. After 6 weeks and after 6 months, we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence, 7-day point prevalence abstinence, and prolonged abstinence using logistic regression analyses.

Results

Of the 1123 respondents, 449 (40.0%) completed the 6-week follow-up questionnaire and 291 (25.9%) completed the 6-month follow-up questionnaire. We used a negative scenario to replace missing values. That is, we considered respondents lost to follow-up to still be smoking. The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence (odds ratio [OR] 1.85, 95% confidence interval [CI] 1.30–2.65), 7-day point prevalence abstinence (OR 2.17, 95% CI 1.44–3.27), and prolonged abstinence (OR 1.99, 95% CI 1.28–3.09) rates reported after 6 weeks. After 6 months, however, no intervention effects could be identified. Results from complete-case analyses were similar.

Conclusions

The results presented suggest that the Web-based computer-tailored smoking cessation program had a significant effect on abstinence reported after a 6-week period. At the 6-month follow-up, however, no intervention effects could be identified. This might be explained by the replacement of missing values on the primary outcome measures due to attrition using a negative scenario. While results were similar when using a less conservative scenario (ie, complete-case analyses), the results should still be interpreted with caution. Further research should aim at identifying strategies that will prevent high attrition in the first place and, subsequently, to identify the best strategies for dealing with missing data when studies have high attrition rates.

Trial Registration

Dutch Trial Register NTR1351; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1351 (Archived by WebCite at http://www.webcitation.org/67egSTWrz)     

A randomised controlled trial of motivational interviewing for smoking cessation

BACKGROUND: Motivational interviewing is a technique used to promote change in addictive behaviour, initially used to treat alcoholism. Despite this, its effectiveness has not been sufficiently demonstrated for giving up smoking. AIM: The aim of the study was to establish whether motivational interviewing, compared with anti-smoking advice, is more effective for giving up the habit. DESIGN OF STUDY: Randomised controlled trial. SETTING: Primary care in Albecete, Spain. METHOD: Random experimental study of 200 smokers assigned to two types of interventions: anti-smoking advice (n = 86) and motivational interviewing (n = 114). Subjects in both groups were offered bupropion when nicotine dependency was high (Fagerstr?m score >7). The success rate was evaluated by intention to treat; point prevalence abstinence was measured 6 and 12 months post intervention by personal testimony, confirmed by means of CO-oximetry (value < 6ppm). RESULTS: The measure of effectiveness of the treatment for giving up smoking after both 6 and 12 months, showed that the motivational interviewing action was 5.2 times higher than anti-smoking advice (18.4 % compared to 3.4%; 95% confidence interval = 1.63 to 17.13). CONCLUSION: The results of our study show that motivational interviewing is more effective than brief advice for giving up smoking.     

Self-help treatment for insomnia: a randomized controlled trial

STUDY OBJECTIVES: Insomnia is a prevalent health complaint that often remains untreated. Several interventions are efficacious but they are not widely available. This study evaluated the efficacy of a self-help behavioral intervention for insomnia. DESIGN: The study used a 2 (conditions; self-help treatment, no treatment control) x 3 (assessments; pretreatment, posttreatment, 6-month follow-up) mixed factorial design. SETTING: This study was part of a larger epidemiologic study conducted with a randomly selected sample of 2001 adults of the province of Quebec in Canada. PARTICIPANTS: One-hundred ninety-two adults (n = 127 women, 65 men; mean age, 46 years) with insomnia, selected from a larger community-based epidemiologic sample, were randomly assigned to self-help treatment (n = 96) or no-treatment control (n = 96). INTERVENTIONS: The self-help intervention included 6 educational booklets mailed weekly to participants and providing information about insomnia, healthy sleep practices, and behavioral sleep scheduling and cognitive strategies. MEASUREMENTS AND RESULTS: Participants completed sleep diaries and questionnaires at pretreatment, posttreatment, and 6-month follow-up. Significant but modest improvements were obtained on subjective sleep parameters for treatment but not control participants. Treated participants averaged nightly gains of 21 minutes of sleep and a reduction of 20 minutes of wakefulness, with a corresponding increase of 4% in sleep efficiency. Improvements were also obtained on measures of insomnia severity (Insomnia Severity Index) and of sleep quality (Pittsburgh Sleep Quality Index), and those changes were maintained at follow-up. CONCLUSIONS: A self-help behavioral intervention was effective in alleviating a broad range of insomnia symptomatology in a community sample. Self-help may be a promising approach to make effective intervention more widely available.     

Online psychoeducational support for infertile women: a randomized controlled trial

BACKGROUND: The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS: A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS: Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress(P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS: This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices.     

Randomized controlled trial of a social support ('buddy') intervention for smoking cessation

OBJECTIVE: To assess the effectiveness of including a social support intervention ('buddy system') in a group treatment programme to aid smoking cessation. METHODS: Five hundred and sixty-three smokers attended groups at a smokers' clinic. These groups were randomized either to be (a) groups in which smokers were paired with another person to provide mutual support (buddy condition: n=237 in 14 groups) or (b) to receive the same treatment without the buddy component (control: n=326 in 20 groups). Participants were seen weekly for the first 4 weeks after stopping then followed up again after 26 weeks. RESULTS: Smokers in the buddy condition were no more likely than smokers in the control condition to stay abstinent at 1, 4 or 26 weeks. The effect was in the right direction at week one post-quit but after controlling for potential confounders the difference was not significant (odds ratio=1.45 (95% CI; 0.92-2.29), p=0.06). CONCLUSIONS: We were unable to show that a buddy system improved abstinence rates of group treatment programmes. This might be due to the high level of social support already achieved through the groups. PRACTICE IMPLICATIONS: The buddy system is a simple and very low cost addition to a group treatment programme; but the results from this study suggest that the kind of buddy system tested may not add substantially to the success rates. However there may be merits in a more intensive or protracted form of buddying.     

Health beliefs as predictors of success of alternate modalities of smoking cessation: Results of a controlled trial

The primary objective of this study was to determine whether health beliefs influenced the outcome of the three alternate modalities of reducing cigarette consumption. The study randomized volunteers either to a control group or to one of three cessation programs, using behavior modification, health education, or hypnosis. A questionnaire was used to document health beliefs, demographic characteristics, and smoking history. Blood samples were taken before and after the completion of intervention programs to measure changes in serum thiocyanate. A follow-up questionnaire was used to assess smoking behavior after 6 months. Statistically significant decreases in serum thiocyanate levels followed participation in each of the three programs. Factor analysis and reliability tests were used to identify four scales reflecting major variable dimensions in the health belief model. Significant correlations between change in serum thiocyanate and two of the scales (general health concern and perceived vulnerability) were found only for the group randomly assigned to the health education intervention program.This research was supported by a three-year grant provided by the Manitoba Medical Services Foundation.     

Multicenter trial of fluoxetine as an adjunct to behavioral smoking cessation treatment

The authors evaluated the efficacy of fluoxetine hydrochloride (Prozac; Eli Lilly and Company, Indianapolis, IN) as an adjunct to behavioral treatment for smoking cessation. Sixteen sites randomized 989 smokers to 3 dose conditions: 10 weeks of placebo, 30 mg, or 60 mg fluoxetine per day. Smokers received 9 sessions of individualized cognitive-behavioral therapy, and biologically verified 7-day self-reported abstinence follow-ups were conducted at 1, 3, and 6 months posttreatment. Analyses assuming missing data counted as smoking observed no treatment difference in outcomes. Pattern-mixture analysis that estimates treatment effects in the presence of missing data observed enhanced quit rates associated with both the 60-mg and 30-mg doses. Results support a modest, short-term effect of fluoxetine on smoking cessation and consideration of alternative models for handling missing data.     

Postpartum smoking cessation and relapse prevention intervention: a structural equation modeling application to behavioral and non-behavioral outcomes of a randomized controlled trial

The aim of the study was to test the effectiveness of a postpartum smoking cessation and relapse prevention intervention. Structural equation modeling techniques were applied to evaluate the impact of the intervention on smoking behavior and on non-behavioral variables derived from the Transtheoretical Model (TTM). Women were randomized to an intervention (I) and control group (C). Smoking status, TTM-variables, and control variables were assessed four weeks, six and 12 months postpartum. Membership in the intervention group significantly predicted non-smoking and higher self-efficacy six months, but not one year postpartum, after controlling for demographic, smoking, and postpartum risk variables.     

Self-administered treatment for smoking cessation

Self-administered treatment for smoking cessation has the potential to reach a broad spectrum of the population of smokers. This article focuses on self-administration of behavioral and pharmacological treatments for smoking cessation. Evidence for the effectiveness of written manuals to self-administer behavioral treatment is mixed. There is no evidence that self-help manuals alone are effective. However, they do increase quit rates when combined with personalized adjuncts such as written feedback and outreach telephone counseling. Efficacy trials of first-line pharmacotherapies (nicotine gum, nicotine patch, and bupropion) result in doubling of cessation rates compared to placebo. It is difficult to evaluate the effectiveness of pharmacotherapies when self-administered under real-world conditions. The general consensus is that they improve quit rates, although poor compliance and early discontinuation reduce their effectiveness. Areas for further research include randomized trials of the use of new technologies (e.g., hand-held computers and the Internet) to disseminate self-administered treatments as well as improved surveillance of the use of self-administered treatment in population-based health surveys.     

A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation

BACKGROUND AND METHODS: Use of nicotine-replacement therapies and the antidepressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects), a nicotine patch (244 subjects), bupropion and a nicotine patch (245 subjects), and placebo (160 subjects) for smoking cessation. Smokers with clinical depression were excluded. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of nicotine-patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8. RESULTS: The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the nicotine-patch group, 30.3 percent in the bupropion group (P<0.001), and 35.5 percent in the group given bupropion and the nicotine patch (P<0.001). By week 7, subjects in the placebo group had gained an average of 2.1 kg, as compared with a gain of 1.6 kg in the nicotine-patch group, a gain of 1.7 kg in the bupropion group, and a gain of 1.1 kg in the combined-treatment group (P<0.05). Weight gain at seven weeks was significantly less in the combined-treatment group than in the bupropion group and the placebo group (P<0.05 for both comparisons). A total of 311 subjects (34.8 percent) discontinued one or both medications. Seventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group (3.8 percent), 16 in the nicotine-patch group (6.6 percent), 29 in the bupropion group (11.9 percent), and 28 in the combined-treatment group (11.4 percent). The most common adverse events were insomnia and headache. CONCLUSIONS: Treatment with sustained-release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant.     

Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial

OBJECTIVE: To compare the effectiveness and tolerability of gabapentin with placebo for the treatment of hot flashes in women who enter menopause naturally. DESIGN: A randomized, double-blind, placebo-controlled trial was conducted across the greater Toronto area between March 2004 and April 2006 in the community and primary care settings. Eligible participants were 200 women in natural menopause, aged 45 to 65 years, having at least 14 hot flashes per week. Study participants were randomized to receive gabapentin 300 mg oral capsules or placebo three times daily for 4 weeks. The primary outcome measure was the mean percentage change from baseline to week 4 in daily hot flash score, determined from participant diaries. Secondary outcome measures included changes in weekly mean hot flash scores and frequencies, quality of life, and adverse events. RESULTS: Of the 197 participants, 193 (98%) completed the study. Analysis was by intention to treat. Hot flash scores decreased by 51% (95% CI: 43%-58%) in the gabapentin group, compared with 26% (95% CI: 18%-35%) on placebo, from baseline to week 4. This twofold improvement was statistically significant (P < 0.001). The Menopause-Specific Quality-of-Life vasomotor score decreased by 1.7 (95% CI: 1.3-2.1; P < 0.001) in the gabapentin group. These women reported greater dizziness (18%), unsteadiness (14%), and drowsiness (12%) at week 1 compared with those taking placebo; however, these symptoms improved by week 2 and returned to baseline levels by week 4. CONCLUSIONS: Gabapentin at 900 mg/day is an effective and well-tolerated treatment for hot flashes.     

Internet‐based treatment for social phobia: a randomized controlled trial

In this study conducted in the French‐speaking part of Switzerland, 52 individuals with social phobia were randomly assigned either to an Internet‐based cognitive–behavioral treatment with minimal contact with therapists via e‐mail or to a waiting‐list control group. Significant differences between the two groups were found at posttreatment on all primary outcome measures (social anxiety measures) and on two of the secondary outcome measures (general symptomatology, therapy goal attainment). On average, within‐groups effect sizes were large for the primary outcomes (Cohen's d=0.82) and for secondary outcomes (Cohen's d=1.04). Moreover, subjects in the treatment group fulfilled the criteria of clinically significant improvement significantly more often than subjects in the control group on all measured dimensions (58% vs. 20%). Users' acceptance of the program was high. The results from the present study lend further support to the hypothesis that Internet‐delivered interventions with minimal therapist contact are a promising treatment approach to social phobia. © 2009 Wiley Periodicals, Inc. J Clin Psychol 65:1–15, 2009.