This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group.
To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose–response relationships between abstinence and adherence to the programs.
The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted.
In the observed case analysis of the randomized sample, abstinence rates were 22% (45/202) in the control group versus 33% (63/190) in the AP program and 31% (53/174) in the AP+ program. The AP program (odds ratio 1.95,
Despite the differences in results caused by the variation in our analysis approaches, we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline. However, adherence to the intervention seems critical for effectiveness. Finally, our results also suggest that more research is needed to assess the optimum intervention dose.
Dutch Trial Register: NTR1892; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1892 (Archived by WebCite at http://www.webcitation.org/693S6uuPM)
Smoking relapse rates can be extremely high (up to 90% in the first 3 months), and only 3%-5% of quitters maintain their quit attempt for 6 months or longer [
Adding action planning components to programs may be a promising strategy for improving smoking relapse prevention programs [
The Internet has proven to be a promising delivery mode for health-promoting and lifestyle-changing interventions (for instance, [
In sum, the main goal of the Stay Quit for You (SQ4U) study was to assess the efficacy of two relapse prevention programs: (1) an action planning (AP) program that provided tailored feedback based on the baseline questionnaire and 6 preparatory and coping planning assignments, and (2) an action planning plus (AP+) program that extended the AP program by providing tailored feedback at 11 time points after the quit date. The efficacy of the programs was compared with that of a control group (with no intervention). Moreover, we aimed to assess possible dose–response relationships between abstinence and adherence to the number of program elements. First, we expected both programs to be more effective than the control condition in fostering continued abstinence 12 months after the start of the study (hypothesis 1). We expected the AP+ program to be the most effective. Moreover, we expected to find a dose–response relationship between continued abstinence and intervention dose (hypothesis 2). Finally, we will provide an overview of the respondents’ program evaluations.
Ethics approval was obtained from the Medical Ethics Committee of Maastricht Academic Hospital and Maastricht University (MEC 08-3-003; NL21414.068.08). The study is registered with the Dutch Trial Register (NTR1892).
We recruited smokers by placing ads in local newspapers, distributing 10,000 flyers in the city of Maastricht, and placing online ads on the websites of national health funds, a national news page, and the Dutch Foundation for a Smoke-free Future. The ads referred the respondents to our research website for more information. All data were gathered via the Web and there was no face-to-face contact between respondents and the study team. A software program randomly assigned a total of 2681 respondents to one of the three conditions using a simple randomization type (see design below). The enrollment and inclusion of respondents is presented in
Enrollment and inclusion of respondents. NA = not applicable. a All respondents as randomly assigned, b modified sample excluding respondents who indicated after their quit date as well as at follow-up that they did not make a quit attempt during the study and respondents who quit too close to follow-up (see Analyses section in the Methods), c minimum dose sample additionally excluding respondents who did not adhere to at least one intervention element.
The SQ4U study was a randomized controlled study with a control condition and two experimental conditions. Respondents registered via the research website and made their own login account (each time they were invited for participation they received this account in the invitation mail). After registration, respondents were randomly assigned to one of the three programs outlined in the Introduction. Respondents in the intervention groups were invited by email or text message (optional) to perform intervention tasks (eg, filling out a planning assignment). The same procedure was used to invite all respondents for the 12-month follow-up measurement. Reminder emails were sent when respondents did not respond to the follow-up measurement, which asked them to report on their smoking behavior using self-assessed questionnaires. Respondents who reported that they were abstinent were asked to take biochemical validation tests (see below). Respondents who completed all parts of their assigned SQ4U variant (including those in the control group) were eligible to win 1 of 20 prizes of €250. A more detailed description of the development, design, study course, biochemical validation, and intervention elements can be found elsewhere [
We used cotinine assessments to validate reports of abstinence in a subsample (n = 70) of the respondents. This verified the nonsmoking status self-reported by respondents at the 12-month follow-up measurement. Only 1 (1%) respondent showed positive cotinine results and admitted to having smoked. Another respondent admitted to smoking when invited for biochemical validation. The smoking status for these 2 (3%) respondents was changed to relapse.
Feedback focused on respondents’ perceptions of smoking and quitting and was based on previously tested effective computer tailoring programs that used the I-Change Model [
Since planning assignments have proven to be promising strategies to foster cessation and prevent relapse, the SQ4U programs incorporated assignments designed to motivate respondents to use these strategies to make a quit attempt (first 3 assignments, prior to quit date) and to prevent relapse (final 3 assignments, after quit date). Two assignments focused on making and carrying out preparatory plans; 2 more assignments addressed coping planning. Finally, 1 assignment focused on a specific coping plan (making an emergency plan for coping in case of a lapse) and 1 assignment required making a specific preparatory plan (planning a reward for abstaining from smoking for some time).
Studies that use ecological momentary assessments to gain in-depth, day-to-day information on the process of quitting have noted that low self-efficacy and negative affect preceded lapsing [
The following basic information was collected about each respondent:
The following questions about intention and motivational factors were based on questions used in previous studies [
o
o
o
o
o
Continued abstinence at 12 months after baseline was the primary outcome. In line with the definitions provided by Hughes et al [
The most common approach to analyzing the effects of interventions is to include all respondents randomly assigned to the programs. The advantage to this approach is that it reflects the situation as it is likely to occur in practice (where low adherence levels and not following program protocols will also be common). This strategy also maintains the balance between randomly assigned groups and preserves sample sizes [
Sample 1 is the
Sample 2, referred to as
Sample 3, referred to as the
For all three samples, we conducted an observed case analysis (only including respondents with follow-up data) and a conservative analysis in which we assumed that participants missing at follow-up had relapsed to smoking. We used a logistic regression analysis to compare the efficacy of the control condition and the SQ4U programs to foster continued smoking abstinence after 12 months. Differences in baseline factors (demographics, smoking-related factors, perceived stress, depression, intention strength, social influence, attitude, self-efficacy, recovery self-efficacy, and preparatory planning) were assessed using chi-square tests for categorical variables and analysis of variance for continuous variables. Attrition was analyzed by logistic regression and included baseline factors. To preserve power, we included only baseline factors on which the three conditions significantly differed at baseline as well as the factors that significantly predicted dropout at follow-up as covariates in the effect analyses. Listwise deletion with regard to missing values was used. Finally, chi-square tests were used to assess the existence of dose-response relationships within the SQ4U programs using the observed cases in sample 2 (the modified sample) to conform to the methods used by Borland et al [
In the control condition, 434 of 636 (68.2%) were lost to follow-up versus 508 of 698 (72.8%) in the AP program and 523 of 697 (75.0%) in the AP+ program (
Means and baseline differences between the three programs in demographic and smoking-related variables.
Characteristic | Overall |
Control |
APa
|
AP+b
|
|
|
|
Female gender, n (%) | 1265 (62.3%) | 381 (59.9%) | 442 (63.3%) | 442 (63.4%) | 2.2 | .33 | |
Age (years), mean (SD) | 40.88 (11.80) | 40.68 (11.81) | 40.75 (11.48) | 41.18 (12.12) | 0.36 | .70 | |
|
6.4 | .17 | |||||
Low | 207 (10.2%) | 57 (9%) | 86 (12%) | 64 (9%) | |||
Medium | 1130 (55.6%) | 357 (56.1%) | 371 (53.2%) | 402 (57.7%) | |||
High | 694 (34.2%) | 222 (34.9%) | 241 (34.5%) | 231 (33.1%) | |||
Cigarettes smoked per day, mean (SD) | 19.85 (8.73) | 19.85 (8.39) | 19.89 (9.36) | 19.80 (8.41) | 0.02 | .98 | |
Smoking duration (years), mean (SD) | 24.81 (11.96) | 24.61 (11.90) | 24.79 (11.58) | 25.01 (12.41) | 0.19 | .83 | |
Previous quit attempts (yes), n (%) | 1887 (92.9%) | 588 (92.5%) | 654 (93.7%) | 645 (92.5%) | 1.0 | .61 | |
Nicotine dependence, mean (SD)d | 4.53 (2.18) | 4.57 (2.21) | 4.48 (2.13) | 4.55 (2.19) | 0.26 | .77 |
a Action planning.
b Action planning plus.
c Degrees of freedom (DF) = 2 for all except for educational level (DF = 4).
d Sum score of abbreviated Fagerström test (0 = not dependent, 9 = very dependent).
12-month abstinence rates per program for the three samples using observed and conservative analyses.
Sample | Observed | Conservative | ||||||
n | n (%) abstinent | n | n (%) abstinent | |||||
Total | Control | APa | AP+b | Total | Control | AP | AP+ | |
1c | 566 | 45 (22%) | 63 (33%) | 53 (31%) | 2031 | 45 (7%) | 63 (9%) | 53 (8%) |
2d | 418 | 45 (34%) | 63 (44%) | 53 (37%) | 1812 | 45 (8%) | 63 (10%) | 53 (8%) |
3e | 389 | 45 (34%) | 60 (46%) | 49 (39%) | 1324 | 45 (8%) | 60 (14%) | 49 (15%) |
a Action planning.
b Action planning plus.
c Including all respondents as randomly assigned.
d Modified sample excluding respondents who indicated after their quit date as well as at follow-up that they did not make a quit attempt during the study and respondents who quit too close to follow-up (see Analyses section in the Methods).
e Minimum dose sample additionally excluding those who adhered to none of the intervention elements of their SQ4U variant.
Regression 12-month continued abstinence on the APa and AP+b program in sample 1 (observed cases, n = 559; conservative analysis, n = 1974), sample 2 (observed cases, n = 412; conservative analysis, n = 1757), and sample 3 (observed cases, n = 383; conservative analysis, n = 1297).
Variable | Observed case analysisc | Conservative analysisd | |||||
ORe | 95% CIf |
|
OR | 95% CI |
|
||
|
|||||||
Gender | 1.15 | 0.77–1.71 | .50 | .91 | 0.64–1.29 | .59 | |
Age | 1.01 | 0.99–1.03 | .26 | 1.02 | 1.01–1.04 | .002 | |
Low education level (highh) | 1.61 | 0.75–3.43 | .22 | .76 | 0.40–1.43 | .40 | |
Pros of relapse | 0.87 | 0.63–1.20 | .39 | 1.00 | 0.76–1.32 | .98 | |
Self-efficacy | 1.51 | 1.14–1.99 | .004 | 1.64 | 1.29–2.07 | <.001 | |
AP program (controlh) | 1.95 | 1.23–3.11 | .005 | 1.38 | 0.92–2.08 | .12 | |
AP+ program (controlh) | 1.61 | 1.00–2.60 | .049 | 1.12 | 0.73–1.70 | .61 | |
|
|||||||
Gender | 1.12 | 0.73–1.73 | .59 | .88 | 0.62–1.25 | .48 | |
Age | 1.01 | 0.99–1.03 | .28 | 1.03 | 1.01–1.04 | .001 | |
Low education level (highh) | 1.69 | 0.73–3.95 | .22 | .71 | 0.37–1.34 | .29 | |
Pros of relapse | 0.81 | 0.57–1.15 | .23 | 1.00 | 0.76–1.32 | .99 | |
Self-efficacy | 1.39 | 1.03–1.89 | .03 | 1.62 | 1.28–2.06 | <.001 | |
AP program (controlh) | 1.71 | 1.03–2.83 | .04 | 1.29 | 0.86–1.95 | .23 | |
AP+ program (controlh) | 1.22 | 0.73–2.03 | .44 | .99 | 0.65–1.52 | .98 | |
|
|||||||
Gender | 1.17 | 0.75–1.83 | .49 | .87 | 0.61–1.26 | .47 | |
Age | 1.01 | 0.99–1.03 | .31 | 1.02 | 1.01–1.04 | .005 | |
Low education level (highh) | 1.95 | 0.81–4.72 | .14 | .87 | 0.45–1.68 | .68 | |
Pros of relapse | 0.86 | 0.60–1.23 | .41 | 1.06 | 0.80–1.42 | .68 | |
Self-efficacy | 1.43 | 1.04–1.96 | .03 | 1.53 | 1.19–1.97 | .001 | |
AP program (controlh) | 1.84 | 1.10–3.07 | .02 | 1.72 | 1.13–2.61 | .01 | |
AP+ program (controlh) | 1.36 | 0.80–2.29 | .26 | 1.76 | 1.13-2.73 | .01 |
a Action planning.
b Action planning plus.
c Sample including only respondents with follow-up data.
d Sample including missing data at follow-up as treatment failures.
e Odds ratio.
f Confidence interval.
g Including all respondents as randomly assigned.
h Reference category.
i Modified sample excluding respondents who indicated after their quit date as well as at follow-up that they did not make a quit attempt during the study and respondents who quit too close to follow-up (see Analyses section in the Methods).
j Minimum dose sample excluding those who did not adhere to at least one of the SQ4U elements.
12-month continued abstinence rates stratified by the number of planning assignments and feedback moments in the modified sample (sample 2).
Stratification | Dose | APa | AP+b | ||
nc | n (%) |
nc | n (%) |
||
Per number of assignments | 0–1 | 27 | 6 (22%) | 23 | 4 (17%) |
2–4 | 53 | 24 (45%) | 49 | 13 (27%) | |
5–6 | 62 | 33 (53%) | 70 | 36 (51%) | |
Total, mean (SD) | 3.71 (2.00) | 3.95 (1.93) | |||
χ2 1 | 7.4 | 14.7 | |||
|
.007 | <.001 | |||
Per number of feedback moments | 0–5 | NAd | NA | 66 | 10 (15%) |
6–7 | NA | NA | 12 | 4 (33%) | |
8–9 | NA | NA | 31 | 19 (61%) | |
10–11 | NA | NA | 33 | 20 (61%) | |
Total, mean (SD) | NA | 5.77 (3.83) | |||
χ2 1 | NA | 24.5 | |||
|
NA | <.001 |
a Action planning.
b Action planning plus.
c Only complete cases.
d Not applicable, as the AP program did not provide tailored feedback after the quit date.
Program evaluation (conducted 6 months after baseline) by respondents from the APa and the AP+b programs.
Evaluation item | Total |
AP |
AP+ |
χ2 2 |
|
||
|
|||||||
Remembered the content | 9.7 | .008 | |||||
Yes | 142 (57.3%) | 72 (53%) | 70 (63%) | ||||
Neutral | 63 (25%) | 32 (23%) | 31 (28%) | ||||
No | 43 (17%) | 33 (24%) | 10 (9%) | ||||
Perceived feedback as useful | 4.4 | .111 | |||||
Yes | 156 (62.9%) | 79 (58%) | 77 (69%) | ||||
Neutral | 68 (27%) | 41 (30%) | 27 (24%) | ||||
No | 24 (10%) | 17 (12%) | 7 (6%) | ||||
Perceived feedback as relevant | 8.8 | .012 | |||||
Yes | 121 (48.8%) | 56 (41%) | 65 (59%) | ||||
Neutral | 98 (40%) | 60 (44%) | 38 (34%) | ||||
No | 29 (12%) | 21 (15%) | 8 (7%) | ||||
Perceived feedback as understandable | 3.8 | .152 | |||||
Yes | 208 (83.9%) | 110 (80.3%) | 98 (88%) | ||||
Neutral | 34 (14%) | 24 (18%) | 10 (9%) | ||||
No | 6 (2%) | 3 (2%) | 3 (3%) | ||||
Recognized own situation in feedback | 0.2 | .92 | |||||
Yes | 117 (47.2%) | 63 (46%) | 54 (49%) | ||||
Neutral | 101 (40.7%) | 57 (42%) | 44 (40%) | ||||
No | 30 (12%) | 17 (12%) | 13 (12%) | ||||
Perceived feedback as credible | 3.6 | .16 | |||||
Yes | 170 (68.5%) | 87 (64%) | 83 (75%) | ||||
Neutral | 67 (27%) | 43 (31%) | 24 (22%) | ||||
No | 11 (4%) | 7 (5%) | 4 (4%) | ||||
Feedback helped to make a quit attempt | 6.7 | .04 | |||||
Yes | 107 (43.1%) | 51 (37%) | 56 (50%) | ||||
Neutral | 73 (29%) | 49 (36%) | 24 (22%) | ||||
No | 68 (27%) | 37 (27%) | 31 (28%) | ||||
Feedback helped to maintain quit attempt | 3.7 | .16 | |||||
Yes | 72 (29%) | 33 (24%) | 39 (35%) | ||||
Neutral | 65 (26%) | 38 (28%) | 27 (24%) | ||||
No | 111 (44.8%) | 66 (48%) | 45 (41%) | ||||
|
n = 164 | n = 93 | n = 71 | ||||
Perceived feedback as useful | 4.0 | .14 | |||||
Yes | 87 (53%) | 49 (53%) | 38 (54%) | ||||
Neutral | 62 (38%) | 32 (34%) | 30 (42%) | ||||
No | 15 (9%) | 12 (13%) | 3 (4%) | ||||
Feedback helped to make a quit attempt | 5.6 | .06 | |||||
Yes | 72 (44% | 37 (40%) | 35 (49%) | ||||
Neutral | 57 (35%) | 30 (32%) | 27 (38%) | ||||
No | 35 (21%) | 26 (28%) | 9 (13%) | ||||
Feedback helped to maintain quit attempt | 5.1 | .08 | |||||
Yes | 51 (31%) | 27 (29%) | 24 (34%) | ||||
Neutral | 56 (34% | 27 (29%) | 29 (41%) | ||||
No | 57 (35%) | 39 (42%) | 18 (25%) | ||||
|
|||||||
Perceived feedback as useful | |||||||
Yes | 66 (63%) | NAc | 66 (63%) | ||||
Neutral | 26 (25%) | NA | 26 (25%) | ||||
No | 12 (12%) | NA | 12 (12%) | ||||
Feedback helped to make a quit attempt | |||||||
Yes | 49 (47%) | NA | 49 (47%) | ||||
Neutral | 32 (31%) | NA | 32 (31%) | ||||
No | 23 (22%) | NA | 23 (22%) | ||||
Feedback helped to maintain quit attempt | |||||||
Yes | 50 (48%) | NA | 50 (48%) | ||||
No | 54 (52%) | NA | 54 (52%) |
a Action planning.
b Action planning plus.
c Not applicable.
The main goal of this study was to evaluate the efficacy of two Web-based smoking relapse prevention programs (AP and AP+) in the SQ4U study with regard to 12-month continued smoking abstinence. Furthermore, we aimed to assess dose-response associations. Despite the potential of the Internet, a recurrent problem in Internet trials is low adherence to the programs [
The results of all three observed case analyses (samples 1, 2, and 3) revealed significant effects in favor of the AP program. We can conclude that most of the analyses support our first hypothesis that planning strategies can be effective in preventing relapse among smokers who are motivated to quit smoking. The AP+ program, on the other hand, only proved to be significantly more effective than the control condition in the randomized sample (sample 1). The approach for sample 2 seems to have created a bias against the AP+ program by excluding respondents who did not make a quit attempt during the study, which resulted in more exclusions of relapsers (since nonquitters cannot be considered to be continued abstinent at follow-up) in the control condition than in the AP+ program (which consisted of elements designed to foster making a quit attempt). This approach may therefore have been too conservative. Furthermore, additional power analyses showed that 2623 respondents would have been needed to find significant differences in abstinence rate between the control group (45/134, 34%) and the AP+ program group (53/142, 37%). Therefore, the lack of significance in sample 2 may be due to power issues. Another possible explanation for lack of significant effect for the AP+ program in sample 2 and sample 3 may be that the program was too intensive and therefore resulted in an overload for the respondents that negatively influenced its efficacy. A comparable result was found in an earlier study conducted among vocational students, which tested the efficacy of a standard in-school program, a computer-tailored program, and a combined program [
When conducting conservative analyses, we found the AP and AP+ programs to be significantly more effective than the control condition in the minimum dose sample (sample 3). However, given the large dropout rate, this conservative approach (coding missing participants as relapsers) may be too conservative. Additional descriptive analyses indicated that about 60% of the respondents who dropped out at follow-up were nonsmokers at their last visit, indicating that interpreting all missing cases as treatment failures may be too conservative, a finding also supported by others [
The abstinence rate of 22% in the control group is another notable finding, since self-quitters generally reach abstinence rates of only 3%-5% [
Finally, the dose-response relationship between abstinence and the number of program elements suggests that a dose-response association may exist. This is because abstinence rates increased by up to 53% (33/62) in the AP program and 51% (36/70) in the AP+ program when doing 5 to 6 planning assignments, and up to 61% (20/33) in the AP+ program when filling out 10-11 feedback questionnaires (on which feedback was provided). These findings suggest, in line with hypothesis 2, that the efficacy of the programs depends on adherence to the program, also found in previous studies [
The SQ4U study was subject to limitations. The first limitation is that the planning assignments and feedback moments were provided at fixed times, while the varying levels of adherence found in our study suggest that programs should perhaps provide support when the respondent needs it most (ie, by real-time support in difficult situations). Research is needed to explore the potential additional efficacy of such an approach. Second, the cut-off point for the minimum dose sample (sample 3) is not based on empirical findings and needs to be explored in additional studies. Third, because of medical ethics guidelines, we could not prevent respondents from using additional help to quit smoking. The use of additional help, however, may interfere with the effects of the programs and may be beneficial or counterproductive. Further research is needed to explore which additional aids may have positive or negative effects. Fourth, our study had a high rate of loss to follow-up (1465/2031, 72.1%), an issue that is very common in comparable studies [
Aside from these limitations, our SQ4U study is the first to test the efficacy of incorporating planning assignments in a Web-based computer-tailored relapse prevention program and of combining planning assignments with multiple tailored feedback moments after the quit date. The study reflected on the findings from different samples, and the results pointed out the importance of using planning strategies and tailored feedback moments after the quit date for smokers who are motivated to quit. Previous studies indicated that a lack of preparatory planning is associated with smoking relapse [
Action planning (program)
Action planning plus (program)
confidence interval
Integrated Change Model
odds ratio
Stay Quit for You
This study was funded by the Dutch Organization for Health Research and Innovation (grant number 6130-0030). We would like to thank Claire Jeukens and Verina Servranck for their contribution to the development and piloting of the SQ4U program materials. We would also like to thank Stivoro for their help in recruiting respondents, as well as the respondents for their participation in the study.
None declared.
CONSORT eHealth V1.6.1 checklist [