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Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Siemer L

PROVIDER: S-EPMC7413278 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.

Siemer Lutz L Brusse-Keizer Marjolein G J MGJ Postel Marloes G MG Ben Allouch Somaya S Sanderman Robbert R Pieterse Marcel E ME

Journal of medical Internet research 20200723 7

<h4>Background</h4>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.<h4>Objective</h4>The objectives of this study were (1) to compare adherence to a blended smoking cess ...[more]

PMID: 32459643

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Project description:BACKGROUND:Blended face-to-face and Web-based treatment is a promising way to deliver cognitive behavioral therapy. Since adherence has been shown to be a measure for treatment's acceptability and a determinant for treatment's effectiveness, in this study, we explored adherence to a new blended smoking cessation treatment (BSCT). OBJECTIVE:The objective of our study was to (1) develop an adequate method to measure adherence to BSCT; (2) define an adequate degree of adherence to be used as a threshold for being adherent; (3) estimate adherence to BSCT; and (4) explore the possible predictors of adherence to BSCT. METHODS:The data of patients (N=75) were analyzed to trace adherence to BSCT delivered at an outpatient smoking cessation clinic. In total, 18 patient activities (eg, using a Web-based smoking diary tool or responding to counselors' messages) were selected to measure adherence; the degree of adherence per patient was compared with quitting success. The minimum degree of adherence of patients who reported abstinence was examined to define a threshold for the detection of adherent patients. The number of adherent patients was calculated for each of the 18 selected activities; the degree of adherence over the course of the treatment was displayed; and the number of patients who were adherent was analyzed. The relationship between adherence and 33 person-, smoking-, and health-related characteristics was examined. RESULTS:The method for measuring adherence was found to be adequate as adherence to BSCT correlated with self-reported abstinence (P=.03). Patients reporting abstinence adhered to at least 61% of BSCT. Adherence declined over the course of the treatment; the percentage of adherent patients per treatment activity ranged from 82% at the start of the treatment to 11%-19% at the final-third of BSCT; applying a 61% threshold, 18% of the patients were classified as adherent. Marital status and social modeling were the best independent predictors of adherence. Patients having a partner had 11-times higher odds of being adherent (OR [odds ratio]=11.3; CI: 1.33-98.99; P=.03). For social modeling, graded from 0 (=partner and friends are not smoking) to 8 (=both partner and nearly all friends are smoking), each unit increase was associated with 28% lower odds of being adherent (OR=0.72; CI: 0.55-0.94; P=.02). CONCLUSIONS:The current study is the first to explore adherence to a blended face-to-face and Web-based treatment (BSCT) based on a substantial group of patients. It revealed a rather low adherence rate to BSCT. The method for measuring adherence to BSCT could be considered adequate because the expected dose-response relationship between adherence and quitting could be verified. Furthermore, this study revealed that marital status and social modeling were independent predictors of adherence. TRIAL REGISTRATION:Netherlands Trial Registry NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113 (Archived by WebCite at http://www.webcitation.org/71BAPwER8).

Project description:BACKGROUND:Blended web-based and face-to-face (F2F) treatment is a promising electronic health service because the strengths of one mode of delivery should compensate for the weaknesses of the other. OBJECTIVE:The aim of this study was to explore this compensation by examining patients' user experience (UX) in a blended smoking cessation treatment (BSCT) in routine care. METHODS:Data on patients' UX were collected through in-depth interviews (n=10) at an outpatient smoking cessation clinic in the Netherlands. A content analysis of the semantic domains was used to analyze patients' UX. To describe the UX, the Hassenzahl UX model was applied, examining 4 of the 5 key elements of UX from a user's perspective: (1) patients' standards and expectations, (2) apparent character (pragmatic and hedonic attributes), (3) usage situation, and (4) consequences (appeal, emotions, and behavior). RESULTS:BSCT appeared to be a mostly positively experienced service. Patients had a positive-pragmatic standard and neutral-open expectation toward BSCT at the treatment start. The pragmatic attributes of the F2F sessions were mostly perceived as positive, whereas the pragmatic attributes of the web sessions were perceived as both positive and negative. For the hedonic attributes, there seemed to be a difference between the F2F and web sessions. Specifically, the hedonic attributes of the web sessions were experienced as mostly negative, whereas those of the F2F sessions were experienced as mostly positive. For the usage situation, the physical and social contexts were experienced positively, whereas the task and technical contexts were experienced negatively. Nevertheless, the consequential appeal of BSCT was positive. However, the consequential emotions and behavior varied, ultimately resulting in diverse combinations of consequential appeal, emotions, and behavior (positive, negative, and mixed). CONCLUSIONS:This study provided insights into the UX of a blended treatment, and the results support the expectation that in a blended treatment, the strengths of one mode of delivery may compensate for the weaknesses of the other. However, in this certain setting, this is mainly achieved in only one way: F2F sessions compensated for the weaknesses of the web sessions. As a practical conclusion, this may mean that the web sessions, supported by the strengths of the F2F sessions, offer an interesting approach for further improving the blended treatment. Our theoretical findings reflect the relevance of the aspects of hedonism, such as fun, joy, or happiness in the UX, which were not mentioned in relation to the web sessions and were only scarcely mentioned in relation to the F2F sessions. Future research should further investigate the role of hedonistic aspects in a blended treatment and whether increased enjoyment of a blended treatment could increase treatment adherence and, ultimately, effectiveness.

Project description:BACKGROUND:Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. OBJECTIVE:This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. METHODS:A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. RESULTS:We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. CONCLUSIONS:Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. TRIAL REGISTRATION:University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).

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:BackgroundPre-treatment factors that increase smokers' risk of experiencing neuropsychiatric adverse events (NPSAEs) when quitting smoking are unknown.ObjectiveTo identify baseline smoker characteristics beyond the history of mental illness that predict which participants were more likely to experience moderate to severe NPSAEs in EAGLES.DesignA prospective correlational cohort study in the context of a multinational, multicenter, double-blind, randomized trial.ParticipantsSmokers without (N = 3984; NPC)/with (N = 4050; PC) histories of, or current clinically stable, psychiatric disorders including mood (N = 2882; 71%), anxiety (N = 782; 19%), and psychotic (N = 386; 10%) disorders.InterventionsBupropion, 150 mg twice daily, or varenicline, 1 mg twice daily, versus active control (nicotine patch, 21 mg/day with taper) and placebo for 12 weeks with 12-week non-treatment follow-up.Main measuresPrimary safety outcome was the incidence of a composite measure of moderate/severe NPSAEs. Associations among baseline demographic/clinical characteristics and the primary safety endpoint were analyzed post hoc via generalized linear regression.Key resultsThe incidence of moderate to severe NPSAEs was higher among smokers in the PC (238/4050; 5.9%) than in the NPC (84/3984; 2.1%). Three baseline characteristics predicted increased risk for experiencing clinically significant NPSAEs when quitting regardless of carrying a psychiatric diagnosis: current symptoms of anxiety (for every ~ 4-unit increase in HADS anxiety score, the absolute risk of occurrence of the NPSAE endpoint increased by 1% in both PC and NPC); prior history of suicidal ideation and/or behavior (PC, 4.4% increase; P = 0.001; NPC, 4.1% increase; P = 0.02), and being of White race (versus Black: PC, 2.9% ± 0.9 [SE] increase; P = 0.002; and NPC, 3.4% ± 0.8 [SE] increase; P = 0.001). Among smokers with psychiatric disorders, younger age, female sex, history of substance use disorders, and proxy measures of nicotine dependence or psychiatric illness severity also predicted greater risk. There were no significant interactions between these characteristics and treatment. Smokers with unstable psychiatric disorders or with current, active substance abuse were excluded from the study.ConclusionsIrrespective of cessation pharmacotherapy use, smokers attempting to quit were more likely to experience moderate to severe NPSAEs if they reported current anxiety or prior suicidal ideation at baseline and were White. In smokers with a psychiatric history, female sex, younger age, and greater severity of nicotine dependence were also predictive.Trial registrationClinicalTrials.gov Identifier: NCT01456936.

Dataset Information

Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.

Publications

Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.

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