scholarly journals Smoking cessation with smartphone applications (SWAPP): study protocol for a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Janina Lüscher ◽  
Corina Berli ◽  
Philipp Schwaninger ◽  
Urte Scholz

Abstract Background Tobacco smoking remains one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real-time. The social context of smokers has, however, been neglected in smartphone apps promoting smoking cessation. This randomized controlled trial investigates the effectiveness of a smartphone app in which smokers quit smoking with the help of a social network member. Methods This protocol describes the design of a single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Participants of this study are adult smokers who smoke at least one cigarette per day and intend to quit smoking at a self-set quit date. Blocking as means of group-balanced randomization is used to allocate participants to intervention or control conditions. Both intervention and control group use a smartphone-compatible device for measuring their daily smoking behavior objectively via exhaled carbon monoxide. In addition, the intervention group is instructed to use the SmokeFree Buddy app, a multicomponent app that also facilitates smoking-cessation specific social support from a buddy over a smartphone application. All participants fill out a baseline diary for three consecutive days and are invited to the lab for a background assessment. They subsequently participate in an end-of-day diary phase from 7 days before and until 20 days after a self-set quit date. Six months after the self-set quit date a follow-up diary for three consecutive days takes place. The primary outcome measures are daily self-reported and objectively-assessed smoking abstinence and secondary outcome measures are daily self-reported number of cigarettes smoked. Discussion This is the first study examining the effectiveness of a smoking cessation mobile intervention using the SmokeFree Buddy app compared to a control group in a real-life setting around a self-set quit date using a portable objective measure to assess smoking abstinence. Opportunities and challenges with running studies with smoking participants and certain design-related decisions are discussed. Trial registration This trial was prospectively registered on 04/04/2018 at ISRCTNregistry: ISRCTN11154315.

10.2196/27162 ◽  
2021 ◽  
Vol 23 (9) ◽  
pp. e27162
Author(s):  
Philipp Schwaninger ◽  
Corina Berli ◽  
Urte Scholz ◽  
Janina Lüscher

Background Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7723-z


10.2196/17251 ◽  
2020 ◽  
Vol 22 (4) ◽  
pp. e17251 ◽  
Author(s):  
Maria Altendorf ◽  
Ciska Hoving ◽  
Julia CM Van Weert ◽  
Eline Suzanne Smit

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


2021 ◽  
Author(s):  
Philipp Schwaninger ◽  
Corina Berli ◽  
Urte Scholz ◽  
Janina Lüscher

BACKGROUND Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (<i>buddy</i>) in daily life. OBJECTIVE The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. METHODS A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. RESULTS A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. CONCLUSIONS Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. CLINICALTRIAL ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7723-z


2018 ◽  
Author(s):  
Ulrika Müssener ◽  
Catharina Linderoth ◽  
Marcus Bendtsen

BACKGROUND Tobacco smoking is the primary cause of preventable premature disease and death worldwide. Evidence of the efficacy of text messaging interventions to reduce smoking behavior is well established, but there is still a need for studies targeting young people, especially because young adult smokers are less likely to seek treatment than older adults. A mobile health intervention, Nicotine Exit (NEXit), targeting smoking among university students was developed to support university students to quit smoking. Short-term effectiveness was measured through a randomized controlled trial, which found that immediately after the 12-week intervention, 26% of smokers in the intervention group had prolonged abstinence compared with 15% in the control group. OBJECTIVE The objective of this study was to explore the experience of being allocated to the control group in the NEXit smoking cessation intervention. METHODS We asked students who were allocated to the control group in the main NEXit randomized controlled trial to report their experiences. An email was sent to the participants with an electronic link to a short questionnaire. We assessed the distribution of the responses to the questionnaire by descriptive analysis. We analyzed free-text comments to 4 questions. RESULTS The response rate for the questionnaire was 33.8% (258/763), and we collected 143 free-text comments. Of the responders, 60.9% (157/258) experienced frustration, disappointment, and irritation about being allocated to the control group; they felt they were being denied support by having to wait for the intervention. Monthly text messages during the waiting period thanking them for taking part in the trial were perceived as negative by 72.3% (189/258), but for some the messages served as a reminder about the decision to quit smoking. Of the responders, 61.2% (158/258) chose to wait to quit smoking until they had access to the intervention, and 29.8% (77/258) decided to try to quit smoking without support. Of the respondents, 77.5% (200/258) claimed they were still smoking and had signed up or were thinking about signing up for the smoking cessation program at the time of the questionnaire. CONCLUSIONS Most of the respondents reported negative feelings about having to wait for the support of the intervention and that they had decided to continue smoking. A similar number decided to wait to quit smoking until they had access to the intervention, and these respondents reported a high interest in the intervention. Free-text comments indicated that some control group participants believed that they had been excluded from the trial, while others were confused when asked to sign up for the intervention again. CLINICALTRIAL ISRCTN Registry ISRCTN75766527; http://www.isrctn.com/ISRCTN75766527 (Archived by WebCite at http://www.webcitation.org/7678sUKbR)


2019 ◽  
Author(s):  
Shu-jie Zhai ◽  
Yi Ruan ◽  
Yue Liu ◽  
Zhen Lin ◽  
Chen Xia ◽  
...  

Abstract Background: Dysmenorrhea seriously affects the ability to perform normal social activities and decreases quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. Methods: The study will be a randomized controlled trial conducted from 1 May 2019 30 May 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into two groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the non-acupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 min on the first day of menstruation. The main outcome measures are the pain intensity score measured by the visual analogue scale, and the onset time of analgesia. The secondary outcome measures are the pain threshold at Yinlingquan (SP 9) , skin temperature at Guanyuan (CV 4) , and expectations and satisfaction of patients as investigated via the Expectation and Treatment Credibility Scale. Discussion: This trial will be the first study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the strict randomization, non-acupressure control, and blinded design. The results may provide a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900021727. Registered on 7 March 2019. http://www.chictr.org.cn/listbycreater.aspx


2019 ◽  
Author(s):  
Maria Altendorf ◽  
Ciska Hoving ◽  
Julia CM Van Weert ◽  
Eline Suzanne Smit

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, <i>P</i>=.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, <i>P</i>=.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. CLINICALTRIAL Dutch Trial Register (NL6512/NRT-6700); https://www.trialregister.nl/trial/6512


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Alla Machulska ◽  
Kristian Kleinke ◽  
Tanja Joan Eiler ◽  
Armin Grünewald ◽  
Rainer Brück ◽  
...  

Abstract Background Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug-taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of cognitive bias modification (CBM). Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple laboratory training sessions. Here, we present a protocol for a randomized controlled design to improve CBM training efficiency and facilitate access to the training by providing mobile-phone-based training sessions at home to current smokers motivated to quit smoking. Methods Participants (n = 100) are current smokers who smoke at least six cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training application (app) aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at 6-week follow up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, and follow up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimization and advancement of CBM treatment for addiction. Trial registration Current Controlled Trials, ISRCTN15690771. Registered on 20 November 2018.


Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.


Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.


2017 ◽  
Vol 96 (7) ◽  
pp. 258-263
Author(s):  
James P. Foshee ◽  
Anita Oh ◽  
Adam Luginbuhl ◽  
Joseph Curry ◽  
William Keane ◽  
...  

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.


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