Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Results of a pilot randomized control trial

2021 ◽  
pp. 107153
Author(s):  
Alicia Allen ◽  
Iva Skobic ◽  
Melanie L Bell ◽  
Kristina Medvescek ◽  
Sharon Allen ◽  
...  
2019 ◽  
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) approaches. 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 lab-training sessions. Here, we present a protocol for a randomized control 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 6 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 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 a six-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, follow-up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion: This RCT 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 optimisation and advancement of CBM treatment for addiction. Trial registration: Registered with Current Controlled Trials: study ID ISRCTN15690771. Registered on 20 November 2018; http://www.isrctn.com/ISRCTN15690771 Key words: Approach Bias, Cogitive Bias Modification, cigarette smoking, nicotine addiction, Randomized Control Trial, smartphone apps


2019 ◽  
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) approaches. 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 lab-training sessions. Here, we present a protocol for a randomized control 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 6 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 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 a six-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, follow-up). After completion of the study, smokers in the control condition will receive access to the training app. Discussion: This RCT 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 optimisation and advancement of CBM treatment for addiction. Trial registration: Registered with Current Controlled Trials: study ID ISRCTN15690771. Registered on 20 November 2018; http://www.isrctn.com/ISRCTN15690771 Key words: Approach Bias, Cogitive Bias Modification, cigarette smoking, nicotine addiction, Randomized Control Trial, smartphone apps


2019 ◽  
Author(s):  
David Pócs ◽  
Tímea Óvári ◽  
Csaba Hamvai ◽  
Oguz Kelemen

BACKGROUND Smoking cessation support on Facebook (FB) is a cost-effective and extensible way to reduce tobacco use among young people. Motivational interviewing (MI) is a practical counselling style in face-to-face smoking cessation support and can be useful in web-based interventions as well. OBJECTIVE This study aimed at identifying which post creation strategies based on MI could achieve positive changes in FB post characteristics and FB users’ comments. METHODS We included MI-adherent posts (N=701) which were not boosted and were targeted at tobacco users. These FB posts have been categorized into five different groups according to specific MI strategies. The control group comprised entertaining and informative posts. Primary outcomes seem to highlight how the content has stimulated interactions (engagement rate), inhibited interactions (negative feedback) or appealed to the audience of the FB page (fan-total reach ratio). The first comments received on the FB posts were evaluated and used as secondary outcomes. We applied the classification of MI approach: change talk (CT), sustain talk (ST), desire, ability, reason, need (DARN), and commitment, activation, taking steps (CAT). RESULTS FB posts which used MI strategies were associated with significantly higher engagement rate (p=.010), higher fan-total reach ratio (p<.001), and more CT (p<.001), DARN (p=.005), or CAT comments (p=.003) compared to the control group. ‘Elaborating CT’ strategies elicited considerably more CT (p<.001) and DARN comments (p=.020). ‘Affirming CT’ strategies obtained higher fan-total reach ratio (p=.011) and generated significantly more CT (p=.006) and CAT comments (p<.001). ‘Reflecting CT’ strategies received significantly higher fan-total reach ratio (p<.001). Finally, ‘relational MI’ strategies achieved significantly higher engagement rate (p<.001) compared to the control group. It should be noted that we did not find significant difference in negative feedback and the number of ST comments. CONCLUSIONS Post creation strategies based on MI stimulated interactions with FB users and generated conversation about tobacco use cessation without relevant negative feedback. Our findings suggest that MI strategies may play a remarkable role in post creation within a web-based smoking cessation intervention. In the future, these strategies could be applicable to other online platforms, such as public health websites, health blogs, mobile applications or social networking groups.


BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040117
Author(s):  
Carole Clair ◽  
Aurélie Augsburger ◽  
Priska Birrer ◽  
Isabella Locatelli ◽  
Joelle Schwarz ◽  
...  

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.


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