scholarly journals A Randomised Controlled Trial Evaluating the Effectiveness and Tolerability of Step-up and Step-down Varenicline Therapy for Smoking Cessation: A Study Protocol

2017 ◽  
Vol 13 (3) ◽  
pp. 179-185
Author(s):  
Aaron D. Drovandi ◽  
Peta-Ann Teague ◽  
Beverley D. Glass ◽  
Bunmi Malau-Aduli
Keyword(s):  
Smoking Cessation ◽  
Adverse Events ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Withdrawal Symptoms ◽  
Secondary Outcome ◽  
Control Group ◽  
Step Down

Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

2021 ◽  
Author(s):  
Krämer Rico
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Online Intervention ◽  
Self Report ◽  
Secondary Outcome ◽  
Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Francesc X Marin-Gomez ◽  
Rocio Garcia-Moreno Marchán ◽  
Anabel Mayos-Fernandez ◽  
Gemma Flores-Mateo ◽  
Esther Granado-Font ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Tobacco Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serious Game ◽  
Control Group ◽  
Randomized Controlled ◽  
Pregnant Smokers

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)

scholarly journals Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis

10.2196/16255 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e16255
Author(s):  
Amika Shah ◽  
Michael Chaiton ◽  
Dolly Baliunas ◽  
Robert Schwartz
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Passive Control ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
The Impact

Background The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. Objective The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. Methods Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. Results A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). Conclusions The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

scholarly journals The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038184
Author(s):  
Rukshar Kaizerali Gobarani ◽  
Michael J Abramson ◽  
Billie Bonevski ◽  
Gregory R Weeks ◽  
Michael J Dooley ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ethics Committees ◽  
Good Clinical Practice ◽  
Withdrawal Symptoms ◽  
Responsible Conduct Of Research ◽  
Control Group ◽  
Efficacy And Safety ◽  
Success Rates

IntroductionSmoking is a leading cause of premature deaths globally. The health benefits of smoking cessation are many. However, majority of quit attempts are unsuccessful. One way to potentially improve success rates is to evaluate new combinations of existing smoking cessation therapies that may work synergistically to decrease the intensity of withdrawal symptoms and cravings.AimsTo evaluate the feasibility, efficacy and safety of the combination of varenicline and nicotine replacement therapy (NRT) lozenges versus varenicline alone in assisting hospitalised smokers to quit.Methods and analysisThis is a multicentre, randomised, placebo-controlled trial. Adults with a history of smoking ≥10 cigarettes per day on average in the 4 weeks prior to their hospitalisation will be recruited. Participants will be randomly assigned to either the intervention group and will receive varenicline and NRT lozenges, or the control group and will receive varenicline and placebo lozenges. All participants will be actively referred to behavioural support from telephone Quitline. Participants are followed up at 1 and 3 weeks and 3, 6 and 12 months from the start of treatment. The primary outcome is carbon monoxide validated prolonged abstinence from 2 weeks to 6 months after treatment initiation. Secondary outcomes include self-reported and biochemically validated prolonged and point prevalence abstinence at 3, 6 and 12 months, self-reported adverse events, withdrawal symptoms and cravings, adherence to treatment, Quitline sessions attended and others. According to the Russell Standard, all randomised participants will be accounted for in the primary intention-to-treat analysis.Ethics and disseminationThe trial will be conducted in compliance with the protocol, the principles of Good Clinical Practice, the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (updated 2015) and the Australian Code for the Responsible Conduct of Research (2018). Approval will be sought from the Human Ethics Committees of all the participating hospitals and the university. Written informed consent will be obtained from each participant at the time of recruitment.Trial registration numberAustralia New Zealand Clinical Trials Registry (ACTRN12618001792213).

scholarly journals Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis (Preprint)

2019 ◽  
Author(s):  
Amika Shah ◽  
Michael Chaiton ◽  
Dolly Baliunas ◽  
Robert Schwartz
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Passive Control ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
The Impact

BACKGROUND The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. OBJECTIVE The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. METHODS Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. RESULTS A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; <i>P</i>=.58; <i>I</i><sup>2</sup>=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; <i>P</i>=.80; <i>I</i><sup>2</sup>=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; <i>P</i>=.90; <i>I</i><sup>2</sup>=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; <i>P</i>=.26; <i>I</i><sup>2</sup>=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (<i>P</i>=.03), 3-month (<i>P</i>&lt;.001), and 6-month <i>(P</i>=.02) follow-ups but not at 12-month follow-up (<i>P</i>=.25). CONCLUSIONS The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

scholarly journals Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: A study protocol for a randomized controlled study

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Alla Machulska ◽  
Kristian Kleinke ◽  
Tanja Joan Eiler ◽  
Armin Grünewald ◽  
Rainer Brück ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Mobile Phone ◽  
Outcome Measures ◽  
Smoking Cessation Intervention ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Quit Smoking ◽  
Cessation Intervention

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.

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
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Smoking Abstinence ◽  
Smartphone Apps ◽  
Randomized Controlled ◽  
Quit Smoking

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.

scholarly journals Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048808
Author(s):  
Claire M Nolan ◽  
Suhani Patel ◽  
Ruth E Barker ◽  
Jessica A Walsh ◽  
Oliver Polgar ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Events ◽  
Outcome Measures ◽  
Care Home ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Definitive Trial

ObjectivesTo assess the acceptability of neuromuscular electrical stimulation (NMES) of the quadriceps muscles in people with idiopathic pulmonary fibrosis (IPF) and to identify whether a future definitive trial is feasible.DesignA randomised, parallel, two-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews.SettingOutpatient department, Royal Brompton and Harefield Hospitals.ParticipantsTwenty-two people with IPF: median (25th, 75th centiles) age 76 (74, 82) years, forced vital capacity 62 (50, 75) % predicted, 6 min walk test distance 289 (149, 360) m.InterventionsUsual care (home-based exercise, weekly telephone support, breathlessness management leaflet) with either placebo or active NMES for 6 weeks, with follow-up at 6 and 12 weeks.Primary outcome measuresFeasibility of recruitment and retention, treatment uptake and adherence, outcome assessments, participant and outcome assessor blinding and adverse events related to interventions.Secondary outcome measuresOutcome measures with potential to be primary or secondary outcomes in a definitive clinical trial. In addition, purposively sampled participants were interviewed to capture their experiences and acceptability of the trial.ResultsOut of 364 people screened, 23 were recruited: 11 were allocated to each group and one was withdrawn prior to randomisation. Compared with the control group, a greater proportion of the intervention group completed the intervention, remained in the trial blinded to group allocation and experienced intervention-related adverse events. Assessor blinding was maintained. The secondary outcome measures were feasible with most missing data associated with the accelerometer. Small participant numbers precluded identification of an outcome measure suitable for a definitive trial. Qualitative findings demonstrated that trial process and active NMES were acceptable but there were concerns about the credibility of placebo NMES.ConclusionsPrimarily owing to recruitment difficulties, a definitive trial using the current protocol to evaluate NMES in people with IPF is not feasible.Trial registration numberNCT03499275.

Sign in / Sign up

Export Citation Format

Share Document