A Randomised Controlled Trial of Inhibitory Control Training for Smoking Cessation: Outcomes, Mediators and Methodological Considerations.
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SUBMITTER: Hughes LK
PROVIDER: S-EPMC8595834 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background:This paper describes the protocol and methodological prerequisites for a randomised controlled exercise intervention. Selected baseline data from the study are also presented, demonstrating some methodological challenges related to exercise intervention trials. The aim of the trial was to study the effects of exercise training on physiological responses to acute psychosocial stress in untrained individuals. Methods:Individuals with a low level of physical activity were invited to participate in an exercise intervention lasting for 6?months. A total of 119 participants were included and went through a peak oxygen uptake test and a psychosocial stress test at baseline. Adrenocorticotropic hormone (ACTH) and cortisol were measured in connection to the stress test to identify the physiological response. Results:Almost 90% of the participants reported themselves as untrained, but results from the objectively measured oxygen uptake did not seem to correspond to the reported sedentary lifestyle. The primary outcome measures at baseline varied between individuals. The mean change from pre-test to peak value was 214% for ACTH and 94% for cortisol. Of these, 13 individuals did not respond in ACTH and/or and cortisol. Discussion:Supposedly untrained individuals seeking participation in an exercise intervention might not be as untrained as they report, a methodological consideration of importance when evaluating the effects of training. Another important consideration is related to the primary outcome measure, which should be measurable and possible to affect. Absence of reaction at baseline means that changes can only be detected as an increased reaction.
| S-EPMC6109819 | biostudies-literature
Project description:BackgroundCommunity pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention.MethodsWe randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months. Smokers were blind to the allocation. The intervention was theory-based consultation skills training for pharmacy staff with environmental prompts (badges, calendars and behavioural cues). The primary outcome was the number of smokers attending an initial consultation and setting a quit date.ResultsThe intervention made no significant difference in setting a quit date, retention or quit rate. A total of 631 adult smokers (service users) enrolled and set a quit date in intervention pharmacies compared to 641 in usual practice pharmacies, a rate ratio of 0.75 (95% CI 0.46 to 1.23) adjusted for site and number of prescriptions. A total of 432 (68%) service users were retained at 4 weeks in intervention and 500 (78%) in usual practice pharmacies (odds ratio 0.80, 0.41 to 1.55). A total of 265 (42%) service users quit smoking at 4 weeks in intervention and 276 (43%) in usual practice pharmacies (0.96, 0.65 to 1.43). The pharmacy staff were positive about the intervention with 90% (56/62) stating that it had improved their skills. Sixty-eight per cent would strongly recommend the training to others although there was no difference in self-efficacy for service delivery between arms. Seventy of 131 (53%) service users did not complete the 6-month follow-up assessment. However, 55/61 (90%) service users who completed follow-up were satisfied or very satisfied with the service. All usual practice arm service users (n = 33) and all but one in the intervention arm (n = 27) would recommend the service to smokers.ConclusionsWe found high levels of retention and acceptable quit rates in the NHS pharmacy stop smoking service. Despite pharmacy staff providing positive feedback on the STOP intervention, it made no difference to service throughput. Thus, other factors may currently limit service capacity to help smokers to quit.Trial registrationISRCTN, ISRCTN16351033 . Retrospectively registered.
| S-EPMC9238035 | biostudies-literature
Project description:BackgroundCigarette smoking among persons living with HIV (PLWH) is a pressing public health concern, and efforts to evaluate cessation treatments are needed. The purpose of the present study was to assess potential mechanisms of a cell phone-delivered intervention for HIV-positive smokers.MethodsData from 350 PLWH enrolled in a randomized smoking cessation treatment trial were utilized. Participants were randomized to either usual care (UC) or a cell phone intervention (CPI) group. The independent variable of interest was treatment group membership, while the dependent variable of interest was smoking abstinence at a 3-month follow-up. The hypothesized treatment mechanisms were depression, anxiety, social support, quit motivation and self-efficacy change scores.ResultsAbstinence rates in the UC and CPI groups were 4.7% (8 of 172) and 15.7% (28 of 178), respectively. The CPI group (vs. UC) experienced a larger decline in depression between baseline and the 3-month follow-up, and a decline in anxiety. Self-efficacy increased for the CPI group and declined for the UC group. Quit motivation and social support change scores did not differ by treatment group. Only self-efficacy met the predefined criteria for mediation. The effect of the cell phone intervention on smoking abstinence through change in self-efficacy was statistically significant (p<0.001) and accounted for 17% of the total effect of the intervention on abstinence.ConclusionsThe findings further emphasize the important mechanistic function of self-efficacy in promoting smoking cessation for PLWH. Additional efforts are required to disentangle the relationships between emotional, distress motivation, and efficacious smoking cessation treatment.
| S-EPMC4461214 | biostudies-literature
Project description:Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components.We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome.This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses.NCT02585206.
| S-EPMC4823397 | biostudies-other
Project description:BACKGROUND:Active smoking increases the risk of tuberculosis (TB) infection 2 to 2.5 times and is significantly associated with recurrent TB and TB mortality. Observational studies have shown associations between smoking and poor TB treatment outcomes such as increased loss to follow-up rate, severity of disease, drug resistance and slow smear conversion. Since most smoking-related immunologic abnormalities are reversible within six weeks of stopping smoking, smoking cessation may have substantial positive effects on TB treatment outcomes, TB relapse and future lung disease. OBJECTIVES:To analyse the effect of tobacco smoking cessation interventions (SCIs) on the treatment outcomes of people with adult pulmonary TB. SEARCH METHODS:We searched the Cochrane Tobacco Addiction Group Specialised Register using free-text and MeSH terms for TB and antitubercular treatment. We also searched MEDLINE and EMBASE using the same topic-related terms, combined with the search terms used to identify trials of tobacco cessation interventions from the Specialised Register. We also searched reference list of articles and reviews, the Conference Paper Index, clinicaltrials.gov and grey literature. The searches are current to 29th July 2015. SELECTION CRITERIA:Individual and cluster-randomised controlled trials (RCTs), regardless of date, language and publication status, studies of adults with pulmonary TB on first-line anti-tubercular drugs, with interventions at either an individual or a population level, delivered separately or as part of a larger tobacco control package. This included any type of behavioural or pharmaceutical intervention or both for smoking cessation. DATA COLLECTION AND ANALYSIS:Using the eligibility criteria, two authors independently checked the abstracts of retrieved studies for relevance, and acquired full trial reports of candidates for inclusion. The authors resolved any disagreements on eligibility by mutual consent, or by recourse to a third author. Two authors intended to independently extract study data from eligible studies into a data extraction form and compare the findings, synthesise data using risk ratios, and assess risk of bias using standard Cochrane methodologies. However, we found no eligible trials. MAIN RESULTS:There were no randomised controlled trials that met the eligibility criteria. A number of potentially eligible studies are underway, and we will assess them for inclusion in the next update of this review. AUTHORS' CONCLUSIONS:There is a lack of high-quality evidence, i.e. RCTs, that tests the effectiveness of cessation interventions in improving TB treatment outcomes. There is a need for good-quality randomised controlled trials that assess the effect of SCIs on TB treatment outcomes in both the short and long term. Establishing such an evidence base would be an essential step towards the implementation of SCIs in TB control programmes worldwide.
| S-EPMC7386791 | biostudies-literature
Project description:AimsTemperament and impulsivity are powerful predictors of addiction treatment outcomes. However, a comprehensive assessment of these features has not been examined in relation to smoking cessation outcomes.MethodsNaturalistic prospective study. Treatment-seeking smokers (n = 140) were recruited as they engaged in an occupational health clinic providing smoking cessation treatment between 2009 and 2013. Participants were assessed at baseline with measures of temperament (Temperament and Character Inventory), trait impulsivity (Barratt Impulsivity Scale), and cognitive impulsivity (Go/No Go, Delay Discounting and Iowa Gambling Task). The outcome measure was treatment status, coded as "dropout" versus "relapse" versus "abstinence" at 3, 6, and 12 months endpoints. Participants were telephonically contacted and reminded of follow-up face to face assessments at each endpoint. The participants that failed to answer the phone calls or self-reported discontinuation of treatment and failed to attend the upcoming follow-up session were coded as dropouts. The participants that self-reported continuing treatment, and successfully attended the upcoming follow-up session were coded as either "relapse" or "abstinence", based on the results of smoking behavior self-reports cross-validated with co-oximetry hemoglobin levels. Multinomial regression models were conducted to test whether temperament and impulsivity measures predicted dropout and relapse relative to abstinence outcomes.ResultsHigher scores on temperament dimensions of novelty seeking and reward dependence predicted poorer retention across endpoints, whereas only higher scores on persistence predicted greater relapse. Higher scores on the trait dimension of non-planning impulsivity but not performance on cognitive impulsivity predicted poorer retention. Higher non-planning impulsivity and poorer performance in the Iowa Gambling Task predicted greater relapse at 3 and 6 months and 6 months respectively.ConclusionTemperament measures, and specifically novelty seeking and reward dependence, predict smoking cessation treatment retention, whereas persistence, non-planning impulsivity and poor decision-making predict smoking relapse.
| S-EPMC4256301 | biostudies-literature
Project description: Not available
| S-EPMC6353172 | biostudies-literature
Project description:OBJECTIVE:To assess the efficacy of an interactive smoking cessation decision-aid application (pp) compared with a smoking cessation static information app on continuous abstinence. DESIGN:Automated double-blind randomised controlled trial with 6 months follow-up (2014-2015). SETTING:Smartphone-based. PARTICIPANTS:684 participants (daily smokers of cigarettes, 18 years old or over) recruited passively from app stores in the USA, Australia, UK and Singapore, and randomised to one of two sub-apps. INTERVENTIONS:Behavioural, decision-aid, smartphone application. MAIN OUTCOMES:Continuous abstinence at 10 days, 1?month, 3 months and 6 months. RESULTS:Smokers who received the decision-aid app were more likely to be continuously abstinent at 1?month compared with the information-only app (28.5% vs 16.9%; relative risk (RR) 1.68; 95%?CI 1.25 to 2.28). The effect was sustained at 3 months (23.8% vs 10.2%; RR 2.08; 95%?CI 1.38 to 3.18) and 6 months (10.2% vs 4.8%; RR 2.02; 95%?CI 1.08 to 3.81). Participants receiving the decision-aid app were also more likely to have made an informed choice (31.9% vs 19.6%) and have lower decisional conflict (19.5% vs 3.9%). CONCLUSION:A smartphone decision-aid app with support features significantly increased smoking cessation and informed choice. With an increasing number of smokers attempting to quit, unassisted evidence-based decision-aid apps can provide an effective and user-friendly option to many who are making quit decisions without healthcare professionals. TRIAL REGISTRATION NUMBER:ACTRN12613000833763.
| S-EPMC5780681 | biostudies-other
Project description:ObjectiveTo determine the effectiveness of a physical activity intervention for smoking cessation during pregnancy.DesignParallel group, randomised controlled, multicentre trial.Setting13 hospitals in England, April 2009 to January 2014.Participants789 pregnant smokers, aged 16-50 years and at 10-24 weeks' gestation, who smoked at least one cigarette daily and were prepared to quit smoking one week after enrollment were randomised (1:1); 785 were included in the intention to treat analyses, with 392 assigned to the physical activity group.InterventionsInterventions began one week before a target quit date. Participants were randomised to six weekly sessions of behavioural support for smoking cessation (control) or to this support plus 14 sessions combining supervised treadmill exercise and physical activity consultations.Main outcome measuresThe primary outcome was continuous smoking abstinence from the target quit date until end of pregnancy, validated by exhaled carbon monoxide or salivary cotinine levels. To assess adherence, levels of moderate-vigorous intensity physical activity were self reported and in a 11.5% (n=90) random subsample of participants, physical activity was objectively measured by an accelerometer.ResultsNo significant difference was found in rates of smoking abstinence at end of pregnancy between the physical activity and control groups (8% v 6%; odds ratio 1.21, 95% confidence interval 0.70 to 2.10). For the physical activity group compared with the control group, there was a 40% (95% confidence interval 13% to 73%), 34% (6% to 69%), and 46% (12% to 91%) greater increase in self reported minutes carrying out physical activity per week from baseline to one week, four weeks, and six weeks post-quit day, respectively. According to the accelerometer data there was no significant difference in physical activity levels between the groups. Participants attended a median of four treatment sessions in the intervention group and three in the control group. Adverse events and birth outcomes were similar between the two groups, except for significantly more caesarean births in the control group than in the physical activity group (29% v 21%, P=0.023).ConclusionAdding a physical activity intervention to behavioural smoking cessation support for pregnant women did not increase cessation rates at end of pregnancy. During pregnancy, physical activity is not recommended for smoking cessation but remains indicated for general health benefits. Trial registration Current Controlled Trials ISRCTN48600346.
| S-EPMC4431606 | biostudies-literature
Project description:This study examined mediators and moderators of short-term treatment effectiveness from the iQUITT Study (Quit Using Internet and Telephone Treatment), a 3-arm randomized trial that compared an interactive smoking cessation Web site with an online social network (enhanced Internet) alone and in conjunction with proactive telephone counseling (enhanced Internet plus phone) to a static Internet comparison condition (basic Internet).The analytic sample was N = 1,236 participants with complete 3-month data on all mediating variables. The primary outcome was 30-day point prevalence abstinence (ppa) at 3 months. Recognizing the importance of temporal precedence in mediation analyses, we also present findings for 6-month outcomes. Purported mediators were treatment utilization and changes in psychosocial constructs. Proposed moderators included baseline demographic, smoking, and psychosocial variables. Mediation analyses examined the extent to which between-arm differences in 30-day ppa could be attributed to differential Web site utilization, telephone counseling, and associated changes in smoking self-efficacy and social support for quitting. Effect modification analyses fitted interactions between treatment and prespecified moderators on abstinence.Significant mediators of 30-day ppa were changes in smoking temptations, quitting confidence, and positive and negative partner support, which were strongly associated with increased Web site utilization. The addition of telephone counseling to an enhanced Web site further improved abstinence rates, partly via an association with increased quitting confidence. Baseline smoking rate was the only significant moderator.Increased treatment utilization and associated changes in several psychosocial measures yielded higher abstinence rates. Findings validate the importance of treatment utilization, smoking self-efficacy, and social support to promote abstinence.
| S-EPMC4342678 | biostudies-literature