Effectiveness of a web-based self-help smoking cessation intervention: protocol of a randomised controlled trial

Background  

Cigarette smoking is a major risk factor for many chronic and fatal illnesses. Stopping smoking directly reduces those risks. The aim of this study is to investigate the effectiveness of a web-based interactive self-help programme for smoking cessation, known as the StopSite, by comparing it to an online self-help guide. Both interventions were based on cognitive-behavioural and self-control principles, but the former provided exercises, feedback and interactive features such as one-to-one chatrooms and a user forum, which facilitated mutual support and experience sharing.     

Telephone support as an adjunct to transdermal nicotine in smoking cessation.

OBJECTIVES: Transdermal nicotine patches have shown considerable promise in improving smoking cessation outcomes. The present study assessed telephone support as an adjunct to a managed care-based, single-session group orientation smoking cessation program with nicotine patch therapy. METHODS: The unit of randomization was the orientation session (n = 35). Subjects (n = 509) were randomly assigned to a group session without telephone support, the session plus access to a toll-free help line, or the session with telephone help line plus active telephone outreach. RESULTS: Contrary to hypothesis, there were no differences between treatment conditions. Overall abstinence rates were 22% at 6 months and 21% at 1 year. Fewer than 1% of eligible subjects called the toll-free help line. An average of 3.8 of a possible 4 calls were completed in the telephone outreach condition. CONCLUSIONS: Abstinence results obtained in this program were comparable to those obtained with more extensive counseling. However, there was no evidence of benefit from telephone support beyond the initial physician-led group orientation session.     

Proactive telephone counseling as an adjunct to minimal intervention for smoking cessation: a meta-analysis

Proactive telephone counseling is an effective adjunct to minimal intervention for smoking cessation, but its effect has not been quantitatively synthesized thoroughly. The present meta-analysis reviewed 22 studies published between January 1990 and December 2003 and found that there was a heterogeneous, significant adjunct effect of proactive telephone counseling for smoking cessation. This meta-analytic review also found that the following study characteristics explained most of the variation in the adjunct effect: year of publication, follow-up time, mean age of participants, proportion of female participants, participants' readiness to quit smoking and number of cigarettes smoked per day before intervention. In other words, based on the 22 studies, proactive telephone counseling is effective as an adjunct to other minimal interventions for younger, male, light-smoking participants. The results of this meta-analytic review imply that researchers and health care providers may need to focus on participants as much as on intervention process to obtain more effective interventions.     

Efficacy of a text messaging (SMS) based smoking cessation intervention for adolescents and young adults: Study protocol of a cluster randomised controlled trial

Background  

Particularly in groups of adolescents with lower educational level the smoking prevalence is still high and constitutes a serious public health problem. There is limited evidence of effective smoking cessation interventions in this group. Individualised text messaging (SMS) based interventions are promising to support smoking cessation and could be provided to adolescents irrespective of their motivation to quit. The aim of the current paper is to outline the study protocol of a trial testing the efficacy of an SMS based intervention for smoking cessation in apprentices.     

One year effectiveness of an individualised smoking cessation intervention at the workplace: a randomised controlled trial

Aims: To assess the effectiveness of a smoking cessation intervention at the workplace. The intervention was adapted to smokers‘ tobacco dependence, and included minimal structured counselling at the first visit (5–8 minutes), nicotine patches for three months, and three sessions of counselling for reinforcement of abstinence (2–3 minutes) over a three month period.     

Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders

Background  

The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD). The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders.     

Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

ABSTRACT: BACKGROUND: Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation. METHODS: Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received "usual care". RESULTS: Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1) vs. 2.7 (SD 3.7) kg). Between group differences were not significant (p=0.23, 95% CI -0.9 to 3.5). In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%). CONCLUSIONS: The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence. Trial registration: Current Controlled Trials ISRCTN73824458.     

The effectiveness and cost-effectiveness of a participative community singing programme as a health promotion initiative for older people: protocol for a randomised controlled trial

Background  

The growth in numbers of older people represents a considerable cost to health and social care services in the United Kingdom. There is an acknowledged need to address issues of social exclusion and both the physical and mental health of this age group. In recent years there has been much interest in the potential contribution of the arts to the health of communities and individuals. There is some evidence that participative singing may be of benefit to older people, however studies to date are limited in number and have lacked rigour. There is therefore a need to build on this knowledge base to provide more quantifiable evidence of both effectiveness and cost effectiveness of singing as a health intervention for this population group.     

Bupropion SR and smoking cessation in actual practice: methods for recruitment,screening, and exclusion for a field trial in a managed-care setting

BACKGROUND: Little is known about the effectiveness of bupropion SR for smoking cessation outside the context of clinical efficacy trials, where in-person screening and treatment occur at a higher level than provided in a typical health care system. This article describes the methods for recruitment, screening for exclusions, and resulting sample in a field trial of bupropion SR undertaken in a managed-care setting. METHODS: A total of 2979 telephone interviews were conducted to screen and identify eligible volunteers using a detailed protocol that allowed for consultation with study physicians when necessary. The volunteers' primary care physicians were given the option to override their eligibility, and pharmacy databases were used to verify medication reporting. RESULTS: A total of 1909 (64%) volunteers were considered eligible for the study. The most common reason for exclusion was use of contraindicated medications (32%), followed by recent use of one of the behavioral cessation programs (14%), brain injury that reduced seizure threshold (14%), current depression (14%), and high levels of alcohol use (13%). CONCLUSIONS: The methods used in this field trial show that it is possible to enroll subjects in an effectiveness trial that is successful from the standpoint of the consumer, provider, and health care system.     

The prevention access and risk taking in young people (PARTY) project protocol: a cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice and motivational interviewing for young people presenting to general practice

ABSTRACT: BACKGROUND: There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. Main outcomes: clinicians' detection of risk-taking and emotional distress, young people's intention to change and reduction of risk taking. Secondary outcomes: pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. METHODS: PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff's self-perceived competency in young people's care and clinicians' detection and response to risk taking behaviours and emotional distress in 14-24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people were interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation. DISCUSSION: The PARTY trial is the first to examine the effectiveness and efficiency of a psychosocial risk screening and counselling intervention for young people attending primary care. It will provide important data on health risk profiles of young people attending general practice and on the effects of the intervention on engagement with primary care and health outcomes over 12 months. Trial registration ISRCTN16059206 Key Words Young people, health risks, screening, motivational interviewing, emotional distress, primary care, health outcomes.     

A randomized trial of a serialized self-help smoking cessation program for pregnant women in an HMO.

We report the results of a population-based randomized clinical trial that tested the effectiveness of a prenatal self-help smoking cessation program. The intervention consisted predominantly of printed materials received through the mail. The population (n = 242) consisted of a socioeconomically and ethnically diverse group of pregnant women enrolled in a large health maintenance organization (HMO) who reported they were smoking at the time of their first prenatal visit. Biochemical confirmation of continuous abstinence achieved prior to the 20th completed week of pregnancy and lasting through delivery revealed 22.2 per cent of the women in the eight-week serialized program quit versus 8.6 per cent of controls with usual care. The adjusted odds ratio was 2.80 (95 per cent CI = 1.17, 6.69). We conclude that a low-cost prenatal self-help intervention can significantly affect the public health problem of smoking during pregnancy and its associated risks for maternal and child health.     

Efficacy of confrontational counselling for smoking cessation in smokers with previously undiagnosed mild to moderate airflow limitation: study protocol of a randomized controlled trial

Background  

The use of spirometry for early detection of chronic obstructive pulmonary disease (COPD) is still an issue of debate, particularly because of a lack of convincing evidence that spirometry has an added positive effect on smoking cessation. We hypothesise that early detection of COPD and confrontation with spirometry for smoking cessation may be effective when applying an approach we have termed "confrontational counselling"; a patient-centred approach which involves specific communication skills and elements of cognitive therapy. An important aspect is to confront the smoker with his/her airflow limitation during the counselling sessions. The primary objective of this study is to test the efficacy of confrontational counselling in comparison to regular health education and promotion for smoking cessation delivered by specialized respiratory nurses in current smokers with previously undiagnosed mild to moderate airflow limitation.     

Risk of convulsions due to the use of bupropion as an aid for smoking cessation

Bupropion is a new aid in smoking cessation. Since marketing of this product in the Netherlands (from December 1999 on), 7 cases of (possible) convulsions have been reported. In 3 cases there was a contraindication in the form of a history of epilepsy. The four other cases concerned tonic-clonic epileptic seizures in patients with no history of epilepsy and no combination with other medication. In view of the seriousness of this, already known, side effect of bupropion, physicians ought to be sensitive to situations with increased risk of this side effect. In addition it is advised to explain to the patient the proper use of bupropion, which is not comparable to nicotine chewing gum and should be swallowed whole due to the slow release properties of the tablet.