Engagement With Motivational Interviewing and Cognitive Behavioral Therapy Components of a Web-Based Alcohol Intervention, Elicitation of Change Talk and Sustain Talk, and Impact on Drinking Outcomes: Secondary Data Analysis.

BACKGROUND: Down Your Drink (DYD) is a widely used unguided web-based alcohol moderation program for the general public based on cognitive behavioral therapy (CBT) and motivational interviewing (MI); it provides users with many opportunities to enter free-text responses. OBJECTIVE: The aim of this study was to assess participants' use of key CBT and MI components, the presence of change talk and sustain talk within their responses, and whether these data are associated with drinking outcomes after 3 months. METHODS: An exploratory secondary data analysis was conducted on data collected in 2008 from the definitive randomized trial of DYD (N=503). Past week alcohol use at baseline and 3-month follow-up were measured with the TOT-AL. Covariates included baseline alcohol use, age, gender, education level, and word count of the responses. Use of MI and CBT components and presence of change talk and sustain talk were coded by two independent coders (Cohen κ range 0.91-1). Linear model regressions on the subsample of active users (n=410) are presented along with a negative binomial regression. RESULTS: The most commonly used component was the listing of pros and cons of drinking. The number of listed high-risk situations was associated with lower alcohol use at 3-month follow-up (Badj -2.15, 95% CI -3.92 to -0.38, P=.02). Findings on the effects of the percentage of change talk and the number of listed strategies to deal with high-risk situations were inconsistent. CONCLUSIONS: An unguided web-based alcohol moderation program can elicit change talk and sustain talk. This secondary analysis suggests that the number of listed high-risk situations can predict alcohol use at 3-month follow-up. Other components show inconsistent findings and should be studied further.

Processing of Alcohol-Related Health Threat in At-Risk Drinkers: An Online Study of Gender-Related Self-Affirmation Effects.

AIMS: Defensiveness in response to threatening health information related to excessive alcohol consumption prevents appropriate behaviour change. Alternatively, self-affirmation may improve cognitive-affective processing of threatening information, thus contributing to successful self-regulation. METHODS: Effects of an online self-affirmation procedure were examined in at-risk university student drinkers. Participants were randomly assigned to a self-affirmation (writing about personally relevant values) or control task (writing about values relevant to another person) prior to presentation of alcohol-related threatening information. Assessment of prosocial feelings (e.g. 'love') after the task served as a manipulation check. Generic and personalized information regarding the link between alcohol use and cancer was presented, followed by assessment of perceived threat, message avoidance and derogation. Page dwell-times served as indirect indices of message engagement. Alcohol consumption and intention to drink less were assessed during the first online session and at 1-week and 1-month follow-up. RESULTS: Although self-affirmation resulted in higher levels of prosocial feelings immediately after the task, there was no effect on behaviour in the self-affirmation group. Effects on intention were moderated by gender, such that men showed lower intention immediately after self-affirmation, but this increased at 1-week follow-up. Women's intention to reduce consumption in the self-affirmation group reduced over time. Trend-level effects on indices of derogation and message acceptance were in the predicted direction only in men. CONCLUSION: It is feasible to perform self-affirmation procedures in an online environment with at-risk drinkers. However, use of internet-based procedures with this population may give rise to (gender-dependent) effects that are substantially diluted compared with lab-based experiments.

Quality of life among hazardous and harmful drinkers: EQ-5D over a 1-year follow-up period.

PURPOSE: To investigate the ability of the EQ-5D to discriminate between levels of alcohol risk in a large sample of hazardous and harmful drinkers, and to explore the relationship between transitions between alcohol risk levels and changes in EQ-5D up to 12 months. METHODS: This is a web-based randomised controlled trial evaluating a novel intervention for hazardous and harmful alcohol consumption. EQ-5D scores were compared among groups of drinkers at baseline (low/medium/high risk according to self-reported past week alcohol consumption), and changes in EQ-5D scores were estimated as a function of changes in alcohol consumption level. RESULTS: Baseline EQ-5D scores were dominated by problems with anxiety/depression, which increased with alcohol risk level, whilst high-risk drinkers also experienced more problems with physical HRQoL dimensions. However, the tool demonstrated a considerable ceiling effect. At follow-up, despite considerable reductions in alcohol consumption across the sample, significant changes in aggregated EQ-5D index scores were only observed for high-risk drinkers at baseline who reduced their drinking, with small improvements (0.04-0.06) compared to those who did not reduce. CONCLUSIONS: Our results suggest that the three-option EQ-5D may not be an optimal primary end point for measuring clinical and cost-effectiveness in randomised controlled trials of interventions among hazardous and harmful alcohol users, although further testing of the sensitivity of the tool in these populations is needed.

Health on the web: randomised trial of work-based online screening and brief intervention for hazardous and harmful drinking.

BACKGROUND: Alcohol misuse is a significant international public health problem. Screening and brief intervention (SBI) in primary care reduces alcohol consumption by about 15 - 30%, sustained over 12 months in hazardous or harmful drinkers but implementation has proved difficult leading to growing interest in exploring the effectiveness of SBI in other settings, including the workplace. Computerised interventions for alcohol misuse can be as effective as traditional face-to-face interventions and may have advantages, including anonymity, convenience and availability. METHODS/DESIGN: Individually randomised controlled trial to determine the effectiveness and cost-effectiveness of offering online screening and brief intervention for alcohol misuse in a workplace. PARTICIPANTS: adults (aged 18 or over) employed by participating employers scoring 5 or more on a three item screen for alcohol misuse (the AUDIT-C) indicating possible hazardous or harmful alcohol consumption, recruited through the offer of an online health check providing screening for a range of health behaviours with personalised feedback. PARTICIPANTS who accept the health check and score 5 or more on the alcohol screen will be randomised to receiving immediate feedback on their alcohol consumption and access to an online intervention offering support in reducing alcohol consumption (Down Your Drink) or delayed feedback and access to Down Your Drink after completion of follow-up data at three months. All employees who take the online health check will receive personalised feedback on other screened health behaviours including diet, physical activity, smoking, and body mass index. The primary outcome is alcohol consumption in the past week at three months; secondary outcomes are the AUDIT, EQ-5D, days off work, number and duration of hospital admissions, costs and use of the intervention. A sample size of 1,472 participants (736 in each arm) provides 90% power with 5% significance to determine a 20% reduction in alcohol consumption. Outcomes between groups at three months will be compared following the intention to treat principle and economic analyses will follow NICE guidance. DISCUSSION: This innovative design avoids recruitment bias by not mentioning alcohol in the invitation and avoids reactivity of assessment by not collecting baseline data on alcohol consumption.

Impact of fatigue as the primary determinant of functional limitations among patients with post-COVID-19 syndrome: a cross-sectional observational study.

OBJECTIVES: To describe self-reported characteristics and symptoms of treatment-seeking patients with post-COVID-19 syndrome (PCS). To assess the impact of symptoms on health-related quality of life (HRQoL) and patients' ability to work and undertake activities of daily living. DESIGN: Cross-sectional single-arm service evaluation of real-time user data. SETTING: 31 post-COVID-19 clinics in the UK. PARTICIPANTS: 3754 adults diagnosed with PCS in primary or secondary care deemed suitable for rehabilitation. INTERVENTION: Patients using the Living With Covid Recovery digital health intervention registered between 30 November 2020 and 23 March 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the baseline Work and Social Adjustment Scale (WSAS). WSAS measures the functional limitations of the patient; scores of ≥20 indicate moderately severe limitations. Other symptoms explored included fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), depression (Patient Health Questionnaire-Eight Item Depression Scale), anxiety (Generalised Anxiety Disorder Scale, Seven-Item), breathlessness (Medical Research Council Dyspnoea Scale and Dyspnoea-12), cognitive impairment (Perceived Deficits Questionnaire, Five-Item Version) and HRQoL (EQ-5D). Symptoms and demographic characteristics associated with more severe functional limitations were identified using logistic regression analysis. RESULTS: 3541 (94%) patients were of working age (18-65); mean age (SD) 48 (12) years; 1282 (71%) were female and 89% were white. 51% reported losing ≥1 days from work in the previous 4 weeks; 20% reported being unable to work at all. Mean WSAS score at baseline was 21 (SD 10) with 53% scoring ≥20. Factors associated with WSAS scores of ≥20 were high levels of fatigue, depression and cognitive impairment. Fatigue was found to be the main symptom contributing to a high WSAS score. CONCLUSION: A high proportion of this PCS treatment-seeking population was of working age with over half reporting moderately severe or worse functional limitation. There were substantial impacts on ability to work and activities of daily living in people with PCS. Clinical care and rehabilitation should address the management of fatigue as the dominant symptom explaining variation in functionality.

Widening access to treatment for alcohol misuse: description and formative evaluation of an innovative web-based service in one primary care trust.

AIMS: To describe the development and evaluation of an innovative web-based service for hazardous or harmful drinkers. METHODS: Patients were identified in General Practice and referred to the new service. Mixed methods were used for evaluation. RESULTS: The service was feasible and acceptable to patients, primary care professionals and commissioners. Users appeared to reduce their alcohol consumption. CONCLUSION: This model may be of interest to other primary care commissioners looking to increase access to alcohol treatments at low cost.

A waitlist-controlled trial of behavioral parent training for fathers of children with ADHD.

Fathers, in general, have been underrepresented in studies of parent training outcome for children with attention deficit hyperactivity disorder (ADHD), and the present study aimed to investigate the efficacy of a behavioral parent training program developed expressly for fathers. The present investigation randomly assigned 55 fathers of children ages 6 to 12 with ADHD to the Coaching Our Acting-out Children: Heightening Essential Skills (COACHES) program or a waitlist control group. Outcomes for the study included objective observations of parent behaviors and parent ratings of child behavior. Results indicated that fathers in the COACHES group reduced their rates of negative talk and increased rates of praise as measured in parent-child observations, and father ratings of the intensity of problem behaviors were reduced, relative to the waitlist condition. Groups did not differ on observations of use of commands or father ratings of child behavior problems. Untreated mothers did not significantly improve on observational measures or behavioral ratings. This study provides preliminary evidence for the efficacy of the COACHES parenting program for fathers of children with ADHD. Results are cast in light of the larger literature on behavioral parent training for ADHD as well as how to best work with fathers of children with ADHD in treatment contexts.

Development, deployment and evaluation of digitally enabled, remote, supported rehabilitation for people with long COVID-19 (Living With COVID-19 Recovery): protocol for a mixed-methods study.

INTRODUCTION: Long COVID-19 is a distressing, disabling and heterogeneous syndrome often causing severe functional impairment. Predominant symptoms include fatigue, cognitive impairment ('brain fog'), breathlessness and anxiety or depression. These symptoms are amenable to rehabilitation delivered by skilled healthcare professionals, but COVID-19 has put severe strain on healthcare systems. This study aims to explore whether digitally enabled, remotely supported rehabilitation for people with long COVID-19 can enable healthcare systems to provide high quality care to large numbers of patients within the available resources. Specific objectives are to (1) develop and refine a digital health intervention (DHI) that supports patient assessment, monitoring and remote rehabilitation; (2) develop implementation models that support sustainable deployment at scale; (3) evaluate the impact of the DHI on recovery trajectories and (4) identify and mitigate health inequalities due to the digital divide. METHODS AND ANALYSIS: Mixed-methods, theoretically informed, single-arm prospective study, combining methods drawn from engineering/computer science with those from biomedicine. There are four work packages (WP), one for each objective. WP1 focuses on identifying user requirements and iteratively developing the intervention to meet them; WP2 combines qualitative data from users with learning from implementation science and normalisation process theory, to promote adoption, scale-up, spread and sustainability of the intervention; WP3 uses quantitative demographic, clinical and resource use data collected by the DHI to determine illness trajectories and how these are affected by use of the DHI; while WP4 focuses on identifying and mitigating health inequalities and overarches the other three WPs. ETHICS AND DISSEMINATION: Ethical approval obtained from East Midlands - Derby Research Ethics Committee (reference 288199). Our dissemination strategy targets three audiences: (1) Policy makers, Health service managers and clinicians responsible for delivering long COVID-19 services; (2) patients and the public; (3) academics. TRIAL REGISTRATION NUMBER: Research Registry number: researchregistry6173.

Impact of length or relevance of questionnaires on attrition in online trials: randomized controlled trial.

BACKGROUND: There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink randomized controlled trial (DYD-RCT). OBJECTIVES: The objective was to determine whether differences in the length and relevance of questionnaires can impact upon loss to follow-up in online trials. METHODS: A randomized controlled trial design was used. All participants who consented to enter DYD-RCT and completed the primary outcome questionnaires were randomized to complete one of four secondary outcome questionnaires at baseline and at follow-up. These questionnaires varied in length (additional 23 or 34 versus 10 items) and relevance (alcohol problems versus mental health). The outcome measure was the proportion of participants who completed follow-up at each of two follow-up intervals: study 1 after 1 and 3 months and study 2 after 3 and 12 months. RESULTS: At all four follow-up intervals there were no significant effects of additional questionnaire length on follow-up. Randomization to the less relevant questionnaire resulted in significantly lower rates of follow-up in two of the four assessments made (absolute difference of 4%, 95% confidence interval [CI] 0%-8%, in both study 1 after 1 month and in study 2 after 12 months). A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance (unadjusted difference, 3%, range 1%-5%, P = .01; difference adjusted for prespecified covariates, 3%, range 0%-5%, P = .05). CONCLUSIONS: Apparently minor differences in study design decisions may have a measurable impact on attrition in trials. Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and, more broadly, of the consequences of what we ask participants to do when we invite them to take part in research studies. TRIAL REGISTRATION: ISRCTN Register 31070347; http://www.controlled-trials.com/ISRCTN31070347/31070347 Archived by WebCite at (http://www.webcitation.org/62cpeyYaY).

Development of a psychologically enhanced interactive online intervention for hazardous drinking.

AIMS: The content of novel interventions is often not well specified. We provide a detailed account of the rationale for and redevelopment of an Internet resource for hazardous drinkers-Down Your Drink (DYD) (www.downyourdrink.org.uk). DEVELOPMENT WORK: An iterative process blended literature reviews of Internet interventions for health conditions and brief treatments for alcohol problems, feedback from users of the original site and from users panels, and completion of a series of developmental tasks. INTERVENTION: The detailed structure and content of the new version of the website is presented. This permits an appreciation of the intended interaction between the user and the intervention, and emphasizes both the freedom of choice available to the user to access diverse material for personal benefit and the value of a clear organizational structure. CONCLUSIONS: Presentation of detailed information on the theoretical underpinning, content and structure of an intervention makes it easier to interpret the results of any evaluation and is likely to be of use to those developing other online interventions for alcohol or other health behaviours.

DIAMOND (DIgital Alcohol Management ON Demand): a feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use recruiting in hospital emergency departments and online.

BACKGROUND: The harmful use of alcohol is a causal factor in more than 200 disease and injury conditions and leads to over 3 million deaths every year worldwide. Relatively few problem alcohol users access treatment due to stigma and lack of services. Alcohol-specific digital health interventions (DHI) may help them, but trial data comparing DHI with face-to-face treatment are lacking. METHODS: We conducted a feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2015 for 12 months. Participants were adults, drinking at hazardous and harmful levels, recruited from hospital emergency departments (ED) in London or recruited online. Participants were randomised to HeLP-Alcohol, a six module DHI with weekly reminder prompts (phone, email or text message), or to face-to-face treatment as usual (TAU). Participants were invited to take part in qualitative interviews after the trial. RESULTS: The trial website was accessed 1074 times: 420 people completed online eligibility questionnaires; 350 did not meet eligibility criteria, 51 declined to participate, and 19 were recruited and randomised. Follow-up data were collected from three participants (retention 3/19), and four agreed to be interviewed for the process evaluation. The main themes of the interviews were:Participants were not at equipoise. They wanted to try the website and were disappointed to be randomised to face-to-face, so they were less engaged and dropped out.Other reasons for drop out included not accepting that they had a drink problem; problem drinking interfering with their ability to take part in a trial or forgetting appointments; having a busy life and being randomised to TAU made it difficult to attend appointments. CONCLUSIONS: This feasibility RCT aimed to test recruitment, randomisation, retention, and data collection methods, but recruited only 19 participants. This illustrates the importance of undertaking feasibility studies prior to fully powered RCTs. From the qualitative interviews we found that potential recruits were not at equipoise for recruitment. An alternative methodology, for example a preference RCT recruiting from multiple locations, needs to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096.

The DYD-RCT protocol: an on-line randomised controlled trial of an interactive computer-based intervention compared with a standard information website to reduce alcohol consumption among hazardous drinkers.

BACKGROUND: Excessive alcohol consumption is a significant public health problem throughout the world. Although there are a range of effective interventions to help heavy drinkers reduce their alcohol consumption, these have little proven population-level impact. Researchers internationally are looking at the potential of Internet interventions in this area. METHODS/DESIGN: In a two-arm randomised controlled trial, an on-line psychologically enhanced interactive computer-based intervention is compared with a flat, text-based information web-site. Recruitment, consent, randomisation and data collection are all on-line. The primary outcome is total past-week alcohol consumption; secondary outcomes include hazardous or harmful drinking, dependence, harm caused by alcohol, and mental health. A health economic analysis is included. DISCUSSION: This trial will provide information on the effectiveness and cost-effectiveness of an on-line intervention to help heavy drinkers drink less. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register ISRCTN31070347.

Internet-based interactive health intervention for the promotion of sensible drinking: patterns of use and potential impact on members of the general public.

BACKGROUND: Heavy drinking is responsible for major health and social problems. Brief interventions have been shown to be effective, but there have been difficulties in reaching those who might benefit from them. Pilot studies have indicated that a Web-based intervention is likely to be acceptable to heavy drinkers and may produce some health benefits. However, there are few data on how many people might use such a program, the patterns of use, and potential benefits. OBJECTIVES: The aim was to examine the demographic characteristics of users of a free, Web-based, 6-week intervention for heavy drinkers and to describe the methods by which users identified the site, the pattern of site use and attrition, the characteristics associated with completing the program, and the self-reported impact on alcohol-related outcomes. METHODS: Cohort study. Visitors to the Web site were offered screening with the Fast Alcohol Screening Test, and those scoring above the cutoff for risky drinking were invited to register with the program. Demographic information was collected routinely at registration, and questionnaires were completed at the end of weeks 1 and 6. The outcome measures assessed dependency (Short Alcohol Dependency Data Questionnaire), harms (modified Alcohol Problems Questionnaire), and mental health (Clinical Outcomes in Routine Evaluation-Outcome Measure). RESULTS: The records of 10,000 users were analyzed. The mean age was 37.4 years, 51.1% were female, 37.5% were single, and 42.4% lived with children. The majority were White British, lived in the United Kingdom, and reported occupations from the higher socioeconomic strata. Over 70% connected to the Down Your Drink (Down Your Drink) site from another Internet-based resource, whereas only 5.8% heard about the site from a health or other professional. Much of the Web site use (40%) was outside normal working hours. Attrition from the program was high, with only 16.5% of registrants completing the whole 6 weeks. For those who completed the program, and the final outcome measures, measures of dependency, alcohol-related problems, and mental health symptoms were all reduced at week 6. CONCLUSIONS: The Web-based intervention was highly used, and those who stayed with the program showed significant reductions in self-reported indicators of dependency, alcohol-related problems, and mental health symptoms; however, this association cannot be assumed to be causal. Programs of this type may have the potential to reach large numbers of heavy drinkers who might not otherwise seek help. There are significant methodological challenges and further research is needed to fully evaluate such interventions.

DIAMOND (DIgital Alcohol Management ON Demand): a mixed methods feasibility RCT and embedded process evaluation of a digital health intervention to reduce hazardous and harmful alcohol use.

BACKGROUND: Alcohol is a major risk factor for preventable illness, with huge cost to healthcare economies. There is a role for alcohol-specific digital health interventions (DHI), but there have been few randomised controlled trials (RCT) comparing DHI with face-to-face treatment. Such trials are complex and face obstacles in recruitment and retention. METHODS: Mixed-methods feasibility RCT of an alcohol DHI, testing recruitment, online data-collection and randomisation processes, with an embedded process evaluation. Recruitment ran from October 2014 for 9 months. Participants were adults drinking at hazardous and harmful levels, attending four community drug and alcohol services (CDAS) in London. Participants completed baseline demographic, alcohol-related and other psychological questionnaires online and were randomised to HeLP-Alcohol, a six-module DHI with weekly reminder prompts (phone, email or text message), which mirrors face-to-face treatment, or to face-to-face treatment at CDAS. Alcohol counsellors took part in qualitative interviews at the end of the study. RESULTS: Alcohol counsellors screened 1253 patients. One thousand one hundred eighty-nine did not meet inclusion criteria so were excluded: 579 were dependent drinkers, 548 had health conditions that made them ineligible to take part and 62 were ineligible for other reasons including homelessness. Of the 64 patients who were eligible to take part, 54 declined to participate, with 36 stating a preference for face-to-face treatment, 13 gave no reason, and 5 gave other reasons including not wanting to use a computer. Ten consented but then 3 changed their minds, so we were able to randomise 7 participants to the study (11% of eligible). Five alcohol counsellors agreed to be interviewed for the process evaluation and provided the following feedback: Although most of their colleagues were enthusiastic about the trial, some were not at equipoise in recruiting; potential participants also declared strong preference to intervention arm from the outset. These factors affected recruitment. Counsellors also lacked time to undertake the data inputting and follow-up of participants in addition to their everyday work. CONCLUSIONS: This feasibility study aimed to test recruitment, randomisation, retention and data collection methods but recruited only 7 participants so these aims were not fully achieved. This illustrates to all researchers of complex interventions the importance of conducting feasibility studies and is generalisable to areas other than alcohol research. CDAS were seeing larger numbers of non-dependent drinkers with complex additional problems than alcohol commissioners expected. CDAS clients and some counsellors were not at equipoise for recruitment. Alternative settings for recruitment need to be explored in future trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN31789096, DOI 10.1186/ISRCTN31789096.

DIgital Alcohol Management ON Demand (DIAMOND) feasibility randomised controlled trial of a web-based intervention to reduce alcohol consumption in people with hazardous and harmful use versus a face-to-face intervention: protocol.

BACKGROUND: "Hazardous and harmful" drinkers make up approximately 23 % of the adult population in England. However, only around 10 % of these people access specialist care, such as face-to-face extended brief treatment in community alcohol services. This may be due to stigma, difficulty accessing services during working hours, a shortage of trained counsellors and limited provision of services in many places. Web-based alcohol treatment programmes may overcome these barriers and may better suit people who are reluctant or unable to attend face-to-face services, but there is a gap in the evidence base for the acceptability, effectiveness and cost-effectiveness of these programmes compared with treatment as usual (TAU) in community alcohol services. This study aims investigate the feasibility of all parts of a randomised controlled trial (RCT) of a psychologically informed web-based alcohol treatment programme called Healthy Living for People who use Alcohol (HeLP-Alcohol) versus TAU in community alcohol services, e.g. recruitment and retention, online data collection methods, and the use and acceptability of the intervention to participants. METHODS: A feasibility RCT delivered in north London community alcohol services, comparing HeLP-Alcohol with TAU. Potential participants are aged ≥18 years referred or self-referred for hazardous and harmful use of alcohol, without co-morbidities or other complex problems. The main purpose of this study is to demonstrate the feasibility of recruiting participants to the study and will test online methods for collecting baseline demographic and outcome questionnaire data, randomising participants and collecting 3-month follow-up data. The acceptability of this intervention will be measured by recruitment and retention rates, automated log-in data collection and an online service satisfaction questionnaire. The feasibility of using tailored text message, email or phone prompt to maintain engagement with the intervention will also be explored. Results of the study will inform a definitive Phase 3 RCT. RESULTS: Recruitment started on 26 September 2014 and will run for 1 year. CONCLUSION: The proposed trial will provide data to inform a fully powered non-inferiority effectiveness and cost-effectiveness RCT comparing HeLP-Alcohol with TAU. TRIAL REGISTRATION: ISRCTN31789096.

Health on the web: randomised controlled trial of online screening and brief alcohol intervention delivered in a workplace setting.

BACKGROUND: Alcohol misuse in England costs around £7.3 billion (US$12.2 billion) annually from lost productivity and absenteeism. Delivering brief alcohol interventions to employees as part of a health check may be acceptable, particularly with online delivery which can provide privacy for this stigmatised behaviour. Research to support this approach is limited and methodologically weak. The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption, delivered in a workplace as part of a health check. METHODS AND FINDINGS: This two-group online individually randomised controlled trial recruited employees from a UK-based private sector organisation (approx. 100,000 employees). 3,375 employees completed the online health check in the three week recruitment period. Of these, 1,330 (39%) scored five or more on the AUDIT-C (indicating alcohol misuse) and were randomised to receive personalised feedback on their alcohol intake, alongside feedback on other health behaviours (n = 659), or to receive feedback on all health behaviours except alcohol intake (n = 671). Participants were mostly male (75%), with a median age of 48 years and half were in managerial positions (55%). Median Body Mass Index was 26, 12% were smokers, median time undertaking moderate/vigorous physical activity a week was 173 minutes and median fruit and vegetable consumption was three portions a day. Eighty percent (n = 1,066) of participants completed follow-up questionnaires at three months. An intention to treat analysis found no difference between experimental groups for past week drinking (primary outcome) (5.6% increase associated with the intervention (95% CI -4.7% to 16.9%; p = .30)), AUDIT (measure of alcohol-related harm) and health utility (EQ-5D). CONCLUSIONS: There was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation. Further research is needed on how to engage a larger proportion of employees in screening. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register ISRCTN50658915.

On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD) website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2) units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3) units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10) or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption, which could be delivered internationally. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN31070347.

Distinguishing features of intrusive images in obsessive-compulsive disorder.

Intrusive imagery is considered to be an important feature in obsessive-compulsive disorder (OCD). The aim of the present study was to investigate whether this imagery has distinctive features relative to other anxiety disorders. Twenty out of twenty-one (95%) individuals with OCD and twenty out of twenty-two (90%) anxious controls reported intrusive images. The groups were compared on the prevalence, number, frequency, characteristics and content of the images, together with associated beliefs, interpretations, and memories of earlier adverse events. Intrusive images in OCD were distinguished from those in other anxiety disorders by their greater frequency, more frequent adoption of a field perspective, and lesser degree of association with memories. Their content more often contained themes of 'unacceptable ideas of harm', and implied a 'dangerous self'. These findings have implications for the use of therapeutic interventions in OCD and suggest that imagery rescripting may have a useful role to play.

How big is the elephant in the room? Estimated and actual IT costs in an online behaviour change trial.

BACKGROUND: The practical and methodological challenges inherent in online behaviour change studies are both novel and complex. We relate our experiences of estimating and managing information technology (IT) research and intervention costs in an ongoing internet trial in the hope that others will find this information useful. FINDINGS: Actual IT costs were approximately twice those that had been originally estimated by external contractors. These original estimates for IT costs allowed little scope for the identification of new needs, which was intrinsic to the iterative nature of the research enterprise. CONCLUSIONS: Making greater provision for the uncertain nature of these costs in future studies is a key practical lesson for the planning of future online behaviour change studies.