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

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

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

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

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

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

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

Titin-truncating variants affect heart function in disease cohorts and the general population

Titin-truncating variants (TTNtv) commonly cause dilated cardiomyopathy (DCM). TTNtv are also encountered in ~1% of the general population, where they may be silent, perhaps reflecting allelic factors. To better understand TTNtv, we integrated TTN allelic series, cardiac imaging and genomic data in humans and studied rat models with disparate TTNtv. In patients with DCM, TTNtv throughout titin were significantly associated with DCM. Ribosomal profiling in rat showed the translational footprint of premature stop codons in Ttn, TTNtv-position-independent nonsense-mediated degradation of the mutant allele and a signature of perturbed cardiac metabolism. Heart physiology in rats with TTNtv was unremarkable at baseline but became impaired during cardiac stress. In healthy humans, machine-learning-based analysis of high-resolution cardiac imaging showed TTNtv to be associated with eccentric cardiac remodeling. These data show that TTNtv have molecular and physiological effects on the heart across species, with a continuum of expressivity in health and disease