Effectiveness of a smartphone app (Drink Less) versus usual digital care for reducing alcohol consumption among increasing-and-higher-risk adult drinkers in the UK: a two-arm, parallel-group, double-blind, randomised controlled trial.

Background: Digital interventions, including apps and websites, can be effective for reducing alcohol consumption. However, many are not evidence- or theory-informed and have not been evaluated. We tested the effectiveness of the Drink Less app for reducing alcohol consumption compared with usual digital care in the UK. Methods: In this two-arm, parallel group, double-blind, randomised controlled trial, we enrolled increasing-and-higher-risk drinkers (AUDIT ≥ 8) in the UK, who were motivated to reduce their alcohol consumption and willing to use a digital intervention to do so, via online methods. Participants were randomly assigned (1:1), using an online algorithm, to receive a web link to download the Drink Less app (intervention) or to the NHS alcohol advice webpage (usual digital care). Researchers were masked to group allocation. Participants were followed up at one, three and six months. The primary outcome was self-reported weekly alcohol consumption at six months, adjusting for baseline consumption. The full analytic sample was used in most analyses, though missing data was treated in different ways. The primary, pre-registered intention-to-treat analysis assumed baseline-carried-forwards. Secondary pre-registered analyses also focused on the full analytic sample and used alternatives including multiple imputation and last observation carried forwards. This trial is registered with the ISRCTN registry, ISRCTN64052601. Findings: Between 07/13/2020 and 03/29/2022, 5602 people were randomly assigned to the Drink Less app (n = 2788) or comparator (n = 2814) groups. Six-month follow-up rates were 79% and 80%, respectively. The primary pre-registered conservative intention-to-treat approach assuming non-responders were drinking at baseline levels of consumption, found a non-significant greater reduction of 0.98 units in weekly alcohol consumption in the intervention group at 6-month follow-up (95% CI -2.67 to 0.70). The data were insensitive to detect the hypothesised effect (Bayes factor = 1.17). Data were not missing completely at random, with 6-month follow-up rates differing in terms of education, occupation, and income. We therefore conducted the pre-registered sensitivity analysis using multiple imputation, showing that the Drink Less app resulted in a 2.00-unit greater weekly reduction at 6-month follow-up compared with the NHS alcohol advice webpage (95% CI -3.76 to -0.24). Fewer than 0.1% of participants in both arms who responded to one, three or six-month follow-up reported adverse events linked to participation in the trial. Interpretation: The Drink Less app may be effective in reducing the alcohol consumption in increasing-and-higher-risk drinkers motivated to reduce their consumption. Funding: NIHR Public Health Research Programme.

Methodological Insights on Recruitment and Retention From a Remote Randomized Controlled Trial Examining the Effectiveness of an Alcohol Reduction App: Descriptive Analysis Study.

BACKGROUND: Randomized controlled trials (RCTs) with no in-person contact (ie, remote) between researchers and participants offer savings in terms of cost and time but present unique challenges. OBJECTIVE: The goal of this study is to examine the differences between different forms of remote recruitment (eg, National Health Service [NHS] website, social media, and radio advertising) in the proportion of participants recruited, demographic diversity, follow-up rates, and cost. We also examine the cost per participant of sequential methods of follow-up (emails, phone calls, postal surveys, and postcards). Finally, our experience with broader issues around study advertising and participant deception is discussed. METHODS: We conducted a descriptive analysis of 5602 increasing-and-higher-risk drinkers (Alcohol Use Disorders Identification Test score ≥8), taking part in a 2-arm, parallel group, remote RCT with a 1:1 allocation, comparing the intervention (Drink Less app) with usual digital care (NHS alcohol advice web page). Participants were recruited between July 2020 and March 2022 and compensated with gift vouchers of up to £36 (a currency exchange rate of £1=US $1.26988 is applicable) for completing follow-up surveys, with 4 stages of follow-up: email reminders, phone calls, postal survey, and postcard. RESULTS: The three main recruitment methods were advertisements on (1) social media (2483/5602, 44.32%), (2) the NHS website (1961/5602, 35.01%), and (3) radio and newspapers (745/5602, 13.3%), with the remaining methods of recruitment accounting 7.37% (413/5602) of the sample. The overall recruitment cost per participant varied from £0 to £11.01. Costs were greater when recruiting participants who were men (£0-£28.85), from an ethnic minority group (£0-£303.81), and more disadvantaged (£0-£49.12). Targeted approaches were useful for recruiting more men but less useful in achieving diversity in ethnicity and socioeconomic status. Follow-up at 6 months was 79.58% (4458/5602). Of those who responded, 92.4% (4119/4458) responded by email. Each additional stage of follow-up resulted in an additional 2-3 percentage points of the overall sample being followed up, although phone calls, postal surveys, and postcards were more resource intensive than email reminders. CONCLUSIONS: For remote RCTs, researchers could benefit from using a range of recruitment methods and cost-targeted approaches to achieve demographic diversity. Automated emails with substantial financial incentives for prompt completion can achieve good follow-up rates, and sequential, offline follow-up options, such as phone calls and postal surveys, can further increase follow-up rates but are comparatively expensive. We also make broader recommendations focused on striking the right balance when designing remote RCTs. Careful planning, ongoing maintenance, and dynamic decision-making are required throughout a trial to balance the competing demands of participation among those eligible, deceptive participation among those who are not eligible, and ensuring no postrandomization bias is introduced by data-checking protocols.

Sign-tracking and goal-tracking in humans: Utilising eye-tracking in clinical and non-clinical populations.

BACKGROUND: In Pavlovian conditioning, learned behaviour varies according to the perceived value of environmental cues. For goal-trackers (GT), the cue merely predicts a reward, whilst for sign-trackers (ST), the cue holds incentive value. The sign-tracking/goal-tracking model is well-validated in animals, but translational work is lacking. Despite the model's relevance to several conditions, including attention deficit hyperactivity disorder (ADHD), we are unaware of any studies that have examined the model in clinical populations. METHODS: The current study used an eye-tracking Pavlovian conditioning paradigm to identify ST and GT in non-clinical (N = 54) and ADHD (N = 57) participants. Eye movements were recorded whilst performing the task. Dwell time was measured for two areas of interest: sign (i.e., cue) and goal (i.e., reward), and an eye-gaze index (EGI) was computed based on the dwell time sign-to-goal ratio. Higher EGI values indicate sign-tracking behaviour. ST and GT were determined using median and tertiary split approaches in both samples. RESULTS: Despite greater propensity for sign-tracking in those with ADHD, there was no significant difference between groups. The oculomotor conditioned response was reward-specific (CS+) and present, at least partly, from the start of the task indicating dispositional and learned components. There were no differences in externalising behaviours between ST and GT for either sample. CONCLUSIONS: Sign-tracking is associated with CS+ trials only. There may be both dispositional and learned components to sign-tracking, potentially more common in those with ADHD. This holds translational potential for understanding individual differences in reward-learning.

The effects of tryptophan loading on Attention Deficit Hyperactivity in adults: A remote double blind randomised controlled trial.

BACKGROUND: Despite the impact and prevalence of Attention Deficit Hyperactivity Disorder (ADHD), current treatment options remain limited and there is a drive for alternative approaches, including those building on evidence of a role for tryptophan (TRP) and serotonin (5-HT). This study aimed to evaluate the effect of acute TRP loading on attention and impulsivity in adults with ADHD. TRIAL DESIGN AND METHODS: We conducted a remote double blind randomised controlled trial (RCT) using TRP loading to examine the effects of a balanced amino acid load in comparison to low and high TRP loading in individuals with ADHD (medicated, N = 48, and unmedicated, N = 46) and controls (N = 50). Participants were randomised into one of three TRP treatment groups using stratified randomisation considering participant group and gender using a 1:1:1 ratio. Baseline testing of attention and impulsivity using the Test of Variables of Attention Task, Delay Discounting Task, and Iowa Gambling Task was followed by consumption of a protein drink (BAL, LOW, or HIGH TRP) before repeated testing. RESULTS AND CONCLUSIONS: No effects of TRP were observed for any of the measures. In the present study, TRP loading did not impact on any measure of attention or impulsivity in those with ADHD or Controls. The findings need to be confirmed in another trial with a larger number of patients that also considers additional measures of dietary protein, plasma TRP and aggression. (Registration ID ISRCTN15119603).

Bot or Not? Detecting and Managing Participant Deception When Conducting Digital Research Remotely: Case Study of a Randomized Controlled Trial.

BACKGROUND: Evaluating digital interventions using remote methods enables the recruitment of large numbers of participants relatively conveniently and cheaply compared with in-person methods. However, conducting research remotely based on participant self-report with little verification is open to automated "bots" and participant deception. OBJECTIVE: This paper uses a case study of a remotely conducted trial of an alcohol reduction app to highlight and discuss (1) the issues with participant deception affecting remote research trials with financial compensation; and (2) the importance of rigorous data management to detect and address these issues. METHODS: We recruited participants on the internet from July 2020 to March 2022 for a randomized controlled trial (n=5602) evaluating the effectiveness of an alcohol reduction app, Drink Less. Follow-up occurred at 3 time points, with financial compensation offered (up to £36 [US $39.23]). Address authentication and telephone verification were used to detect 2 kinds of deception: "bots," that is, automated responses generated in clusters; and manual participant deception, that is, participants providing false information. RESULTS: Of the 1142 participants who enrolled in the first 2 months of recruitment, 75.6% (n=863) of them were identified as bots during data screening. As a result, a CAPTCHA (Completely Automated Public Turing Test to Tell Computers and Humans Apart) was added, and after this, no more bots were identified. Manual participant deception occurred throughout the study. Of the 5956 participants (excluding bots) who enrolled in the study, 298 (5%) were identified as false participants. The extent of this decreased from 110 in November 2020, to a negligible level by February 2022 including a number of months with 0. The decline occurred after we added further screening questions such as attention checks, removed the prominence of financial compensation from social media advertising, and added an additional requirement to provide a mobile phone number for identity verification. CONCLUSIONS: Data management protocols are necessary to detect automated bots and manual participant deception in remotely conducted trials. Bots and manual deception can be minimized by adding a CAPTCHA, attention checks, a requirement to provide a phone number for identity verification, and not prominently advertising financial compensation on social media. TRIAL REGISTRATION: ISRCTN Number ISRCTN64052601; https://doi.org/10.1186/ISRCTN64052601.

The Effects of Different Exercise Approaches on Attention Deficit Hyperactivity Disorder in Adults: A Randomised Controlled Trial.

Attention deficit hyperactivity disorder (ADHD) results in significant functional impairment. Current treatments, particularly for adults, are limited. Previous research indicates that exercise may offer an alternative approach to managing ADHD, but research into different types of exercise and adult populations is limited. The aim of this study was to examine the effects of acute exercise (aerobic cycling vs mind-body yoga exercises) on symptoms of ADHD in adults. Adults with ADHD (N = 82) and controls (N = 77) were randomly allocated to 10 min of aerobic (cycling) or mind-body (Hatha yoga) exercise. Immediately before and after exercise, participants completed the Test of Variables of Attention task, Delay Discounting Task, and Iowa Gambling Task to measure attention and impulsivity. Actigraphy measured movement frequency and intensity. Both groups showed improved temporal impulsivity post-exercise, with cycling beneficial to all, whilst yoga only benefited those with ADHD. There were no effects of exercise on attention, cognitive or motor impulsivity, or movement in those with ADHD. Exercise reduced attention and increased movement in controls. Exercise can improve temporal impulsivity in adult ADHD but did not improve other symptoms and worsened some aspects of performance in controls. Exercise interventions should be further investigated.

Effects of captions, transcripts and reminders on learning and perceptions of lecture capture.

Lecture capture is popular within Higher Education, but previous research suggests that students do not always optimally select content to review, nor do they make the most of specific functions. In the current study conducted in the 2019/20 academic year, we used a repeated-measures crossover design to establish the effects of transcripts with closed captioning, and email reminders, on use (self-reported and system analytics), perceptions of lecture capture and student performance, as measured by multiple-choice question (MCQ) tests designed to assess the module learning outcomes. System analytics (N = 129) and survey data (N = 42) were collected from students alongside qualitative data from semi-structured interviews (N = 8). We found that students value lecture capture highly, but do not access it extensively during the teaching period. The availability of transcripts and closed captions did not impact the amount of capture use or performance on MCQ tests, but did result in more positive perceptions of capture, including increased likelihood of recommending it to others. The use of email reminders referring students to specific segments of capture and reminding them of the functionality had no impact on any measure, although qualitative data suggested that the content of reminders may be used in revision rather than during the teaching period, which fell outside the period we investigated. Collectively, these data suggest that the use of captions and transcripts may be beneficial to students by allowing dual processing of visual and audio content, and a searchable resource to help consolidate their learning but there is little evidence to support reminders. Supplementary Information: The online version contains supplementary material available at 10.1186/s41239-022-00327-9.

Tryptophan modulation in individuals with attention deficit hyperactivity disorder: a systematic review.

The serotonergic system is implicated in ADHD, but the impact of serotonin's precursor molecule, tryptophan, on ADHD symptomology remains unclear. Systematic searches of randomised controlled trials with an experimental tryptophan intervention in children and adults with ADHD identified 14 studies measuring core and related symptoms of the condition. Risk of bias was assessed using the Cochrane Risk of Bias tool. The 14 studies all used acute tryptophan depletion procedures, and most did not investigate core ADHD symptoms (inattention, impulsivity, hyperactivity) as primary outcome measures. Only two studies examined attention and revealed mixed effects of tryptophan. Similar effects were found for impulsivity in a small number of studies. No studies investigated hyperactivity. Most studies focused on reactive aggression, but samples were heterogenous and small, rendering potential meta-analyses inconclusive or misleading. However, the narrative analysis indicates tryptophan interventions may impact reactive aggression. More research is needed on the effect of tryptophan modulation on core ADHD symptoms, especially in adults, using more diverse samples to determine potential as an intervention. From current data, tryptophan modulation appears to alter aggressive behaviour in ADHD; however, the available studies were insufficient for the planned meta-analysis.

Predicting stress and mental wellbeing among doctoral researchers.

BACKGROUND: Although mental health in higher education is increasingly recognised as a public health issue, postgraduate research students are often overlooked. Recent studies indicate a high prevalence of mental distress in this population. AIMS: This study assesses the experience of doctoral researchers and identifies factors influencing mental wellbeing and perceived stress. METHODS: A cross-sectional study examined how key demographic, individual and contextual factors related to stress and mental wellbeing in a sample of 431 doctoral researchers in the United Kingdom. RESULTS: Respondents gave positive reports about their supervisory relationship and identified feeling confidently prepared for their work. Family support, good general health, sleep and low levels of self-depreciation predicted stronger mental wellbeing and lower levels of stress. Students who were confident about their future career and felt well prepared for their studies were less stressed and those who were achievement orientated had better mental wellbeing. CONCLUSIONS: Focused attention on exploring career options and building confidence may help reduce stress among doctoral researchers. Taking steps to tackle the imposter phenomenon may help further. These could include addressing fear of failure, improving confidence in research ability and clarifying the role of doctoral researchers within the wider academic community.