Droperidolv. haloperidol for sedation of aggressive behaviour in acute mental health: Randomised controlled trial

BackgroundAgitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients.AimsTo compare the effectiveness and safety of haloperidolv. droperidol for patients with agitation and aggression.MethodIn a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries.ResultsFrom 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15–30, range 10–75) for haloperidolv. 25 min (IQR 15–30, range 10–115) for droperidol (P= 0.89). Additional sedation was used more often with haloperidol (13%v. 5%,P= 0.06), but adverse effects were less common with haloperidol (1%v. 5%,P= 0.12). There were 8 staff injuries.ConclusionsBoth haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

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Efficacy of therapist-delivered transdiagnostic CBT for patients with persistent physical symptoms in secondary care: a randomised controlled trial

Psychological Medicine ◽

10.1017/s0033291721001793 ◽

2021 ◽

pp. 1-11

Author(s):

Trudie Chalder ◽

Meenal Patel ◽

Matthew Hotopf ◽

Rona Moss-Morris ◽

Mark Ashworth ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Medical Care ◽

Social Adjustment ◽

Primary Outcome ◽

Controlled Trial ◽

Physical Symptoms ◽

End Of Treatment ◽

Significant Difference ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS) are debilitating to patients. As many specific PPS syndromes share common behavioural, cognitive, and affective influences, transdiagnostic treatments might be effective for this patient group. We evaluated the clinical efficacy and cost-effectiveness of a therapist-delivered, transdiagnostic cognitive behavioural intervention (TDT-CBT) plus (+) standard medical care (SMC) v. SMC alone for the treatment of patients with PPS in secondary medical care. Methods A two-arm randomised controlled trial, with measurements taken at baseline and at 9, 20, 40- and 52-weeks post randomisation. The primary outcome measure was the Work and Social Adjustment Scale (WSAS) at 52 weeks. Secondary outcomes included mood (PHQ-9 and GAD-7), symptom severity (PHQ-15), global measure of change (CGI), and the Persistent Physical Symptoms Questionnaire (PPSQ). Results We randomised 324 patients and 74% were followed up at 52 weeks. The difference between groups was not statistically significant for the primary outcome (WSAS at 52 weeks: estimated difference −1.48 points, 95% confidence interval from −3.44 to 0.48, p = 0.139). However, the results indicated that some secondary outcomes had a treatment effect in favour of TDT-CBT + SMC with three outcomes showing a statistically significant difference between groups. These were WSAS at 20 weeks (p = 0.016) at the end of treatment and the PHQ-15 (p = 0.013) and CGI at 52 weeks (p = 0.011). Conclusion We have preliminary evidence that TDT-CBT + SMC may be helpful for people with a range of PPS. However, further study is required to maximise or maintain effects seen at end of treatment.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0241704 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241704

Author(s):

Jennifer Wild ◽

Shama El-Salahi ◽

Michelle Degli Esposti ◽

Graham R. Thew

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Report ◽

Post Traumatic Stress ◽

Emergency Responders ◽

Significant Difference ◽

Randomised Controlled ◽

Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

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O04 Clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injection for hip OA: a randomised controlled trial (HIT)

Rheumatology ◽

10.1093/rheumatology/keaa110.003 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Zoe Paskins ◽

Kieran Bromley ◽

Martyn Lewis ◽

Gemma Hughes ◽

Emily Hughes ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Pain Intensity ◽

Primary Outcome ◽

Controlled Trial ◽

Hip Pain ◽

Ultrasound Guided ◽

Life Years ◽

Significant Difference ◽

Randomised Controlled

Abstract Background Evidence of the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis (OA) is limited. The HIT trial compared the clinical and cost-effectiveness of an ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride combined with best current treatment (BCT) with (i) BCT alone (primary objective) and (ii) an USGI of 5ml 1% lidocaine only combined with BCT (EudraCT:2014-003412-37). Methods This was a pragmatic, three-parallel arm, single-blind, randomised controlled trial in adults with moderate-severe painful hip OA recruited from community musculoskeletal services and primary care. Participants were randomised equally to: (1) BCT alone, (2) BCT plus USGI triamcinolone/lidocaine, or (3) BCT plus USGI lidocaine only. Outcomes were collected postally at 2 weeks, 2, 4 and 6 months. The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months (repeated measures analysis). Secondary outcomes included function (WOMAC), and, for cost-utility analysis, general health (EQ-5D-5L) and healthcare utilisation. 204 participants were required to detect a minimum difference of 1 point in mean pain NRS score between arms (1) and (2) with 80% power (5% two-tailed significance level, 15% loss to follow-up). Analysis was by intention-to-treat. Results 199 participants were recruited (43% male, mean age 63 years), 67 to arm (1) and 66 each to arms (2) and (3). Primary outcome completion rates were 95% at 2 weeks, 94% at 2 months, 90% at 4 months, and 89% at 6 months. Greater mean improvement in hip pain intensity (0-10 NRS) over 6 months was seen with BCT plus USGI triamcinolone/lidocaine compared with BCT alone: -1.43 (95%CI -2.15,-0.72). Greater mean improvement in pain intensity was seen at 2 weeks (-3.17; -4.06,-2.28) and 2 months (-1.81;-2.71,-0.92), but not at 4 (-0.86;-1.78,0.05) or 6 months (0.12; -0.80,1.04). Participants treated with BCT plus USGI triamcinolone/lidocaine compared with BCT alone had greater mean improvement in function (WOMAC-F -5.47;(-9.41,-1.53)) over 6 months. There was no statistically significant difference in hip pain intensity over 6 months between BCT plus USGI triamcinolone/lidocaine compared with BCT plus USGI lidocaine (-0.52;-1.21,0.18). There was one possible treatment-related serious adverse event: a participant with no signs of infection at randomisation died from endocarditis four months after USGI triamcinolone/lidocaine. BCT plus USGI triamcinolone/lidocaine was less costly (mean cost difference per participant £-161.59) and associated with significantly higher quality-adjusted life-years (QALYs) than BCT only over 6 months (mean difference 0.0477 (0.0257,0.0699). Conclusion USGI triamcinolone/lidocaine plus BCT leads to greater improvements in pain and function over 6 months in adults with hip OA than BCT alone, and was highly cost-effective. There was no significant difference in hip pain intensity between the groups receiving USGI triamcinolone/lidocaine and USGI lidocaine only, raising the possibility of a degree of placebo effect. Disclosures Z. Paskins None. K. Bromley None. M. Lewis None. G. Hughes None. E. Hughes None. A. Cherrington None. A. Hall None. M. Holden None. R. Oppong None. J. Kigozi None. K. Stevenson None. A. Menon None. P. Roberts None. G. Peat None. C. Jinks None. N.E. Foster None. C.D. Mallen None. E. Roddy None.

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Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2018.2 ◽

2018 ◽

Vol 213 (1) ◽

pp. 404-411 ◽

Cited By ~ 12

Author(s):

Ulrika Karlsson Stigsdotter ◽

Sus Sola Corazon ◽

Ulrik Sidenius ◽

Patrik Karlsson Nyed ◽

Helmer Bøving Larsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Well Being ◽

Behavioural Therapy ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Significant Difference ◽

Increasing Demand ◽

Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

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Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040183 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040183

Author(s):

Dominika Kwasnicka ◽

Aleksandra Luszczynska ◽

Martin S Hagger ◽

Eleanor Quested ◽

Sherry L Pagoto ◽

...

Keyword(s):

Time Series ◽

Weight Loss ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Weight Loss Maintenance ◽

Control Group ◽

Promote Weight Loss ◽

Secondary Outcomes ◽

Randomised Controlled

IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.

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Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study

BMJ Open ◽

10.1136/bmjopen-2017-020500 ◽

2018 ◽

Vol 8 (8) ◽

pp. e020500 ◽

Cited By ~ 24

Author(s):

James W F Catto ◽

Pramit Khetrapal ◽

Gareth Ambler ◽

Rachael Sarpong ◽

Muhammad Shamim Khan ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Sample Size ◽

Radical Cystectomy ◽

Feasibility Study ◽

Primary Outcome ◽

Controlled Trial ◽

Robot Assisted ◽

Link Type ◽

Secondary Outcomes ◽

Randomised Controlled

IntroductionBladder cancer (BC) is a common malignancy and one of the most expensive to manage. Radical cystectomy (RC) with pelvic lymphadenectomy is a gold standard treatment for high-risk BC. Reductions in morbidity and mortality from RC may be achieved through robot-assisted RC (RARC). Prospective comparisons between open RC (ORC) and RARC have been limited by sample size, use of extracorporeal reconstruction and use of outcomes important for ORC. Conversely, while RARC is gaining in popularity, there is little evidence to suggest it is superior to ORC. We are undertaking a prospective randomised controlled trial (RCT) to compare RARC with intracorporeal reconstruction (iRARC) and ORC using multimodal outcomes to explore qualitative and quantitative recovery after surgery.Methods and analysisiROC is a multicentre prospective RCT in English National Health Service (NHS) cancer centres. We will randomise 320 patients undergoing RC to either iRARC or ORC. Treatment allocation will occur after trial entry and consent. The primary outcome is days alive and out of hospital within the first 90 days from surgery. Secondary outcomes will measure functional recovery (activity trackers, chair-to-stand tests and health related quality of life (HRQOL) questionnaires), morbidity (complications and readmissions), cost-effectiveness (using EuroQol-5 Domain-5 levels (EQ-5D-5L) and unit costs) and surgeon fatigue. Patients will be analysed according to intention to treat. The primary outcome will be transformed and analysed using regression. All statistical assumptions will be investigated. Secondary outcomes will be analysed using appropriate regression methods. An internal feasibility study of the first 30 patients will evaluate recruitment rates, acceptance of randomised treatment choice, compliance outcome collection and to revise our sample size.Ethics and disseminationThe study has ethical approval (REC reference 16/NE/0418). Findings will be made available to patients, clinicians, funders and the NHS through peer-reviewed publications, social media and patient support groups.Trial registration numbersISRCTN13680280andNCT03049410.

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Characteristics of participants who benefit most from personalised nutrition: findings from the pan-European Food4Me randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114520000653 ◽

2020 ◽

Vol 123 (12) ◽

pp. 1396-1405 ◽

Cited By ~ 1

Author(s):

Katherine M. Livingstone ◽

Carlos Celis-Morales ◽

Santiago Navas-Carretero ◽

Rodrigo San-Cristobal ◽

Hannah Forster ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Plasma Concentrations ◽

Well Being ◽

Healthy Eating Index ◽

Dietary Advice ◽

Personalised Nutrition ◽

Secondary Outcomes ◽

Randomised Controlled

AbstractLittle is known about who would benefit from Internet-based personalised nutrition (PN) interventions. This study aimed to evaluate the characteristics of participants who achieved greatest improvements (i.e. benefit) in diet, adiposity and biomarkers following an Internet-based PN intervention. Adults (n 1607) from seven European countries were recruited into a 6-month, randomised controlled trial (Food4Me) and randomised to receive conventional dietary advice (control) or PN advice. Information on dietary intake, adiposity, physical activity (PA), blood biomarkers and participant characteristics was collected at baseline and month 6. Benefit from the intervention was defined as ≥5 % change in the primary outcome (Healthy Eating Index) and secondary outcomes (waist circumference and BMI, PA, sedentary time and plasma concentrations of cholesterol, carotenoids and omega-3 index) at month 6. For our primary outcome, benefit from the intervention was greater in older participants, women and participants with lower HEI scores at baseline. Benefit was greater for individuals reporting greater self-efficacy for ‘sticking to healthful foods’ and who ‘felt weird if [they] didn’t eat healthily’. Participants benefited more if they reported wanting to improve their health and well-being. The characteristics of individuals benefiting did not differ by other demographic, health-related, anthropometric or genotypic characteristics. Findings were similar for secondary outcomes. These findings have implications for the design of more effective future PN intervention studies and for tailored nutritional advice in public health and clinical settings.

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Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-024256 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024256 ◽

Cited By ~ 7

Author(s):

Elizabeth G Ryan ◽

Ewen M Harrison ◽

Rupert M Pearse ◽

Simon Gates

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Gastrointestinal Surgery ◽

Evidence Based ◽

Bayesian Analyses ◽

Therapy Algorithm ◽

Significant Difference ◽

Randomised Controlled ◽

The Impact

ObjectiveThe traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.Design, setting, participants and interventionsThe OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.MethodsWe repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.ResultsAlthough OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.ConclusionsThe use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.Trial registration numberISRCTN04386758; Post-results.

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Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial.

10.31234/osf.io/d5kjq ◽

2019 ◽

Author(s):

Aleksandra Herbec ◽

Lion Shahab ◽

Jamie Brown ◽

Harveen Kaur Ubhi ◽

Emma Beard ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Point Prevalence ◽

Management Tools ◽

Exact Test ◽

Significant Difference ◽

Continuous Abstinence ◽

Randomised Controlled

Introduction: Delivery of craving management tools (CMTs) via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remainslimited, especially in real-world settings. This study evaluated the effectiveness of adding CMTs in a cessation app (BupaQuit).Methods: The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with CMT with a control app version withoutCMT. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015-March 2016), with no researcher involvement, and individually randomised within the app to the intervention (n=208) or control (n=217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher’s exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed.Results: Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p=0.58;RR=0.86, 95% Confidence Interval (CI)=0.54-1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs. 17.1%, p=0.51;RR=0.85, 95%CI=0.54-1.32; 6-month sustained: 11.1% vs 13.4%, p=0.55,RR=0.83,95%CI=0.50-1.38). Bayes factors supported the null hypothesis (B[0, 0,1.0986]=.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs. 10.5/5; time spent: 401.8/202s vs. 325.8/209s).Conclusions: The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

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