scholarly journals A direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT study): results and challenges of an automated randomised controlled trial. (Preprint)

Author(s):  
Richard Morriss ◽  
Catherine Kaylor-Hughes ◽  
Matthew Rawsthorne ◽  
Neil Coulson ◽  
Sandra Simpson ◽  
...  

BMJ ◽  
2018 ◽  
pp. k1959 ◽  
Author(s):  
Rosie Dobson ◽  
Robyn Whittaker ◽  
Yannan Jiang ◽  
Ralph Maddison ◽  
Matthew Shepherd ◽  
...  


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032110 ◽  
Author(s):  
Christian Baumgartner ◽  
Elena Bilevicius ◽  
Yasser Khazaal ◽  
Sophia Achab ◽  
Susanne Schaaf ◽  
...  

IntroductionThe past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries.Methods and analysisThis two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle.Ethics and disseminationThe RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings.Trial registration numberCurrent Controlled Trials registry (ISRCTN16339434).





2017 ◽  
Vol 32 (5) ◽  
pp. 605-625 ◽  
Author(s):  
Roy A. Willems ◽  
Lilian Lechner ◽  
Peter Verboon ◽  
Ilse Mesters ◽  
Iris M. Kanera ◽  
...  


BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033520 ◽  
Author(s):  
Shilpa Patel ◽  
Felix Achana ◽  
Dawn Carnes ◽  
Sandra Eldridge ◽  
David R Ellard ◽  
...  

IntroductionChronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysisChronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and disseminationThis trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration numberISRCTN79708100.





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