scholarly journals Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032110 ◽  
Author(s):  
Christian Baumgartner ◽  
Elena Bilevicius ◽  
Yasser Khazaal ◽  
Sophia Achab ◽  
Susanne Schaaf ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Problem Gambling ◽  
Medical Devices ◽  
Controlled Trial ◽  
Intervention Programme ◽  
Web Based ◽  
Related Disorder ◽  
Self Help ◽  
Study Results ◽  
Randomised Controlled

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).

scholarly journals Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017908 ◽  
Author(s):  
Stanley Sai-Chuen Hui ◽  
Yao Jie Xie ◽  
Ron Chi-Wai Kwok ◽  
Eric Wing-Cheung Tam ◽  
Winnie Wing Sze Mak ◽  
...  
Keyword(s):  
Physical Activity ◽  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Middle Aged ◽  
Intervention Programme ◽  
Study Results ◽  
Randomised Controlled

IntroductionHong Kong is a highly urbanised city where many people work long hours. The limited time and lack of professional instruction are the typical barriers to exercise. The purpose of this study is to test the effectiveness of an information technology-based lifestyle intervention programme on improving physical activity (PA) level and health status in a sample of middle-aged Hong Kong adults.Methods and analysisA two-arm parallel randomised controlled trial named ‘Follow Your Virtual Trainer’ will be conducted among 200 physically inactive Chinese adults aged from 40 to 65 years. Those randomly allocated to an intervention group will be under the instruction of a web-based computer software termed ‘Virtual Trainer (VT)’ to conduct a 3-month self-planned PA programme. A series of online seminars with healthy lifestyle information will be released to the participants biweekly for 3 months. After that, 6 months observation will follow. Those in the control group will only receive a written advice of standard PA recommendation and the textual content of the seminars. The assessments will be implemented at baseline, the 3rd, 6th and 9th months. The primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire. The secondary outcomes include cardiorespiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behaviour mediators and maintenance of PA. The main effectiveness of the intervention will be assessed by a linear mixed model that tests the random effect of treatment on outcomes at the 3rd, 6th and 9th months.Ethics and disseminationThis trial has been approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (CRE 2015235). The study results will be presented at scientific conferences and published in peer-reviewed journals.Trial registration numberNCT02553980.

scholarly journals Internet-based self-help for depression: randomised controlled trial

2005 ◽  
Vol 187 (5) ◽  
pp. 456-461 ◽  
Author(s):  
Gerhard Andersson ◽  
Jan Bergström ◽  
Fredrik Holländare ◽  
Per Carlbring ◽  
Viktor Kaldo ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Discussion Group ◽  
Behavioural Therapy ◽  
Web Based ◽  
Short Supply ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundMajor depression can be treated by means of cognitive–behavioural therapy but as skilled therapists are in short supply there is a need for self-help approaches. Many individuals with depression use the internet for discussion of symptoms and to share their experience.AimsTo investigate the effects of an internet-administered self-help programme including participation in a monitored, web-based discussion group, compared with participation in web-based discussion group only.MethodA randomised controlled trial was conducted to compare the effects of internet-based cognitive–behavioural therapy with minimal therapist contact (plus participation in a discussion group) with the effects of participation in a discussion group only.ResultsInternet-based therapy with minimal therapist contact, combined with activity in a discussion group, resulted in greater reductions of depressive symptoms compared with activity in a discussion group only (waiting-list control group). At 6 months' follow-up, improvement was maintained to a large extent.ConclusionsInternet-delivered cognitive–behavioural therapy should be pursued further as a complement or treatment alternative for mild-to-moderate depression.

scholarly journals Evaluation of an interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2): study protocol for a process evaluation accompanying a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e046874
Author(s):  
Lisa Wenzel ◽  
Christoph Heesen ◽  
Jutta Scheiderbauer ◽  
Markus van de Loo ◽  
Sascha Köpke ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Complex Interventions ◽  
Intervention Programme ◽  
Online Chat ◽  
Web Based ◽  
Randomised Controlled

IntroductionProcess evaluations accompanying complex interventions examine the implementation process of the underlying intervention, identify mechanisms of impact and assess contextual factors. This paper presents the protocol for a process evaluation conducted alongside the randomised controlled trial POWER@MS2. The trial comprises the evaluation of a web-based complex intervention on relapse management in 188 people with multiple sclerosis conducted in 20 centres. The web-based intervention programme focuses on relapse treatment decision making and includes a decision aid, a nurse-led webinar and an online chat. With the process evaluation presented here, we aim to assess participants’ responses to and interactions with the intervention to understand how and why the intervention produces change.Methods and analysisA mixed methods design is used to explore the acceptance of the intervention as well as its use and impact on participants. Participants are people with multiple sclerosis, neurologists, nurses and stakeholders. Quantitative semistandardised evaluation forms will be collected throughout the study. Qualitative semistructured telephone interviews will be conducted at the end of the study with selected participants, especially people with multiple sclerosis and neurologists. Quantitative data will be collected and analysed descriptively. Based on the results, the qualitative interviews will be conducted and analysed thematically, and the results will be merged in a joint display table.Ethics and disseminationThe process evaluation has received ethical approval from the Ethical Committee of the University of Lübeck (reference 19–024). Findings will be disseminated in peer-reviewed journals, at conferences, meetings and on relevant patient websites.Trial registration numberNCT04233970.

scholarly journals Study protocol for a randomised controlled trial examining the effect of blood and plasma donation on serum perfluoroalkyl and polyfluoroalkyl substance (PFAS) levels in firefighters

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044833
Author(s):  
Gabriel Silver ◽  
Yordanka Krastev ◽  
Miriam K Forbes ◽  
Brenton Hamdorf ◽  
Barry Lewis ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Effects ◽  
Whole Blood ◽  
Sulfonic Acid ◽  
Controlled Trial ◽  
Adverse Health Effects ◽  
Plasma Donation ◽  
Adverse Health ◽  
Study Results ◽  
Randomised Controlled

IntroductionPerfluoroalkyl and polyfluoroalkyl substances (PFAS) are a diverse group of compounds that have been used in hundreds of industrial applications and consumer products including aqueous film-forming foam (AFFF) for many years. Multiple national and international health and environmental agencies have accepted that PFAS exposures are associated with numerous adverse health effects. Australian firefighters have been shown to have elevated levels of PFAS in their blood, specifically perfluorooctane sulfonic acid (PFOS) and perfluorohexane sulfonic acid (PFHxS), due to the historical use of AFFF. While PFAS concentrations decline over time once the source of exposure has been removed, their potential adverse health effects are such that it would be prudent to develop an intervention to lower levels at a faster rate than occurs via natural elimination rates.Methods and analysisThis is a randomised controlled trial of current and former Australian firefighters in the Metropolitan Fire Brigade/Fire Rescue Victoria, and contractors, with previous occupational exposure to PFAS and baseline elevated PFOS levels. The study is investigating whether whole blood donation every 12 weeks or plasma donation every 6 weeks will significantly reduce PFAS levels, compared with a control group. We have used covariate-adaptive randomisation to balance participants’ sex and blood PFAS levels between the three groups and would consider a 25% reduction in serum PFOS and PFHxS levels to be potentially clinically significant after 12 months of whole blood or plasma donation. A secondary analysis of health biomarkers is being made of changes between screening and week 52 in all three groups.Ethics and disseminationThis trial has been approved by Macquarie University Human Research Ethics Committee (reference number: 3855), final protocol V.2 dated 12 June 2019. Study results will be disseminated via peer-reviewed publications and presentations at conferences.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619000204145).

scholarly journals Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042953
Author(s):  
Martin John Connor ◽  
Taimur Tariq Shah ◽  
Katarzyna Smigielska ◽  
Emily Day ◽  
Johanna Sukumar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
Androgen Receptor ◽  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Metastatic Prostate Cancer ◽  
Controlled Trial ◽  
Pelvic Lymph Node ◽  
Study Results ◽  
Randomised Controlled

IntroductionSurvival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in addition to standard androgen deprivation therapy (ADT). Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit. In this setting, IP2-ATLANTA will explore progression-free survival (PFS) outcomes with the addition of sequential multimodal local and metastasis-directed treatments compared with standard care alone.MethodsA phase II, prospective, multicentre, three-arm randomised controlled trial incorporating an embedded feasibility pilot. All men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer, within 4 months of commencing ADT and of performance status 0 to 2 are eligible. Patients will be randomised to Control (standard of care (SOC)) OR Intervention 1 (minimally invasive ablative therapy to prostate±pelvic lymph node dissection (PLND)) OR Intervention 2 (cytoreductive radical prostatectomy±PLND OR prostate radiotherapy±pelvic lymph node radiotherapy (PLNRT)). Metastatic burden will be prespecified using the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease (CHAARTED) definition. Men with low burden disease in intervention arms are eligible for metastasis-directed therapy, in the form of stereotactic ablative body radiotherapy (SABR) or surgery. Standard systemic therapy will be administered in all arms with ADT±upfront systemic chemotherapy or androgen receptor agents. Patients will be followed-up for a minimum of 2 years. Primary outcome: PFS. Secondary outcomes include predictive factors for PFS and overall survival; urinary, sexual and rectal side effects. Embedded feasibility sample size is 80, with 918 patients required in the main phase II component. Study recruitment commenced in April 2019, with planned follow-up completed by April 2024.Ethics and disseminationApproved by the Health Research Authority (HRA) Research Ethics Committee Wales-5 (19/WA0005). Study results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03763253; ISCRTN58401737

scholarly journals Web-based early intervention for children with motor difficulties aged 3–8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e046561
Author(s):  
Chantal Camden ◽  
Jill G Zwicker ◽  
Melanie Morin ◽  
Tibor Schuster ◽  
Melanie Couture ◽  
...  
Keyword(s):  
Early Intervention ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Parental Knowledge ◽  
Performance Measure ◽  
Performance Goals ◽  
Web Based ◽  
Study Results ◽  
Motor Difficulties ◽  
Randomised Controlled

IntroductionMild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.Methods and analysisA family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.Ethics and disseminationThe CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.Trial registration numberNCT04254302.

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