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Background: Despite the success of gold standard cognitive-behavioral therapy for problem and disordered gambling, the majority of individuals with gambling problems do not seek or receive professional treatment. Thus, the development of less intrusive self-directed interventions has been encouraged. Bibliotherapy for problem gambling has shown promise, both alone and in combination with motivational interviews, but there is still a lack of online self-directed intervention research. The current randomized controlled trial proposes to assess the additive benefit of a single digital motivational interview delivered in conjunction with an online self-directed treatment program for problem gambling and gambling disorder.Methods: A two-arm randomized controlled trial will be conducted, wherein eligible participants (N=270) will be recruited across Canada via internet advertisements posted to several platforms. All participants will receive access to an online self-directed gambling intervention program. Participants will be randomly assigned to either complete the online program alone or receive a digital motivational interview, conducted through an online audioconferencing platform (i.e., Microsoft Teams) to supplement the online program. The primary outcomes of gambling severity, frequency, and expenditures will be tracked along with secondary outcomes (i.e., depression, anxiety, general distress, alcohol use, and online program user data) over a 24-month period. It is expected that participants in both groups will experience a reduction in symptoms across the board, but more substantial improvements will be observed in the group that receives a supplemental motivational interview.Discussion: The results of this trial will expand upon prior gambling intervention research by informing best practices for the provision of online self-help for problem gambling.Trial Registration: ISRCTN ISRCTN13009468 . Registered on 7 July 2020. [ABSTRACT FROM AUTHOR]

Background: Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain.Objectives and Methods: Aims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries. We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results. We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup analyses; and the use of routinely collected data for RCTs.Discussion: The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time. [ABSTRACT FROM AUTHOR]

Introduction: The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial., Methods and Analysis: Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered., Ethics and Dissemination: The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations., Trial Registration Number: ClinicalTrials.gov registry (NCT03821649)., Competing Interests: Competing interests: AO: evidence reviewer for ILCOR 2015, and writer for AHA/HSFC Guidelines on CPR and Resuscitation in 2015. Receives salary support from the Canadian Institutes of Health Research, the Schwartz/Reisman Emergency Medicine Institute, and the University of Toronto Department of Family and Community Medicine. AO is an evidence reviewer for the International Liaison Committee on Resuscitation and a coauthor for the 2015 American Heart Association Guidelines for CPR and ECC concerning opioid overdose and 2019 American Heart Association Guidelines updates on First Aid. CH: Contract with Toronto Central Local Health Integration Network as primary care clinical lead for the mid-east Toronto sub-region. MK: speaker honoraria from the Ontario Pharmacists Association continuing education programs on the topic of opioid use disorder. I do not address take home naloxone beyond mentioning that the programme exists (Major >$5000). Advisory Committee Member, Health Quality Ontario, Quality Standard on Opioid Use Disorder, but recused from voting on standards that involved take-home naloxone. PL: Advisory Committee Member, Health Quality Ontario, Quality Standard: Opioid Use Disorder; Quality Statement 6 pertains to access to naloxone and overdose education. LM: contributor to the 2015 guidelines and ILCOR consensus on science where opioid management was reviewed and updated., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)