Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemi- nation of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. In- dividuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to- treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help. Trial registration: Clinicaltrials.gov as NCT04074681. Registered 22 July 2019

Smartphone Apps for the Treatment of Mental Disorders: Systematic Review

Background: Smartphone apps are an increasingly popular means for delivering psychological interventions to patients suffering from a mental disorder. In line with this popularity, there is a need to analyze and summarize the state of the art, both from a psychological and technical perspective. Objective: This study aimed to systematically review the literature on the use of smartphones for psychological interventions. Our systematic review has the following objectives: (1) analyze the coverage of mental disorders in research articles per year; (2) study the types of assessment in research articles per mental disorder per year; (3) map the use of advanced technical features, such as sensors, and novel software features, such as personalization and social media, per mental disorder; (4) provide an overview of smartphone apps per mental disorder; and (5) provide an overview of the key characteristics of empirical assessments with rigorous designs (ie, randomized controlled trials [RCTs]). Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for systematic reviews were followed. We performed searches in Scopus, Web of Science, American Psychological Association PsycNET, and Medical Literature Analysis and Retrieval System Online, covering a period of 6 years (2013-2018). We included papers that described the use of smartphone apps to deliver psychological interventions for known mental disorders. We formed multidisciplinary teams, comprising experts in psychology and computer science, to select and classify articles based on psychological and technical features. Results: We found 158 articles that met the inclusion criteria. We observed an increasing interest in smartphone-based interventions over time. Most research targeted disorders with high prevalence, that is, depressive (31/158,19.6%) and anxiety disorders (18/158, 11.4%). Of the total, 72.7% (115/158) of the papers focused on six mental disorders: depression, anxiety, trauma and stressor-related, substance-related and addiction, schizophrenia spectrum, and other psychotic disorders, or a combination of disorders. More than half of known mental disorders were not or very scarcely (<3%) represented. An increasing number of studies were dedicated to assessing clinical effects, but RCTs were still a minority (25/158, 15.8%). From a technical viewpoint, interventions were leveraging the improved modalities (screen and sound) and interactivity of smartphones but only sparingly leveraged their truly novel capabilities, such as sensors, alternative delivery paradigms, and analytical methods. Conclusions: There is a need for designing interventions for the full breadth of mental disorders, rather than primarily focusing on most prevalent disorders. We further contend that an increasingly systematic focus, that is, involving RCTs, is needed to improve the robustness and trustworthiness of assessments. Regarding technical aspects, we argue that further exploration and innovative use of the novel capabilities of smartphones are needed to fully realize their potential for the treatment of mental health disorders

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P &lt; 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)