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Safety and User Experience of a Generative Artificial Intelligence Digital Mental Health Intervention: Exploratory Randomized Controlled Trial

Safety and User Experience of a Generative Artificial Intelligence Digital Mental Health Intervention: Exploratory Randomized Controlled Trial

We conducted a 2-week exploratory double-blind randomized controlled trial comparing a Woebot for mood and anxiety with generative elements (Gen-W-MA, 81/160, 50.6%) against a rules-based version of this same product, that is, Woebot for mood and anxiety (W-MA, 79/160, 49.3%). W-MA is an investigational DMHI that delivers a guided self-help program using cognitive behavioral therapy, psychoeducation, and self-management tools through brief conversations with a relational agent named Woebot (Woebot Health).

Timothy R Campellone, Megan Flom, Robert M Montgomery, Lauren Bullard, Maddison C Pirner, Aaron Pavez, Michelle Morales, Devin Harper, Catherine Oddy, Tom O'Connor, Jade Daniels, Stephanie Eaneff, Valerie L Forman-Hoffman, Casey Sackett, Alison Darcy

J Med Internet Res 2025;27:e67365

Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics in General Practices (Project RELIEF): Protocol for a Single-Arm Exploratory Feasibility Study

Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics in General Practices (Project RELIEF): Protocol for a Single-Arm Exploratory Feasibility Study

A single-arm, exploratory pilot study with accompanying process evaluation will be conducted to pilot the case management program. Conducting a pilot study provides a good opportunity to assess feasibility of a full-scale study and can be considered an essential prerequisite to enhancing likelihood of success of the main study. Pilot studies should be well designed with clear feasibility objectives, and explicit criteria for determining feasibility [19].

Regina Poß-Doering, Sabrina Brinkmöller, Alexandra Balzer, Viktoria Sophie Wurmbach, Cinara Paul, Regina Stolz, Marco Richard Zugaj, Jonas Tesarz, Michel Wensing, Cornelia Straßner

JMIR Res Protoc 2025;14:e66335

Effectiveness of Continuous Glucose Monitoring on Short-Term, In-Hospital Mortality Among Frail and Critically Ill Patients With COVID-19: Randomized Controlled Trial

Effectiveness of Continuous Glucose Monitoring on Short-Term, In-Hospital Mortality Among Frail and Critically Ill Patients With COVID-19: Randomized Controlled Trial

We thus performed an exploratory, prospective, open-label, parallel, single-center, randomized controlled trial (RCT) to investigate the effectiveness of CGM on short-term, in-hospital mortality among frail and critically ill patients with COVID-19. This is an exploratory, prospective, open-label, parallel, single-center RCT.

Jiawei Shang, Ziming Yuan, Zuoyan Zhang, Quanhong Zhou, Yan Zou, Wei Wang

J Med Internet Res 2025;27:e67012

Evaluation of the Continuing Education Training “Beratende für Digitale Gesundheitsversorgung” (“Consultant for Digital Healthcare”): Protocol for an Effectiveness Study

Evaluation of the Continuing Education Training “Beratende für Digitale Gesundheitsversorgung” (“Consultant for Digital Healthcare”): Protocol for an Effectiveness Study

The study is planned as an exploratory intervention feasibility study with a follow-up survey. Through a mixed methods approach, the qualitative and quantitative survey methods used are combined in a nonsequential design [29,30]. This means that the results of the individual parts should enable a better overall understanding of the research questions raised [30].

Bernhard Kraft, Thomas Kuscher, Susann Zawatzki, Sebastian Hofstetter, Patrick Jahn

JMIR Res Protoc 2024;13:e57860

Availability of Alcohol on an Online Third-Party Delivery Platform Across London Boroughs, England: Exploratory Cross-Sectional Study

Availability of Alcohol on an Online Third-Party Delivery Platform Across London Boroughs, England: Exploratory Cross-Sectional Study

We conducted an exploratory, cross-sectional study across London, England, using data from Deliveroo. We extracted the number of outlets offering alcohol on Deliveroo across 32 London boroughs (excluding City of London due to a small population). London was selected pragmatically. Deliveroo was chosen as it is one of the United Kingdom’s most popular platforms [8], and preliminary assessments showed that it had more alcohol outlets compared with similar platforms.

Casey Sharpe, Saloni Bhuptani, Mike Jecks, Nick Sheron, Clive Henn, Robyn Burton

JMIR Form Res 2024;8:e54587

An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial

An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial

The study is a 2-arm, exploratory randomized controlled trial comparing an intervention group (Purrble) with an active control group (noninteractive plush toy). The deployment period will be 4 weeks and will include daily parent self-report measures via ecological momentary assessment (EMA), as well as weekly validated surveys with a 1-month and 6-month follow-up (see Figure 1). The intervention period will start immediately after children receive their arm-appropriate toys.

Petr Slovak, Brett Q Ford, Sherri Widen, Claudia Daudén Roquet, Nikki Theofanopoulou, James J Gross, Benjamin Hankin, Predrag Klasnja

JMIR Res Protoc 2021;10(11):e28914