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Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial

Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial

Due to the paucity of cannabis harm reduction research in this population, a preliminary assessment of trial feasibility and intervention acceptability as well as an initial assessment of key clinical outcomes were necessary before conducting a large-scale randomized controlled trial (RCT) of CHAMPS [28]. As EIS represent the mainstay of treatment for FEP [29], we opted to evaluate this novel intervention as an adjunctive clinical tool to existing services.

Stephanie Coronado-Montoya, Amal Abdel-Baki, José Côté, David Crockford, Simon Dubreucq, Benedikt Fischer, Pamela Lachance-Touchette, Tania Lecomte, Sophie L'Heureux, Clairélaine Ouellet-Plamondon, Marc-André Roy, Ovidiu Tatar, Phillip Tibbo, Marie Villeneuve, Anne Wittevrongel, Didier Jutras-Aswad

JMIR Res Protoc 2023;12:e53094


Mobile Electrocardiograms in the Detection of Subclinical Atrial Fibrillation in High-Risk Outpatient Populations: Protocol for an Observational Study

Mobile Electrocardiograms in the Detection of Subclinical Atrial Fibrillation in High-Risk Outpatient Populations: Protocol for an Observational Study

Reference 5: Detecting and Diagnosing Atrial Fibrillation (D2AF): study protocol for a cluster randomised controlled trial ablation and medical therapy for atrial fibrillation in heart failure patients: a meta-analysis of randomized controlled trialsrandomized controlled trial controlled trials

Ajay Mittal, Yasmine Elkaldi, Susana Shih, Riken Nathu, Mark Segal

JMIR Res Protoc 2024;13:e52647


Effectiveness of a Mobile Phone Messaging–Based Message Framing Intervention for Improving Maternal Health Service Uptake and Newborn Care Practice in Rural Jimma Zone, Ethiopia: Protocol for a Cluster Randomized Controlled Trial

Effectiveness of a Mobile Phone Messaging–Based Message Framing Intervention for Improving Maternal Health Service Uptake and Newborn Care Practice in Rural Jimma Zone, Ethiopia: Protocol for a Cluster Randomized Controlled Trial

A 3-arm, cluster-randomized trial design with a 1:1 allocation ratio was used. The participants in the intervention were assigned to 3 arms: gain-framed, loss-framed, and control. The detailed description of each arm is presented as follows: Women in this arm received an automated gain-framed message.

Gebeyehu Bulcha, Hordofa Gutema Abdissa, Josef Noll, Demisew Amenu Sori, Zewdie Birhanu Koricha

JMIR Res Protoc 2024;13:e52395


A Mobile Intervention Designed Specifically for Older Adults With Frailty to Support Healthy Eating: Pilot Randomized Controlled Trial

A Mobile Intervention Designed Specifically for Older Adults With Frailty to Support Healthy Eating: Pilot Randomized Controlled Trial

However, most interventions are not designed for older frail users, lack theory-based strategies, and have not been evaluated in randomized trials [17]. Many older individuals may have lower digital literacy compared to younger populations, and systems repurposed for older users often overlook the vital characteristics and usability needs of this demographic [18].

Yan Su, Kuan-Ching Wu, Shao-Yun Chien, Aishwarya Naik, Oleg Zaslavsky

JMIR Form Res 2023;7:e50870


Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial

Varenicline Combined With Oral Nicotine Replacement Therapy and Smartphone-Based Medication Reminders for Smoking Cessation: Feasibility Randomized Controlled Trial

The combination of varenicline and nicotine patches has been evaluated in several randomized trials [10-14]. Two meta-analyses have indicated that varenicline combined with the nicotine patch was more effective than varenicline alone for promoting smoking abstinence at 3- and 6-month follow-up across studies [15,16]. However, no published studies to date have reported on the combined impact of varenicline and oral NRT on smoking cessation in a full-scale randomized trial.

Munjireen Sifat, Emily T Hébert, Jasjit S Ahluwalia, Michael S Businelle, Joseph J C Waring, Summer G Frank-Pearce, Chase Bryer, Lizbeth Benson, Stefani Madison, Lourdes G Planas, Irina Baranskaya, Darla E Kendzor

JMIR Form Res 2023;7:e48857


Efficacy of Digital Dance on Brain Imagery, Cognition, and Health: Randomized Controlled Trial

Efficacy of Digital Dance on Brain Imagery, Cognition, and Health: Randomized Controlled Trial

Hence, this randomized controlled trial (RCT) aimed to study hypothetical benefits of digital somatosensory dance games on structural and functional brain imaging findings, cognitive performance, physical health, and mental health biomarkers. This RCT enrolled community residents aged ≥55 years in Taipei, Taiwan, from August 31, 2020, to June 27, 2021, and followed them for 6 months; however, the trial was interrupted for approximately 3 months due to the COVID-19 pandemic (Figure 1).

Heng-Hsin Tung, Chen-Yuan Kuo, Pei-Lin Lee, Chih-Wen Chang, Kun-Hsien Chou, Ching-Po Lin, Liang-Kung Chen

J Med Internet Res 2024;26:e57694


Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years: Randomized Controlled Trial

Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years: Randomized Controlled Trial

Randomized controlled trials (RCTs) with adult participants have similarly shown improvements in depressive symptoms, anxiety, and resilience among those who completed at least 2 activities per week relative to a control group [49,50]. However, Happify for Teens has yet to be tested empirically. Therefore, in this study, we recruited adolescents aged 13 to 17 years who reported elevated stress and rumination.

Eliane M Boucher, Haley Ward, Cynthia J Miles, Robert D Henry, Sarah Elizabeth Stoeckl

J Med Internet Res 2024;26:e54282


Examining the Feasibility, Acceptability, and Preliminary Efficacy of an Immersive Virtual Reality–Assisted Lower Limb Strength Training for Knee Osteoarthritis: Mixed Methods Pilot Randomized Controlled Trial

Examining the Feasibility, Acceptability, and Preliminary Efficacy of an Immersive Virtual Reality–Assisted Lower Limb Strength Training for Knee Osteoarthritis: Mixed Methods Pilot Randomized Controlled Trial

Quantitative and qualitative data were conducted concurrently in a 12-week, 2-arm, pilot randomized controlled trial design (CHi CTR2100046313). This study was conducted in Hong Kong from June 1, 2021, to March 18, 2022, in 3 separate batches. All collected quantitative and qualitative data were equally weighted, independently analyzed, and then integrated to generate results [26].

Hermione Hin Man Lo, Marques Ng, Pak Yiu Hugo Fong, Harmony Hoi Ki Lai, Bo Wang, Samuel Yeung-shan Wong, Regina Wing Shan Sit

JMIR Serious Games 2024;12:e52563


Seasonal Malaria Chemoprevention Therapy in Children Up To 9 Years of Age: Protocol for a Cluster-Randomized Trial Study

Seasonal Malaria Chemoprevention Therapy in Children Up To 9 Years of Age: Protocol for a Cluster-Randomized Trial Study

The current population in the district is 282,570, with approximately 4% of its population The study was as a 3-arm cluster-randomized design, as illustrated in Figure 1. Study design of a 3-arm cluster-randomized trial on age targets for season malaria chemoprevention. The study was performed from July 2019 to March 2023. AQ: amodiaquine; DHA: dihydroartemisinin; PQ: piperaquine; SP: sulfadoxine-pyrimethamine. The study population includes children aged 3 months to 9 years in each village.

Mahamoudou Toure, Jeffrey G Shaffer, Daouda Sanogo, Soumba Keita, Moussa Keita, Fousseyni Kane, Bourama Traore, Djeneba Dabitao, Aissata Kone, Cheick Oumar Doumbia, Joseph Keating, Joshua Yukich, Helle H Hansson, Alyssa E Barry, Mahamadou Diakité, Michael Alifrangis, Seydou Doumbia

JMIR Res Protoc 2024;13:e51660


MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial

The goal of this study is to conduct a pilot randomized controlled trial (RCT) of MASI with 50 adolescents and young adults with HIV, ages 15-21 years, to (1) assess its feasibility and acceptability and (2) explore preliminary effects on ART adherence and social support.

Marta I Mulawa, Jacqueline Hoare, Elizabeth T Knippler, Bulelwa Mtukushe, Mluleki Matiwane, Kathryn E Muessig, Maryam Al-Mujtaba, T Harper Wilkinson, Alyssa Platt, Joseph R Egger, Lisa B Hightow-Weidman

JMIR Res Protoc 2023;12:e47137