RCTs - Protocols/Proposals (funded, already peer-reviewed, non-eHealth)

Solution-Focused Brief Intervention for Substance Use: Protocol for a Multisite Randomized Controlled Trial

Karla González-Suitt, Alvaro Vergés, Rodrigo Portilla Huidobro, Bárbara Donoso Vargas

JMIR Res Protoc 2025 (Nov 11); 14:e75628

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Acute Adenosine Receptor Antagonism in Combination With Acute Intermittent Hypoxia to Promote Breathing Plasticity in Amyotrophic Lateral Sclerosis: Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial

Priscila Sales de Campos, May Smith-Hublou, Wendy L Olsen, Wagner Souza Leite, James P Wymer, Nicholas J Napoli, Alicia K Vose, Michael T Pulley, Gordon S Mitchell, Barbara K Smith

JMIR Res Protoc 2025 (Nov 07); 14:e76105

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Effects of Aerobic Training Versus Behavioral Intervention to Increase Physical Activity for Disease Control in Patients With Asthma: Protocol for a Randomized Trial

David Halen Araujo Pinheiro, Ronaldo Aparecido da Silva, Adriana Claudia Lunardi, Vitoria Zacarias Cervera, Regina Maria Carvalho-Pinto, Fabiano Francisco de Lima, Celso R F Carvalho

JMIR Res Protoc 2025 (Oct 30); 14:e78603

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A Comprehensive and Structured Follow-Up for Persons With Multiple Sclerosis (CoreDISTparticipation) to Optimize Physical Functions, Health, and Employment: Protocol for a Prospective, Single-Blinded Randomized Controlled Trial and Health Economic Evaluation

Britt Normann, Marianne Sivertsen, Tonje B Braaten, Hans Olav Melberg, Hanne Kristin Fikke, Marianne Elvik, Ellen Christin Arntzen

JMIR Res Protoc 2025 (Oct 08); 14:e74988

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The Effectiveness of the Use of Silver Fluoride and Teledentistry to Manage and Prevent Childhood Caries Among Aboriginal Children in Remote Communities: Protocol for a Cluster Randomized Controlled Trial

Peter Arrow, Susan Piggott, Lorraine Anderson, Dawn Bessarab, Lisa Jamieson, David Atkinson, Hien Ngo, Sanjeewa Kularatna, Utsana Tonmukayakul, Soniya Nanda, Jilen Patel, Lorraine Powell, Mohamed Estai

JMIR Res Protoc 2025 (Oct 07); 14:e72227

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Culturally Tailored Diabetes Self-Management Education and Support Programs in Black African and Caribbean Adults With Type 2 Diabetes (HEAL-D): Protocol for a Multicenter, Pragmatic Randomized Controlled Trial

Louise M Goff, Drusus A Johnson, Vicky Bell, Susan Blyden, Peter Bower, Jeremy Dale, Tess Harris, Andrew Healey, Eleanor Hoverd, Huajie Jin, Tony Kelly, Carol Rivas, Clare Robinson, Jayne Thorpe, Sandra Tomlinson, Michael Ussher, Charlotte Wahlich, Barbara McGowan

JMIR Res Protoc 2025 (Sep 30); 14:e71861

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Social Transfers for Exclusive Breastfeeding in Brazil: Protocol for a Randomized Controlled Trial

Stephanie Khoury, Alexandra Brentani, Helena Brentani, Jarlei Fiamoncini, Rossana Francisco, Ana Carolina Onofre, Silvia Elise Rodrigues Henrique, Günther Fink, Jordyn Wallenborn

JMIR Res Protoc 2025 (Sep 24); 14:e75796

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An Iteratively Adapted Transdiagnostic Prevention Program for Diverse High School Settings (U-PEACE): Protocol for a Randomized Controlled Trial

Clarissa Victoria Velez, Mileini Campez-Pardo, Jennifer Mariam Canovas, Paloma Maria Pedronzo, Yeojin Amy Ahn, Chelsea Faye Dale, Sannisha K Dale, Lisa Gwynn, Amanda Jensen-Doss, Elizabeth R Pulgaron, Sara Mijares St George, Jill Ehrenreich-May

JMIR Res Protoc 2025 (Sep 24); 14:e74080

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Integrated Model of Cancer Control for Early Detection and Treatment in Adolescents and Young Adults Living With HIV: Protocol for a Cluster Randomized Controlled Trial

Sanjana Batabyal, Praveen Zirali, Sonja Hoover, Ronald Mungoni, Nachela Chelwa, Drosin Mulenga, Mildred Lusaka, Laura Nyblade, Madeleine Jones, Catherine Kasongo Mwaba, Michael Mbizvo, Sujha Subramanian

JMIR Res Protoc 2025 (Aug 29); 14:e68254

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Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: Protocol for a Pilot Randomized Controlled Trial

Yongle Zhan, Xiaohao Ruan, Yishuo Wu, Tsun Tsun Stacia Chun, Chi Yao, Ruofan Shi, Jiacheng Liu, Salida Ali, Ruochen Ma, Da Huang, Yi Gao, Ying Xu, Lu Chen, Qijun Du, Ada Tsui-Lin Ng, Cho Wing Bryan Li, Danfeng Xu, Rong Na

JMIR Res Protoc 2025 (Aug 26); 14:e72597

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Comparison of 5-Day Multidaily Neuronavigated Theta-Burst Sessions With 6-Week Standard Repetitive Transcranial Magnetic Stimulation (the Dutch Depression Outcome Trial): Protocol for a Randomized Controlled Trial

Annemiek Dols, Tom Biemans, Coen Coomans, Philip van Eijndhoven, Iris Dalhuisen, Ysbrand D van der Werf, Chris Vriend, Elvira S Amaral Gomes, Alexander T Sack, Teresa Schuhmann, Mashood Chaudhry, Martijn Arns, Bethany Hipple Walters, Ben Wijnen, Andrew Zalesky, Robin Cash, Daniel M Blumberger, Karel WF Scheepstra, Adriaan W Hoogendoorn, Odile A van den Heuvel, Eric van Exel, The D-DOTT Consortium

JMIR Res Protoc 2025 (Aug 21); 14:e70121

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Investigating the Effects of a High-Load Resistance Training Program on Bone Health in Wheelchair Users (the BoneWheel Study): Protocol for a Randomized Controlled Trial

Linn Christin Risvang, Vegard Strøm, Jan-Willem van Dijk, Hannah Rice, Øyvind Sandbakk, Lars Peder Bovim, Julia Kathrin Baumgart, Marte Bentzen, Truls Raastad, Kristin L Jonvik

JMIR Res Protoc 2025 (Aug 08); 14:e70125

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Efficacy of Manual Wheelchair Skills Training for Improving Skills and Confidence in People With Hereditary Degenerative Disorders: Protocol for a Sequential Multimethods Study

Ernest Niyomwungere, François Routhier, Cynthia Gagnon, R Lee Kirby, Xavier Rodrigue, Isabelle Lessard, Josiane Lettre, Krista L Best

JMIR Res Protoc 2025 (Jul 31); 14:e66974

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Exploring Ways to Reduce Heavy Drinking by Increasing Hope Among Midlife Women in Australia: Protocol for a Mixed Methods Study

Paul R Ward, Megan Warin, Sarah MacLean, Belinda Lunnay, Catherine Palmer, Samantha Meyer, Tonda Hughes, Antonia Lyons, Emily Nicholls

JMIR Res Protoc 2025 (Jul 24); 14:e72628

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Sodium Oxybate as a Potential New Treatment for Catatonia in Patients With Depression, Bipolar Disorder, or a Psychotic Disorder: Protocol for a Randomized Controlled Trial

Lilian Bot, Josine G van Mill, Laetitia J C A Smarius, Adriaan W Hoogendoorn, Bram W C Storosum, Christiaan H Vinkers, Gabriel E Jacobs, Gert Jan Lammers, Hanna M Heller, Jantine C A Colen-de Koning, Joris J B van der Vlugt, Marloes S Oudijn, Martijn S van Noorden, Pierre M Bet, Rolf Fronczek, Heleen S van der Heijden, Sjors M M Lange, Ysbrand D van der Werf, Eric R van Exel

JMIR Res Protoc 2025 (Jul 24); 14:e68356

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Intervention for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders: Protocol for a Randomized Controlled Hybrid Effectiveness-Implementation Trial

Kathryn Bruzios, Paige M Shaffer, Daniel M Blonigen, Michael A Cucciare, Michael Andre, Thomas Byrne, Jennifer Smith, David Smelson

JMIR Res Protoc 2025 (Jul 18); 14:e70750

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An Intervention to Support Higher Education Teachers’ Teaching Processes and Well-Being: Protocol for an Intervention Study

Liisa Postareff, Anna Parpala, Petri Nokelainen, Merly Kosenkranius, Ilmari Puhakka, Laura Pylväs, Heta Rintala, Milla Räisänen, Anna Wallin

JMIR Res Protoc 2025 (Jun 25); 14:e65428

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A Customized Neural Transcranial Magnetic Stimulation Target for Functional Disability Among Veterans With Co-Occurring Alcohol Use Disorder and Mild Traumatic Brain Injury: Protocol for a Pilot Randomized Controlled Trial

Amy A Herrold, Alexandra L Aaronson, Dulal Bhaumik, Timothy Durazzo, Sherri L Livengood, Alma Ramic, Patrick Riordan, Neil Jordan, Todd Parrish, Trudy Mallinson, Ibuola O Kale, Andrea Billups, Kelly Krese, Sandra Kletzel, Noah S Philip, Theresa L Bender Pape

JMIR Res Protoc 2025 (Jun 23); 14:e64909

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Improving HIV Prevention Among Heterosexual Men Seeking Sexually Transmitted Infection Services in Malawi: Protocol for a Type I Effectiveness-Implementation Hybrid Randomized Controlled Trial of Systems Navigator–Delivered Integrated Prevention Package (HPTN 112-NJIRA Study)

Sarah E Rutstein, Laura Limarzi-Klyn, Jane S Chen, Yaw O Agyei, Shahnaz Ahmed, Ian Bell, Myron Cohen, Jessica M Fogel, Vivian Go, Dan Haines, Erica L Hamilton, Irving F Hoffman, Mina C Hosseinipour, Mark A Marzinke, William C Miller, Mathews Mukatipa, Julie Pulerwitz, Hans M L Spiegel, Ting Ye, Mitch Matoga

JMIR Res Protoc 2025 (Jun 18); 14:e72981

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Reducing Heavy Drinking Through the “Sober Curious” Movement in Australia: Protocol for a Mixed Methods Study

Paul Russell Ward, Michael Savic, Sarah MacLean, Belinda Lunnay, Antonia Lyons, Tonda Hughes, Kerry London, Gabriel Caluzzi, Simone Pettigrew, Amy Pennay, Samantha Meyer, Tristan Duncan, Nicole Lee

JMIR Res Protoc 2025 (Jun 10); 14:e72631

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