A Smartphone-Based Psychological Intervention for Nonsuicidal Self-Injury (Kalmer App): Protocol for a Multicenter Double-Blind Randomized Controlled Trial
Por:
Julià A, Jaén I, Conesa Giménez M, García-Palacios A, Pascual JC, Sintes A, Lara A, Méndez I, Romero S, Puntí J, Soler J, Solé-Casals J, López-Solà M and Vega D
Publicada:
1 ene 2026
Ahead of Print:
27 ene 2026
Resumen:
Background: Nonsuicidal self-injury (NSSI), defined as the deliberate, self-inflicted damage of body tissue without suicidal intent, is increasingly prevalent among adolescents and young adults and poses a major public health concern. Current treatments are often costly, difficult to access, and not tailored to the specific needs of young people. Mobile health (mHealth) interventions represent a promising avenue for scalable, accessible, and cost-effective support for NSSI, especially when combined with real-time assessments and personalized treatment strategies. Objective: This randomized controlled trial will evaluate the effectiveness of Kalmer, a brief app-based intervention for reducing NSSI and improving emotional well-being. The study has 2 aims: (1) to evaluate a newly developed app-based intervention for adolescents and young adults engaging in NSSI and (2) to assess predictors of treatment outcomes for this app-based intervention. We hypothesize that participants receiving a mobile app-based brief intervention specifically tailored to address NSSI will show a greater reduction in NSSI frequency at the end of treatment and at follow-up than participants receiving a nonspecific app-based intervention. In this paper, we present our study protocol. Methods: This 2-arm randomized controlled trial, lasting 6 weeks, will include 240 participants aged 14 to 24 years who engage in NSSI. The intervention app, Kalmer, was developed through iterativeconsultation with clinical and research experts and guided by survey results and evidence-based frameworks such as dialectical behavior therapy and cognitive behavioral therapy. The intervention will include 5 core components: distress tolerance, emotion regulation, mindfulness and self-compassion, interpersonal regulation, and problem-focused coping. The app will deliver multimedia-based ecological momentary interventions triggered by real-time ecological momentary assessments to tailor support to users' current contexts and needs. Participants are randomized to receive either the Kalmer intervention or a psychoeducational control app. The primary outcome will be NSSI frequency, assessed through self-report at baseline, 6 weeks after intervention, and at 1-month and 3-month follow-ups. Results: Ethics approval was obtained in December 2022. As of January 2026, a total of 145 participants had consented to participate in the study and completed baseline assessments. Preliminary data show high app engagement and acceptability and positive user feedback regarding app usability and content. Recruitment is ongoing. Conclusions: This study will provide evidence on the effectiveness of a mobile app-based intervention for NSSI and will explore potential mechanisms of change, supporting the development of accessible digital mental health tools for adolescents and young adults. Trial Registration: International Standard Randomized Controlled Trial Number Registry ISRCTN63093907; https://www.isrctn.com/ISRCTN63093907 International Registered Report Identifier (IRRID): DERR1-10.2196/86413
Filiaciones:
Julià A:
Fundació Sanitària d'Igualada, Igualada, Spain
Department of Psychiatry and Forensic Medicine, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain
Department of Psychiatry, Hospital Universitari d'Igualada, Consorci Sanitari de l'Anoia, Igualada, Spain
Jaén I:
Department of Developmental, Educational, Social and Methodology Psychology, Universitat Jaume I, Castellón de la Plana, Spain
Conesa Giménez M:
Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain
García-Palacios A:
Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain
CIBER de Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain
Pascual JC:
Mental Health and Psychiatry Department, Vic Hospital Consortium, Vic, Spain
Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Madrid, Spain
Sintes A:
Servicio de Psiquiatría y Psicología, Hospital Sant Joan de Déu Barcelona, Barcelona, Catalonia, Spain
Lara A:
Servicio de Salud Mental Infanto Juvenil, ALTHAIA, Xarxa Assistencial Universitaria de Manresa, Manresa, Spain
Méndez I:
Servei de Psiquiatria & Psicologia Infantil Juvenil, Hospital Universitari Mútua de Terrassa, Fundació Recerca Mútua de Terrassa, Terrassa, Spain
Romero S:
Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Madrid, Spain
Department of Child and Adolescent Psychiatry and Psychology, 2021SGR01319, Institute of Neuroscience, Hospital Clínic de Barcelona, Barcelona, Spain
Neuropsychology and Neuroimaging Group, Clinical and Experimental Neurosciences Area, IDIBAPS, Barcelona, Spain
Puntí J:
Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Madrid, Spain
Salut Mental, Corporació Sanitària Parc Taulí de Sabadell, Sabadell, Spain
Department of Clinical and Health Psychology, Faculty of Psychology and Speech Therapy, Universitat Autònoma de Barcelona, Barcelona, Spain
Soler J:
Department of Psychiatry and Forensic Medicine, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain
Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III, Madrid, Madrid, Spain
Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica- Sant Pau (IIB-SANT PAU), Barcelona, Spain
Solé-Casals J:
Data and Signal Processing Group, Universitat de Vic - Universitat Central de Catalunya, Vic, Spain
Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom
López-Solà M:
Neuropsychology and Neuroimaging Group, Clinical and Experimental Neurosciences Area, IDIBAPS, Barcelona, Spain
Department of Medicine, Unit of Psychological Medicine, Universitat de Barcelona, Barcelona, Spain
Institute of Neurosciences, Universitat de Barcelona, Barcelona, Catalonia, Spain
Vega D:
Fundació Sanitària d'Igualada, Igualada, Spain
Department of Psychiatry, Hospital Universitari d'Igualada, Consorci Sanitari de l'Anoia, Igualada, Spain
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