Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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The comprehensive model addresses the biological, psychological, and social dimensions of substance use disorders through a structured sequence of phases: initial assessment, detoxification, withdrawal management, rehabilitation, social reintegration, and follow-up care. The core innovation of this study lies in the implementation of a digital application specifically designed to monitor patients' clinical status, detect early warning signs of relapse, and deliver timely, personalized interventions.
A longitudinal quasi-experimental study will be conducted with a sample of 150 individuals diagnosed with substance use disorders (including alcohol, cocaine, and other stimulants). Validated assessment instruments will be used to evaluate clinical progress, comparing outcomes between patients receiving standard treatment and those receiving the same treatment augmented by the digital tool.
Key outcome variables include reduction in withdrawal symptoms, decrease in craving, improvement in emotional well-being and psychosocial functioning, relapse rates, and patient satisfaction. In addition, the feasibility, acceptability, and clinical utility of the technological tool in therapeutic follow-up will be assessed.
The study is expected to provide empirical evidence on the added value of the digital tool in addiction treatment, with the aim of optimizing existing clinical protocols and enhancing the long-term effectiveness of intervention strategies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard Treatment Group
Participants in this group will receive the standard multidisciplinary treatment for substance use disorders, including clinical evaluation, medical detoxification, psychological and psychiatric therapy, occupational rehabilitation, and social reintegration, without the use of the digital tool
Standard Multidisciplinary Treatment
Comprehensive intervention including structured phases: initial assessment, detoxification, withdrawal management, psychological and psychiatric therapy, rehabilitation, and follow-up care. Delivered by a multidisciplinary team according to established clinical protocols.
Digital-Assisted Treatment Group
Participants in this group will receive the same standard multidisciplinary treatment as Arm 1, complemented by a digital tool designed for real-time monitoring, early relapse detection, and personalized feedback throughout the follow-up phase
Standard Multidisciplinary Treatment
Comprehensive intervention including structured phases: initial assessment, detoxification, withdrawal management, psychological and psychiatric therapy, rehabilitation, and follow-up care. Delivered by a multidisciplinary team according to established clinical protocols.
Digital Monitoring Tool
In addition to standard care, participants will use a mobile application that monitors clinical indicators, detects early signs of relapse risk, and provides personalized alerts and intervention prompts. The tool is designed to support both patients and clinicians in decision-making and therapeutic follow-up.
Interventions
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Standard Multidisciplinary Treatment
Comprehensive intervention including structured phases: initial assessment, detoxification, withdrawal management, psychological and psychiatric therapy, rehabilitation, and follow-up care. Delivered by a multidisciplinary team according to established clinical protocols.
Digital Monitoring Tool
In addition to standard care, participants will use a mobile application that monitors clinical indicators, detects early signs of relapse risk, and provides personalized alerts and intervention prompts. The tool is designed to support both patients and clinicians in decision-making and therapeutic follow-up.
Eligibility Criteria
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Inclusion Criteria
* Signing the informed consent.
* Own a smartphone with internet access and an iOS or Android operating system.
Exclusion Criteria
* Refusal to install the mobile application.
* Inability to understand and sign the informed consent form for any reason.
18 Years
90 Years
ALL
No
Sponsors
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Universidad Carlos III de Madrid
UNKNOWN
Clínica Nuestra Señora de la Paz
OTHER
Responsible Party
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Principal Investigators
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Juan Jesús Muñoz García, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro San Juan de Dios de Ciempozuelos
Antonio Artés, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Signal Theory at Universidad Carlos III
Apolo Zepeda Avilés, Medical Director
Role: PRINCIPAL_INVESTIGATOR
Hospital San Juan de Dios de Gipuzkoa
Enrique Bermúdez Navas, Psychiatrist
Role: PRINCIPAL_INVESTIGATOR
Centro Asistencial San Juan de Dios Palencia
Placidia Franco Suárez-Bárcena, Technical Director
Role: PRINCIPAL_INVESTIGATOR
Centro Asistencial San Juan de Dios Palencia
Rafael Salom Borrás, PhD
Role: PRINCIPAL_INVESTIGATOR
Clínica Nuestra Señora de la Paz, Orden Hospitalaria San Juan de Dios, Madrid, Spain
Álvaro Pico Rada, Medical Director
Role: PRINCIPAL_INVESTIGATOR
Clínica Nuestra Señora de la Paz, Orden Hospitalaria San Juan de Dios, Madrid, Spain
Central Contacts
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References
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Salom R, Pico Rada A, Munoz Garcia JJ, Garcia-Mieres H, Artes-Rodriguez A. Digital relapse prevention plan for substance use disorders: study protocol for a multicentre randomised controlled trial. BMJ Health Care Inform. 2025 Nov 24;32(1):e101808. doi: 10.1136/bmjhci-2025-101808.
Other Identifiers
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CPP2022-00953
Identifier Type: -
Identifier Source: org_study_id
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