Prevention of Relapse in Behavioral Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Multidisciplinary Treatment, Digital Monitoring Tool.
- Who it may be relevant to
- Registry conditions: Substance-related Disorders. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevention of Relapse in Behavioral Disorders: Study Protocol of a Randomized Control Trial
Overview
This study aims to validate the effectiveness of a digital tool for monitoring and early relapse detection in addiction treatment. It compares outcomes between a traditional multidisciplinary model and the same model enhanced by the technology. The research seeks to demonstrate the tool's added clinical value in improving long-term recovery outcomes.
Detailed description
The primary objective of this research project is to scientifically validate the effectiveness of a technological tool for monitoring and early detection of relapse in addiction treatment. The study will focus on comparing two approaches: the traditional comprehensive multidisciplinary treatment model and the same model enhanced by the integration of a digital technology.
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.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis [Time frame: Throughout the intervention and follow-up phases (baseline to 12 months)]
- Biological Verification of Substance Use Relapse via Toxicological Testing: Breath Alcohol Testing [Time frame: Throughout the intervention and follow-up phases (baseline to 12 months)]
Secondary outcome measures (4)
- WHOQOL-BREF [Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
- Purpose in Life Test - Short Form (PIL-10) [Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
- Beliefs About Substance Use and Craving Beliefs Questionnaire [Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
Eligibility criteria
Inclusion criteria
- Understand spoken and written Spanish.
- Signing the informed consent.
- Own a smartphone with internet access and an iOS or Android operating system.
Exclusion criteria
- Institutionalized or incarcerated patients, or those anticipating imminent incarceration, without regular access to mobile phone use.
- Refusal to install the mobile application.
- Inability to understand and sign the informed consent form for any reason.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 2 centers
- Centro de San Juan de Dios de Ciempozuelos — Ciempozuelos
- Clínica Nuestra Señora de la Paz — Madrid
Publications
- 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. PMID 41290251
Identifiers
NCT: NCT07052175 · CPP2022-00953