Prevention of Relapse in Behavioral Disorders

NCT07052175 | Not Yet Recruiting DMC

• 1 other identifier: CPP2022-00953
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Substance-related Disorders

Keywords

Substance use disorders; relapse prevention; multidisciplinary treatment; digital health; monitoring

Outcome Measures

Primary Outcomes (2)

• Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis

  To objectively identify episodes of relapse (e.g., alcohol or other substance use) during treatment, periodic toxicological screenings will be performed as part of the therapeutic monitoring process. These screenings are conducted by clinical personnel and include urinalysis: detection of recent use of psychoactive substances through urine samples, providing an objective measure of treatment adherence.

  Throughout the intervention and follow-up phases (baseline to 12 months)

• Biological Verification of Substance Use Relapse via Toxicological Testing: Breath Alcohol Testing

  To objectively identify episodes of alcohol relapse during treatment, periodic toxicological screenings will be conducted as part of the therapeutic monitoring process. These screenings will be carried out by clinical staff and will include Breath Alcohol Testing: measurement of breath alcohol concentration using spirometry-based devices to detect recent alcohol consumption.

  Throughout the intervention and follow-up phases (baseline to 12 months)

Secondary Outcomes (4)

• WHOQOL-BREF

  Baseline, post-treatment (3 months), and follow-up (6 and 12 months)

• Purpose in Life Test - Short Form (PIL-10)

  Baseline, post-treatment (3 months), and follow-up (6 and 12 months)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, post-treatment (3 months), and follow-up (6 and 12 months)

• Beliefs About Substance Use and Craving Beliefs Questionnaire

  Baseline, post-treatment (3 months), and follow-up (6 and 12 months)

Other Outcomes (1)

• Patient Satisfaction with the Digital Application

  Post-treatment (3 months)

Study Arms (2)

Standard Treatment Group

ACTIVE COMPARATOR

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

Behavioral: Standard Multidisciplinary Treatment

Digital-Assisted Treatment Group

EXPERIMENTAL

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

Behavioral: Standard Multidisciplinary Treatment; Behavioral: Digital Monitoring Tool

Interventions

Standard Multidisciplinary Treatment BEHAVIORAL

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; Standard Treatment Group

Digital Monitoring Tool BEHAVIORAL

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.

Digital-Assisted Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand spoken and written Spanish.
• Signing the informed consent.
• Own a smartphone with internet access and an iOS or Android operating system.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clínica Nuestra Señora de la Paz: lead
• Universidad Carlos III de Madrid: collaborator

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Juan Jesús Muñoz García, PhD

  Centro San Juan de Dios de Ciempozuelos

  PRINCIPAL INVESTIGATOR

• Antonio Artés, PhD

  Department of Signal Theory at Universidad Carlos III

  PRINCIPAL INVESTIGATOR

• Apolo Zepeda Avilés, Medical Director

  Hospital San Juan de Dios de Gipuzkoa

  PRINCIPAL INVESTIGATOR

• Enrique Bermúdez Navas, Psychiatrist

  Centro Asistencial San Juan de Dios Palencia

  PRINCIPAL INVESTIGATOR

• Placidia Franco Suárez-Bárcena, Technical Director

  Centro Asistencial San Juan de Dios Palencia

  PRINCIPAL INVESTIGATOR

• Rafael Salom Borrás, PhD

  Clínica Nuestra Señora de la Paz, Orden Hospitalaria San Juan de Dios, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Álvaro Pico Rada, Medical Director

  Clínica Nuestra Señora de la Paz, Orden Hospitalaria San Juan de Dios, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Salom Borrás, PhD

CONTACT

+34 914 15 60 00; rafael.salom@sjd.es

Álvaro Pico Rada, Psychiatrist and Medical Direc

CONTACT

+34 914 15 60 00; alvaro.pico@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial, efficacy study

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share