Prevention of Relapse in Behavioral Disorders (PreCare)

Prevention of Relapse in Behavioral Disorders: Study Protocol of a Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Substance-related Disorders
• Intervention / Treatment: Behavioral: Standard Multidisciplinary Treatment; Behavioral: Digital Monitoring Tool

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael Salom Borrás, PhD; Phone Number: +34 914 15 60 00; Email: rafael.salom@sjd.es
• Study Contact Backup: Name: Álvaro Pico Rada, Psychiatrist and Medical Direc; Phone Number: +34 914 15 60 00; Email: alvaro.pico@sjd.es

Study Locations

• Spain
  • Madrid
    • Ciempozuelos, Madrid, Spain, 28350
      • Recruiting
      • Centro de San Juan de Dios de Ciempozuelos
      • Contact: Rafael Salom; Phone Number: 918930001; Email: rafael.salom@sjd.es
    • Madrid, Madrid, Spain, 28033
      • Recruiting
      • Clínica Nuestra Señora de la Paz
      • Contact: Rafael Salom; Phone Number: 914156000; Email: rafael.salom@sjd.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHOQOL-BREF	A 26-item instrument assessing perceived quality of life across four domains: physical health, psychological well-being, social relationships, and environmental context. Items are rated on a 5-point Likert scale, and domain scores are transformed to a 0-100 scale. Demonstrates good internal consistency, with Cronbach's alpha ranging from 0.69 (physical) to 0.90 (spirituality/religion/personal beliefs).	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Purpose in Life Test - Short Form (PIL-10)	A 10-item self-report scale assessing life purpose and personal meaning, adapted from the original PIL (Crumbaugh & Maholick, 1969). Responses are rated on a 7-point Likert scale, with total scores ranging from 10 to 70. Higher scores reflect greater perceived purpose. The scale includes two dimensions: (a) life satisfaction and meaning, and (b) goals and direction. Shows good psychometric properties (α = .85 overall; .84 for life satisfaction and .69 for goals and purpose).	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Patient Health Questionnaire-9 (PHQ-9)	A 9-item self-report tool assessing depressive symptom severity over the past two weeks, based on DSM-IV criteria. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score of 0-27. A cut-off score of 10 yields sensitivity of 0.78 and specificity of 0.87. Spanish versions show excellent reliability (α = 0.78-0.90), with current data showing α = .93.	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Beliefs About Substance Use and Craving Beliefs Questionnaire	25 items self-report questionnaire designed to assess maladaptive beliefs related to substance use and beliefs about substance craving. Each item is rated on a 5-point Likert scale ranging from "totally disagree" to "totally agree". Higher total scores reflect stronger dysfunctional beliefs associated with substance use (e.g., perceived benefits or inevitability of use). The instrument shows excellent internal consistency (Cronbach's alpha = 0.87).	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction with the Digital Application	27-item ad hoc questionnaire using a 5-point Likert scale (scale from 1 to 5, with 1 being "Not at all" and 5 being "Very much") to assess patient satisfaction with the application's usability, safety, and overall experience. Higher scores indicate greater satisfaction.	Post-treatment (3 months)

Collaborators and Investigators

• Sponsor: Clínica Nuestra Señora de la Paz
• Collaborators: Universidad Carlos III de Madrid
• Investigators: Principal Investigator: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 26, 2025
• First Posted (Actual): July 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: relapse prevention; digital health; monitoring; Substance use disorders; multidisciplinary treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: CPP2022-00953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD information will not be shared due to the sensitivity of the data it contains, which could allow for the direct or indirect identification of patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No