Prevention of Relapse in Behavioral Disorders
ConditionSubstance-related Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorClínica Nuestra Señora de la Paz
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand spoken and written Spanish.
Signing the informed consent.
Own a smartphone with internet access and an iOS or Android operating system.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Multidisciplinary Treatment
BehavioralComprehensive 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
BehavioralIn 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Standard Treatment GroupActive comparator 1 intervention
Group B: Digital-Assisted Treatment GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Throughout the intervention and follow-up phases (baseline to 12 months)2
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.
Time frame
Throughout the intervention and follow-up phases (baseline to 12 months)Secondary outcomes
1
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).
Time frame
Baseline, post-treatment (3 months), and follow-up (6 and 12 months)2
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).
Time frame
Baseline, post-treatment (3 months), and follow-up (6 and 12 months)3
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.
Time frame
Baseline, post-treatment (3 months), and follow-up (6 and 12 months)4
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).
Time frame
Baseline, post-treatment (3 months), and follow-up (6 and 12 months)Other outcomes
1
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.
Time frame
Post-treatment (3 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Clínica Nuestra Señora de la Paz
Lead sponsor
Universidad Carlos III de Madrid
Collaborator
Source ClinicalTrials.gov