Prevention of Relapse in Behavioral Disorders

Not Applicable

Not yet recruiting

• Conditions: Substance-related Disorders

• Registration Number: NCT07052175
• Lead Sponsor: Clínica Nuestra Señora de la Paz

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.

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis	Throughout the intervention and follow-up phases (baseline to 12 months)	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.
Biological Verification of Substance Use Relapse via Toxicological Testing: Breath Alcohol Testing	Throughout the intervention and follow-up phases (baseline to 12 months)	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.

Secondary Outcome Measures

Name	Time	Method
WHOQOL-BREF	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)	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).
Purpose in Life Test - Short Form (PIL-10)	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)	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).
Patient Health Questionnaire-9 (PHQ-9)	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)	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.
Beliefs About Substance Use and Craving Beliefs Questionnaire	Baseline, post-treatment (3 months), and follow-up (6 and 12 months)	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).