Prevention of Relapse in Behavioral Disorders

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis [Срок оценки: Throughout the intervention and follow-up phases (baseline to 12 months)]
• Biological Verification of Substance Use Relapse via Toxicological Testing: Breath Alcohol Testing [Срок оценки: Throughout the intervention and follow-up phases (baseline to 12 months)]

Вторичные конечные точки (4)

• WHOQOL-BREF [Срок оценки: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
• Purpose in Life Test - Short Form (PIL-10) [Срок оценки: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]
• Beliefs About Substance Use and Craving Beliefs Questionnaire [Срок оценки: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 2 центра

• Centro de San Juan de Dios de Ciempozuelos — Ciempozuelos
• Clínica Nuestra Señora de la Paz — Madrid

Публикации

• 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

Идентификаторы

NCT: NCT07052175 · CPP2022-00953

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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