Prevention of Relapse in Behavioral Disorders: Study Protocol of a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand spoken and written Spanish.
- •Signing the informed consent.
- •Own a smartphone with internet access and an iOS or Android operating system.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Standard Multidisciplinary Treatment (Behavioral)
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
干预措施: Standard Multidisciplinary Treatment (Behavioral)
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
干预措施: Digital Monitoring Tool (Behavioral)
结局指标
主要结局
Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis
时间窗: 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
时间窗: 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.
次要结局
- 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))