Prevention of Relapse in Behavioral Disorders (PreCare)

Clínica Nuestra Señora de la Paz

Status: Not yet enrolling

Conditions: Substance-related Disorders

Treatments: Behavioral: Digital Monitoring Tool; Behavioral: Standard Multidisciplinary Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07052175

CPP2022-00953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Standard Treatment Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Multidisciplinary Treatment

Digital-Assisted Treatment Group

Experimental group

Description:

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

Treatment:

Behavioral: Standard Multidisciplinary Treatment

Behavioral: Digital Monitoring Tool