Substance-related DisordersPreCareNCT07052175
Prevention of Relapse in Behavioral Disorders
A study testing Standard Multidisciplinary Treatment and Digital Monitoring Tool in people with Substance-related Disorders, run by Clínica Nuestra Señora de la Paz at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- Standard Multidisciplinary Treatment and Digital Monitoring Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand spoken and written Spanish.
- Signing the informed consent.
- Own a smartphone with internet access and an iOS or Android operating system.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Centro de San Juan de Dios de Ciempozuelos
Ciempozuelos, Madrid, 28350
Rafael Salom, 918930001, rafael.salom@sjd.es
- Recruiting
Clínica Nuestra Señora de la Paz
Madrid, Madrid, 28033
Rafael Salom, 914156000, rafael.salom@sjd.es
About this study
Official title: Prevention of Relapse in Behavioral Disorders: Study Protocol of a Randomized Control 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.
Read the 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.
- Conditions
- Substance-related Disorders
- Being tested
- Standard Multidisciplinary Treatment, Digital Monitoring Tool
- Keywords
- Substance use disorders, relapse prevention, multidisciplinary treatment, digital health, monitoring
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Multidisciplinary TreatmentBehavioural
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.
Digital Monitoring ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Group | Active comparator | 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 Receives: Behavioral: Standard Multidisciplinary Treatment |
| Digital-Assisted Treatment Group | Experimental | 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 Receives: Behavioral: Standard Multidisciplinary Treatment; Behavioral: Digital Monitoring Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the intervention and follow-up phases (baseline to 12 months)
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.
Measured: Throughout the intervention and follow-up phases (baseline to 12 months)
Secondary outcomes (4)
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).
Measured: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
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).
Measured: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
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.
Measured: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
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).
Measured: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial, efficacy study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica Nuestra Señora de la Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Carlos III de Madrid
- Responsible party
- Sponsor
- Investigators
- Juan Jesús Muñoz García, PhD, Principal investigator, Centro San Juan de Dios de CiempozuelosAntonio Artés, PhD, Principal investigator, Department of Signal Theory at Universidad Carlos IIIApolo Zepeda Avilés, Medical Director, Principal investigator, Hospital San Juan de Dios de GipuzkoaEnrique Bermúdez Navas, Psychiatrist, Principal investigator, Centro Asistencial San Juan de Dios PalenciaPlacidia Franco Suárez-Bárcena, Technical Director, Principal investigator, Centro Asistencial San Juan de Dios PalenciaRafael Salom Borrás, PhD, Principal investigator, Clínica Nuestra Señora de la Paz, Orden Hospitalaria San Juan de Dios, Madrid, SpainÁlvaro Pico Rada, Medical Director, Principal investigator, Clínica Nuestra Señora de la Paz, Orden Hospitalaria San Juan de Dios, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052175
- Sponsor's protocol ID
- CPP2022-00953
- Acronym
- PreCare
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD information will not be shared due to the sensitivity of the data it contains, which could allow for the direct or indirect identification of patients.
Publications
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.
PubMed 41290251
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Relapse in Behavioral Disorders: Study Protocol of a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07052175
- Acronym / sponsor ID
- PreCare / CPP2022-00953
- Conditions
- Substance-related Disorders
- Keywords
- Substance use disorders, relapse prevention, multidisciplinary treatment, digital health, monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clínica Nuestra Señora de la PazUniversity, hospital or other
- Collaborators
- Universidad Carlos III de Madrid
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial, efficacy study
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Group | Active comparator | Behavioral: Standard Multidisciplinary TreatmentParticipants 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 |
| Digital-Assisted Treatment Group | Experimental | Behavioral: Standard Multidisciplinary Treatment, Behavioral: Digital Monitoring ToolParticipants 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Understand spoken and written Spanish.
- Signing the informed consent.
- Own a smartphone with internet access and an iOS or Android operating system.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Multidisciplinary TreatmentComprehensive 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. | Behavioural | Digital-Assisted Treatment Group, Standard Treatment Group |
| Digital Monitoring ToolIn 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. | Behavioural | Digital-Assisted Treatment Group |
Primary outcome
Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis
Time frame: 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
Time frame: 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.
4 secondary outcomes
WHOQOL-BREF
Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Purpose in Life Test - Short Form (PIL-10)
Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Beliefs About Substance Use and Craving Beliefs Questionnaire
Time frame: Baseline, post-treatment (3 months), and follow-up (6 and 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 41290251Salom 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.
- Individual participant dataSharing planned: No. IPD information will not be shared due to the sensitivity of the data it contains, which could allow for the direct or indirect identification of patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Jesús Muñoz García, PhD principal investigator
Centro San Juan de Dios de Ciempozuelos
Antonio Artés, PhD principal investigator
Department of Signal Theory at Universidad Carlos III
Apolo Zepeda Avilés, Medical Director principal investigator
Hospital San Juan de Dios de Gipuzkoa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Multidisciplinary Treatment and Digital Monitoring Tool in people with Substance-related Disorders, run by Clínica Nuestra Señora de la Paz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael Salom Borrás, PhD (+34 914 15 60 00, rafael.salom@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Verification of Substance Use Relapse via Toxicological Testing: Urinalysis (time frame: Throughout the intervention and follow-up phases (baseline to 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.