Actively Recruiting

Age: 18Years +
All Genders
ID06470698

Neuropsychological Assessment in Real Time of the Implicit Cognition in the Prediction of Relapse of Patients With Substance Use Disorder

Led by University of Huelva · Updated on 2024-06-24

130

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Huelva

Lead Sponsor

M

Ministerio de Economía y Competitividad, Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating patients with substance use disorders, specifically alcohol or cocaine addiction, to understand psychological factors and cravings during treatment. This observational study uses repeated assessments over time to explore how real-time psychological measures relate to relapse risk. The study involves 130 participants from the Provincial Service for Drug Dependence and Addictions in Huelva, Spain, recruited using stratified random sampling to reflect gender and substance type. Participants undergo an initial baseline evaluation including psychological and neuropsychological tests lasting about 90 minutes, during which they are trained to use a mobile platform. This platform is used daily for 12 days to complete ecological momentary assessments (EMA) that collect data on substance use, mood, anxiety, triggering situations, and cognitive bias through alternating tests (Drug Stroop Task and WAT-DUD). Throughout the study, participants continue their regular treatment supervised by clinical professionals. Participants' involvement includes completing daily and temptation-triggered assessments via the mobile platform. Follow-up data on treatment adherence and relapse are collected at three and six months from medical records. Researchers monitor engagement through phone calls and messages designed to encourage participation. The main outcomes measured are differences in assessment scores between daily and temptation times, relationships between craving episodes and test scores, and the impact of substance type and gender. Data will be analyzed statistically to identify patterns related to relapse risk over an average of two years.

CONDITIONS

Brief Title

EMA for Predicting Treatment Outcomes in Patients With SUD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients starting treatment for cocaine or alcohol addiction as their main substance
  • Diagnosis of mild, moderate, or severe Substance Use Disorder according to DSM-5
  • Residency in Huelva during the study follow-up
  • Willingness to participate and provide informed consent
  • Ownership of a mobile device compatible with the study app
Not Eligible

You will not qualify if you...

  • Severe or unstable mental disorders as assessed by clinical team
  • Physical or mental conditions that prevent completing study tests
  • Under 18 years of age
  • Current opioid use

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment and Training

Duration - 1 day

Participants complete a baseline assessment including psychological and craving measures and receive training on using the mobile platform for daily and temptation assessments.

1 visit (in-person)

Ecological Momentary Assessment (EMA) Period

Duration - 12 days

Participants access the mobile platform daily during a preset time window to complete daily assessments and additionally whenever they experience risk of substance use. These assessments include cognitive bias tests, craving, depression, anxiety, drug attitude, triggering situations, and consumption questions.

Daily platform access during the 12-day period with additional access as needed

Long-term Monitoring

Duration - 6 months

Participants are monitored through their ongoing substance use treatment program, with follow-up information collected at three and six months regarding current situation, adherence, involvement, substance use, and relapses.

Follow-up data collected by clinical professionals; contact maintained via phone calls and messages to encourage participation

Trial Site Locations

Total: 1 location

1

University of Huelva

Huelva, Spain, 21007

Actively Recruiting

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Research Team

A

Ana Segura-Barriga, Graduate

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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