EMA for Predicting Treatment Outcomes in Patients With SUD

NCT06470698 | Recruiting

• 1 other identifier: PID2020-119829RB-100
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This longitudinal repeated measures study will evaluate participants at the beginning of treatment through an assessment of psychological measures and craving. They will be trained to use a mobile platform, which will be available for 12 days. The assessment will be conducted via Ecological Momentary Assessment (EMA), with scheduled daily access and during situations of consumption risk. Each access will include questions on substance use, depression, anxiety, triggering situations, attitude towards drugs, and a cognitive bias test. The platform will alternate between two tests (Drug Stroop Task and WAT-DUD). Participants will follow a treatment program supervised by professionals. The study aims to recruit 130 participants (65 for alcohol, 65 for cocaine) from the Provincial Service for Drug Dependence and Addictions in Huelva (SPDA). Participants, selected via stratified random sampling, must reside in Huelva, sign informed consent, have a compatible mobile device, and be over 18. Anonymity will be ensured through alphanumeric codes. Upon treatment admission, selected patients will be informed of their participation in the study. Interviews, conducted by psychologists, will outline the study objectives and duration. Patients agreeing to participate will sign informed consent and receive an identification code. Baseline assessment data will be integrated into a database for subsequent statistical analysis. The assessment encompasses the collection of four blocks of information: Block 1. Patients medical history initiated during treatment admission. Block 2. Neuropsychological battery developed by the research team for the baseline evaluation. Block 3. Neuropsychological battery developed by the research team for the web platform measured through Ecological Momentary Assessment (EMA). Block 4. Follow-up information at three and six months provided by SPDA professionals through the patients medical history. To ensure compliance with participant follow-up, a mixed monitoring protocol has been developed, which includes phone calls and WhatsApp messages. This protocol is designed according to social exchange theory so that participants perceive the benefits of their participation as outweighing the costs. The statistical analysis involves identifying outliers and trimming distributions. Data will be averaged per test per person, considering different conditions. Repeated measures ANOVA will analyze factors such as gender and substance type to address study objectives, examining interactions and conducting planned contrasts for specific comparisons.

Conditions

Substance Use Disorders; Substance Use

Keywords

Ecological Momentary Assessment; Substance Use Disorder; Cocaine; Alcohol; Treatment; Gender

Outcome Measures

Primary Outcomes (4)

• Differences between daily access scores and temptation access scores

  We may find statistically significant differences between the scores obtained during episodes of temptation to consume or purchase substances and those obtained from daily measures, with higher scores during temptation episodes. These differences will be observed in both groups, among both men and women.

  Through study completion, an average of 2 years

• Relationship between number of episodes of temptations and scores in the tests

  It may be that during the monitoring, those participants who experience a higher number of episodes of temptation will have elevated levels in the scheduled measures. Those participants who have higher scores during episodes of temptation will have a greater number of episodes of consumption. These relationships will be observed in both groups, among both men and women.

  Through study completion, an average of 2 years

• Differences based on the type of substance

  There may be statistically significant differences in the test scores based on the type of substance.

  Through study completion, an average of 2 years

• Relationship between the studied variables and variables associated with gender.

  We may find differences in test scores based on gender-related variables.

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals receiving treatment for Substance Use Disorder (SUD) at the Provincial Service for Drug Dependence and Addictions (SPDA) in the province of Huelva, Spain.

You may qualify if:

• Patients initiating treatment for addiction to cocaine or alcohol as the primary substance.
• Patients with a diagnosis of Substance Use Disorder of mild, moderate, or severe severity, according to the 5th Edition of the DSM (Diagnostic and Statistical Manual of Mental Disorders).
• Maintaining residency in the province of Huelva during the study\'s follow-up period.
• Willingness to participate in the study by providing informed consent.
• Possessing a mobile device that meets the necessary technical requirements for the installation and operation of the application.

You may not qualify if:

• Patients with severe, unstable mental disorders, as assessed by the clinical team at the treatment centers.
• Patients with physical or mental disorders that hinder the execution of the tests and assessments included in the study.
• Patients under the age of 18.
• Patients with opioid consumption.

Sponsors & Collaborators

• University of Huelva: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• State Research Agency, Spain: collaborator

Study Sites (1)

University of Huelva

Huelva, 21007, Spain

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Coitus

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Enrique Moraleda-Barreno, PhD

  University of Huelva

  PRINCIPAL INVESTIGATOR

• José A. Lorca-Marín, PhD

  University of Huelva

  PRINCIPAL INVESTIGATOR

• Ana Segura-Barriga, Graduate

  University of Huelva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Segura-Barriga, Graduate

CONTACT

+34 682 78 15 22; ana.segura@dpces.uhu.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 24, 2024
• Study Start: July 21, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

ES (1)