EMA for Predicting Treatment Outcomes in Patients With SUD

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

Sponsors & Collaborators

• Ministerio de Economía y Competitividad, Spain

  collaborator OTHER_GOV

• State Research Agency, Spain

  collaborator OTHER_GOV

• University of Huelva

  lead OTHER

Principal Investigators

• Enrique Moraleda-Barreno, PhD · University of Huelva

• José A. Lorca-Marín, PhD · University of Huelva

• Ana Segura-Barriga, Graduate · University of Huelva

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-21

Primary Completion

2025-08-31

Completion

2025-08-31

Countries

• Spain

Study Locations