EMA for Predicting Treatment Outcomes in Patients With SUD
NCT Number: NCT06470698
Acronym: TEMPTATION
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Substance Use Disorders|Substance Use
Sponsor: University of Huelva
Collaborators: Ministerio de Economía y Competitividad, Spain|Agencia Estatal de Investigación, Spain
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-21
Completion Date: 2025-08
Locations: University of Huelva, Huelva, 21007, Spain

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.

Primary Outcome Measures: 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