NCT07925281 Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder Using Eye-tracking, Physiological, and Interoceptive Measures (ERAD)
| NCT ID | NCT07925281 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université Catholique de Louvain |
| Condition | Alcohol Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2026-11-02 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2026-11-02 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to investigate emotional recognition and emotional reactivity in individuals with severe Alcohol Use Disorder (sAUD), Major Depressive Disorder (MDD), comorbid sAUD and depressive symptoms (sAUD+DS), and healthy controls. The main questions this study aims to answer are: * Do individuals with sAUD, MDD, sAUD+DS, and healthy controls exhibit different patterns of emotional recognition and emotional reactivity in response to dynamic emotional stimuli? * How are emotional recognition and emotional reactivity related to each other? * How are these emotional processes associated with psycho-affective, socio-emotional, stress-related, interoceptive, and disorder-specific factors? * Do emotional recognition and emotional reactivity predict clinical outcomes at 6- and 12-month follow-up assessments? Participants will: * Complete two experimental sessions involving dynamic emotional facial expression and emotional scene tasks * Provide emotion identification, subjective emotional ratings (type, intensity, and valence), and and self-reported bodily sensations using an emotional body map (InteroMap) * Undergo eye-tracking, pupillometry, electrodermal activity, and cardiac activity recordings during emotional tasks * Complete questionnaires assessing psycho-affective, socio-emotional, stress-related, and disorder-specific factors * Provide saliva and hair samples for cortisol assessment * Participate in follow-up clinical assessments at 6 and 12 months Researchers will compare emotional recognition and emotional reactivity profiles across the sAUD, MDD, sAUD+DS, and healthy control groups, and evaluate their predictive value for future clinical outcomes.
Eligibility Criteria
Inclusion Criteria: All participants must: * Be aged 18 to 70 years, fluent in French, and able to provide written informed consent. * Have normal or corrected-to-normal vision, without ocular conditions that could interfere with eye-tracking or pupillometry data quality. Patients with severe Alcohol Use Disorder (sAUD) * Meet DSM-5 criteria for severe Alcohol Use Disorder. * Be tested during the third week of abstinence. * Have no history of neurological, endocrinal, or infectious disease, diagnosed anxiety or depressive disorder, or other substance use disorder (except tobacco). Patients with Major Depressive Disorder (MDD) * Meet DSM-5 criteria for a current Major Depressive Episode. * Have no history of neurological disease, severe alcohol use disorder, other substance use disorder (except tobacco), or other psychiatric disorders (e.g., bipolar disorder, schizophrenia). Patients with severe Alcohol Use Disorder and Depressive Symptoms (sAUD+DS) * Meet the same inclusion criteria as the sAUD group. * Present moderate to severe depressive symptoms persisting after withdrawal, confirmed by a clinical diagnosis using the Mini International Neuropsychiatric Interview (MINI). Healthy Controls (HC) * Recruited from the general population, matched to patients for age, sex, and education. * Have no current or past psychiatric or neurological disorder. * Present subclinical levels of alcohol consumption (AUDIT score \<7 for men, \<6 for women) and depressive symptoms (BDI-II score \<10). Exclusion Criteria: * Cognitive impairment, uncorrected visual deficits, or any condition preventing understanding of instructions or reliable task performance (e.g., major attention or comprehension difficulties); * Ophthalmological conditions that could compromise eye-tracking or pupillometry data quality; * Dermatological conditions or excessive sweating that may interfere with electrodermal and cardiac activity recording; * Cardiac conditions or devices that could affect ECG recording (e.g., pacemaker, defibrillator, severe uncontrolled arrhythmias), or use of medications strongly influencing heart rate. * Acute intoxication or withdrawal state at the time of testing; * Current diagnosis of psychotic disorder, bipolar disorder, or neurological disease; * Pregnancy; * Ongoing participation in another interventional or clinical study that could interfere with behavioral or physiological measures; * For healthy controls: use of psychotropic medication or history of substance use disorder.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07925281 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07925281 currently recruiting?
Yes, NCT07925281 is actively recruiting participants. Contact the research team at edelweiss.touron@uclouvain.be for enrollment information.
Where is the NCT07925281 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT07925281 clinical trial?
NCT07925281 is sponsored by Université Catholique de Louvain. The trial plans to enroll 280 participants.