An observational study in Alcohol Use Disorder and Major Depressive Disorder (MDD), sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Université Catholique de Louvain · Observational
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:
Participants will:
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.
Severe Alcohol Use Disorder (sAUD) and Major Depressive Disorder (MDD) are among the most prevalent and debilitating mental health disorders, often co-occurring and exacerbating each other's symptoms, which complicates the clinical course and increases the risk of relapse of both disorders. Although their comorbidity is well-established, the mechanisms linking these disorders remain unclear.
Impaired emotional processing is a crucial component of this understanding. Deficits in emotional recognition (i.e., the ability to accurately identify and interpret emotions expressed by others) and responses (i.e., self-report, behavioral, and physiological reactions to emotional stimuli) contribute to significant difficulties in daily functioning and social interactions, as well as to the risk of relapse in these two psychiatric conditions.
Despite they offered crucial insights on the understanding of emotional processing in sAUD and MDD, previous studies presented several key limits hampering the evolution of this research field as (1) they used non-ecological stimulations, namely static pictures or isolated auditory cues, neglecting the multimodal and complex nature of emotional stimuli in everyday life; (2) they predominantly focused on behavioral data or a single measurement modality, offering limited information regarding the physiological correlates of these deficits or the potential of multidimensional analyses; (3) none of them included a group of patients with comorbid sAUD and depressive symptoms, leaving the combined or additive effects of these conditions unexamined; (4) predictive approaches remain largely underexplored.
ERAD addresses these gaps by investigating emotional recognition and emotional reactivity in individuals with sAUD (n=70), MDD (n=70), and sAUD+DS (n=70) compared to healthy controls (n=70), using two complementary experimental paradigms: (1) a dynamic emotional facial expression recognition task with congruent emotional prosody, and (2) an emotional induction task based on dynamic emotional scenes. This multidimensional approach integrates: the identification of emotions expressed by others (basic emotions), self-reported emotional experiences (intensity and valence), measures of visual exploration (eye-tracking), autonomic nervous system responses (pupillometry, electrodermal activity, and cardiac activity), biological stress markers (cortisol), and interoceptive measures assessed through emotional body maps (InteroMap).
ERAD aims to provide a transdiagnostic understanding of emotional processes and their predictive value for future clinical outcomes in sAUD, MDD, and their comorbidity, with potential implications for targeted and personalized prevention and treatment strategies.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 280 is above the median of 159 across 183 observational studies indexed under Alcoholism.
Browse Alcoholism studies →Université Catholique de Louvain is the lead sponsor of 154 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For patients:
For healthy controls:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All participants must:
Patients with severe Alcohol Use Disorder (sAUD)
Patients with Major Depressive Disorder (MDD)
Patients with severe Alcohol Use Disorder and Depressive Symptoms (sAUD+DS)
Healthy Controls (HC)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Emotional Reactivity Experimental Protocol
Other: Emotional Reactivity Experimental Protocol
Other: Emotional Reactivity Experimental Protocol
Other: Emotional Reactivity Experimental Protocol
Standardized experimental protocol including: (1) completion of questionnaires assessing psycho-affective, socio-emotional, stress-related, and disorder-specific factors; (2) exposure to dynamic emotional facial expressions and emotional scenes to assess emotional recognition and reactivity; (3) recording of eye-tracking, pupillometry, electrodermal activity, and cardiac activity responses; (4) assessment of bodily sensations using an emotional body map; (5) salivary and hair cortisol collection; and (6) follow-up clinical assessments at 6 and 12 months. Procedures are identical across all study groups.
Multidimensional assessment of emotional recognition and emotional reactivity to dynamic emotional stimuli
Participants are exposed to dynamic emotional stimuli (facial expressions and emotional scenes). Five dimensions are measured: (1) Emotional recognition, facial expression task only: accuracy rate and reaction time ; (2) Self-report: ratings of emotion type, intensity and valence ; (3) Behavioral: eye-tracking indices such as gaze patterns, number and duration of fixations, and saccades within areas of interest ; (4) Physiology: pupillometry (pupil size variations), electrodermal activity (skin conductance responses), and cardiac activity (heart rate, heart rate variability, and cardiac deceleration) ; (5) Interoception, emotional scene task only: self-reported bodily sensations on a body map. All measures are compared between the four groups.
Time frame: Throughout the entire study, during approximately 22 months
Relationships between emotional recognition and emotional reactivity (self-reported, behavioral and physiological)
Within each group, associations are examined between emotional recognition (facial expression task: accuracy rate and reaction time) and measures of emotional reactivity to dynamic emotional stimuli (self-reported emotional ratings ; eye-tracking measures ; pupil size variations; skin conductance responses; and cardiac activity). The consistency between subjective ratings and objective responses is also assessed for each emotion, to identify congruence or discrepancy. Associations are compared between each patient group and healthy controls.
Time frame: Throughout the entire study, during approximately 22 months
Associations of emotional recognition and reactivity with psycho-affective, socio-emotional, stress, interoceptive and disorder-specific factors
Within each group, associations are examined between emotional processing (emotional recognition and emotional reactivity, as defined in the primary outcome measures) and: (1) psycho-affective factors (depressive and anxiety symptoms, BDI/STAI; rumination, RSS); (2) socio-emotional abilities (emotion regulation strategies, DERS; interpersonal problems, IIP); (3) stress markers (salivary and hair cortisol levels); (4) interoceptive abilities; (5) disorder-specific characteristics (duration of current or past depressive or alcohol use disorder). The role of these factors as mediators or moderators is also tested in the relationships between emotional processing and depressive severity (BDI) or alcohol consumption (AUDIT). Associations are compared between each patient group and healthy controls.
Time frame: Throughout the entire study, during approximately 22 months
Prediction of clinical status at 6 and 12 months by baseline emotional recognition and reactivity
Baseline emotional recognition and emotional reactivity (as defined in the primary outcome measures) are tested as predictors of clinical status at 6 and 12 months in participants with sAUD, MDD and sAUD+DS. Clinical status is assessed during follow-up phone calls and includes: (1) relapse; (2) alcohol consumption (AUDIT); (3) presence and severity of depressive symptoms (BDI).
Time frame: Throughout the entire study, during approximately 22 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2026 (actual). Primary completion is estimated for Sep 2028, 22 months after the start.
Of 74 non-industry observational studies under Alcoholism, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 65. This study's planned 22 months is below that.
Counting every sponsor, half of 76 studies reached it within 40 months; a quarter within 21 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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