Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder Using Eye-tracking, Physiological, and Interoceptive Measures (ERAD) (ERAD)

November 3, 2026 updated by: Université Catholique de Louvain

Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder: a Multidimensional Approach Combining Dynamic Emotional Stimuli, Eye Tracking, Pupillometry, Electrodermal and Cardiac Activity, and Biological Measures of Stress and Interoception

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Belgium
      • Brussels, Belgium, Belgium, 1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For patients:

  • Cliniques Universitaires Saint-Luc (gastro-hepatology unit and the Institute of Psychiatry (IPI)) Bruxelles
  • Hôpital Psychiatrique du Beau-Vallon Namur
  • Grand Hôpital de Charleroi
  • Cliniques Saint-Pierre Ottignies

For healthy controls:

• Faculté de Psychologie de l'Université Catholique de Louvain

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_CONTROL
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
severe Alcohol Use Disorder (sAUD)
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.
Major Depressive Disorder (MDD)
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.
Comorbid sAUD and Depressive Symptoms (sAUD+DS)
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.
Healthy Controls (HC)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multidimensional assessment of emotional recognition and emotional reactivity to dynamic emotional stimuli
Time Frame: Throughout the entire study, during approximately 22 months

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.
Throughout the entire study, during approximately 22 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relationships between emotional recognition and emotional reactivity (self-reported, behavioral and physiological)
Time Frame: Throughout the entire study, during approximately 22 months

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.
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
Time Frame: Throughout the entire study, during approximately 22 months

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.
Throughout the entire study, during approximately 22 months
Prediction of clinical status at 6 and 12 months by baseline emotional recognition and reactivity
Time Frame: Throughout the entire study, during approximately 22 months

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).
Throughout the entire study, during approximately 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fonds Spécial de Recherche (FSR), UCLouvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B4032025000122
  • 2025/11DEC/520 (Other Identifier: Comité d'éthique hospitalo-facultaire Saint-Luc - UCLouvain)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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