Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder Using Eye-tracking, Physiological, and Interoceptive Measures (ERAD) (ERAD)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Edelweiss Touron, PhD
- 電話番号：+32470052024
- メール：edelweiss.touron@uclouvain.be
研究連絡先のバックアップ
- 名前：Pierre Maurage, PhD
- 電話番号：+3210474804
- メール：pierre.maurage@uclouvain.be
研究場所
-
-
Belgium
-
Brussels、Belgium、ベルギー、1200
- 募集
- Cliniques Universitaires Saint-Luc
-
コンタクト：
- Philippe De Timary, PhD
- 電話番号：+3227642160
- メール：philippe.detimary@uclouvain.be
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
severe Alcohol Use Disorder (sAUD)
|
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)
|
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)
|
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)
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Multidimensional assessment of emotional recognition and emotional reactivity to dynamic emotional stimuli
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Relationships between emotional recognition and emotional reactivity (self-reported, behavioral and physiological)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- B4032025000122
- 2025/11DEC/520 (その他の識別子：Comité d'éthique hospitalo-facultaire Saint-Luc - UCLouvain)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。