Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients (REAL)
Study of Mechanisms of Emotion Regulation in Short- and Long-term Alcohol-abstinent Patients
Background:
Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol.
Main aim:
Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD.
Secondary objectives:
Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The recording was performed for all participants during presentation of high emotional inducing stimuli presenting human interactions (pictures and video sequences). For each participant physiological responses (pupil diameter, heart rate, and skin conductance) were recorded before, during and after induction.
Participants were asked to evaluate the intensity and the valence of emotional stimuli.
In addition, a neurological evaluation, a clinical and cognitive assessment were performed.
Neurological, clinical and cognitive evaluation - Each participant had a clinical structured interview, a neurological evaluation, self-administered assessment (Hospital Anxiety & Depression Scale, Emotional Skills Profile, Obsessive Compulsive Drinking Scale, and cognitive assessment (Montreal Cognitive Assessment).
Physiological assessment - The recording was performed for all participants during the presentation of pictures (static stimuli) or videos (dynamic stimuli) selected according to their high emotional intensity (positive, neutral and negative valence), representing human interactions. For each participant heart rate, electrodermal activity, and pupil diameter were recorded during three experimental conditions: rest, induction (presentation of stimuli) and after induction (recovery). Participants were asked to evaluate the intensity and valence of the pictures and videos using the Self-Assessment Manikin.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Lille, Frankreich, 59037
- CSAPA
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Lille, Frankreich
- CHRU Lille, Fontan2
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
- Short term alcohol abstinent patients (STA, after 1month of withdrawal)
- Long-term alcohol abstinent individuals (at least six months of abstinence)
- Healthy control participants (C)
Beschreibung
Inclusion Criteria:
For STA and LTA groups :
- a diagnosis of severe alcohol use disorder (DSM5 criteria, 2013 confirmed by an addictonologist and a psychologist),
- successful completion of withdrawal,
- an intended treatment length of at least 1 month (for the STA group) or at least 6 months (for the LTA group).
For Control participants (C) :
- social drinkers, and were recruited from the general population (e.g. at the university).
Exclusion Criteria:
- with delusional psychiatric disorders (and/or medication for psychiatric disorders (excepted anxiolytics),
- neurological or cardiological disorders,
- taking medication that may act on heart rate or alter the regulation of body temperature or cognitive functions,
- with active co-dependence (except for tobacco)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Kontrollgruppe
Gesunde Themen
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STA group
Short-term alcohol abstinent patients (after 1 month of withdrawal)
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LTA group
Long-term alcohol abstinent patients (at least 6 months of abstinence)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Heart Rate Variability
Zeitfenster: 3 years
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High measuring heart rate
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3 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Electrodermal response
Zeitfenster: 3 years
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skin conductance
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3 years
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pupil diameter
Zeitfenster: 3 years
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pupil diameter
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3 years
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HAD score
Zeitfenster: 3 years
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Score at the Hospital Anxiety & Depression Scale
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3 years
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MocA assessment
Zeitfenster: 3 years
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Montréal cognitive Assessement score
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3 years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Olivier COTTENCIN, MD, PhD, University Hospital, Lille
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2013_31
- 2014-A00105-42 (Andere Kennung: ID-RCB number, ANSM)
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