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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Lille, Frankrig, 59037
- CSAPA
-
Lille, Frankrig
- CHRU Lille, Fontan2
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
- 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)
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Kontrolgruppe
Sunde emner
|
|
|
STA group
Short-term alcohol abstinent patients (after 1 month of withdrawal)
|
|
|
LTA group
Long-term alcohol abstinent patients (at least 6 months of abstinence)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart Rate Variability
Tidsramme: 3 years
|
High measuring heart rate
|
3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Electrodermal response
Tidsramme: 3 years
|
skin conductance
|
3 years
|
|
pupil diameter
Tidsramme: 3 years
|
pupil diameter
|
3 years
|
|
HAD score
Tidsramme: 3 years
|
Score at the Hospital Anxiety & Depression Scale
|
3 years
|
|
MocA assessment
Tidsramme: 3 years
|
Montréal cognitive Assessement score
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Olivier COTTENCIN, MD, PhD, University Hospital, Lille
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013_31
- 2014-A00105-42 (Anden identifikator: ID-RCB number, ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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