Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)

• Registration Number: NCT02881983
• Lead Sponsor: University Hospital, Lille

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-29
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LTA group	the presentation of pictures (static stimuli) or videos (dynamic stimuli)	Long-term alcohol abstinent patients (at least 6 months of abstinence)
Control group	the presentation of pictures (static stimuli) or videos (dynamic stimuli)	Healthy subjects
STA group	the presentation of pictures (static stimuli) or videos (dynamic stimuli)	Short-term alcohol abstinent patients (after 1 month of withdrawal)

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	3 years	High measuring heart rate

Secondary Outcome Measures

Name	Time	Method
Electrodermal response	3 years	skin conductance
pupil diameter	3 years	pupil diameter
MocA assessment	3 years	Montréal cognitive Assessement score
HAD score	3 years	Score at the Hospital Anxiety \& Depression Scale

Trial Locations

Locations (2)

CSAPA; 🇫🇷 Lille, France

CHRU Lille, Fontan2; 🇫🇷 Lille, France