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).

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Other: the presentation of pictures (static stimuli) or videos (dynamic stimuli)

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • CSAPA
  • Lille, France
    • CHRU Lille, Fontan2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	High measuring heart rate	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrodermal response	skin conductance	3 years
pupil diameter	pupil diameter	3 years
HAD score	Score at the Hospital Anxiety & Depression Scale	3 years
MocA assessment	Montréal cognitive Assessement score	3 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Olivier COTTENCIN, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: emotion processing; alcohol use disorder; abstinence; sympathetic system; parasympathetic system
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: 2013_31; 2014-A00105-42 (Other Identifier: ID-RCB number, ANSM)

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