Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients

Alcohol Use Disorder Clinical Trial

— REAL  

Official title:

Study of Mechanisms of Emotion Regulation in Short- and Long-term Alcohol-abstinent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881983
• Other study ID #: 2013_31
• Secondary ID: 2014-A00105-42
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: August 24, 2017
• Start date: April 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder

Intervention

Other:
• the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Locations

Country	Name	City	State
France	CHRU Lille, Fontan2	Lille
France	CSAPA	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	High measuring heart rate	3 years
Secondary	Electrodermal response	skin conductance	3 years
Secondary	pupil diameter	pupil diameter	3 years
Secondary	HAD score	Score at the Hospital Anxiety & Depression Scale	3 years
Secondary	MocA assessment	Montréal cognitive Assessement score	3 years