Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients

NCT ID: NCT02881983

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-04-30

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.

Conditions

Alcohol Use Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

STA group

Short-term alcohol abstinent patients (after 1 month of withdrawal)

the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Intervention Type: OTHER

LTA group

Long-term alcohol abstinent patients (at least 6 months of abstinence)

the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Intervention Type: OTHER

Control group

Healthy subjects

the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Intervention Type: OTHER

Interventions

the presentation of pictures (static stimuli) or videos (dynamic stimuli)

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier COTTENCIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CSAPA

Lille, , France

CHRU Lille, Fontan2

Lille, , France

Countries

France

Other Identifiers

2014-A00105-42

Identifier Type: OTHER

Identifier Source: secondary_id

2013_31

Identifier Type: -

Identifier Source: org_study_id