Clinical Trials Directory

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CompletedNCT02881983

Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients

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

Status
Completed
Phase
Study type
Observational
Enrollment
112 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERthe presentation of pictures (static stimuli) or videos (dynamic stimuli)

Timeline

Start date
2014-04-01
Primary completion
2017-04-01
Completion
2017-04-01
First posted
2016-08-29
Last updated
2017-08-25

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02881983. Inclusion in this directory is not an endorsement.