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Completed

NCT Number: NCT02881983

Study of Mechanisms of Emotion Regulation in 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).

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Lille, Fontan2, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

Primary outcomes

  1. Heart Rate Variability

    Time frame: 3 years

    High measuring heart rate

Secondary outcomes

  1. Electrodermal response

    Time frame: 3 years

    skin conductance

  2. pupil diameter

    Time frame: 3 years

    pupil diameter

  3. HAD score

    Time frame: 3 years

    Score at the Hospital Anxiety & Depression Scale

  4. MocA assessment

    Time frame: 3 years

    Montréal cognitive Assessement score

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: REAL

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2016
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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