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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Lille, França, 59037
- CSAPA
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Lille, França
- CHRU Lille, Fontan2
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
- 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)
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Grupo de controle
Sujeitos saudáveis
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STA group
Short-term alcohol abstinent patients (after 1 month of withdrawal)
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|
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LTA group
Long-term alcohol abstinent patients (at least 6 months of abstinence)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Heart Rate Variability
Prazo: 3 years
|
High measuring heart rate
|
3 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Electrodermal response
Prazo: 3 years
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skin conductance
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3 years
|
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pupil diameter
Prazo: 3 years
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pupil diameter
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3 years
|
|
HAD score
Prazo: 3 years
|
Score at the Hospital Anxiety & Depression Scale
|
3 years
|
|
MocA assessment
Prazo: 3 years
|
Montréal cognitive Assessement score
|
3 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Olivier COTTENCIN, MD, PhD, University Hospital, Lille
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2013_31
- 2014-A00105-42 (Outro identificador: ID-RCB number, ANSM)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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