REF-BIP: Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05922956

Collaborator

Centre Hospitalier le Vinatier (Other), Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise (Other), Centre de santé mentale MGEN (Other), Centre Hospitalier Philippe Pinel, Amiens (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The facial emotion recognition is a basic social skill for successful social interactions. Several meta-analyses and recent studies found impairments of the perception of facial emotions in patients with euthymic bipolar disorder. Few studies compared recognition of facial emotions impairments during euthymia in patients with bipolar disorder type 1 and 2. These studies included low population samples (N<60). There were discrepancies in results of these studies. Szanto suggested that facial emotion recognition impairments were correlated with suicidal risk and social isolation. These impairments should be taking into account regarding psycho-social treatments in patients with bipolar disorder.

This study aims to evaluate facial emotion recognition in patients with bipolar I and II disorders compared to healthy controls, using the facial emotion recognition test (TREF). The objective of the present study is to compare TREF scores in a group of patients with bipolar 1, a group of patients with bipolar 2 disorder and a group with healthy controls. In addition, the investigators will investigate the relationships between TREF scores and levels of self-esteem and mental well-being.

Condition or Disease	Intervention/Treatment	Phase
Social Cognition Facial Emotion Recognition Facial Affect Bipolar Disorder I and II	Other: Facial emotion recognition test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with bipolar disorder 1	Other: Facial emotion recognition test Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires
Experimental: patients with bipolar disorder 2	Other: Facial emotion recognition test Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires
Active Comparator: healthy controls	Other: Facial emotion recognition test Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires

Arm

Intervention/Treatment

Experimental: patients with bipolar disorder 1

Other: Facial emotion recognition test

Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires

Experimental: patients with bipolar disorder 2

Other: Facial emotion recognition test

Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires

Active Comparator: healthy controls

Other: Facial emotion recognition test

Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires

Outcome Measures

Primary Outcome Measures

variation of TREF scores in tree groups of subjects [16 months]
TREF scores in tree groups of subjects (group of patients with bipolar disorder 1, group of patients with bipolar disorder 2 and group of healthy controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient group :
Male or female patients, between 18 and 60 years old
Diagnosis of Bipolar Disorder I or Bipolar Disorder II according to DSM-IV criteria, using the French version of the Mini-International Neuropsychiatric Interview (MINI)
Strictly euthymic defined by Hamilton Depression Rating Scale (17 items) ≤ 5 and Young Mania Rating Scale ≤ 5 for at least two months.
Native French speakers
Affiliated to the French social security system
Giving their written informed consent

Control group :

Male or female control subjects, aged between 18 and 60 years old, assessed using TREF
Native French speakers
Giving their written informed consent

Exclusion Criteria:

Patient group :
History of mental retardation assessed by the French version of the National Adult Reading Test
Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.)
Electroconvulsive therapy within the last 6 months
Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI).
Learning disability or difficulty with fluent use of the French language
Patient with mandatory care
Long-Term use of non-psychotropic medication with psychotropic effects (opiates, Baclofen)

Control group :

History of mental retardation estimated by the French version of the National Adult Reading Test
Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.)
Current Mood disorder/ Lifetime Psychotic Disorder according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI)
Neither history of psychotic or affective disorders in a first-degree family member
Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI)
Learning disability or difficulty with fluent use of the French language
Long-Term use of non-psychotropic drugs with psychotropic effects (opiates, Baclofen) and psychotropic drugs