Emotional Proactive Processing in Bipolar Disorder (PROEMO_BP)

The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

Study Overview

• Status: Active, not recruiting
• Conditions: Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder
• Intervention / Treatment: Behavioral: Emotional Stroop Task

Detailed Description

This is a case-control non-interventional study comparing bipolar patients to matched healthy controls during one assessment visit at the University Hospital of Grenoble.

The experimentation phase takes place in three stages: first, the experimenter collects demographic data (age and level of study, lack of medical history and treatments that may interfere with the task). For bipolar subjects, it also collects the type of bipolarity, the type and date of the last episode, the age of the onset of the disease and the treatment.

Secondly, the subject performs a classic Stroop task lasting 3 to 5 minutes, including instructions.

Finally, the subject performs the two main tasks: the emotional Stroop task lasting about 20 minutes and then the task of emotional stimuli categorization lasting about 15 minutes.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Isère
    • La Tronche, Isère, France, 38 700
      • CHU Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

bipolar patients cohort followed-up in the Expert Center of University Hospital of Grenoble

Description

Inclusion Criteria:

• Right-handed
• Francophones
• Bipolar disorder diagnosis (for patients) according to DSM-5 / CIM-10 criteria
• Affiliation to the French social security insurance

Exclusion Criteria:

• uncorrected perceptual disturbance
• psychiatric disorders other than bipolarity as the main psychiatric disorder or a condition which may affect the tasks proposed for the patients' group
• subject under legal protection
• subject deprived of freedoms by a judicial or administrative decision
• drug abuse less than 12 hours before the assessment

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bipolar patients; Bipolar patients (type I,II, NOS) of the bipolar disorder expert center of CHU Grenoble Alpes.	Behavioral: Emotional Stroop Task; Classic Stroop task The subject names one of the 3 colors of the crosses on a sheet.Then, the subject must read the words written on the sheet for 45 seconds.These are the words: RED, BLUE and GREEN, written in black color. The subject must name the color of the word. Emotional Stroop task This is a computed task in which the patient is asked to answer both as accurately and as quickly as possible. The target stimulus is an emotional face of joy or anger, surmounted by the word "joy" or "anger".The subject must respond using the arrow corresponding to the face he sees. A training phase is offered to the subject. 3 / Categorization task For each trial the participant will visualize a short emotional film or not. Then, the participant will have to choose, the emotion corresponding to what he just saw. A training period is offered too.; Other Names: Classic Stroop Task; Categorization of Emotional Stimuli Task
Healthy controls; Volunteers without any psychiatric disease matching inclusion criteria	Behavioral: Emotional Stroop Task; Classic Stroop task The subject names one of the 3 colors of the crosses on a sheet.Then, the subject must read the words written on the sheet for 45 seconds.These are the words: RED, BLUE and GREEN, written in black color. The subject must name the color of the word. Emotional Stroop task This is a computed task in which the patient is asked to answer both as accurately and as quickly as possible. The target stimulus is an emotional face of joy or anger, surmounted by the word "joy" or "anger".The subject must respond using the arrow corresponding to the face he sees. A training phase is offered to the subject. 3 / Categorization task For each trial the participant will visualize a short emotional film or not. Then, the participant will have to choose, the emotion corresponding to what he just saw. A training period is offered too.; Other Names: Classic Stroop Task; Categorization of Emotional Stimuli Task

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
performances at the emotional Stroop task	percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)	day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity to interference during Stroop tasks	-reaction time (in seconds) in the different conditions of the task (reading in the congruent condition, interference during the incongruent condition)	day1
Effect of mood state (depressive state) on behavioral tasks' performances	assessment of the impact of mood scales (MADRS) scores on behavioral tasks performances	day 1
Effect of mood state (hypo/manic state) on behavioral tasks' performances	assessment of the impact of mood scales (YMRS) scores on behavioral tasks performances	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Mircea Polosan, MD, PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Beffara B, Wicker B, Vermeulen N, Ouellet M, Bret A, Molina MJ, Mermillod M. Reduction of interference effect by low spatial frequency information priming in an emotional Stroop task. J Vis. 2015;15(6):16. doi: 10.1167/15.6.16.
• Golden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cognition; bipolar disorder; emotion; stroop; proactive emotional processing
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder
• Other Study ID Numbers: 38RC19.387; 2019-A03026-51 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If the patient accepts all the characteristics useful for the study will be available in our results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No