Emotional Proactive Processing in Bipolar Disorder

Bipolar Disorder Clinical Trial

— PROEMO_BP  

Official title:

Emotional Proactive Processing in Bipolar Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04561622
• Other study ID #: 38RC19.387
• Secondary ID: 2019-A03026-51
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	La Tronche	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Golden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performances at the emotional Stroop task	percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)	day1
Secondary	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
Secondary	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
Secondary	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