PROEMO_BP: Emotional Proactive Processing in Bipolar Disorder

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04561622
Collaborator
(none)
60
1
24
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Emotional Proactive Processing in Bipolar Disorder
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. performances at the emotional Stroop task [day1]

      percentage of correct answers ( in %), reaction time ( in seconds) and inverse efficiency score ( N.A)

    Secondary Outcome Measures

    1. sensitivity to interference during Stroop tasks [day1]

      -reaction time (in seconds) in the different conditions of the task (reading in the congruent condition, interference during the incongruent condition)

    2. Effect of mood state (depressive state) on behavioral tasks' performances [day 1]

      assessment of the impact of mood scales (MADRS) scores on behavioral tasks performances

    3. Effect of mood state (hypo/manic state) on behavioral tasks' performances [day 1]

      assessment of the impact of mood scales (YMRS) scores on behavioral tasks performances

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Grenoble Alpes La Tronche Isère France 38 700

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT04561622
    Other Study ID Numbers:
    • 38RC19.387
    • 2019-A03026-51
    First Posted:
    Sep 23, 2020
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Grenoble
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022