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Evaluation of Stroop Effect in Patients With Schizophrenia (STROOP)

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ClinicalTrials.gov Identifier: NCT03163706
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Université d'Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
The main objective of this study is to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Modified Stroop effect Not Applicable

Detailed Description:

First, participants will receive six categories of stimuli presented in a classical way: (1) incongruous stimulus classical (BLUE written in green for example); (2) associated incongruous stimuli (SKY written in green for example); (3) conventional congruent stimuli (BLUE written in blue for example); (4) associated congruent stimuli (SKY written in blue for example); (5) neutral words (BRIDGE written in green for example); And (6) neutral stimulus (XXXX written in green for example).

In a second step (after a 5 minute break), they will receive these six categories of stimuli, but only half will be presented in a classic way and the other half will be presented in order to attract attention as in Augustinova and Ferrand 2007). To do this, in (1) incongruous stimuli classical like BLUE, a single letter (like B for example) will be colored in green for example and the rest of the word (LUE) will appear in gray); In (2) incongruous stimuli associated as SKY, only K for example will be green and the rest of the word will appear in gray); In (3) conventional congruent stimuli such as BLUE, only B for example will be written in blue and the rest of the word will appear in gray); In (4) associated congruent stimuli such as SKY only K for example will be written in blue and the rest of the word will appear in gray); In (5) neutral words like BRIDGE, only D will be colored in green for example and the rest of the word will appear in gray; And finally, in (6) neutral stimuli like XXXX, only one X will be colored in green for example and the rest of the X will appear in gray.

The task will be to name the color of each word (by stating the color verbally) as quickly and correctly as possible, while ignoring the written word. In this experiment, we will measure the time taken to denominate the color (in milliseconds) as well as the percentages of incorrect answers.

The first step allows to determine the stroop effect and the second the semantic conflict.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Other
Official Title: Evaluation of Stroop Effect in Patients With Schizophrenia
Actual Study Start Date : September 21, 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Schizophrenia patients
Patients with DSM-5 criteria of schizophrenia
Behavioral: Modified Stroop effect
to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).

Control group
Control, no schizophrenia
Behavioral: Modified Stroop effect
to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).




Primary Outcome Measures :
  1. Semantic conflict in stroop test [ Time Frame: at day 1 ]
    The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. By comparing the stroop effect and the semantic conflict between patients and controls, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).


Secondary Outcome Measures :
  1. Response conflict in stroop test [ Time Frame: at day 1 ]

    The stroop effect consists of the semantic and the response conflict. In patients with schizophrenia, the stroop effect is longer than in controls. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol).

    Therefore, we can determine whether the slowing observed in patients is due to a general slowdown (semantic and response conflict) or specific slowness (semantic or response conflict).




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For both:

  • MMSE score greater than or equal to, 22 if no grade ; 23 if study certificate or CAP or college without patent ; 25 if patent or school without the tray ; 26 or more when bin
  • IQ ≥ 75 (fNART)
  • Lextale score ≥ 28
  • Age: between 18 and 45 years

For patients :

  • DSM-5 criteria of schizophrenia
  • Patients followed as outpatients,
  • Age of onset of the disease less than 40 years,
  • Patients whose disease has stabilized: no changes psychotropic treatment for at least 1 month
  • Not more of a benzodiazepine,
  • Patients on protection of justice or not,

For controls :

  • Matched for sex to patient
  • Age-matched (+/- 3 years) to patient
  • Matched for IQ (score fNART +/- 10% to patients
  • Matched for Lextale score+/- 10% to patients

Exclusion Criteria:

For patients :

  • Any other comorbid psychiatric diagnosis of Axis I DSM-5
  • Extrapyramidal syndrome or tardive dyskinesia (AIMS score <2 BARS score <2 and score Simpson and Angus <3)
  • Calgary depression scale ≥ 6
  • Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
  • Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
  • Use of alcohol or cannabis before the age of 15 years
  • Alcohol abuse in the past 6 months.
  • Cannabis abuse in the past 6 months and cannabis use in the last 3 months.
  • Patients with impaired vision or hearing preventing the realization of the tests.

For controls:

  • Any psychiatric diagnosis according to DSM-5, including addictions (excluding tobacco)
  • Score HADS Anxiety ≥ 8 and Depression ≥ 8
  • SCL90R: global severity score GSI> 0.33 for women and> 0.27 for men, or score diversity PST symptoms> 18.49 for men and> 21.97 for women or score of degree of discomfort PSDI> 1.27 for men and> 1.3 for women, scoring in the subscale Psychotic Features> 0.
  • Presence of a personality disorder at PDQ4 +
  • Head injuries, brain injuries or diseases,
  • vision or hearing problems preventing the realization of the tests.
  • Current or past addiction to all toxic substances (including alcohol and cannabis) except tobacco.
  • Current or past use of all toxic consumption (excluding alcohol, tobacco and cannabis).
  • Long-term Anticholinergic treatment.
  • Related to the first degree diagnosed with a psychotic disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163706


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
Contact: Isabelle JALENQUES 04 73 75 48 78 ijalenques@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Contact: Isabelle JALENQUES    04 73 75 48 78    ijalenques@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Université d'Auvergne

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03163706     History of Changes
Other Study ID Numbers: CHU-330
2014-A00957-40 ( Other Identifier: 2014-A00957-40 )
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Schizophrenia
Stroop effect
Semantic conflict
Response conflict

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders