ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness and Cognition in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03318640
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
Mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. In schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, HF) system. The investigator propose a session of Mindfulness Based Stress Reduction (MBSR) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (HF), self-awareness (being well in one's body and being aware of their own actions; EASE) and cognition (attention) in relation to the management of conflicts or emotions. The study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, Michael's Game and Tom Remed).

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Mindfulness Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison between treated group or not
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia
Estimated Study Start Date : June 2, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Mindfulness
Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month.
Behavioral: Mindfulness
Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month

No Intervention: Control
Patient will have usual medical care.



Primary Outcome Measures :
  1. High Frequency spectral power [ Time Frame: 2 months ]
    High Frequency spectral power


Secondary Outcome Measures :
  1. Score [ Time Frame: 2 months ]
    Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE)

  2. Score [ Time Frame: 2 months ]
    The five facet questionnaire Mindfulness Questionary Freiburg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia (men only)
  • aged 18-55
  • with no change in antipsychotic medication and clinical status within four weeks prior to the study
  • affiliates or entitled to a social security scheme
  • who have given their informed consent before participating in the study.

Exclusion Criteria:

  • History of head trauma, neurological disease or not stabilized serious physical illness
  • Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months
  • Beta blocking and anti-arrhythmic medications.

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): NCT03318640


Contacts
Contact: Beatrice DEYGAS 0477127655 beatrice.deygas@chu-st-etienne.fr
Contact: Anne GROSSELIN 0477127743 ext 33 anne.grosselin@chu-st-etienne.fr

Locations
France
CHU Saint Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Anne GROSSELIN       anne.grosselin@chu-st-etienne.fr   
Principal Investigator: Anne GROSSELIN         
Sub-Investigator: Catherine MASSOUBRE         
Sub-Investigator: Romain POMMIER         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Fondation de l'Avenir
Investigators
Principal Investigator: Anne GROSSELIN CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03318640     History of Changes
Other Study ID Numbers: 1708181
2017-A02921-52 ( Other Identifier: ANSM )
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
schizophrenia
mindfulness
parasympathetic system

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