Mindfulness and Cognition in Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring schizophrenia, mindfulness, parasympathetic system
Eligibility 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.
Sites / Locations
- CHU Saint EtienneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness
Control
Arm Description
Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month.
Patient will have usual medical care.
Outcomes
Primary Outcome Measures
High Frequency spectral power
High Frequency spectral power
Secondary Outcome Measures
Score
Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE)
Score
The five facet questionnaire Mindfulness Questionary Freiburg
Full Information
NCT ID
NCT03318640
First Posted
October 19, 2017
Last Updated
January 15, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Fondation de l'Avenir
1. Study Identification
Unique Protocol Identification Number
NCT03318640
Brief Title
Mindfulness and Cognition in Schizophrenia
Official Title
Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Fondation de l'Avenir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, mindfulness, parasympathetic system
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison between treated group or not
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient will have usual medical care.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month
Primary Outcome Measure Information:
Title
High Frequency spectral power
Description
High Frequency spectral power
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Score
Description
Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE)
Time Frame
2 months
Title
Score
Description
The five facet questionnaire Mindfulness Questionary Freiburg
Time Frame
2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice DEYGAS
Phone
0477127655
Email
beatrice.deygas@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne GROSSELIN
Phone
0477127743
Ext
33
Email
anne.grosselin@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne GROSSELIN
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne GROSSELIN
Email
anne.grosselin@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Anne GROSSELIN, MD
First Name & Middle Initial & Last Name & Degree
Catherine MASSOUBRE, MD PhD
First Name & Middle Initial & Last Name & Degree
Tania FERRAGUT, MD
First Name & Middle Initial & Last Name & Degree
Amandine BORDRON, MD
First Name & Middle Initial & Last Name & Degree
Marie-Christine OUVRY, MD
First Name & Middle Initial & Last Name & Degree
Nathalie VIALLON, MD
First Name & Middle Initial & Last Name & Degree
Stéphane BOYER, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness and Cognition in Schizophrenia
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