Mindfulness and Cognition in Schizophrenia

December 12, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • CHU Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Frequency spectral power
Time Frame: 2 months
High Frequency spectral power
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score
Time Frame: 2 months
Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE)
2 months
Score
Time Frame: 2 months
The five facet questionnaire Mindfulness Questionary Freiburg
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Fondation de l'Avenir

Investigators

  • Principal Investigator: Anne GROSSELIN, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2018

Primary Completion (Actual)

May 3, 2021

Study Completion (Actual)

July 12, 2021

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1708181
  • 2017-A02921-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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