Schizophrenia Clinical Trial
Official title:
Effect of Mindfulness (MBSR) on the Parasympathetic System and Cognition in Schizophrenia
Verified date | December 2023 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 34 |
Est. completion date | July 12, 2021 |
Est. primary completion date | May 3, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Saint Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Fondation de l'Avenir |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | High Frequency spectral power | High Frequency spectral power | 2 months | |
Secondary | Score | Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE) | 2 months | |
Secondary | Score | The five facet questionnaire Mindfulness Questionary Freiburg | 2 months |
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