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Clinical Trials/NCT03318640
NCT03318640TerminatedNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country34 target enrollmentStarted: September 11, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
34
Locations
1
Primary Endpoint
High Frequency spectral power

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Mindfulness

Experimental

Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month.

Intervention: Mindfulness (Behavioral)

Control

No Intervention

Patient will have usual medical care.

Outcomes

Primary Outcomes

High Frequency spectral power

Time Frame: 2 months

High Frequency spectral power

Secondary Outcomes

  • Score(2 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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