Mindfulness and Cognition in Schizophrenia

NCT03318640 | Terminated

• 2 other identifiers: 17081812017-A02921-52
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Keywords

schizophrenia; mindfulness; parasympathetic system

Outcome Measures

Primary Outcomes (1)

• High Frequency spectral power

  High Frequency spectral power

  2 months

Secondary Outcomes (2)

• Score

  2 months

• Score

  2 months

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness

Control

NO INTERVENTION

Patient will have usual medical care.

Interventions

Mindfulness BEHAVIORAL

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

Mindfulness

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

CHU Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne GROSSELIN

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between treated group or not

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: September 11, 2018
• Primary Completion: May 3, 2021
• Study Completion: July 12, 2021
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)