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Mindfulness and Cognition in Schizophrenia

NCT ID: NCT03318640

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2021-07-12

Brief Summary

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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).

Detailed Description

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Conditions

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Schizophrenia

Keywords

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schizophrenia mindfulness parasympathetic system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison between treated group or not
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mindfulness

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

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

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

Control

Patient will have usual medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fondation de l'Avenir

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne GROSSELIN

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02921-52

Identifier Type: OTHER

Identifier Source: secondary_id

1708181

Identifier Type: -

Identifier Source: org_study_id