Mindfulness and Cognition in Schizophrenia

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03318640

Enrollment

Registered

2017-10-24

Start date

2018-09-11

Completion date

2021-07-12

Last updated

2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, mindfulness, parasympathetic system

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).

Interventions

BEHAVIORALMindfulness

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Comparison between treated group or not

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
High Frequency spectral power	2 months	High Frequency spectral power

Secondary

Measure	Time frame	Description
Score	2 months	Score of PANSS (POSITIVE AND NEGATIVE SYNDROME SCALE)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026