Schizophrenia Clinical Trial
Official title:
Cardiac Coherence Training to Reduce Anxiety in Remitted Schizophrenia
Introduction: Health care that addresses the emotional regulation capacity of patients with
schizophrenia confronted with daily stress may contribute to a less anxious life. A
psycho-physiological training (cardiac coherence training; CCT) focusing on emotion
regulation is known to decrease anxiety for non-clinical individuals.
Methods: the investigators performed a pilot cross sectional survey to explore the benefits
of CCT for clinically stable patients with schizophrenia. Ten patients were enrolled in the
program consisting in height to twelve weekly one hour session program during a 2-month
follow-up. Standardised questionnaires were used before and after the intervention assessing
anxiety, well-being outcomes, and how patients deal with stress and stressors.
Ten subjects, five women and five men, all volunteers, were included in the study. The
patients were all clients of the rehabilitation center for psychotic disorders (Le Vinatier
hospital) situated in Lyon, France. Criteria for entry into the study included: a Diagnostic
and Statistical Manual of Mental Disorder-4 diagnosis of schizophrenia as confirmed by the
Mini International Neuropsychiatric Interview for DSM-IV (MINI); age between 18 and 65;
being clinically stable (i.e. not having required hospitalization or increases in medication
as a result of an exacerbation of acute symptoms over the previous three months.
All subjects completed a set of "paper and pencil" standardized assessments at
pre-intervention and immediately after the end of the intervention.
Trait and State anxiety was assessed using the French version of the Spielberger
State-Trait-Anxiety Inventory (S-STAI).
Three questionnaires were used in order to evaluate the outcomes quality of life of
patients. 1/ The Positive And Negative Syndrome Scale (PANSS); 2/ Patient's body/mind
perceptions were assessed using mindfulness concept (Freiburg Mindfulness Inventory, FMI),
and 3/ Patients' quality of life was evaluated using the Warwick-Edinburgh Mental Well-Being
Scale (WEMWBS).
One questionnaire was used to assess how patients deal with stress and stressors (the
Derogatis Stress Profile, DSP).
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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