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How Reducing Anxiety in Schizophrenia

Cardiac Coherence Training to Reduce Anxiety in Remitted Schizophrenia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02390271
Enrollment
10
Registered
2015-03-17
Start date
2010-06-30
Completion date
2011-06-30
Last updated
2015-03-17

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

Conditions

Schizophrenia

Brief summary

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.

Detailed description

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).

Interventions

OTHERemotion focused therapy training

The Cardiac Coherence Training (CCT) incorporates a series of emotion-refocusing and restructuring techniques involving the use of biofeedback to control heart rate variability

Sponsors

Institut de Recherche Biomedicale des Armees
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of remitted schizophrenia

Exclusion criteria

* exacerbation of schizophrenic symptoms over the previous three months (hospitalization or increases in medication)

Design outcomes

Primary

MeasureTime frameDescription
psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)up to two monthsoutcomes assessed before and after the 3-month Cardiac Coherence Training

Secondary

MeasureTime frameDescription
psychometric outcome: Freiburg Mindfulness Inventory (FMI)up to two monthsoutcomes assessed before and after the 3-month Cardiac Coherence Training

Outcome results

None listed

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