How Reducing Anxiety in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cardiac Coherence Training to Reduce Anxiety in Remitted Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390271
• Other study ID #: m trousselard
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2015
• Last updated: March 10, 2015
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2015
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosis of remitted schizophrenia

Exclusion Criteria:

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• emotion 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)	outcomes assessed before and after the 3-month Cardiac Coherence Training	up to two months	Yes
Secondary	psychometric outcome: Freiburg Mindfulness Inventory (FMI)	outcomes assessed before and after the 3-month Cardiac Coherence Training	up to two months	Yes