How Reducing Anxiety in Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Other: emotion focused therapy training

• Registration Number: NCT02390271
• Lead Sponsor: Institut de Recherche Biomedicale des Armees

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).

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-09
• Study Completion: 2011-06
• Status Verified: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Study First Posted: 2015-03-17
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• diagnosis of remitted schizophrenia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
emotion focused therapy training CCT	emotion focused therapy training	The general training includes in an individual adjusted way the following techniques: biofeedback-assisted breathing classes that erase negative emotion involving the cardiac and limbic neural pathways, control one's own and other's emotions, mastering positive cognition and enhance self-concept, anchoring positive memories, learning how to recognize psychological reversal in others

Primary Outcome Measures

Name	Time	Method
psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)	up to two months	outcomes assessed before and after the 3-month Cardiac Coherence Training

Secondary Outcome Measures

Name	Time	Method
psychometric outcome: Freiburg Mindfulness Inventory (FMI)	up to two months	outcomes assessed before and after the 3-month Cardiac Coherence Training