How Reducing Anxiety in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
emotion focused therapy training
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- diagnosis of remitted schizophrenia
Exclusion Criteria:
- exacerbation of schizophrenic symptoms over the previous three months (hospitalization or increases in medication)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
emotion focused therapy training CCT
Arm Description
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
Outcomes
Primary Outcome Measures
psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)
outcomes assessed before and after the 3-month Cardiac Coherence Training
Secondary Outcome Measures
psychometric outcome: Freiburg Mindfulness Inventory (FMI)
outcomes assessed before and after the 3-month Cardiac Coherence Training
Full Information
NCT ID
NCT02390271
First Posted
March 4, 2015
Last Updated
March 10, 2015
Sponsor
Institut de Recherche Biomedicale des Armees
1. Study Identification
Unique Protocol Identification Number
NCT02390271
Brief Title
How Reducing Anxiety in Schizophrenia
Official Title
Cardiac Coherence Training to Reduce Anxiety in Remitted Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche Biomedicale des Armees
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
emotion focused therapy training CCT
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
emotion focused therapy training
Other Intervention Name(s)
Cardiac Coherence Training
Intervention Description
The Cardiac Coherence Training (CCT) incorporates a series of emotion-refocusing and restructuring techniques involving the use of biofeedback to control heart rate variability
Primary Outcome Measure Information:
Title
psychometric outcome: Spielberger State Anxiety Inventory (S-STAI)
Description
outcomes assessed before and after the 3-month Cardiac Coherence Training
Time Frame
up to two months
Secondary Outcome Measure Information:
Title
psychometric outcome: Freiburg Mindfulness Inventory (FMI)
Description
outcomes assessed before and after the 3-month Cardiac Coherence Training
Time Frame
up to two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of remitted schizophrenia
Exclusion Criteria:
exacerbation of schizophrenic symptoms over the previous three months (hospitalization or increases in medication)
12. IPD Sharing Statement
Learn more about this trial
How Reducing Anxiety in Schizophrenia
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