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How Reducing Anxiety in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
emotion focused therapy training
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 4, 2015
    Last Updated
    March 10, 2015
    Sponsor
    Institut de Recherche Biomedicale des Armees
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    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

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